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‘No Hint of Benefit’ in Large Colchicine Trial

Article Type
Changed
Fri, 11/15/2024 - 13:46

Colchicine does not protect against major cardiovascular adverse events after an acute myocardial infarction, according to a multinational placebo-controlled trial of more than 7000 patients.

The CLEAR SYNERGY (OASIS 9) study, called “the largest trial ever of colchicine in acute MI,” showed no hint of benefit in an adverse event curve for colchicine relative to placebo over 5 years, which suggests that the role of this drug after myocardial infarction (MI) “is uncertain,” Sanjit Jolly, MD, an interventional cardiologist at Hamilton Health Sciences and a professor of medicine at McMaster University in Hamilton, Ontario, Canada, reported at Transcatheter Cardiovascular Therapeutics (TCT) 2024.

For the primary composite outcome — cardiovascular death, MI, stroke, and ischemia-driven revascularization — the event curves in the colchicine and placebo groups remained essentially superimposed over 5 years of follow-up, with only a slight separation after 4 years. The hazard ratio for the primary endpoint showed a 1% difference in favor of colchicine (hazard ratio [HR], 0.99; P = .93).

There were no meaningful differences in any of the individual endpoint components; all 95% CIs straddled the line of unity. Rates of cardiovascular death (3.3% vs 3.2%) and stroke (1.4% vs 1.2%) were numerically higher in the colchicine group than in the placebo group. Rates of MI (2.9% vs 3.1%) and ischemia-driven revascularization (4.6% vs 4.7%) were numerically lower in the colchicine group.

 

No Difference

No adverse outcomes, including all-cause death (4.6% vs 5.1%), approached significance, with the exception of noncardiovascular death (13.0% vs 1.9%). For this outcome, the 95% CI stopped just short of the line of unity (HR, 0.68; 95% CI, 0.46-0.99).

Rates of adverse events (31.9% vs 31.7%; P = .86), serious adverse events (6.7% vs 7.4%; P = .22), and serious infections (2.5% vs 2.9%; P = .85) were similar in the colchicine and placebo groups, but diarrhea, a known side effect of colchicine, was higher in the colchicine group (10.2% vs 6.6%; P < .001).

Given these results, a panelist questioned the use of the word “uncertain” to describe the findings during the late-breaker session in which these results were presented.

“I think you are selling yourself short,” said J. Dawn Abbott, MD, director of the Interventional Cardiology Fellowship Training Program at the Lifespan Cardiovascular Institute, Brown University in Providence, Rhode Island. Based on the size and conduct of this trial, she called the results “definitive” and suggested that the guidelines should be adjusted.

 

The OASIS 9 Trial

In OASIS 9, 3528 patients were randomized to colchicine, and 3534 were randomized to placebo. A second randomization in both groups was to spironolactone or placebo; these results will be presented at the upcoming American Heart Association (AHA) 2024 meeting. Both analyses will be published in The New England Journal of Medicine at that time, Jolly reported.

The study involved 104 sites in Australia, Egypt, Europe, Nepal, and North America. Follow-up in both groups exceeded 99%. Most patients had an ST-elevation MI (STEMI), but about 5% of those enrolled had a non-STEMI. Less than 10% of patients had experienced a previous MI.

Less than 5% of patients were discharged on sodium-glucose cotransporter 2 therapy, and more than 95% were discharged on aspirin and a statin. Nearly 80% were discharged on an angiotensin-converting enzyme inhibitor, and most patients received an anticoagulant. More than 95% of patients were implanted with a drug-eluting stent.

At month 3, C-reactive protein levels were significantly lower in the colchicine group than in the placebo group. C-reactive protein is a biomarker for the anti-inflammatory effect that is considered to be colchicine’s primary mechanism of action. An anti-inflammatory effect has been cited as the probable explanation for the positive results shown in the COLCOT and LODOCO2 trials, published in 2019 and 2020, respectively.

In COLCOT, which randomized 4745 patients who experienced an acute MI in the previous 30 days, colchicine was associated with a 23% reduction in a composite major cardiovascular adverse events endpoint relative to placebo (HR, 0.77; P = .02). In LODOCO2, which randomized 5522 patients with chronic coronary disease, colchicine was associated with a 31% reduction in an adverse event composite endpoint (HR, 0.68; P < .0001).

However, two more recent trials — CONVINCE and CHANCE-3 — showed no difference between colchicine and placebo for the endpoint of recurrent stroke at 90 days. CONVINCE, with approximately 3000 patients, was relatively small, whereas CHANCE-3 randomized more than 8000 patients and showed no effect on the risk for stroke (HR, 0.98; 95% CI, 0.83-1.16).

 

New Data Challenge Guidelines

Of these trials, COLCOT was the most similar to OASIS 9, according to Jolly. Among the differences, OASIS 9 was initiated earlier and was larger than the other trials, so it had more power to address the study question.

Given the absence of benefit, Jolly indicated that OASIS 9 might disrupt both the joint American College of Cardiology and AHA guidelines, which gave colchicine a class 2b recommendation in 2023, and the European Society of Cardiology guidelines, which gave colchicine a 2a recommendation.

“This is a big deal for me,” said Ajay J. Kirtane, director of the Interventional Cardiovascular Care program at Columbia University in New York City. As someone who is now using colchicine routinely, these data have changed his opinion.

The previous data supporting the use of colchicine “were just so-so,” he explained. “Now I have a good rationale” for foregoing the routine use of this therapy.

Jolly said that he had put his own father on colchicine after an acute MI on the basis of the guidelines, but immediately took him off this therapy when the data from OASIS 9 were unblinded.

“The only signal from this trial was an increased risk of diarrhea,” Jolly said. The results, at the very least, suggest that colchicine “is not for everyone” after an acute MI, although he emphasized that these results do not rule out the potential for benefit from anti-inflammatory therapy. Ongoing trials, including one targeting interleukin 6, a cytokine associated with inflammation, remain of interest, he added.

A version of this article first appeared on Medscape.com.

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Colchicine does not protect against major cardiovascular adverse events after an acute myocardial infarction, according to a multinational placebo-controlled trial of more than 7000 patients.

The CLEAR SYNERGY (OASIS 9) study, called “the largest trial ever of colchicine in acute MI,” showed no hint of benefit in an adverse event curve for colchicine relative to placebo over 5 years, which suggests that the role of this drug after myocardial infarction (MI) “is uncertain,” Sanjit Jolly, MD, an interventional cardiologist at Hamilton Health Sciences and a professor of medicine at McMaster University in Hamilton, Ontario, Canada, reported at Transcatheter Cardiovascular Therapeutics (TCT) 2024.

For the primary composite outcome — cardiovascular death, MI, stroke, and ischemia-driven revascularization — the event curves in the colchicine and placebo groups remained essentially superimposed over 5 years of follow-up, with only a slight separation after 4 years. The hazard ratio for the primary endpoint showed a 1% difference in favor of colchicine (hazard ratio [HR], 0.99; P = .93).

There were no meaningful differences in any of the individual endpoint components; all 95% CIs straddled the line of unity. Rates of cardiovascular death (3.3% vs 3.2%) and stroke (1.4% vs 1.2%) were numerically higher in the colchicine group than in the placebo group. Rates of MI (2.9% vs 3.1%) and ischemia-driven revascularization (4.6% vs 4.7%) were numerically lower in the colchicine group.

 

No Difference

No adverse outcomes, including all-cause death (4.6% vs 5.1%), approached significance, with the exception of noncardiovascular death (13.0% vs 1.9%). For this outcome, the 95% CI stopped just short of the line of unity (HR, 0.68; 95% CI, 0.46-0.99).

Rates of adverse events (31.9% vs 31.7%; P = .86), serious adverse events (6.7% vs 7.4%; P = .22), and serious infections (2.5% vs 2.9%; P = .85) were similar in the colchicine and placebo groups, but diarrhea, a known side effect of colchicine, was higher in the colchicine group (10.2% vs 6.6%; P < .001).

Given these results, a panelist questioned the use of the word “uncertain” to describe the findings during the late-breaker session in which these results were presented.

“I think you are selling yourself short,” said J. Dawn Abbott, MD, director of the Interventional Cardiology Fellowship Training Program at the Lifespan Cardiovascular Institute, Brown University in Providence, Rhode Island. Based on the size and conduct of this trial, she called the results “definitive” and suggested that the guidelines should be adjusted.

 

The OASIS 9 Trial

In OASIS 9, 3528 patients were randomized to colchicine, and 3534 were randomized to placebo. A second randomization in both groups was to spironolactone or placebo; these results will be presented at the upcoming American Heart Association (AHA) 2024 meeting. Both analyses will be published in The New England Journal of Medicine at that time, Jolly reported.

The study involved 104 sites in Australia, Egypt, Europe, Nepal, and North America. Follow-up in both groups exceeded 99%. Most patients had an ST-elevation MI (STEMI), but about 5% of those enrolled had a non-STEMI. Less than 10% of patients had experienced a previous MI.

Less than 5% of patients were discharged on sodium-glucose cotransporter 2 therapy, and more than 95% were discharged on aspirin and a statin. Nearly 80% were discharged on an angiotensin-converting enzyme inhibitor, and most patients received an anticoagulant. More than 95% of patients were implanted with a drug-eluting stent.

At month 3, C-reactive protein levels were significantly lower in the colchicine group than in the placebo group. C-reactive protein is a biomarker for the anti-inflammatory effect that is considered to be colchicine’s primary mechanism of action. An anti-inflammatory effect has been cited as the probable explanation for the positive results shown in the COLCOT and LODOCO2 trials, published in 2019 and 2020, respectively.

In COLCOT, which randomized 4745 patients who experienced an acute MI in the previous 30 days, colchicine was associated with a 23% reduction in a composite major cardiovascular adverse events endpoint relative to placebo (HR, 0.77; P = .02). In LODOCO2, which randomized 5522 patients with chronic coronary disease, colchicine was associated with a 31% reduction in an adverse event composite endpoint (HR, 0.68; P < .0001).

However, two more recent trials — CONVINCE and CHANCE-3 — showed no difference between colchicine and placebo for the endpoint of recurrent stroke at 90 days. CONVINCE, with approximately 3000 patients, was relatively small, whereas CHANCE-3 randomized more than 8000 patients and showed no effect on the risk for stroke (HR, 0.98; 95% CI, 0.83-1.16).

 

New Data Challenge Guidelines

Of these trials, COLCOT was the most similar to OASIS 9, according to Jolly. Among the differences, OASIS 9 was initiated earlier and was larger than the other trials, so it had more power to address the study question.

Given the absence of benefit, Jolly indicated that OASIS 9 might disrupt both the joint American College of Cardiology and AHA guidelines, which gave colchicine a class 2b recommendation in 2023, and the European Society of Cardiology guidelines, which gave colchicine a 2a recommendation.

“This is a big deal for me,” said Ajay J. Kirtane, director of the Interventional Cardiovascular Care program at Columbia University in New York City. As someone who is now using colchicine routinely, these data have changed his opinion.

The previous data supporting the use of colchicine “were just so-so,” he explained. “Now I have a good rationale” for foregoing the routine use of this therapy.

Jolly said that he had put his own father on colchicine after an acute MI on the basis of the guidelines, but immediately took him off this therapy when the data from OASIS 9 were unblinded.

“The only signal from this trial was an increased risk of diarrhea,” Jolly said. The results, at the very least, suggest that colchicine “is not for everyone” after an acute MI, although he emphasized that these results do not rule out the potential for benefit from anti-inflammatory therapy. Ongoing trials, including one targeting interleukin 6, a cytokine associated with inflammation, remain of interest, he added.

A version of this article first appeared on Medscape.com.

Colchicine does not protect against major cardiovascular adverse events after an acute myocardial infarction, according to a multinational placebo-controlled trial of more than 7000 patients.

The CLEAR SYNERGY (OASIS 9) study, called “the largest trial ever of colchicine in acute MI,” showed no hint of benefit in an adverse event curve for colchicine relative to placebo over 5 years, which suggests that the role of this drug after myocardial infarction (MI) “is uncertain,” Sanjit Jolly, MD, an interventional cardiologist at Hamilton Health Sciences and a professor of medicine at McMaster University in Hamilton, Ontario, Canada, reported at Transcatheter Cardiovascular Therapeutics (TCT) 2024.

For the primary composite outcome — cardiovascular death, MI, stroke, and ischemia-driven revascularization — the event curves in the colchicine and placebo groups remained essentially superimposed over 5 years of follow-up, with only a slight separation after 4 years. The hazard ratio for the primary endpoint showed a 1% difference in favor of colchicine (hazard ratio [HR], 0.99; P = .93).

There were no meaningful differences in any of the individual endpoint components; all 95% CIs straddled the line of unity. Rates of cardiovascular death (3.3% vs 3.2%) and stroke (1.4% vs 1.2%) were numerically higher in the colchicine group than in the placebo group. Rates of MI (2.9% vs 3.1%) and ischemia-driven revascularization (4.6% vs 4.7%) were numerically lower in the colchicine group.

 

No Difference

No adverse outcomes, including all-cause death (4.6% vs 5.1%), approached significance, with the exception of noncardiovascular death (13.0% vs 1.9%). For this outcome, the 95% CI stopped just short of the line of unity (HR, 0.68; 95% CI, 0.46-0.99).

Rates of adverse events (31.9% vs 31.7%; P = .86), serious adverse events (6.7% vs 7.4%; P = .22), and serious infections (2.5% vs 2.9%; P = .85) were similar in the colchicine and placebo groups, but diarrhea, a known side effect of colchicine, was higher in the colchicine group (10.2% vs 6.6%; P < .001).

Given these results, a panelist questioned the use of the word “uncertain” to describe the findings during the late-breaker session in which these results were presented.

“I think you are selling yourself short,” said J. Dawn Abbott, MD, director of the Interventional Cardiology Fellowship Training Program at the Lifespan Cardiovascular Institute, Brown University in Providence, Rhode Island. Based on the size and conduct of this trial, she called the results “definitive” and suggested that the guidelines should be adjusted.

 

The OASIS 9 Trial

In OASIS 9, 3528 patients were randomized to colchicine, and 3534 were randomized to placebo. A second randomization in both groups was to spironolactone or placebo; these results will be presented at the upcoming American Heart Association (AHA) 2024 meeting. Both analyses will be published in The New England Journal of Medicine at that time, Jolly reported.

The study involved 104 sites in Australia, Egypt, Europe, Nepal, and North America. Follow-up in both groups exceeded 99%. Most patients had an ST-elevation MI (STEMI), but about 5% of those enrolled had a non-STEMI. Less than 10% of patients had experienced a previous MI.

Less than 5% of patients were discharged on sodium-glucose cotransporter 2 therapy, and more than 95% were discharged on aspirin and a statin. Nearly 80% were discharged on an angiotensin-converting enzyme inhibitor, and most patients received an anticoagulant. More than 95% of patients were implanted with a drug-eluting stent.

At month 3, C-reactive protein levels were significantly lower in the colchicine group than in the placebo group. C-reactive protein is a biomarker for the anti-inflammatory effect that is considered to be colchicine’s primary mechanism of action. An anti-inflammatory effect has been cited as the probable explanation for the positive results shown in the COLCOT and LODOCO2 trials, published in 2019 and 2020, respectively.

In COLCOT, which randomized 4745 patients who experienced an acute MI in the previous 30 days, colchicine was associated with a 23% reduction in a composite major cardiovascular adverse events endpoint relative to placebo (HR, 0.77; P = .02). In LODOCO2, which randomized 5522 patients with chronic coronary disease, colchicine was associated with a 31% reduction in an adverse event composite endpoint (HR, 0.68; P < .0001).

However, two more recent trials — CONVINCE and CHANCE-3 — showed no difference between colchicine and placebo for the endpoint of recurrent stroke at 90 days. CONVINCE, with approximately 3000 patients, was relatively small, whereas CHANCE-3 randomized more than 8000 patients and showed no effect on the risk for stroke (HR, 0.98; 95% CI, 0.83-1.16).

 

New Data Challenge Guidelines

Of these trials, COLCOT was the most similar to OASIS 9, according to Jolly. Among the differences, OASIS 9 was initiated earlier and was larger than the other trials, so it had more power to address the study question.

Given the absence of benefit, Jolly indicated that OASIS 9 might disrupt both the joint American College of Cardiology and AHA guidelines, which gave colchicine a class 2b recommendation in 2023, and the European Society of Cardiology guidelines, which gave colchicine a 2a recommendation.

“This is a big deal for me,” said Ajay J. Kirtane, director of the Interventional Cardiovascular Care program at Columbia University in New York City. As someone who is now using colchicine routinely, these data have changed his opinion.

The previous data supporting the use of colchicine “were just so-so,” he explained. “Now I have a good rationale” for foregoing the routine use of this therapy.

Jolly said that he had put his own father on colchicine after an acute MI on the basis of the guidelines, but immediately took him off this therapy when the data from OASIS 9 were unblinded.

“The only signal from this trial was an increased risk of diarrhea,” Jolly said. The results, at the very least, suggest that colchicine “is not for everyone” after an acute MI, although he emphasized that these results do not rule out the potential for benefit from anti-inflammatory therapy. Ongoing trials, including one targeting interleukin 6, a cytokine associated with inflammation, remain of interest, he added.

A version of this article first appeared on Medscape.com.

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Heat Waves Pose Significant Health Risks for Dually Eligible Older Individuals

Article Type
Changed
Tue, 11/12/2024 - 11:39

 

TOPLINE:

Heat waves are associated with an increase in heat-related emergency department visits, hospitalizations, and deaths among dually eligible individuals older than 65 years.

METHODOLOGY:

  • The researchers conducted a retrospective time-series study using national Medicare and Medicaid data from 2016 to 2019 to assess the link between heat waves during warm months and adverse health events.
  • A total of 5,448,499 dually eligible individuals (66% women; 20% aged ≥ 85 years) were included from 28,404 zip code areas across 50 states and Washington, DC.
  • Heat waves were defined as three or more consecutive days of extreme heat with a maximum temperature of at least 90 °F and within the 97th percentile of daily maximum temperatures for each zip code.
  • Primary outcomes were daily counts of heat-related emergency department visits and hospitalizations.
  • Secondary outcomes were all-cause and heat-specific emergency department visits, all-cause and heat-specific hospitalizations, deaths, and long-term nursing facility placements within 3 months after a heat wave.

TAKEAWAY:

  • Heat waves were associated with a 10% increase in heat-related emergency department visits (incidence rate ratio [IRR], 1.10; 95% CI, 1.08-1.12) and a 7% increase in heat-related hospitalizations (IRR, 1.07; 95% CI, 1.04-1.09).
  • Mortality rates were 4% higher during heat wave days than during non–heat wave days (IRR, 1.04; 95% CI, 1.01-1.07).
  • No significant difference was found in rates of long-term nursing facility placements or heat-related emergency department visits for nursing facility residents.
  • All racial and ethnic groups showed higher incidence rates of heat-related emergency department visits during heat waves, especially among beneficiaries identified as Asian (IRR, 1.21; 95% CI, 1.12-1.29). Rates were higher among individuals residing in the Northwest, Ohio Valley, and the West.

IN PRACTICE:

“In healthcare settings, clinicians should incorporate routine heat wave risk assessments into clinical practice, especially in regions more susceptible to extreme heat, for all dual-eligible beneficiaries and other at-risk patients,” wrote Jose F. Figueroa, MD, MPH, of the Harvard T.H. Chan School of Public Health in Boston, in an invited commentary. “Beyond offering preventive advice, clinicians can adjust medications that may increase their patients’ susceptibility during heat waves, or they can refer patients to social workers and social service organizations to ensure that they are protected at home.”

SOURCE:

This study was led by Hyunjee Kim, PhD, of the Center for Health Systems Effectiveness at Oregon Health & Science University, Portland. It was published online in JAMA Health Forum.

LIMITATIONS:

This study relied on a claims database to identify adverse events, which may have led to omissions in coding, particularly for heat-related conditions if the diagnostic codes for heat-related symptoms had not been adopted. This study did not adjust for variations in air quality or green space, which could have confounded the association of interest. Indoor heat exposures or adaptive behaviors, such as air conditioning use, were not considered. The analysis could not compare the association of heat waves with adverse events between those with dual eligibility and those without dual eligibility.

DISCLOSURES:

This study was supported by the National Institute on Aging. One author reported receiving grants from the National Institutes of Health outside the submitted work. No other disclosures were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Heat waves are associated with an increase in heat-related emergency department visits, hospitalizations, and deaths among dually eligible individuals older than 65 years.

METHODOLOGY:

  • The researchers conducted a retrospective time-series study using national Medicare and Medicaid data from 2016 to 2019 to assess the link between heat waves during warm months and adverse health events.
  • A total of 5,448,499 dually eligible individuals (66% women; 20% aged ≥ 85 years) were included from 28,404 zip code areas across 50 states and Washington, DC.
  • Heat waves were defined as three or more consecutive days of extreme heat with a maximum temperature of at least 90 °F and within the 97th percentile of daily maximum temperatures for each zip code.
  • Primary outcomes were daily counts of heat-related emergency department visits and hospitalizations.
  • Secondary outcomes were all-cause and heat-specific emergency department visits, all-cause and heat-specific hospitalizations, deaths, and long-term nursing facility placements within 3 months after a heat wave.

TAKEAWAY:

  • Heat waves were associated with a 10% increase in heat-related emergency department visits (incidence rate ratio [IRR], 1.10; 95% CI, 1.08-1.12) and a 7% increase in heat-related hospitalizations (IRR, 1.07; 95% CI, 1.04-1.09).
  • Mortality rates were 4% higher during heat wave days than during non–heat wave days (IRR, 1.04; 95% CI, 1.01-1.07).
  • No significant difference was found in rates of long-term nursing facility placements or heat-related emergency department visits for nursing facility residents.
  • All racial and ethnic groups showed higher incidence rates of heat-related emergency department visits during heat waves, especially among beneficiaries identified as Asian (IRR, 1.21; 95% CI, 1.12-1.29). Rates were higher among individuals residing in the Northwest, Ohio Valley, and the West.

IN PRACTICE:

“In healthcare settings, clinicians should incorporate routine heat wave risk assessments into clinical practice, especially in regions more susceptible to extreme heat, for all dual-eligible beneficiaries and other at-risk patients,” wrote Jose F. Figueroa, MD, MPH, of the Harvard T.H. Chan School of Public Health in Boston, in an invited commentary. “Beyond offering preventive advice, clinicians can adjust medications that may increase their patients’ susceptibility during heat waves, or they can refer patients to social workers and social service organizations to ensure that they are protected at home.”

SOURCE:

This study was led by Hyunjee Kim, PhD, of the Center for Health Systems Effectiveness at Oregon Health & Science University, Portland. It was published online in JAMA Health Forum.

LIMITATIONS:

This study relied on a claims database to identify adverse events, which may have led to omissions in coding, particularly for heat-related conditions if the diagnostic codes for heat-related symptoms had not been adopted. This study did not adjust for variations in air quality or green space, which could have confounded the association of interest. Indoor heat exposures or adaptive behaviors, such as air conditioning use, were not considered. The analysis could not compare the association of heat waves with adverse events between those with dual eligibility and those without dual eligibility.

DISCLOSURES:

This study was supported by the National Institute on Aging. One author reported receiving grants from the National Institutes of Health outside the submitted work. No other disclosures were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

Heat waves are associated with an increase in heat-related emergency department visits, hospitalizations, and deaths among dually eligible individuals older than 65 years.

METHODOLOGY:

  • The researchers conducted a retrospective time-series study using national Medicare and Medicaid data from 2016 to 2019 to assess the link between heat waves during warm months and adverse health events.
  • A total of 5,448,499 dually eligible individuals (66% women; 20% aged ≥ 85 years) were included from 28,404 zip code areas across 50 states and Washington, DC.
  • Heat waves were defined as three or more consecutive days of extreme heat with a maximum temperature of at least 90 °F and within the 97th percentile of daily maximum temperatures for each zip code.
  • Primary outcomes were daily counts of heat-related emergency department visits and hospitalizations.
  • Secondary outcomes were all-cause and heat-specific emergency department visits, all-cause and heat-specific hospitalizations, deaths, and long-term nursing facility placements within 3 months after a heat wave.

TAKEAWAY:

  • Heat waves were associated with a 10% increase in heat-related emergency department visits (incidence rate ratio [IRR], 1.10; 95% CI, 1.08-1.12) and a 7% increase in heat-related hospitalizations (IRR, 1.07; 95% CI, 1.04-1.09).
  • Mortality rates were 4% higher during heat wave days than during non–heat wave days (IRR, 1.04; 95% CI, 1.01-1.07).
  • No significant difference was found in rates of long-term nursing facility placements or heat-related emergency department visits for nursing facility residents.
  • All racial and ethnic groups showed higher incidence rates of heat-related emergency department visits during heat waves, especially among beneficiaries identified as Asian (IRR, 1.21; 95% CI, 1.12-1.29). Rates were higher among individuals residing in the Northwest, Ohio Valley, and the West.

IN PRACTICE:

“In healthcare settings, clinicians should incorporate routine heat wave risk assessments into clinical practice, especially in regions more susceptible to extreme heat, for all dual-eligible beneficiaries and other at-risk patients,” wrote Jose F. Figueroa, MD, MPH, of the Harvard T.H. Chan School of Public Health in Boston, in an invited commentary. “Beyond offering preventive advice, clinicians can adjust medications that may increase their patients’ susceptibility during heat waves, or they can refer patients to social workers and social service organizations to ensure that they are protected at home.”

SOURCE:

This study was led by Hyunjee Kim, PhD, of the Center for Health Systems Effectiveness at Oregon Health & Science University, Portland. It was published online in JAMA Health Forum.

LIMITATIONS:

This study relied on a claims database to identify adverse events, which may have led to omissions in coding, particularly for heat-related conditions if the diagnostic codes for heat-related symptoms had not been adopted. This study did not adjust for variations in air quality or green space, which could have confounded the association of interest. Indoor heat exposures or adaptive behaviors, such as air conditioning use, were not considered. The analysis could not compare the association of heat waves with adverse events between those with dual eligibility and those without dual eligibility.

DISCLOSURES:

This study was supported by the National Institute on Aging. One author reported receiving grants from the National Institutes of Health outside the submitted work. No other disclosures were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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How Extreme Rainfall Amplifies Health Risks

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Changed
Wed, 11/06/2024 - 12:34

Climate change is intensifying the variability of precipitation caused by extreme daily and overall rainfall events. Awareness of the effects of these events is crucial for understanding the complex health consequences of climate change. The connections between health and climate have been recognized by physicians and patients even when climatology did not have the status of an exact science. Physicians have often advised their patients to move to a better climate, and when they did, the recommendation was rarely based on precise scientific knowledge. However, the benefits of changing environments were often so evident that they were indisputable.

Today, advanced models, satellite imagery, and biological approaches such as environmental epigenetics are enhancing our understanding of health risks related to climate change.
 

Extreme Rainfall and Health

The increase in precipitation variability is linked to climate warming, which leads to higher atmospheric humidity and extreme rainfall events. These manifestations can cause rapid weather changes, increasing interactions with harmful aerosols and raising the risk for various cardiovascular and respiratory conditions. However, a full understanding of the association between rain and health has been hindered by conflicting results and methodological issues (limited geographical locations and short observation durations) in studies.

The association between rainfall intensity and health effects is likely nonlinear. Moderate precipitation can mitigate summer heat and help reduce air pollution, an effect that may lower some environmental health risks. Conversely, intense, low-frequency, short-duration rainfall events can have particularly harmful effects on health, as such events can trigger rapid weather changes, increased proliferation of pathogens, and a rise in the risk of various pollutants, potentially exacerbating health conditions.
 

Rain and Mortality

Using an intensity-duration-frequency model of three rainfall indices (high intensity, low frequency, short duration), a study published in October 2024 combined these with mortality data from 34 countries or regions. Researchers estimated associations between mortality (all cause, cardiovascular, and respiratory) and rainfall events with different return periods (the average time expected before an extreme event of a certain magnitude occurs again) and crucial effect modifiers, including climatic, socioeconomic, and urban environmental conditions.

The analysis included 109,954,744 deaths from all causes; 31,164,161 cardiovascular deaths; and 11,817,278 respiratory deaths. During the study period, from 1980 to 2020, a total of 50,913 rainfall events with a 1-year return period, 8362 events with a 2-year return period, and 3301 events with a 5-year return period were identified.

The most significant finding was a global positive association between all-cause mortality and extreme rainfall events with a 5-year return period. One day of extreme rainfall with a 5-year return period was associated with a cumulative relative risk (RRc) of 1.08 (95% CI, 1.05-1.11) for daily mortality from all causes. Rainfall events with a 2-year return period were associated with increased daily respiratory mortality (RRc, 1.14), while no significant effect was observed for cardiovascular mortality during the same period. Rainfall events with a 5-year return period were associated with an increased risk for both cardiovascular mortality (RRc, 1.05) and respiratory mortality (RRc, 1.29), with the respiratory mortality being significantly higher.
 

Points of Concern

According to the authors, moderate to high rainfall can exert protective effects through two main mechanisms: Improving air quality (rainfall can reduce the concentration of particulate matter 2.5 cm in diameter or less in the atmosphere) and behavioral changes in people (more time spent in enclosed environments, reducing direct exposure to outdoor air pollution and nonoptimal temperatures). As rainfall intensity increases, the initial protective effects may be overshadowed by a cascade of negative impacts including:

  • Critical resource disruptions: Intense rainfall can cause severe disruptions to access to healthcare, infrastructure damage including power outages, and compromised water and food quality.
  • Physiological effects: Increased humidity levels facilitate the growth of airborne pathogens, potentially triggering allergic reactions and respiratory issues, particularly in vulnerable individuals. Rapid shifts in atmospheric pressure and temperature fluctuations can lead to cardiovascular and respiratory complications.
  • Indirect effects: Extreme rainfall can have profound effects on mental health, inducing stress and anxiety that may exacerbate pre-existing mental health conditions and indirectly contribute to increased overall mortality from nonexternal causes.

The intensity-response curves for the health effects of heavy rainfall showed a nonlinear trend, transitioning from a protective effect at moderate levels of rainfall to a risk for severe harm when rainfall intensity became extreme. Additionally, the significant effects of extreme events were modified by various types of climate and were more pronounced in areas characterized by low variability in precipitation or sparse vegetation cover.

The study demonstrated that various local factors, such as climatic conditions, climate type, and vegetation cover, can potentially influence cardiovascular and respiratory mortality and all-cause mortality related to precipitation. The findings may help physicians convey to their patients the impact of climate change on their health.

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Climate change is intensifying the variability of precipitation caused by extreme daily and overall rainfall events. Awareness of the effects of these events is crucial for understanding the complex health consequences of climate change. The connections between health and climate have been recognized by physicians and patients even when climatology did not have the status of an exact science. Physicians have often advised their patients to move to a better climate, and when they did, the recommendation was rarely based on precise scientific knowledge. However, the benefits of changing environments were often so evident that they were indisputable.

Today, advanced models, satellite imagery, and biological approaches such as environmental epigenetics are enhancing our understanding of health risks related to climate change.
 

Extreme Rainfall and Health

The increase in precipitation variability is linked to climate warming, which leads to higher atmospheric humidity and extreme rainfall events. These manifestations can cause rapid weather changes, increasing interactions with harmful aerosols and raising the risk for various cardiovascular and respiratory conditions. However, a full understanding of the association between rain and health has been hindered by conflicting results and methodological issues (limited geographical locations and short observation durations) in studies.

The association between rainfall intensity and health effects is likely nonlinear. Moderate precipitation can mitigate summer heat and help reduce air pollution, an effect that may lower some environmental health risks. Conversely, intense, low-frequency, short-duration rainfall events can have particularly harmful effects on health, as such events can trigger rapid weather changes, increased proliferation of pathogens, and a rise in the risk of various pollutants, potentially exacerbating health conditions.
 

Rain and Mortality

Using an intensity-duration-frequency model of three rainfall indices (high intensity, low frequency, short duration), a study published in October 2024 combined these with mortality data from 34 countries or regions. Researchers estimated associations between mortality (all cause, cardiovascular, and respiratory) and rainfall events with different return periods (the average time expected before an extreme event of a certain magnitude occurs again) and crucial effect modifiers, including climatic, socioeconomic, and urban environmental conditions.

The analysis included 109,954,744 deaths from all causes; 31,164,161 cardiovascular deaths; and 11,817,278 respiratory deaths. During the study period, from 1980 to 2020, a total of 50,913 rainfall events with a 1-year return period, 8362 events with a 2-year return period, and 3301 events with a 5-year return period were identified.

The most significant finding was a global positive association between all-cause mortality and extreme rainfall events with a 5-year return period. One day of extreme rainfall with a 5-year return period was associated with a cumulative relative risk (RRc) of 1.08 (95% CI, 1.05-1.11) for daily mortality from all causes. Rainfall events with a 2-year return period were associated with increased daily respiratory mortality (RRc, 1.14), while no significant effect was observed for cardiovascular mortality during the same period. Rainfall events with a 5-year return period were associated with an increased risk for both cardiovascular mortality (RRc, 1.05) and respiratory mortality (RRc, 1.29), with the respiratory mortality being significantly higher.
 

Points of Concern

According to the authors, moderate to high rainfall can exert protective effects through two main mechanisms: Improving air quality (rainfall can reduce the concentration of particulate matter 2.5 cm in diameter or less in the atmosphere) and behavioral changes in people (more time spent in enclosed environments, reducing direct exposure to outdoor air pollution and nonoptimal temperatures). As rainfall intensity increases, the initial protective effects may be overshadowed by a cascade of negative impacts including:

  • Critical resource disruptions: Intense rainfall can cause severe disruptions to access to healthcare, infrastructure damage including power outages, and compromised water and food quality.
  • Physiological effects: Increased humidity levels facilitate the growth of airborne pathogens, potentially triggering allergic reactions and respiratory issues, particularly in vulnerable individuals. Rapid shifts in atmospheric pressure and temperature fluctuations can lead to cardiovascular and respiratory complications.
  • Indirect effects: Extreme rainfall can have profound effects on mental health, inducing stress and anxiety that may exacerbate pre-existing mental health conditions and indirectly contribute to increased overall mortality from nonexternal causes.

The intensity-response curves for the health effects of heavy rainfall showed a nonlinear trend, transitioning from a protective effect at moderate levels of rainfall to a risk for severe harm when rainfall intensity became extreme. Additionally, the significant effects of extreme events were modified by various types of climate and were more pronounced in areas characterized by low variability in precipitation or sparse vegetation cover.

The study demonstrated that various local factors, such as climatic conditions, climate type, and vegetation cover, can potentially influence cardiovascular and respiratory mortality and all-cause mortality related to precipitation. The findings may help physicians convey to their patients the impact of climate change on their health.

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Climate change is intensifying the variability of precipitation caused by extreme daily and overall rainfall events. Awareness of the effects of these events is crucial for understanding the complex health consequences of climate change. The connections between health and climate have been recognized by physicians and patients even when climatology did not have the status of an exact science. Physicians have often advised their patients to move to a better climate, and when they did, the recommendation was rarely based on precise scientific knowledge. However, the benefits of changing environments were often so evident that they were indisputable.

Today, advanced models, satellite imagery, and biological approaches such as environmental epigenetics are enhancing our understanding of health risks related to climate change.
 

Extreme Rainfall and Health

The increase in precipitation variability is linked to climate warming, which leads to higher atmospheric humidity and extreme rainfall events. These manifestations can cause rapid weather changes, increasing interactions with harmful aerosols and raising the risk for various cardiovascular and respiratory conditions. However, a full understanding of the association between rain and health has been hindered by conflicting results and methodological issues (limited geographical locations and short observation durations) in studies.

The association between rainfall intensity and health effects is likely nonlinear. Moderate precipitation can mitigate summer heat and help reduce air pollution, an effect that may lower some environmental health risks. Conversely, intense, low-frequency, short-duration rainfall events can have particularly harmful effects on health, as such events can trigger rapid weather changes, increased proliferation of pathogens, and a rise in the risk of various pollutants, potentially exacerbating health conditions.
 

Rain and Mortality

Using an intensity-duration-frequency model of three rainfall indices (high intensity, low frequency, short duration), a study published in October 2024 combined these with mortality data from 34 countries or regions. Researchers estimated associations between mortality (all cause, cardiovascular, and respiratory) and rainfall events with different return periods (the average time expected before an extreme event of a certain magnitude occurs again) and crucial effect modifiers, including climatic, socioeconomic, and urban environmental conditions.

The analysis included 109,954,744 deaths from all causes; 31,164,161 cardiovascular deaths; and 11,817,278 respiratory deaths. During the study period, from 1980 to 2020, a total of 50,913 rainfall events with a 1-year return period, 8362 events with a 2-year return period, and 3301 events with a 5-year return period were identified.

The most significant finding was a global positive association between all-cause mortality and extreme rainfall events with a 5-year return period. One day of extreme rainfall with a 5-year return period was associated with a cumulative relative risk (RRc) of 1.08 (95% CI, 1.05-1.11) for daily mortality from all causes. Rainfall events with a 2-year return period were associated with increased daily respiratory mortality (RRc, 1.14), while no significant effect was observed for cardiovascular mortality during the same period. Rainfall events with a 5-year return period were associated with an increased risk for both cardiovascular mortality (RRc, 1.05) and respiratory mortality (RRc, 1.29), with the respiratory mortality being significantly higher.
 

Points of Concern

According to the authors, moderate to high rainfall can exert protective effects through two main mechanisms: Improving air quality (rainfall can reduce the concentration of particulate matter 2.5 cm in diameter or less in the atmosphere) and behavioral changes in people (more time spent in enclosed environments, reducing direct exposure to outdoor air pollution and nonoptimal temperatures). As rainfall intensity increases, the initial protective effects may be overshadowed by a cascade of negative impacts including:

  • Critical resource disruptions: Intense rainfall can cause severe disruptions to access to healthcare, infrastructure damage including power outages, and compromised water and food quality.
  • Physiological effects: Increased humidity levels facilitate the growth of airborne pathogens, potentially triggering allergic reactions and respiratory issues, particularly in vulnerable individuals. Rapid shifts in atmospheric pressure and temperature fluctuations can lead to cardiovascular and respiratory complications.
  • Indirect effects: Extreme rainfall can have profound effects on mental health, inducing stress and anxiety that may exacerbate pre-existing mental health conditions and indirectly contribute to increased overall mortality from nonexternal causes.

The intensity-response curves for the health effects of heavy rainfall showed a nonlinear trend, transitioning from a protective effect at moderate levels of rainfall to a risk for severe harm when rainfall intensity became extreme. Additionally, the significant effects of extreme events were modified by various types of climate and were more pronounced in areas characterized by low variability in precipitation or sparse vegetation cover.

The study demonstrated that various local factors, such as climatic conditions, climate type, and vegetation cover, can potentially influence cardiovascular and respiratory mortality and all-cause mortality related to precipitation. The findings may help physicians convey to their patients the impact of climate change on their health.

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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On Second Thought: Aspirin for Primary Prevention — What We Really Know

Article Type
Changed
Wed, 11/13/2024 - 02:26

This transcript has been edited for clarity

Aspirin. Once upon a time, everybody over age 50 years was supposed to take a baby aspirin. Now we make it a point to tell people to stop. What is going on?  

Our recommendations vis-à-vis aspirin have evolved at a dizzying pace. The young’uns watching us right now don’t know what things were like in the 1980s. The Reagan era was a wild, heady time where nuclear war was imminent and we didn’t prescribe aspirin to patients. 

That only started in 1988, which was a banner year in human history. Not because a number of doves were incinerated by the lighting of the Olympic torch at the Seoul Olympics — look it up if you don’t know what I’m talking about — but because 1988 saw the publication of the ISIS-2 trial, which first showed a mortality benefit to prescribing aspirin post–myocardial infarction (MI).

Giving patients aspirin during or after a heart attack is not controversial. It’s one of the few things in this business that isn’t, but that’s secondary prevention — treating somebody after they develop a disease. Primary prevention, treating them before they have their incident event, is a very different ballgame. Here, things are messy. 

For one thing, the doses used have been very inconsistent. We should point out that the reason for 81 mg of aspirin is very arbitrary and is rooted in the old apothecary system of weights and measurements. A standard dose of aspirin was 5 grains, where 20 grains made 1 scruple, 3 scruples made 1 dram, 8 drams made 1 oz, and 12 oz made 1 lb - because screw you, metric system. Therefore, 5 grains was 325 mg of aspirin, and 1 quarter of the standard dose became 81 mg if you rounded out the decimal. 

People have tried all kinds of dosing structures with aspirin prophylaxis. The Physicians’ Health Study used a full-dose aspirin, 325 mg every 2 days, while the Hypertension Optimal Treatment (HOT) trial tested 75 mg daily and the Women’s Health Study tested 100 mg, but every other day. 

Ironically, almost no one has studied 81 mg every day, which is weird if you think about it. The bigger problem here is not the variability of doses used, but the discrepancy when you look at older vs newer studies.

Older studies, like the Physicians’ Health Study, did show a benefit, at least in the subgroup of patients over age 50 years, which is probably where the “everybody over 50 should be taking an aspirin” idea comes from, at least as near as I can tell. 

More recent studies, like the Women’s Health Study, ASPREE, or ASPIRE, didn’t show a benefit. I know what you’re thinking: Newer stuff is always better. That’s why you should never trust anybody over age 40 years. The context of primary prevention studies has changed. In the ‘80s and ‘90s, people smoked more and we didn’t have the same medications that we have today. We talked about all this in the beta-blocker video to explain why beta-blockers don’t seem to have a benefit post MI.

We have a similar issue here. The magnitude of the benefit with aspirin primary prevention has decreased because we’re all just healthier overall. So, yay! Progress! Here’s where the numbers matter. No one is saying that aspirin doesn’t help. It does. 

If we look at the 2019 meta-analysis published in JAMA, there is a cardiovascular benefit. The numbers bear that out. I know you’re all here for the math, so here we go. Aspirin reduced the composite cardiovascular endpoint from 65.2 to 60.2 events per 10,000 patient-years; or to put it more meaningfully in absolute risk reduction terms, because that’s my jam, an absolute risk reduction of 0.41%, which means a number needed to treat of 241, which is okay-ish. It’s not super-great, but it may be justifiable for something that costs next to nothing. 

The tradeoff is bleeding. Major bleeding increased from 16.4 to 23.1 bleeds per 10,000 patient-years, or an absolute risk increase of 0.47%, which is a number needed to harm of 210. That’s the problem. Aspirin does prevent heart disease. The benefit is small, for sure, but the real problem is that it’s outweighed by the risk of bleeding, so you’re not really coming out ahead. 

The real tragedy here is that the public is locked into this idea of everyone over age 50 years should be taking an aspirin. Even today, even though guidelines have recommended against aspirin for primary prevention for some time, data from the National Health Interview Survey sample found that nearly one in three older adults take aspirin for primary prevention when they shouldn’t be. That’s a large number of people. That’s millions of Americans — and Canadians, but nobody cares about us. It’s fine. 

That’s the point. We’re not debunking aspirin. It does work. The benefits are just really small in a primary prevention population and offset by the admittedly also really small risks of bleeding. It’s a tradeoff that doesn’t really work in your favor.

But that’s aspirin for cardiovascular disease. When it comes to cancer or DVT prophylaxis, that’s another really interesting story. We might have to save that for another time. Do I know how to tease a sequel or what?

Labos, a cardiologist at Kirkland Medical Center, Montreal, Quebec, Canada, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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This transcript has been edited for clarity

Aspirin. Once upon a time, everybody over age 50 years was supposed to take a baby aspirin. Now we make it a point to tell people to stop. What is going on?  

Our recommendations vis-à-vis aspirin have evolved at a dizzying pace. The young’uns watching us right now don’t know what things were like in the 1980s. The Reagan era was a wild, heady time where nuclear war was imminent and we didn’t prescribe aspirin to patients. 

That only started in 1988, which was a banner year in human history. Not because a number of doves were incinerated by the lighting of the Olympic torch at the Seoul Olympics — look it up if you don’t know what I’m talking about — but because 1988 saw the publication of the ISIS-2 trial, which first showed a mortality benefit to prescribing aspirin post–myocardial infarction (MI).

Giving patients aspirin during or after a heart attack is not controversial. It’s one of the few things in this business that isn’t, but that’s secondary prevention — treating somebody after they develop a disease. Primary prevention, treating them before they have their incident event, is a very different ballgame. Here, things are messy. 

For one thing, the doses used have been very inconsistent. We should point out that the reason for 81 mg of aspirin is very arbitrary and is rooted in the old apothecary system of weights and measurements. A standard dose of aspirin was 5 grains, where 20 grains made 1 scruple, 3 scruples made 1 dram, 8 drams made 1 oz, and 12 oz made 1 lb - because screw you, metric system. Therefore, 5 grains was 325 mg of aspirin, and 1 quarter of the standard dose became 81 mg if you rounded out the decimal. 

People have tried all kinds of dosing structures with aspirin prophylaxis. The Physicians’ Health Study used a full-dose aspirin, 325 mg every 2 days, while the Hypertension Optimal Treatment (HOT) trial tested 75 mg daily and the Women’s Health Study tested 100 mg, but every other day. 

Ironically, almost no one has studied 81 mg every day, which is weird if you think about it. The bigger problem here is not the variability of doses used, but the discrepancy when you look at older vs newer studies.

Older studies, like the Physicians’ Health Study, did show a benefit, at least in the subgroup of patients over age 50 years, which is probably where the “everybody over 50 should be taking an aspirin” idea comes from, at least as near as I can tell. 

More recent studies, like the Women’s Health Study, ASPREE, or ASPIRE, didn’t show a benefit. I know what you’re thinking: Newer stuff is always better. That’s why you should never trust anybody over age 40 years. The context of primary prevention studies has changed. In the ‘80s and ‘90s, people smoked more and we didn’t have the same medications that we have today. We talked about all this in the beta-blocker video to explain why beta-blockers don’t seem to have a benefit post MI.

We have a similar issue here. The magnitude of the benefit with aspirin primary prevention has decreased because we’re all just healthier overall. So, yay! Progress! Here’s where the numbers matter. No one is saying that aspirin doesn’t help. It does. 

If we look at the 2019 meta-analysis published in JAMA, there is a cardiovascular benefit. The numbers bear that out. I know you’re all here for the math, so here we go. Aspirin reduced the composite cardiovascular endpoint from 65.2 to 60.2 events per 10,000 patient-years; or to put it more meaningfully in absolute risk reduction terms, because that’s my jam, an absolute risk reduction of 0.41%, which means a number needed to treat of 241, which is okay-ish. It’s not super-great, but it may be justifiable for something that costs next to nothing. 

The tradeoff is bleeding. Major bleeding increased from 16.4 to 23.1 bleeds per 10,000 patient-years, or an absolute risk increase of 0.47%, which is a number needed to harm of 210. That’s the problem. Aspirin does prevent heart disease. The benefit is small, for sure, but the real problem is that it’s outweighed by the risk of bleeding, so you’re not really coming out ahead. 

The real tragedy here is that the public is locked into this idea of everyone over age 50 years should be taking an aspirin. Even today, even though guidelines have recommended against aspirin for primary prevention for some time, data from the National Health Interview Survey sample found that nearly one in three older adults take aspirin for primary prevention when they shouldn’t be. That’s a large number of people. That’s millions of Americans — and Canadians, but nobody cares about us. It’s fine. 

That’s the point. We’re not debunking aspirin. It does work. The benefits are just really small in a primary prevention population and offset by the admittedly also really small risks of bleeding. It’s a tradeoff that doesn’t really work in your favor.

But that’s aspirin for cardiovascular disease. When it comes to cancer or DVT prophylaxis, that’s another really interesting story. We might have to save that for another time. Do I know how to tease a sequel or what?

Labos, a cardiologist at Kirkland Medical Center, Montreal, Quebec, Canada, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity

Aspirin. Once upon a time, everybody over age 50 years was supposed to take a baby aspirin. Now we make it a point to tell people to stop. What is going on?  

Our recommendations vis-à-vis aspirin have evolved at a dizzying pace. The young’uns watching us right now don’t know what things were like in the 1980s. The Reagan era was a wild, heady time where nuclear war was imminent and we didn’t prescribe aspirin to patients. 

That only started in 1988, which was a banner year in human history. Not because a number of doves were incinerated by the lighting of the Olympic torch at the Seoul Olympics — look it up if you don’t know what I’m talking about — but because 1988 saw the publication of the ISIS-2 trial, which first showed a mortality benefit to prescribing aspirin post–myocardial infarction (MI).

Giving patients aspirin during or after a heart attack is not controversial. It’s one of the few things in this business that isn’t, but that’s secondary prevention — treating somebody after they develop a disease. Primary prevention, treating them before they have their incident event, is a very different ballgame. Here, things are messy. 

For one thing, the doses used have been very inconsistent. We should point out that the reason for 81 mg of aspirin is very arbitrary and is rooted in the old apothecary system of weights and measurements. A standard dose of aspirin was 5 grains, where 20 grains made 1 scruple, 3 scruples made 1 dram, 8 drams made 1 oz, and 12 oz made 1 lb - because screw you, metric system. Therefore, 5 grains was 325 mg of aspirin, and 1 quarter of the standard dose became 81 mg if you rounded out the decimal. 

People have tried all kinds of dosing structures with aspirin prophylaxis. The Physicians’ Health Study used a full-dose aspirin, 325 mg every 2 days, while the Hypertension Optimal Treatment (HOT) trial tested 75 mg daily and the Women’s Health Study tested 100 mg, but every other day. 

Ironically, almost no one has studied 81 mg every day, which is weird if you think about it. The bigger problem here is not the variability of doses used, but the discrepancy when you look at older vs newer studies.

Older studies, like the Physicians’ Health Study, did show a benefit, at least in the subgroup of patients over age 50 years, which is probably where the “everybody over 50 should be taking an aspirin” idea comes from, at least as near as I can tell. 

More recent studies, like the Women’s Health Study, ASPREE, or ASPIRE, didn’t show a benefit. I know what you’re thinking: Newer stuff is always better. That’s why you should never trust anybody over age 40 years. The context of primary prevention studies has changed. In the ‘80s and ‘90s, people smoked more and we didn’t have the same medications that we have today. We talked about all this in the beta-blocker video to explain why beta-blockers don’t seem to have a benefit post MI.

We have a similar issue here. The magnitude of the benefit with aspirin primary prevention has decreased because we’re all just healthier overall. So, yay! Progress! Here’s where the numbers matter. No one is saying that aspirin doesn’t help. It does. 

If we look at the 2019 meta-analysis published in JAMA, there is a cardiovascular benefit. The numbers bear that out. I know you’re all here for the math, so here we go. Aspirin reduced the composite cardiovascular endpoint from 65.2 to 60.2 events per 10,000 patient-years; or to put it more meaningfully in absolute risk reduction terms, because that’s my jam, an absolute risk reduction of 0.41%, which means a number needed to treat of 241, which is okay-ish. It’s not super-great, but it may be justifiable for something that costs next to nothing. 

The tradeoff is bleeding. Major bleeding increased from 16.4 to 23.1 bleeds per 10,000 patient-years, or an absolute risk increase of 0.47%, which is a number needed to harm of 210. That’s the problem. Aspirin does prevent heart disease. The benefit is small, for sure, but the real problem is that it’s outweighed by the risk of bleeding, so you’re not really coming out ahead. 

The real tragedy here is that the public is locked into this idea of everyone over age 50 years should be taking an aspirin. Even today, even though guidelines have recommended against aspirin for primary prevention for some time, data from the National Health Interview Survey sample found that nearly one in three older adults take aspirin for primary prevention when they shouldn’t be. That’s a large number of people. That’s millions of Americans — and Canadians, but nobody cares about us. It’s fine. 

That’s the point. We’re not debunking aspirin. It does work. The benefits are just really small in a primary prevention population and offset by the admittedly also really small risks of bleeding. It’s a tradeoff that doesn’t really work in your favor.

But that’s aspirin for cardiovascular disease. When it comes to cancer or DVT prophylaxis, that’s another really interesting story. We might have to save that for another time. Do I know how to tease a sequel or what?

Labos, a cardiologist at Kirkland Medical Center, Montreal, Quebec, Canada, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Fewer Recurrent Cardiovascular Events Seen With TNF Inhibitor Use in Axial Spondyloarthritis

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Changed
Tue, 10/15/2024 - 16:13

 

TOPLINE:

Tumor necrosis factor (TNF) inhibitors are associated with a reduced risk for recurrent cardiovascular events in patients with radiographic axial spondyloarthritis (axSpA) and a history of cardiovascular events.

METHODOLOGY:

  • The researchers conducted a nationwide cohort study using data from the Korean National Claims Database, including 413 patients diagnosed with cardiovascular events following a radiographic axSpA diagnosis.
  • Of all patients, 75 received TNF inhibitors (mean age, 51.9 years; 92% men) and 338 did not receive TNF inhibitors (mean age, 60.7 years; 74.9% men).
  • Patients were followed from the date of the first cardiovascular event to the date of recurrence, the last date with claims data, or up to December 2021.
  • The study outcome was recurrent cardiovascular events that occurred within 28 days of the first incidence and included myocardial infarction and stroke.
  • The effect of TNF inhibitor exposure on the risk for recurrent cardiovascular events was assessed using an inverse probability weighted Cox regression analysis.

TAKEAWAY:

  • The incidence of recurrent cardiovascular events in patients with radiographic axSpA was 32 per 1000 person-years.
  • The incidence was 19 per 1000 person-years in the patients exposed to TNF inhibitors, whereas it was 36 per 1000 person-years in those not exposed to TNF inhibitors.
  • Exposure to TNF inhibitors was associated with a 67% lower risk for recurrent cardiovascular events than non-exposure (P = .038).

IN PRACTICE:

“Our data add to previous knowledge by providing more direct evidence that TNFi [tumor necrosis factor inhibitors] could reduce the risk of recurrent cardiovascular events,” the authors wrote.
 

SOURCE:

The study was led by Oh Chan Kwon, MD, PhD, and Hye Sun Lee, PhD, Yonsei University College of Medicine, Seoul, South Korea. It was published online on October 4, 2024, in Arthritis Research & Therapy.

LIMITATIONS:

The lack of data on certain cardiovascular risk factors such as obesity, smoking, and lifestyle may have led to residual confounding. The patient count in the TNF inhibitor exposure group was not adequate to analyze each TNF inhibitor medication separately. The study included only Korean patients, limiting the generalizability to other ethnic populations. The number of recurrent stroke events was relatively small, making it infeasible to analyze myocardial infarction and stroke separately.

DISCLOSURES:

The study was funded by Yuhan Corporation as part of its “2023 Investigator Initiated Translation Research Program.” The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Tumor necrosis factor (TNF) inhibitors are associated with a reduced risk for recurrent cardiovascular events in patients with radiographic axial spondyloarthritis (axSpA) and a history of cardiovascular events.

METHODOLOGY:

  • The researchers conducted a nationwide cohort study using data from the Korean National Claims Database, including 413 patients diagnosed with cardiovascular events following a radiographic axSpA diagnosis.
  • Of all patients, 75 received TNF inhibitors (mean age, 51.9 years; 92% men) and 338 did not receive TNF inhibitors (mean age, 60.7 years; 74.9% men).
  • Patients were followed from the date of the first cardiovascular event to the date of recurrence, the last date with claims data, or up to December 2021.
  • The study outcome was recurrent cardiovascular events that occurred within 28 days of the first incidence and included myocardial infarction and stroke.
  • The effect of TNF inhibitor exposure on the risk for recurrent cardiovascular events was assessed using an inverse probability weighted Cox regression analysis.

TAKEAWAY:

  • The incidence of recurrent cardiovascular events in patients with radiographic axSpA was 32 per 1000 person-years.
  • The incidence was 19 per 1000 person-years in the patients exposed to TNF inhibitors, whereas it was 36 per 1000 person-years in those not exposed to TNF inhibitors.
  • Exposure to TNF inhibitors was associated with a 67% lower risk for recurrent cardiovascular events than non-exposure (P = .038).

IN PRACTICE:

“Our data add to previous knowledge by providing more direct evidence that TNFi [tumor necrosis factor inhibitors] could reduce the risk of recurrent cardiovascular events,” the authors wrote.
 

SOURCE:

The study was led by Oh Chan Kwon, MD, PhD, and Hye Sun Lee, PhD, Yonsei University College of Medicine, Seoul, South Korea. It was published online on October 4, 2024, in Arthritis Research & Therapy.

LIMITATIONS:

The lack of data on certain cardiovascular risk factors such as obesity, smoking, and lifestyle may have led to residual confounding. The patient count in the TNF inhibitor exposure group was not adequate to analyze each TNF inhibitor medication separately. The study included only Korean patients, limiting the generalizability to other ethnic populations. The number of recurrent stroke events was relatively small, making it infeasible to analyze myocardial infarction and stroke separately.

DISCLOSURES:

The study was funded by Yuhan Corporation as part of its “2023 Investigator Initiated Translation Research Program.” The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

Tumor necrosis factor (TNF) inhibitors are associated with a reduced risk for recurrent cardiovascular events in patients with radiographic axial spondyloarthritis (axSpA) and a history of cardiovascular events.

METHODOLOGY:

  • The researchers conducted a nationwide cohort study using data from the Korean National Claims Database, including 413 patients diagnosed with cardiovascular events following a radiographic axSpA diagnosis.
  • Of all patients, 75 received TNF inhibitors (mean age, 51.9 years; 92% men) and 338 did not receive TNF inhibitors (mean age, 60.7 years; 74.9% men).
  • Patients were followed from the date of the first cardiovascular event to the date of recurrence, the last date with claims data, or up to December 2021.
  • The study outcome was recurrent cardiovascular events that occurred within 28 days of the first incidence and included myocardial infarction and stroke.
  • The effect of TNF inhibitor exposure on the risk for recurrent cardiovascular events was assessed using an inverse probability weighted Cox regression analysis.

TAKEAWAY:

  • The incidence of recurrent cardiovascular events in patients with radiographic axSpA was 32 per 1000 person-years.
  • The incidence was 19 per 1000 person-years in the patients exposed to TNF inhibitors, whereas it was 36 per 1000 person-years in those not exposed to TNF inhibitors.
  • Exposure to TNF inhibitors was associated with a 67% lower risk for recurrent cardiovascular events than non-exposure (P = .038).

IN PRACTICE:

“Our data add to previous knowledge by providing more direct evidence that TNFi [tumor necrosis factor inhibitors] could reduce the risk of recurrent cardiovascular events,” the authors wrote.
 

SOURCE:

The study was led by Oh Chan Kwon, MD, PhD, and Hye Sun Lee, PhD, Yonsei University College of Medicine, Seoul, South Korea. It was published online on October 4, 2024, in Arthritis Research & Therapy.

LIMITATIONS:

The lack of data on certain cardiovascular risk factors such as obesity, smoking, and lifestyle may have led to residual confounding. The patient count in the TNF inhibitor exposure group was not adequate to analyze each TNF inhibitor medication separately. The study included only Korean patients, limiting the generalizability to other ethnic populations. The number of recurrent stroke events was relatively small, making it infeasible to analyze myocardial infarction and stroke separately.

DISCLOSURES:

The study was funded by Yuhan Corporation as part of its “2023 Investigator Initiated Translation Research Program.” The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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New Evidence That Plaque Buildup Shouldn’t Be Ignored

Article Type
Changed
Thu, 10/10/2024 - 14:32

 

Subclinical disease detected on imaging predicts death, report investigators who show that plaque burden found on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.

The work not only highlights the importance of early detection, but it also has clinical implications, said Valentin Fuster, MD, president of the Mount Sinai Fuster Heart Hospital in New York. “It’s going to change things,” he said. “What I believe is going to happen is that we will begin to evaluate people with risk factors at age 30 using imaging. Today, we evaluate people at age 50 using clinical practice guidelines.”

Fuster’s team developed 3D vascular ultrasound to assess plaque burden and applied it in a prospective cohort study known as BioImage. The researchers assessed 6102 patients in Chicago, Illinois, and Fort Lauderdale, Florida, using 3D vascular ultrasound of the carotid artery and another well-established modality — coronary artery calcium, determined by CT.

Participants had no cardiovascular symptoms, yet their plaque burden and calcium scores at the beginning of the study were significantly associated with death during the 15 years of follow-up, even after taking risk factors and medication into account. The results are published in the Journal of the American College of Cardiology.

“Now, there is no question that subclinical disease on imaging predicts mortality,” said Fuster.

David J. Maron, MD, a preventive cardiologist at the Stanford University School of Medicine in California, calls the finding “very important.”

“The presence of atherosclerosis is powerful knowledge to guide the intensity of therapy and to motivate patients and clinicians to treat it,” said Maron, who is the co-author of an accompanying editorial and was not involved in the study.
 

Predicting Risk Early

The research also showed that the risk for death increases if the burden of plaque in the carotid artery increases over time. Both plaque burden shown on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.

Maron says recent studies of younger populations, such as Progression of Early Subclinical Atherosclerosis (PESA) and Coronary Artery Risk Development in Young Adults (CARDIA), show that “risk factors at a young age have much more impact on arterial disease than when we measure risk factors at older age.” The CARDIA study showed signs of atherosclerosis in patients as young as in their twenties. This paradigm shift to early detection will now be possible thanks to technological advances like 3D vascular ultrasound.

Maron said he agrees with screening earlier in life. “The risk of having an event is related to the plaque burden and the number of years that a patient has been exposed to that burden. The earlier in life we can identify the burden to slow, arrest, or even reverse the plaque, the better.”

Maron points out that the study looked at an older population and did not include information on cause of death. While a study of younger people and data on cardiac causes of death would be useful, he says the study’s conclusions remain significant.
 

3D Vascular Ultrasound vs Coronary Artery Calcium

While both imaging methods in the study predicted death better than cardiovascular risk factors alone, each option has advantages.

For coronary artery calcium, “there’s a huge amount of literature demonstrating the association with cardiovascular events, there’s a standardized scoring system, there are widespread facilities for computed tomography, and there is not a lot of variability in the measurement — it’s not dependent on the operator,” said Maron.

But there is one drawback. The scoring system –— the Agatston score — can paradoxically go up following aggressive lowering of low-density lipoprotein cholesterol. “Once coronary calcium is present, it is challenging to interpret a repeat scan because we don’t know if the increase in score is due to progression or increasing density of the calcium, which is a sign of healing,” said Maron.

Vascular ultrasound avoids this problem and can also identify early noncalcified plaques and monitor their progression before they would appear on CT. Furthermore, the imaging does not add to lifetime radiation dose, as CT does, Fuster said.

3D ultrasound technology will soon be available in an inexpensive, automated, and easy-to-use format, he explains. Fuster envisions a scenario in which a nurse in a low-income country, using a cell phone app, will be able to assess atherosclerosis in a patient’s femoral artery. “In less than 1 hour, we can predict disease much more rigorously than with risk factors alone,” he said. “I think this is very exciting.”
 

Progression Increases Risk

Finding any atherosclerosis means an increased risk for death, but a greater burden or amount of atherosclerosis increases that risk, said Fuster. Progression of atherosclerosis increases risk even further. 

The study looked at changes in atherosclerosis burden on vascular ultrasound in a subset of 732 patients a median of 8.9 years after their first test. Those with progression had a higher risk for death than those with regression or no atherosclerosis. “Progression is much more significant in predicting mortality than atherosclerosis findings alone,” Fuster said.

Maron said this finding points to “two great values from noninvasive imaging of atherosclerosis.” Not only does imaging detect atherosclerosis, but it can also characterize the burden and any calcification. Further, it allows doctors to monitor the response to interventions such as lifestyle changes and medical therapy. “Serial imaging of plaque burden will really enhance the management of atherosclerosis,” said Maron. “If we discover that someone is progressing rapidly, we can intensify therapy.”

He says imaging results also provide needed motivation for both clinicians and patients to take action that would prevent the deaths that result from atherosclerosis.
 

A version of this article appeared on Medscape.com.

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Subclinical disease detected on imaging predicts death, report investigators who show that plaque burden found on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.

The work not only highlights the importance of early detection, but it also has clinical implications, said Valentin Fuster, MD, president of the Mount Sinai Fuster Heart Hospital in New York. “It’s going to change things,” he said. “What I believe is going to happen is that we will begin to evaluate people with risk factors at age 30 using imaging. Today, we evaluate people at age 50 using clinical practice guidelines.”

Fuster’s team developed 3D vascular ultrasound to assess plaque burden and applied it in a prospective cohort study known as BioImage. The researchers assessed 6102 patients in Chicago, Illinois, and Fort Lauderdale, Florida, using 3D vascular ultrasound of the carotid artery and another well-established modality — coronary artery calcium, determined by CT.

Participants had no cardiovascular symptoms, yet their plaque burden and calcium scores at the beginning of the study were significantly associated with death during the 15 years of follow-up, even after taking risk factors and medication into account. The results are published in the Journal of the American College of Cardiology.

“Now, there is no question that subclinical disease on imaging predicts mortality,” said Fuster.

David J. Maron, MD, a preventive cardiologist at the Stanford University School of Medicine in California, calls the finding “very important.”

“The presence of atherosclerosis is powerful knowledge to guide the intensity of therapy and to motivate patients and clinicians to treat it,” said Maron, who is the co-author of an accompanying editorial and was not involved in the study.
 

Predicting Risk Early

The research also showed that the risk for death increases if the burden of plaque in the carotid artery increases over time. Both plaque burden shown on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.

Maron says recent studies of younger populations, such as Progression of Early Subclinical Atherosclerosis (PESA) and Coronary Artery Risk Development in Young Adults (CARDIA), show that “risk factors at a young age have much more impact on arterial disease than when we measure risk factors at older age.” The CARDIA study showed signs of atherosclerosis in patients as young as in their twenties. This paradigm shift to early detection will now be possible thanks to technological advances like 3D vascular ultrasound.

Maron said he agrees with screening earlier in life. “The risk of having an event is related to the plaque burden and the number of years that a patient has been exposed to that burden. The earlier in life we can identify the burden to slow, arrest, or even reverse the plaque, the better.”

Maron points out that the study looked at an older population and did not include information on cause of death. While a study of younger people and data on cardiac causes of death would be useful, he says the study’s conclusions remain significant.
 

3D Vascular Ultrasound vs Coronary Artery Calcium

While both imaging methods in the study predicted death better than cardiovascular risk factors alone, each option has advantages.

For coronary artery calcium, “there’s a huge amount of literature demonstrating the association with cardiovascular events, there’s a standardized scoring system, there are widespread facilities for computed tomography, and there is not a lot of variability in the measurement — it’s not dependent on the operator,” said Maron.

But there is one drawback. The scoring system –— the Agatston score — can paradoxically go up following aggressive lowering of low-density lipoprotein cholesterol. “Once coronary calcium is present, it is challenging to interpret a repeat scan because we don’t know if the increase in score is due to progression or increasing density of the calcium, which is a sign of healing,” said Maron.

Vascular ultrasound avoids this problem and can also identify early noncalcified plaques and monitor their progression before they would appear on CT. Furthermore, the imaging does not add to lifetime radiation dose, as CT does, Fuster said.

3D ultrasound technology will soon be available in an inexpensive, automated, and easy-to-use format, he explains. Fuster envisions a scenario in which a nurse in a low-income country, using a cell phone app, will be able to assess atherosclerosis in a patient’s femoral artery. “In less than 1 hour, we can predict disease much more rigorously than with risk factors alone,” he said. “I think this is very exciting.”
 

Progression Increases Risk

Finding any atherosclerosis means an increased risk for death, but a greater burden or amount of atherosclerosis increases that risk, said Fuster. Progression of atherosclerosis increases risk even further. 

The study looked at changes in atherosclerosis burden on vascular ultrasound in a subset of 732 patients a median of 8.9 years after their first test. Those with progression had a higher risk for death than those with regression or no atherosclerosis. “Progression is much more significant in predicting mortality than atherosclerosis findings alone,” Fuster said.

Maron said this finding points to “two great values from noninvasive imaging of atherosclerosis.” Not only does imaging detect atherosclerosis, but it can also characterize the burden and any calcification. Further, it allows doctors to monitor the response to interventions such as lifestyle changes and medical therapy. “Serial imaging of plaque burden will really enhance the management of atherosclerosis,” said Maron. “If we discover that someone is progressing rapidly, we can intensify therapy.”

He says imaging results also provide needed motivation for both clinicians and patients to take action that would prevent the deaths that result from atherosclerosis.
 

A version of this article appeared on Medscape.com.

 

Subclinical disease detected on imaging predicts death, report investigators who show that plaque burden found on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.

The work not only highlights the importance of early detection, but it also has clinical implications, said Valentin Fuster, MD, president of the Mount Sinai Fuster Heart Hospital in New York. “It’s going to change things,” he said. “What I believe is going to happen is that we will begin to evaluate people with risk factors at age 30 using imaging. Today, we evaluate people at age 50 using clinical practice guidelines.”

Fuster’s team developed 3D vascular ultrasound to assess plaque burden and applied it in a prospective cohort study known as BioImage. The researchers assessed 6102 patients in Chicago, Illinois, and Fort Lauderdale, Florida, using 3D vascular ultrasound of the carotid artery and another well-established modality — coronary artery calcium, determined by CT.

Participants had no cardiovascular symptoms, yet their plaque burden and calcium scores at the beginning of the study were significantly associated with death during the 15 years of follow-up, even after taking risk factors and medication into account. The results are published in the Journal of the American College of Cardiology.

“Now, there is no question that subclinical disease on imaging predicts mortality,” said Fuster.

David J. Maron, MD, a preventive cardiologist at the Stanford University School of Medicine in California, calls the finding “very important.”

“The presence of atherosclerosis is powerful knowledge to guide the intensity of therapy and to motivate patients and clinicians to treat it,” said Maron, who is the co-author of an accompanying editorial and was not involved in the study.
 

Predicting Risk Early

The research also showed that the risk for death increases if the burden of plaque in the carotid artery increases over time. Both plaque burden shown on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.

Maron says recent studies of younger populations, such as Progression of Early Subclinical Atherosclerosis (PESA) and Coronary Artery Risk Development in Young Adults (CARDIA), show that “risk factors at a young age have much more impact on arterial disease than when we measure risk factors at older age.” The CARDIA study showed signs of atherosclerosis in patients as young as in their twenties. This paradigm shift to early detection will now be possible thanks to technological advances like 3D vascular ultrasound.

Maron said he agrees with screening earlier in life. “The risk of having an event is related to the plaque burden and the number of years that a patient has been exposed to that burden. The earlier in life we can identify the burden to slow, arrest, or even reverse the plaque, the better.”

Maron points out that the study looked at an older population and did not include information on cause of death. While a study of younger people and data on cardiac causes of death would be useful, he says the study’s conclusions remain significant.
 

3D Vascular Ultrasound vs Coronary Artery Calcium

While both imaging methods in the study predicted death better than cardiovascular risk factors alone, each option has advantages.

For coronary artery calcium, “there’s a huge amount of literature demonstrating the association with cardiovascular events, there’s a standardized scoring system, there are widespread facilities for computed tomography, and there is not a lot of variability in the measurement — it’s not dependent on the operator,” said Maron.

But there is one drawback. The scoring system –— the Agatston score — can paradoxically go up following aggressive lowering of low-density lipoprotein cholesterol. “Once coronary calcium is present, it is challenging to interpret a repeat scan because we don’t know if the increase in score is due to progression or increasing density of the calcium, which is a sign of healing,” said Maron.

Vascular ultrasound avoids this problem and can also identify early noncalcified plaques and monitor their progression before they would appear on CT. Furthermore, the imaging does not add to lifetime radiation dose, as CT does, Fuster said.

3D ultrasound technology will soon be available in an inexpensive, automated, and easy-to-use format, he explains. Fuster envisions a scenario in which a nurse in a low-income country, using a cell phone app, will be able to assess atherosclerosis in a patient’s femoral artery. “In less than 1 hour, we can predict disease much more rigorously than with risk factors alone,” he said. “I think this is very exciting.”
 

Progression Increases Risk

Finding any atherosclerosis means an increased risk for death, but a greater burden or amount of atherosclerosis increases that risk, said Fuster. Progression of atherosclerosis increases risk even further. 

The study looked at changes in atherosclerosis burden on vascular ultrasound in a subset of 732 patients a median of 8.9 years after their first test. Those with progression had a higher risk for death than those with regression or no atherosclerosis. “Progression is much more significant in predicting mortality than atherosclerosis findings alone,” Fuster said.

Maron said this finding points to “two great values from noninvasive imaging of atherosclerosis.” Not only does imaging detect atherosclerosis, but it can also characterize the burden and any calcification. Further, it allows doctors to monitor the response to interventions such as lifestyle changes and medical therapy. “Serial imaging of plaque burden will really enhance the management of atherosclerosis,” said Maron. “If we discover that someone is progressing rapidly, we can intensify therapy.”

He says imaging results also provide needed motivation for both clinicians and patients to take action that would prevent the deaths that result from atherosclerosis.
 

A version of this article appeared on Medscape.com.

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Is Wildfire Smoke More Toxic Than General Air Pollution?

Article Type
Changed
Mon, 10/07/2024 - 12:53

Wildfire-related air pollution in Europe kills more than non-wildfire air pollution. As climate change exacerbates the frequency and violence of wildfires, researchers are studying the health implications of mitigation methods such as prescribed fires.

Presenting at the annual congress of the European Respiratory Society (ERS), Cathryn Tonne, PhD, an environmental epidemiologist at the Instituto de Salud Global de Barcelona, Spain, said wildfire-related PM2.5 is more toxic than general PM2.5, leading to significantly higher mortality rates.

Prescribed, controlled fires have been employed worldwide to reduce the chance of uncontrolled, catastrophic fires. However, researchers wonder whether the techniques reduce the overall fire-related PM2.5 or add up to it. “Prescribed fire increases ecosystem resilience and can reduce the risk of catastrophic wildfire,” said Jason Sacks, MPH, an epidemiologist in the Center for Public Health and Environmental Assessment in the Office of Research and Development at the Environmental Protection Agency (EPA), at the congress. “But it also leads to poorer air quality and health impacts, and we still don’t know what this means at a regional scale.”
 

Wildfire Pollution Kills More Than Other Air Pollution

Researchers at the Instituto de Salud Global de Barcelona used a large dataset of daily mortality data from 32 European countries collected through the EARLY-ADAPT project. They utilized the SILAM model to derive daily average concentrations of wildfire-related PM2.5, non-fire PM2.5, and total PM2.5 levels. They also employed GEOSTAT population grids at a 1-km resolution to calculate the attributable number of deaths across different regions, specifically focusing on data from 2006, 2011, and 2018.

The data analysis indicated that the relative risk per unit of PM2.5 is substantially larger for wildfire-related PM2.5, compared with non-fire PM2.5. “We essentially assume that wildfire smoke PM2.5 has the same toxicity as total PM2.5, but it’s increasingly clear that’s likely not the case,” Dr. Tonne said, presenting the study.

When employing exposure-response functions (ERFs) specific to wildfire smoke, researchers found that the attributable deaths from all causes of wildfire PM2.5 were approximately 10 times larger than those calculated using total PM2.5 exposure estimates. Dr. Tonne explained that this stark difference highlights the critical need for tailored ERFs that accurately reflect the unique health risks posed by wildfire smoke.

“Respiratory mortality usually has the strongest relative risks, and we’re seeing that in this study as well,” Dr. Tonne said. “Wildfire smoke seems to operate through quite immediate mechanisms, likely through inflammation and oxidative stress.”

One significant challenge of the study was the lack of uniform spatial resolution across all countries involved in the analysis. This inconsistency may affect how accurately mortality estimates can be attributed to specific PM2.5 sources. Additionally, the study had limited statistical power for generating age- and sex-specific mortality estimates, which could obscure important demographic differences in vulnerability to wildfire smoke exposure. The analysis was also constrained to data available only up to 2020, thereby excluding critical wildfire events from subsequent years, such as those in 2022 and 2023, which may have further elucidated the health impacts of wildfire smoke in Europe.
 

Fires Prescription

Prescribed fires or controlled burns are intentional fires set by land managers under carefully managed conditions.

Historically, many forested areas have been subjected to fire suppression practices, which allow combustible materials like dry leaves, twigs, and shrubs to accumulate over time. This buildup leads to a higher likelihood of severe, uncontrollable wildfires. Prescribed fires can reduce these fuel loads and improve the health and resilience of ecosystems.

They release fewer pollutants and emissions than the large-scale, unmanageable wildfires they help prevent because they happen at lower temperatures. But they still introduce pollutants in the air that can negatively affect nearby communities’ health.

People with preexisting respiratory conditions, such as asthma or chronic obstructive pulmonary disease (COPD), are particularly vulnerable to smoke, which can trigger health issues like breathing difficulties, coughing, and eye irritation. The cumulative impact of increased burns raises concerns about long-term air quality, especially in densely populated areas. “We need to understand if we’re actually tipping the scale to having less wildfire smoke or just increasing the total amount of smoke.”

Mitigation strategies include accurately picking the right timing and weather conditions to determine when and where to conduct controlled burns and effective and timely communication to inform local communities about upcoming burns, the potential for smoke exposure, and how to protect themselves.

There is a growing need to improve public messaging around prescribed fires, Mr. Sacks said, because often the message communicated is oversimplified, such as “there will be smoke, but don’t worry. But that’s not the message we want to convey, especially for people with asthma or COPD.”

Instead, he said public health agencies should provide clearer, science-based guidance on the risks for smoke exposure and practical steps people can take to reduce their risk.
 

What Can Doctors Do?

Chris Carlsten, MD, director of the Centre for Lung Health and professor and head of the Respiratory Medicine Division at the University of British Columbia, Vancouver, Canada, told this news organization that determining whether an exacerbation of a respiratory condition is caused by fire exposure or other factors, such as viral infections, is complex because both can trigger similar responses and may complement each other. “It’s very difficult for any individual to know whether, when they’re having an exacerbation of asthma or COPD, that’s due to the fire,” he said. Fire smoke also increases infection risks, further complicating diagnosis.

Dr. Carlsten suggested that physicians could recommend preventative use of inhalers for at-risk patients when wildfires occur rather than waiting for symptoms to worsen. “That is a really interesting idea that could be practical.” Still, he advises caution, stressing that patients should consult their providers because not all may react well to increased inhaler use.

He also highlighted a significant shift in the healthcare landscape, noting that traditionally, the focus has been on the cardiovascular impacts of pollution, particularly traffic-related pollution. However, as wildfire smoke becomes a growing issue, the focus is shifting back to respiratory problems, with profound implications for healthcare resources, budgets, and drug approvals based on the burden of respiratory disease. “Fire smoke is becoming more of a problem. This swing back to respiratory has huge implications for healthcare systems and respiratory disease burden.”

Mr. Sacks and Dr. Carlsten reported no relevant financial relationships. The study presented by Dr. Tonne received funding from the European Union’s Horizon Europe research and innovation programme under Grant Agreement No. 101057131.
 

A version of this article first appeared on Medscape.com.

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Wildfire-related air pollution in Europe kills more than non-wildfire air pollution. As climate change exacerbates the frequency and violence of wildfires, researchers are studying the health implications of mitigation methods such as prescribed fires.

Presenting at the annual congress of the European Respiratory Society (ERS), Cathryn Tonne, PhD, an environmental epidemiologist at the Instituto de Salud Global de Barcelona, Spain, said wildfire-related PM2.5 is more toxic than general PM2.5, leading to significantly higher mortality rates.

Prescribed, controlled fires have been employed worldwide to reduce the chance of uncontrolled, catastrophic fires. However, researchers wonder whether the techniques reduce the overall fire-related PM2.5 or add up to it. “Prescribed fire increases ecosystem resilience and can reduce the risk of catastrophic wildfire,” said Jason Sacks, MPH, an epidemiologist in the Center for Public Health and Environmental Assessment in the Office of Research and Development at the Environmental Protection Agency (EPA), at the congress. “But it also leads to poorer air quality and health impacts, and we still don’t know what this means at a regional scale.”
 

Wildfire Pollution Kills More Than Other Air Pollution

Researchers at the Instituto de Salud Global de Barcelona used a large dataset of daily mortality data from 32 European countries collected through the EARLY-ADAPT project. They utilized the SILAM model to derive daily average concentrations of wildfire-related PM2.5, non-fire PM2.5, and total PM2.5 levels. They also employed GEOSTAT population grids at a 1-km resolution to calculate the attributable number of deaths across different regions, specifically focusing on data from 2006, 2011, and 2018.

The data analysis indicated that the relative risk per unit of PM2.5 is substantially larger for wildfire-related PM2.5, compared with non-fire PM2.5. “We essentially assume that wildfire smoke PM2.5 has the same toxicity as total PM2.5, but it’s increasingly clear that’s likely not the case,” Dr. Tonne said, presenting the study.

When employing exposure-response functions (ERFs) specific to wildfire smoke, researchers found that the attributable deaths from all causes of wildfire PM2.5 were approximately 10 times larger than those calculated using total PM2.5 exposure estimates. Dr. Tonne explained that this stark difference highlights the critical need for tailored ERFs that accurately reflect the unique health risks posed by wildfire smoke.

“Respiratory mortality usually has the strongest relative risks, and we’re seeing that in this study as well,” Dr. Tonne said. “Wildfire smoke seems to operate through quite immediate mechanisms, likely through inflammation and oxidative stress.”

One significant challenge of the study was the lack of uniform spatial resolution across all countries involved in the analysis. This inconsistency may affect how accurately mortality estimates can be attributed to specific PM2.5 sources. Additionally, the study had limited statistical power for generating age- and sex-specific mortality estimates, which could obscure important demographic differences in vulnerability to wildfire smoke exposure. The analysis was also constrained to data available only up to 2020, thereby excluding critical wildfire events from subsequent years, such as those in 2022 and 2023, which may have further elucidated the health impacts of wildfire smoke in Europe.
 

Fires Prescription

Prescribed fires or controlled burns are intentional fires set by land managers under carefully managed conditions.

Historically, many forested areas have been subjected to fire suppression practices, which allow combustible materials like dry leaves, twigs, and shrubs to accumulate over time. This buildup leads to a higher likelihood of severe, uncontrollable wildfires. Prescribed fires can reduce these fuel loads and improve the health and resilience of ecosystems.

They release fewer pollutants and emissions than the large-scale, unmanageable wildfires they help prevent because they happen at lower temperatures. But they still introduce pollutants in the air that can negatively affect nearby communities’ health.

People with preexisting respiratory conditions, such as asthma or chronic obstructive pulmonary disease (COPD), are particularly vulnerable to smoke, which can trigger health issues like breathing difficulties, coughing, and eye irritation. The cumulative impact of increased burns raises concerns about long-term air quality, especially in densely populated areas. “We need to understand if we’re actually tipping the scale to having less wildfire smoke or just increasing the total amount of smoke.”

Mitigation strategies include accurately picking the right timing and weather conditions to determine when and where to conduct controlled burns and effective and timely communication to inform local communities about upcoming burns, the potential for smoke exposure, and how to protect themselves.

There is a growing need to improve public messaging around prescribed fires, Mr. Sacks said, because often the message communicated is oversimplified, such as “there will be smoke, but don’t worry. But that’s not the message we want to convey, especially for people with asthma or COPD.”

Instead, he said public health agencies should provide clearer, science-based guidance on the risks for smoke exposure and practical steps people can take to reduce their risk.
 

What Can Doctors Do?

Chris Carlsten, MD, director of the Centre for Lung Health and professor and head of the Respiratory Medicine Division at the University of British Columbia, Vancouver, Canada, told this news organization that determining whether an exacerbation of a respiratory condition is caused by fire exposure or other factors, such as viral infections, is complex because both can trigger similar responses and may complement each other. “It’s very difficult for any individual to know whether, when they’re having an exacerbation of asthma or COPD, that’s due to the fire,” he said. Fire smoke also increases infection risks, further complicating diagnosis.

Dr. Carlsten suggested that physicians could recommend preventative use of inhalers for at-risk patients when wildfires occur rather than waiting for symptoms to worsen. “That is a really interesting idea that could be practical.” Still, he advises caution, stressing that patients should consult their providers because not all may react well to increased inhaler use.

He also highlighted a significant shift in the healthcare landscape, noting that traditionally, the focus has been on the cardiovascular impacts of pollution, particularly traffic-related pollution. However, as wildfire smoke becomes a growing issue, the focus is shifting back to respiratory problems, with profound implications for healthcare resources, budgets, and drug approvals based on the burden of respiratory disease. “Fire smoke is becoming more of a problem. This swing back to respiratory has huge implications for healthcare systems and respiratory disease burden.”

Mr. Sacks and Dr. Carlsten reported no relevant financial relationships. The study presented by Dr. Tonne received funding from the European Union’s Horizon Europe research and innovation programme under Grant Agreement No. 101057131.
 

A version of this article first appeared on Medscape.com.

Wildfire-related air pollution in Europe kills more than non-wildfire air pollution. As climate change exacerbates the frequency and violence of wildfires, researchers are studying the health implications of mitigation methods such as prescribed fires.

Presenting at the annual congress of the European Respiratory Society (ERS), Cathryn Tonne, PhD, an environmental epidemiologist at the Instituto de Salud Global de Barcelona, Spain, said wildfire-related PM2.5 is more toxic than general PM2.5, leading to significantly higher mortality rates.

Prescribed, controlled fires have been employed worldwide to reduce the chance of uncontrolled, catastrophic fires. However, researchers wonder whether the techniques reduce the overall fire-related PM2.5 or add up to it. “Prescribed fire increases ecosystem resilience and can reduce the risk of catastrophic wildfire,” said Jason Sacks, MPH, an epidemiologist in the Center for Public Health and Environmental Assessment in the Office of Research and Development at the Environmental Protection Agency (EPA), at the congress. “But it also leads to poorer air quality and health impacts, and we still don’t know what this means at a regional scale.”
 

Wildfire Pollution Kills More Than Other Air Pollution

Researchers at the Instituto de Salud Global de Barcelona used a large dataset of daily mortality data from 32 European countries collected through the EARLY-ADAPT project. They utilized the SILAM model to derive daily average concentrations of wildfire-related PM2.5, non-fire PM2.5, and total PM2.5 levels. They also employed GEOSTAT population grids at a 1-km resolution to calculate the attributable number of deaths across different regions, specifically focusing on data from 2006, 2011, and 2018.

The data analysis indicated that the relative risk per unit of PM2.5 is substantially larger for wildfire-related PM2.5, compared with non-fire PM2.5. “We essentially assume that wildfire smoke PM2.5 has the same toxicity as total PM2.5, but it’s increasingly clear that’s likely not the case,” Dr. Tonne said, presenting the study.

When employing exposure-response functions (ERFs) specific to wildfire smoke, researchers found that the attributable deaths from all causes of wildfire PM2.5 were approximately 10 times larger than those calculated using total PM2.5 exposure estimates. Dr. Tonne explained that this stark difference highlights the critical need for tailored ERFs that accurately reflect the unique health risks posed by wildfire smoke.

“Respiratory mortality usually has the strongest relative risks, and we’re seeing that in this study as well,” Dr. Tonne said. “Wildfire smoke seems to operate through quite immediate mechanisms, likely through inflammation and oxidative stress.”

One significant challenge of the study was the lack of uniform spatial resolution across all countries involved in the analysis. This inconsistency may affect how accurately mortality estimates can be attributed to specific PM2.5 sources. Additionally, the study had limited statistical power for generating age- and sex-specific mortality estimates, which could obscure important demographic differences in vulnerability to wildfire smoke exposure. The analysis was also constrained to data available only up to 2020, thereby excluding critical wildfire events from subsequent years, such as those in 2022 and 2023, which may have further elucidated the health impacts of wildfire smoke in Europe.
 

Fires Prescription

Prescribed fires or controlled burns are intentional fires set by land managers under carefully managed conditions.

Historically, many forested areas have been subjected to fire suppression practices, which allow combustible materials like dry leaves, twigs, and shrubs to accumulate over time. This buildup leads to a higher likelihood of severe, uncontrollable wildfires. Prescribed fires can reduce these fuel loads and improve the health and resilience of ecosystems.

They release fewer pollutants and emissions than the large-scale, unmanageable wildfires they help prevent because they happen at lower temperatures. But they still introduce pollutants in the air that can negatively affect nearby communities’ health.

People with preexisting respiratory conditions, such as asthma or chronic obstructive pulmonary disease (COPD), are particularly vulnerable to smoke, which can trigger health issues like breathing difficulties, coughing, and eye irritation. The cumulative impact of increased burns raises concerns about long-term air quality, especially in densely populated areas. “We need to understand if we’re actually tipping the scale to having less wildfire smoke or just increasing the total amount of smoke.”

Mitigation strategies include accurately picking the right timing and weather conditions to determine when and where to conduct controlled burns and effective and timely communication to inform local communities about upcoming burns, the potential for smoke exposure, and how to protect themselves.

There is a growing need to improve public messaging around prescribed fires, Mr. Sacks said, because often the message communicated is oversimplified, such as “there will be smoke, but don’t worry. But that’s not the message we want to convey, especially for people with asthma or COPD.”

Instead, he said public health agencies should provide clearer, science-based guidance on the risks for smoke exposure and practical steps people can take to reduce their risk.
 

What Can Doctors Do?

Chris Carlsten, MD, director of the Centre for Lung Health and professor and head of the Respiratory Medicine Division at the University of British Columbia, Vancouver, Canada, told this news organization that determining whether an exacerbation of a respiratory condition is caused by fire exposure or other factors, such as viral infections, is complex because both can trigger similar responses and may complement each other. “It’s very difficult for any individual to know whether, when they’re having an exacerbation of asthma or COPD, that’s due to the fire,” he said. Fire smoke also increases infection risks, further complicating diagnosis.

Dr. Carlsten suggested that physicians could recommend preventative use of inhalers for at-risk patients when wildfires occur rather than waiting for symptoms to worsen. “That is a really interesting idea that could be practical.” Still, he advises caution, stressing that patients should consult their providers because not all may react well to increased inhaler use.

He also highlighted a significant shift in the healthcare landscape, noting that traditionally, the focus has been on the cardiovascular impacts of pollution, particularly traffic-related pollution. However, as wildfire smoke becomes a growing issue, the focus is shifting back to respiratory problems, with profound implications for healthcare resources, budgets, and drug approvals based on the burden of respiratory disease. “Fire smoke is becoming more of a problem. This swing back to respiratory has huge implications for healthcare systems and respiratory disease burden.”

Mr. Sacks and Dr. Carlsten reported no relevant financial relationships. The study presented by Dr. Tonne received funding from the European Union’s Horizon Europe research and innovation programme under Grant Agreement No. 101057131.
 

A version of this article first appeared on Medscape.com.

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Ultra-Processed Doesn’t Always Mean Bad — Here’s How to Tell

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Thu, 09/12/2024 - 14:56

 

You may have been warned that ultra-processed foods can wreak havoc on your health. But not all of them are created equal. 

A new study out of The Lancet Regional Health – Americas looked at different types of ultra-processed foods and found that some were even linked with lower risks of cardiovascular diseasecoronary heart disease, and stroke

“Avoiding all ultra-processed foods is not practical for most people,” said Dariush Mozaffarian, MD, a cardiologist, public health scientist, and director of the Food is Medicine Institute at Tufts University in Boston, Massachusetts. “So, it is helpful to start to understand, within the category of all processing, what food might be more or less harmful.”

Researchers analyzed food questionnaires from three large groups of US adults, with most people in their review being White and female. The study found that sugary and artificially sweetened drinks, along with processed meats, were linked to a greater risk of cardiovascular disease and coronary heart disease. But cereals, savory snacks, and yogurt and dairy-based desserts were linked to a lower risk of these diseases. Ultra-processed cereals and breads were also linked to a lower stroke risk. 
 

The Truth About Processed Meat

Studies show that cured, salted, or smoked meats are linked to certain cancers.

“We know that sugar-sweetened beverages are associated with metabolic derangement for things like higher glucose levels, insulin resistance, visceral obesityprediabetesdiabetes, and higher triglycerides,” said Ashish Sarraju, MD, a cardiologist with the Cleveland Clinic in Ohio. “Added sugars associated with all of those things are in turn risk factors for heart disease.” Sugar-sweetened beverages are often very high in sugar, artificial colors, and other additives, and almost “nothing beneficial” in terms of ingredients, Dr. Mozaffarian said. “They’re also consumed in very high doses, very quickly.”

Processed meats have 400% higher levels of salt, compared with unprocessed meats, said Dr. Mozaffarian. They also contain high levels of added nitrates, which are a carcinogen that could also affect the heart and blood vessels. Certain ultra-processed foods, such as bacon, are often fried at sky-high temperatures, which can trigger inflammatory compounds. 

“If you put together the inflammatory effects, the salt, and the nitrates, this is a package of food that can really build to cause harm,” said Dr. Mozaffarian. The World Health Organization has also classified processed meats (bacon, ham, salami) as a group one carcinogen, he noted.

“Processed meats are typically high in saturated fats, sodium, and preservatives, which can increase blood pressure, promote inflammation, and negatively affect cholesterol levels, leading to a higher risk of coronary heart disease, said Joseph A. Daibes, DO, an interventional cardiologist at Lenox Hill Hospital, New York City. “The study underscores the importance of limiting these types of foods to reduce cardiovascular risk.”

But considering that breakfast cereals – albeit highly processed – are a top source of whole grains for Americans, it makes sense that they are linked with lower risk of heart disease, said Dr. Mozaffarian. 

“They have fiber, bran, whole grains, and they also have sugar, and additives,” he said. “But on average, putting all those things together, this study suggested that the net effect is beneficial. That doesn’t mean they couldn’t be more beneficial if we made them less processed, but they don’t seem to have harm.”

The active probiotics and fermentation in yogurt can make it a healthy snack of choice, as there has been more and more research showing that fermented foods with probiotics are good for heart health and work against metabolic disease, or a cluster of conditions that can increase the risk of stroke, heart disease, and type 2 diabetes, Dr. Mozaffarian said.

Savory snacks, cereals, and yogurt and dairy-based desserts may also be less calorie dense than sugary beverages and processed meats, said Dr. Daibes. 

“Additionally, the type of fat used in savory snacks and the presence of probiotics in yogurt may have neutral or even positive effects on heart health, as opposed to the harmful fats and additives found in many ultra-processed foods,” he said.
 

How Ultra-Processed Foods Can Harm Your Health 

There are “clear and concerning links” between eating ultra-processed foods and getting heart disease, according to Dr. Daibes. “In real-life clinical practice, it’s a rather clear and straightforward relationship – the patients who tend to have poorer diets, with more ultra-processed and nutrient-barren foods, tend to have worse health outcomes, both cardiovascular and otherwise.”

Processing foods is centered on breaking down the natural structures of foods, as well as the loss of their natural nutrients, Dr. Mozaffarian explained. When you include the word “ultra,” this refers to putting in industrial additives.

“I think refined starches (such as wheat, corn, and rice) and sugars are some of the biggest harms because it leads to a big spike in blood glucose,” Dr. Mozaffarian said. “But also, those refined starches and sugars are digested so quickly in the stomach and small intestine that you starve your gut bacteria in your large intestines.” 

Many “good-for-you ingredients,” such as fermentable fibers and bio-active compounds, are found in unprocessed, whole foods like fruits, vegetables, nuts, beans, and seeds, noted Dr. Mozaffarian. High levels of salt in ultra-processed foods are another cause for concern, as are other additives such as artificial flavorings, sweeteners, and thickeners. 
 

Opting for Whole Foods

There may be people looking to eat cleaner, unprocessed foods, but high cost and a lack of access to them could create challenges. Dr. Sarraju advises his patients to simply do their best to eat foods in their whole-ingredient form and avoid prepackaged foods as much as possible.

A version of this article first appeared on WebMD.com.

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You may have been warned that ultra-processed foods can wreak havoc on your health. But not all of them are created equal. 

A new study out of The Lancet Regional Health – Americas looked at different types of ultra-processed foods and found that some were even linked with lower risks of cardiovascular diseasecoronary heart disease, and stroke

“Avoiding all ultra-processed foods is not practical for most people,” said Dariush Mozaffarian, MD, a cardiologist, public health scientist, and director of the Food is Medicine Institute at Tufts University in Boston, Massachusetts. “So, it is helpful to start to understand, within the category of all processing, what food might be more or less harmful.”

Researchers analyzed food questionnaires from three large groups of US adults, with most people in their review being White and female. The study found that sugary and artificially sweetened drinks, along with processed meats, were linked to a greater risk of cardiovascular disease and coronary heart disease. But cereals, savory snacks, and yogurt and dairy-based desserts were linked to a lower risk of these diseases. Ultra-processed cereals and breads were also linked to a lower stroke risk. 
 

The Truth About Processed Meat

Studies show that cured, salted, or smoked meats are linked to certain cancers.

“We know that sugar-sweetened beverages are associated with metabolic derangement for things like higher glucose levels, insulin resistance, visceral obesityprediabetesdiabetes, and higher triglycerides,” said Ashish Sarraju, MD, a cardiologist with the Cleveland Clinic in Ohio. “Added sugars associated with all of those things are in turn risk factors for heart disease.” Sugar-sweetened beverages are often very high in sugar, artificial colors, and other additives, and almost “nothing beneficial” in terms of ingredients, Dr. Mozaffarian said. “They’re also consumed in very high doses, very quickly.”

Processed meats have 400% higher levels of salt, compared with unprocessed meats, said Dr. Mozaffarian. They also contain high levels of added nitrates, which are a carcinogen that could also affect the heart and blood vessels. Certain ultra-processed foods, such as bacon, are often fried at sky-high temperatures, which can trigger inflammatory compounds. 

“If you put together the inflammatory effects, the salt, and the nitrates, this is a package of food that can really build to cause harm,” said Dr. Mozaffarian. The World Health Organization has also classified processed meats (bacon, ham, salami) as a group one carcinogen, he noted.

“Processed meats are typically high in saturated fats, sodium, and preservatives, which can increase blood pressure, promote inflammation, and negatively affect cholesterol levels, leading to a higher risk of coronary heart disease, said Joseph A. Daibes, DO, an interventional cardiologist at Lenox Hill Hospital, New York City. “The study underscores the importance of limiting these types of foods to reduce cardiovascular risk.”

But considering that breakfast cereals – albeit highly processed – are a top source of whole grains for Americans, it makes sense that they are linked with lower risk of heart disease, said Dr. Mozaffarian. 

“They have fiber, bran, whole grains, and they also have sugar, and additives,” he said. “But on average, putting all those things together, this study suggested that the net effect is beneficial. That doesn’t mean they couldn’t be more beneficial if we made them less processed, but they don’t seem to have harm.”

The active probiotics and fermentation in yogurt can make it a healthy snack of choice, as there has been more and more research showing that fermented foods with probiotics are good for heart health and work against metabolic disease, or a cluster of conditions that can increase the risk of stroke, heart disease, and type 2 diabetes, Dr. Mozaffarian said.

Savory snacks, cereals, and yogurt and dairy-based desserts may also be less calorie dense than sugary beverages and processed meats, said Dr. Daibes. 

“Additionally, the type of fat used in savory snacks and the presence of probiotics in yogurt may have neutral or even positive effects on heart health, as opposed to the harmful fats and additives found in many ultra-processed foods,” he said.
 

How Ultra-Processed Foods Can Harm Your Health 

There are “clear and concerning links” between eating ultra-processed foods and getting heart disease, according to Dr. Daibes. “In real-life clinical practice, it’s a rather clear and straightforward relationship – the patients who tend to have poorer diets, with more ultra-processed and nutrient-barren foods, tend to have worse health outcomes, both cardiovascular and otherwise.”

Processing foods is centered on breaking down the natural structures of foods, as well as the loss of their natural nutrients, Dr. Mozaffarian explained. When you include the word “ultra,” this refers to putting in industrial additives.

“I think refined starches (such as wheat, corn, and rice) and sugars are some of the biggest harms because it leads to a big spike in blood glucose,” Dr. Mozaffarian said. “But also, those refined starches and sugars are digested so quickly in the stomach and small intestine that you starve your gut bacteria in your large intestines.” 

Many “good-for-you ingredients,” such as fermentable fibers and bio-active compounds, are found in unprocessed, whole foods like fruits, vegetables, nuts, beans, and seeds, noted Dr. Mozaffarian. High levels of salt in ultra-processed foods are another cause for concern, as are other additives such as artificial flavorings, sweeteners, and thickeners. 
 

Opting for Whole Foods

There may be people looking to eat cleaner, unprocessed foods, but high cost and a lack of access to them could create challenges. Dr. Sarraju advises his patients to simply do their best to eat foods in their whole-ingredient form and avoid prepackaged foods as much as possible.

A version of this article first appeared on WebMD.com.

 

You may have been warned that ultra-processed foods can wreak havoc on your health. But not all of them are created equal. 

A new study out of The Lancet Regional Health – Americas looked at different types of ultra-processed foods and found that some were even linked with lower risks of cardiovascular diseasecoronary heart disease, and stroke

“Avoiding all ultra-processed foods is not practical for most people,” said Dariush Mozaffarian, MD, a cardiologist, public health scientist, and director of the Food is Medicine Institute at Tufts University in Boston, Massachusetts. “So, it is helpful to start to understand, within the category of all processing, what food might be more or less harmful.”

Researchers analyzed food questionnaires from three large groups of US adults, with most people in their review being White and female. The study found that sugary and artificially sweetened drinks, along with processed meats, were linked to a greater risk of cardiovascular disease and coronary heart disease. But cereals, savory snacks, and yogurt and dairy-based desserts were linked to a lower risk of these diseases. Ultra-processed cereals and breads were also linked to a lower stroke risk. 
 

The Truth About Processed Meat

Studies show that cured, salted, or smoked meats are linked to certain cancers.

“We know that sugar-sweetened beverages are associated with metabolic derangement for things like higher glucose levels, insulin resistance, visceral obesityprediabetesdiabetes, and higher triglycerides,” said Ashish Sarraju, MD, a cardiologist with the Cleveland Clinic in Ohio. “Added sugars associated with all of those things are in turn risk factors for heart disease.” Sugar-sweetened beverages are often very high in sugar, artificial colors, and other additives, and almost “nothing beneficial” in terms of ingredients, Dr. Mozaffarian said. “They’re also consumed in very high doses, very quickly.”

Processed meats have 400% higher levels of salt, compared with unprocessed meats, said Dr. Mozaffarian. They also contain high levels of added nitrates, which are a carcinogen that could also affect the heart and blood vessels. Certain ultra-processed foods, such as bacon, are often fried at sky-high temperatures, which can trigger inflammatory compounds. 

“If you put together the inflammatory effects, the salt, and the nitrates, this is a package of food that can really build to cause harm,” said Dr. Mozaffarian. The World Health Organization has also classified processed meats (bacon, ham, salami) as a group one carcinogen, he noted.

“Processed meats are typically high in saturated fats, sodium, and preservatives, which can increase blood pressure, promote inflammation, and negatively affect cholesterol levels, leading to a higher risk of coronary heart disease, said Joseph A. Daibes, DO, an interventional cardiologist at Lenox Hill Hospital, New York City. “The study underscores the importance of limiting these types of foods to reduce cardiovascular risk.”

But considering that breakfast cereals – albeit highly processed – are a top source of whole grains for Americans, it makes sense that they are linked with lower risk of heart disease, said Dr. Mozaffarian. 

“They have fiber, bran, whole grains, and they also have sugar, and additives,” he said. “But on average, putting all those things together, this study suggested that the net effect is beneficial. That doesn’t mean they couldn’t be more beneficial if we made them less processed, but they don’t seem to have harm.”

The active probiotics and fermentation in yogurt can make it a healthy snack of choice, as there has been more and more research showing that fermented foods with probiotics are good for heart health and work against metabolic disease, or a cluster of conditions that can increase the risk of stroke, heart disease, and type 2 diabetes, Dr. Mozaffarian said.

Savory snacks, cereals, and yogurt and dairy-based desserts may also be less calorie dense than sugary beverages and processed meats, said Dr. Daibes. 

“Additionally, the type of fat used in savory snacks and the presence of probiotics in yogurt may have neutral or even positive effects on heart health, as opposed to the harmful fats and additives found in many ultra-processed foods,” he said.
 

How Ultra-Processed Foods Can Harm Your Health 

There are “clear and concerning links” between eating ultra-processed foods and getting heart disease, according to Dr. Daibes. “In real-life clinical practice, it’s a rather clear and straightforward relationship – the patients who tend to have poorer diets, with more ultra-processed and nutrient-barren foods, tend to have worse health outcomes, both cardiovascular and otherwise.”

Processing foods is centered on breaking down the natural structures of foods, as well as the loss of their natural nutrients, Dr. Mozaffarian explained. When you include the word “ultra,” this refers to putting in industrial additives.

“I think refined starches (such as wheat, corn, and rice) and sugars are some of the biggest harms because it leads to a big spike in blood glucose,” Dr. Mozaffarian said. “But also, those refined starches and sugars are digested so quickly in the stomach and small intestine that you starve your gut bacteria in your large intestines.” 

Many “good-for-you ingredients,” such as fermentable fibers and bio-active compounds, are found in unprocessed, whole foods like fruits, vegetables, nuts, beans, and seeds, noted Dr. Mozaffarian. High levels of salt in ultra-processed foods are another cause for concern, as are other additives such as artificial flavorings, sweeteners, and thickeners. 
 

Opting for Whole Foods

There may be people looking to eat cleaner, unprocessed foods, but high cost and a lack of access to them could create challenges. Dr. Sarraju advises his patients to simply do their best to eat foods in their whole-ingredient form and avoid prepackaged foods as much as possible.

A version of this article first appeared on WebMD.com.

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Beyond Weight Loss, Limited Bariatric Surgery Benefits in Older Adults

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Thu, 09/12/2024 - 12:53

 

TOPLINE:

For older adults with obesity, bariatric surgery does not appear to significantly reduce the risk for obesity-related cancer and cardiovascular disease (CVD), as it does in younger adults.

METHODOLOGY:

  • Bariatric surgery has been shown to decrease the risk for obesity-related cancer and CVD but is typically reserved for patients aged < 60 years. Whether the same holds for patients who undergo surgery at older ages is unclear.
  • Researchers analyzed nationwide data from three countries (Denmark, Finland, and Sweden) to compare patients with no history of cancer or CVD and age ≥ 60 years who underwent bariatric surgery against matched controls who received nonoperative treatment for obesity.
  • The main outcome was obesity-related cancer, defined as a composite outcome of breast, endometrial, esophageal, colorectal, and kidney cancer. The secondary outcome was CVD, defined as a composite of myocardial infarction, ischemic stroke, and cerebral hemorrhage.
  • Analyses were adjusted for diabetes, hypertension, peripheral vascular disease, chronic obstructive pulmonary disease, kidney disease, and frailty.

TAKEAWAY:

  • Of the 15,300 patients (66.4% women) included, 2550 underwent bariatric surgery (including gastric bypass in 1930) and 12,750 matched controls received nonoperative treatment for obesity.
  • During a median 5.8 years of follow-up, 658 (4.3%) people developed obesity-related cancer and 1436 (9.4%) developed CVD.
  • Bariatric surgery in adults aged ≥ 60 years was not associated with a reduced risk for obesity-related cancer (hazard ratio [HR], 0.81) or CVD (HR, 0.86) compared with matched nonoperative controls.
  • Bariatric surgery appeared to be associated with a decreased risk for obesity-related cancer in women (HR, 0.76).
  • There was a decreased risk for both obesity-related cancer (HR, 0.74) and CVD (HR, 0.82) in patients who underwent gastric bypass.

IN PRACTICE:

“The findings from this study suggest a limited role of bariatric surgery in older patients for the prevention of obesity-related cancer or cardiovascular disease,” the authors wrote, noting that this “may be explained by the poorer weight loss and resolution of comorbidities observed in patients who underwent surgery at an older age.”

SOURCE:

The study, with first author Peter Gerber, MD, PhD, Department of Surgery, Capio St Göran’s Hospital, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

Data on smoking status and body mass index were not available. The observational design limited the ability to draw causal inferences. The null association between bariatric surgery and outcomes may be due to limited power.

DISCLOSURES:

The study was funded by the Swedish Society of Medicine. The authors reported no conflicts of interest.

A version of this article first appeared on Medscape.com.

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TOPLINE:

For older adults with obesity, bariatric surgery does not appear to significantly reduce the risk for obesity-related cancer and cardiovascular disease (CVD), as it does in younger adults.

METHODOLOGY:

  • Bariatric surgery has been shown to decrease the risk for obesity-related cancer and CVD but is typically reserved for patients aged < 60 years. Whether the same holds for patients who undergo surgery at older ages is unclear.
  • Researchers analyzed nationwide data from three countries (Denmark, Finland, and Sweden) to compare patients with no history of cancer or CVD and age ≥ 60 years who underwent bariatric surgery against matched controls who received nonoperative treatment for obesity.
  • The main outcome was obesity-related cancer, defined as a composite outcome of breast, endometrial, esophageal, colorectal, and kidney cancer. The secondary outcome was CVD, defined as a composite of myocardial infarction, ischemic stroke, and cerebral hemorrhage.
  • Analyses were adjusted for diabetes, hypertension, peripheral vascular disease, chronic obstructive pulmonary disease, kidney disease, and frailty.

TAKEAWAY:

  • Of the 15,300 patients (66.4% women) included, 2550 underwent bariatric surgery (including gastric bypass in 1930) and 12,750 matched controls received nonoperative treatment for obesity.
  • During a median 5.8 years of follow-up, 658 (4.3%) people developed obesity-related cancer and 1436 (9.4%) developed CVD.
  • Bariatric surgery in adults aged ≥ 60 years was not associated with a reduced risk for obesity-related cancer (hazard ratio [HR], 0.81) or CVD (HR, 0.86) compared with matched nonoperative controls.
  • Bariatric surgery appeared to be associated with a decreased risk for obesity-related cancer in women (HR, 0.76).
  • There was a decreased risk for both obesity-related cancer (HR, 0.74) and CVD (HR, 0.82) in patients who underwent gastric bypass.

IN PRACTICE:

“The findings from this study suggest a limited role of bariatric surgery in older patients for the prevention of obesity-related cancer or cardiovascular disease,” the authors wrote, noting that this “may be explained by the poorer weight loss and resolution of comorbidities observed in patients who underwent surgery at an older age.”

SOURCE:

The study, with first author Peter Gerber, MD, PhD, Department of Surgery, Capio St Göran’s Hospital, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

Data on smoking status and body mass index were not available. The observational design limited the ability to draw causal inferences. The null association between bariatric surgery and outcomes may be due to limited power.

DISCLOSURES:

The study was funded by the Swedish Society of Medicine. The authors reported no conflicts of interest.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

For older adults with obesity, bariatric surgery does not appear to significantly reduce the risk for obesity-related cancer and cardiovascular disease (CVD), as it does in younger adults.

METHODOLOGY:

  • Bariatric surgery has been shown to decrease the risk for obesity-related cancer and CVD but is typically reserved for patients aged < 60 years. Whether the same holds for patients who undergo surgery at older ages is unclear.
  • Researchers analyzed nationwide data from three countries (Denmark, Finland, and Sweden) to compare patients with no history of cancer or CVD and age ≥ 60 years who underwent bariatric surgery against matched controls who received nonoperative treatment for obesity.
  • The main outcome was obesity-related cancer, defined as a composite outcome of breast, endometrial, esophageal, colorectal, and kidney cancer. The secondary outcome was CVD, defined as a composite of myocardial infarction, ischemic stroke, and cerebral hemorrhage.
  • Analyses were adjusted for diabetes, hypertension, peripheral vascular disease, chronic obstructive pulmonary disease, kidney disease, and frailty.

TAKEAWAY:

  • Of the 15,300 patients (66.4% women) included, 2550 underwent bariatric surgery (including gastric bypass in 1930) and 12,750 matched controls received nonoperative treatment for obesity.
  • During a median 5.8 years of follow-up, 658 (4.3%) people developed obesity-related cancer and 1436 (9.4%) developed CVD.
  • Bariatric surgery in adults aged ≥ 60 years was not associated with a reduced risk for obesity-related cancer (hazard ratio [HR], 0.81) or CVD (HR, 0.86) compared with matched nonoperative controls.
  • Bariatric surgery appeared to be associated with a decreased risk for obesity-related cancer in women (HR, 0.76).
  • There was a decreased risk for both obesity-related cancer (HR, 0.74) and CVD (HR, 0.82) in patients who underwent gastric bypass.

IN PRACTICE:

“The findings from this study suggest a limited role of bariatric surgery in older patients for the prevention of obesity-related cancer or cardiovascular disease,” the authors wrote, noting that this “may be explained by the poorer weight loss and resolution of comorbidities observed in patients who underwent surgery at an older age.”

SOURCE:

The study, with first author Peter Gerber, MD, PhD, Department of Surgery, Capio St Göran’s Hospital, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

Data on smoking status and body mass index were not available. The observational design limited the ability to draw causal inferences. The null association between bariatric surgery and outcomes may be due to limited power.

DISCLOSURES:

The study was funded by the Swedish Society of Medicine. The authors reported no conflicts of interest.

A version of this article first appeared on Medscape.com.

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Old, Frail Patients: Study More, Intervene Less?

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Thu, 09/12/2024 - 12:21

Lessons From SENIOR-RITA

 

The ability to save cardiac muscle during an acute coronary syndrome with percutaneous coronary intervention (PCI) made cardiology one of the most popular fields in medicine.

But acute coronary syndromes come in different categories. While rapid PCI clearly benefits patients with ST-segment elevation myocardial infarction (STEMI), the best use of angiography and PCI for patients with non–ST-segment elevation myocardial infarction (NSTEMI) is more complex.

The evidence for early invasive vs conservative strategies in patients with NSTEMI is mixed. There have been many trials and meta-analyses, and generally, outcomes are similar with either approach. Perhaps if one looks with enough optimism, there is a benefit for the more aggressive approach in higher-risk patients.

Despite the similar outcomes with the two strategies, most patients are treated with the early invasive approach. Early and invasive fit the spirit of modern cardiology.

Yet, older patients with acute coronary syndromes present a different challenge. NSTEMI trials, like most trials, enrolled mostly younger adults. 

Whether evidence obtained in young people applies to older patients is one of the most common and important questions in all of medical practice. Older patients may be at higher risk for a primary outcome, but they also have greater risks for harm from therapy as well as more competing causes of morbidity and mortality. 

Only a handful of smaller trials have enrolled older patients with NSTEMI. These trials have produced little evidence that an early invasive approach should be preferred.
 

The SENIOR-RITA Trial

At ESC, Vijay Kunadian, MD, from Newcastle, England, presented results of SENIOR-RITA, a large trial comparing an invasive vs conservative strategy in NSTEMI patients 75 years of age or older. 

In the conservative arm, coronary angiography was allowed if the patient deteriorated and the procedure was clinically indicated in the judgment of the treating physicians.

Slightly more than 1500 patients with NSTEMI were randomly assigned to either strategy in 48 centers in the United Kingdom. Their mean age was 82 years, nearly half were women, and about a third were frail. 

Over 4 years of follow-up, the primary outcome of cardiovascular (CV) death or MI occurred at a similar rate in both arms: 25.6% vs 26.3% for invasive vs conservative, respectively (HR, 0.94; 95% CI, 0.77-1.14; P =.53). 

Rates of CV death were also not significantly different (15.8% vs 14.2%; HR, 1.11; 95% CI, 0.86-1.44). 

The rate of nonfatal MI was slightly lower in the invasive arm (11.7% vs 15.0%; HR, 0.75; 95% CI, 0.57-0.99).

Some other notable findings: Fewer than half of patients in the invasive arm underwent revascularization. Coronary angiography was done in about a quarter of patients in the conservative arm, and revascularization in only 14%. 

 

Comments

Because medicine has improved and patients live longer, cardiologists increasingly see older adults with frailty. It’s important to study these patients. 

The authors tell us that 1 in 5 patients screened were enrolled, and those not enrolled were similar in age and were treated nearly equally with either strategy. Not all trials offer this information; it’s important because knowing that patients in a trial are representative helps us translate evidence to our actual patients. 

Another positive was the investigators’ smart choice of cardiovascular death and MI as their primary outcome. Strategy trials are usually open label. If they had included an outcome that requires a decision from a clinician, such as unplanned revascularization, then bias becomes a possibility when patients and clinicians are aware of the treatment assignment. (I wrote about poor endpoint choice in the ABYSS trial.) 

The most notable finding in SENIOR-RITA was that approximately 76% of patients in the conservative arm did not have a coronary angiogram and 86% were not revascularized. 

Yet, the rate of CV death and MI were similar during 4 years of follow-up. This observation is nearly identical to the findings in chronic stable disease, seen in the ISCHEMIA trial. (See Figure 6a in the paper’s supplement.) 

I take two messages from this consistent observation: One is that medical therapy is quite good at treating coronary artery disease not associated with acute vessel closure in STEMI. 

The other is that using coronary angiography and revascularization as a bailout, in only a fraction of cases, achieves the same result, so the conservative strategy should be preferred.

I am not sure that the SENIOR-RITA researchers see it this way. They write in their discussion that “clinicians are often reluctant to offer an invasive strategy to frail older adults.” They then remind readers that modern PCI techniques (radial approach) have low rates of adverse events. 

Perhaps I misread their message, but that paragraph seemed like it was reinforcing our tendency to offer invasive approaches to patients with NSTEMI. 

I feel differently. When a trial reports similar outcomes with two strategies, I think we should favor the one with less intervention. I feel even more strongly about this philosophy in older patients with frailty.

Are we not in the business of helping people with the least amount of intervention?

The greatest challenge for the cardiologist of today is not a lack of treatment options, but whether we should use all options in older, frailer adults. 

Good on the SENIOR-RITA investigators, for they have shown that we can avoid intervention in the vast majority of older adults presenting with NSTEMI. 

Dr. Mandrola practices cardiac electrophysiology in Louisville, Kentucky, and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Lessons From SENIOR-RITA

Lessons From SENIOR-RITA

 

The ability to save cardiac muscle during an acute coronary syndrome with percutaneous coronary intervention (PCI) made cardiology one of the most popular fields in medicine.

But acute coronary syndromes come in different categories. While rapid PCI clearly benefits patients with ST-segment elevation myocardial infarction (STEMI), the best use of angiography and PCI for patients with non–ST-segment elevation myocardial infarction (NSTEMI) is more complex.

The evidence for early invasive vs conservative strategies in patients with NSTEMI is mixed. There have been many trials and meta-analyses, and generally, outcomes are similar with either approach. Perhaps if one looks with enough optimism, there is a benefit for the more aggressive approach in higher-risk patients.

Despite the similar outcomes with the two strategies, most patients are treated with the early invasive approach. Early and invasive fit the spirit of modern cardiology.

Yet, older patients with acute coronary syndromes present a different challenge. NSTEMI trials, like most trials, enrolled mostly younger adults. 

Whether evidence obtained in young people applies to older patients is one of the most common and important questions in all of medical practice. Older patients may be at higher risk for a primary outcome, but they also have greater risks for harm from therapy as well as more competing causes of morbidity and mortality. 

Only a handful of smaller trials have enrolled older patients with NSTEMI. These trials have produced little evidence that an early invasive approach should be preferred.
 

The SENIOR-RITA Trial

At ESC, Vijay Kunadian, MD, from Newcastle, England, presented results of SENIOR-RITA, a large trial comparing an invasive vs conservative strategy in NSTEMI patients 75 years of age or older. 

In the conservative arm, coronary angiography was allowed if the patient deteriorated and the procedure was clinically indicated in the judgment of the treating physicians.

Slightly more than 1500 patients with NSTEMI were randomly assigned to either strategy in 48 centers in the United Kingdom. Their mean age was 82 years, nearly half were women, and about a third were frail. 

Over 4 years of follow-up, the primary outcome of cardiovascular (CV) death or MI occurred at a similar rate in both arms: 25.6% vs 26.3% for invasive vs conservative, respectively (HR, 0.94; 95% CI, 0.77-1.14; P =.53). 

Rates of CV death were also not significantly different (15.8% vs 14.2%; HR, 1.11; 95% CI, 0.86-1.44). 

The rate of nonfatal MI was slightly lower in the invasive arm (11.7% vs 15.0%; HR, 0.75; 95% CI, 0.57-0.99).

Some other notable findings: Fewer than half of patients in the invasive arm underwent revascularization. Coronary angiography was done in about a quarter of patients in the conservative arm, and revascularization in only 14%. 

 

Comments

Because medicine has improved and patients live longer, cardiologists increasingly see older adults with frailty. It’s important to study these patients. 

The authors tell us that 1 in 5 patients screened were enrolled, and those not enrolled were similar in age and were treated nearly equally with either strategy. Not all trials offer this information; it’s important because knowing that patients in a trial are representative helps us translate evidence to our actual patients. 

Another positive was the investigators’ smart choice of cardiovascular death and MI as their primary outcome. Strategy trials are usually open label. If they had included an outcome that requires a decision from a clinician, such as unplanned revascularization, then bias becomes a possibility when patients and clinicians are aware of the treatment assignment. (I wrote about poor endpoint choice in the ABYSS trial.) 

The most notable finding in SENIOR-RITA was that approximately 76% of patients in the conservative arm did not have a coronary angiogram and 86% were not revascularized. 

Yet, the rate of CV death and MI were similar during 4 years of follow-up. This observation is nearly identical to the findings in chronic stable disease, seen in the ISCHEMIA trial. (See Figure 6a in the paper’s supplement.) 

I take two messages from this consistent observation: One is that medical therapy is quite good at treating coronary artery disease not associated with acute vessel closure in STEMI. 

The other is that using coronary angiography and revascularization as a bailout, in only a fraction of cases, achieves the same result, so the conservative strategy should be preferred.

I am not sure that the SENIOR-RITA researchers see it this way. They write in their discussion that “clinicians are often reluctant to offer an invasive strategy to frail older adults.” They then remind readers that modern PCI techniques (radial approach) have low rates of adverse events. 

Perhaps I misread their message, but that paragraph seemed like it was reinforcing our tendency to offer invasive approaches to patients with NSTEMI. 

I feel differently. When a trial reports similar outcomes with two strategies, I think we should favor the one with less intervention. I feel even more strongly about this philosophy in older patients with frailty.

Are we not in the business of helping people with the least amount of intervention?

The greatest challenge for the cardiologist of today is not a lack of treatment options, but whether we should use all options in older, frailer adults. 

Good on the SENIOR-RITA investigators, for they have shown that we can avoid intervention in the vast majority of older adults presenting with NSTEMI. 

Dr. Mandrola practices cardiac electrophysiology in Louisville, Kentucky, and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

 

The ability to save cardiac muscle during an acute coronary syndrome with percutaneous coronary intervention (PCI) made cardiology one of the most popular fields in medicine.

But acute coronary syndromes come in different categories. While rapid PCI clearly benefits patients with ST-segment elevation myocardial infarction (STEMI), the best use of angiography and PCI for patients with non–ST-segment elevation myocardial infarction (NSTEMI) is more complex.

The evidence for early invasive vs conservative strategies in patients with NSTEMI is mixed. There have been many trials and meta-analyses, and generally, outcomes are similar with either approach. Perhaps if one looks with enough optimism, there is a benefit for the more aggressive approach in higher-risk patients.

Despite the similar outcomes with the two strategies, most patients are treated with the early invasive approach. Early and invasive fit the spirit of modern cardiology.

Yet, older patients with acute coronary syndromes present a different challenge. NSTEMI trials, like most trials, enrolled mostly younger adults. 

Whether evidence obtained in young people applies to older patients is one of the most common and important questions in all of medical practice. Older patients may be at higher risk for a primary outcome, but they also have greater risks for harm from therapy as well as more competing causes of morbidity and mortality. 

Only a handful of smaller trials have enrolled older patients with NSTEMI. These trials have produced little evidence that an early invasive approach should be preferred.
 

The SENIOR-RITA Trial

At ESC, Vijay Kunadian, MD, from Newcastle, England, presented results of SENIOR-RITA, a large trial comparing an invasive vs conservative strategy in NSTEMI patients 75 years of age or older. 

In the conservative arm, coronary angiography was allowed if the patient deteriorated and the procedure was clinically indicated in the judgment of the treating physicians.

Slightly more than 1500 patients with NSTEMI were randomly assigned to either strategy in 48 centers in the United Kingdom. Their mean age was 82 years, nearly half were women, and about a third were frail. 

Over 4 years of follow-up, the primary outcome of cardiovascular (CV) death or MI occurred at a similar rate in both arms: 25.6% vs 26.3% for invasive vs conservative, respectively (HR, 0.94; 95% CI, 0.77-1.14; P =.53). 

Rates of CV death were also not significantly different (15.8% vs 14.2%; HR, 1.11; 95% CI, 0.86-1.44). 

The rate of nonfatal MI was slightly lower in the invasive arm (11.7% vs 15.0%; HR, 0.75; 95% CI, 0.57-0.99).

Some other notable findings: Fewer than half of patients in the invasive arm underwent revascularization. Coronary angiography was done in about a quarter of patients in the conservative arm, and revascularization in only 14%. 

 

Comments

Because medicine has improved and patients live longer, cardiologists increasingly see older adults with frailty. It’s important to study these patients. 

The authors tell us that 1 in 5 patients screened were enrolled, and those not enrolled were similar in age and were treated nearly equally with either strategy. Not all trials offer this information; it’s important because knowing that patients in a trial are representative helps us translate evidence to our actual patients. 

Another positive was the investigators’ smart choice of cardiovascular death and MI as their primary outcome. Strategy trials are usually open label. If they had included an outcome that requires a decision from a clinician, such as unplanned revascularization, then bias becomes a possibility when patients and clinicians are aware of the treatment assignment. (I wrote about poor endpoint choice in the ABYSS trial.) 

The most notable finding in SENIOR-RITA was that approximately 76% of patients in the conservative arm did not have a coronary angiogram and 86% were not revascularized. 

Yet, the rate of CV death and MI were similar during 4 years of follow-up. This observation is nearly identical to the findings in chronic stable disease, seen in the ISCHEMIA trial. (See Figure 6a in the paper’s supplement.) 

I take two messages from this consistent observation: One is that medical therapy is quite good at treating coronary artery disease not associated with acute vessel closure in STEMI. 

The other is that using coronary angiography and revascularization as a bailout, in only a fraction of cases, achieves the same result, so the conservative strategy should be preferred.

I am not sure that the SENIOR-RITA researchers see it this way. They write in their discussion that “clinicians are often reluctant to offer an invasive strategy to frail older adults.” They then remind readers that modern PCI techniques (radial approach) have low rates of adverse events. 

Perhaps I misread their message, but that paragraph seemed like it was reinforcing our tendency to offer invasive approaches to patients with NSTEMI. 

I feel differently. When a trial reports similar outcomes with two strategies, I think we should favor the one with less intervention. I feel even more strongly about this philosophy in older patients with frailty.

Are we not in the business of helping people with the least amount of intervention?

The greatest challenge for the cardiologist of today is not a lack of treatment options, but whether we should use all options in older, frailer adults. 

Good on the SENIOR-RITA investigators, for they have shown that we can avoid intervention in the vast majority of older adults presenting with NSTEMI. 

Dr. Mandrola practices cardiac electrophysiology in Louisville, Kentucky, and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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