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AMSTERDAM – In patients with acute ST-segment elevation myocardial infarction, stenting of significant coronary stenoses not responsible for the infarction as well as the infarct-producing lesion led to substantially better outcomes than an intervention that only targeted the infarct-related stenosis in a randomized, multicenter trial with 465 patients.
The results appeared to refute the prevailing recommendation from cardiology societies to limit the percutaneous coronary intervention (PCI) done during acute treatment of ST-segment elevation myocardial infarction (STEMI) to the infarct-related lesion, especially when the secondary lesions are not clearly causing ongoing hemodynamic instability.
The new findings "make it clear that preventive PCI is a better strategy than restricting a further intervention to those patients with refractory angina or a subsequent myocardial infarction," Dr. David S. Wald reported on Sept. 1 at the annual congress of the European Society of Cardiology. Simultaneous with Dr. Wald’s report, the results appeared in an article published online (N. Engl. J. Med. 2013 [doi:10.156/NEJMoa1305520]).
Current guidelines on management of STEMI recommend PCI for the infarct-related artery only (Eur. Heart J. 2012;33:2569-619; Circulation 2013;127:529-55), primarily because, until now, scant evidence existed that a different strategy helped patients. "This uncertainty has led to variations in practice, with some cardiologists performing immediate preventive PCI in spite of the guidelines, some delaying preventive PCI until recovery from the acute episode, and others limiting the procedure to patients with recurrent symptoms or evidence of ischemia," noted Dr. Wald, an interventional cardiologist at the Wolfson Institute of Preventive Medicine of the Queen Mary University of London.
Dr. Wald acknowledged, however, that his study did not address whether patients would be better served by a staged approach that delayed preventive PCI of significant, noninfarct related stenoses in a second PCI procedure, whether the benefits extend to treating noninfarct stenoses that occlude less than half of a coronary artery, and whether a similar strategy would help patients with non-ST–elevation MI (NSTEMI).
The Preventive Angioplasty in Acute Myocardial Infarction (PRAMI) trial enrolled consecutive patients of any age at five U.K. centers during April 2008 to January 2013. The study focused on STEMI patients because patients with a NSTEMI often do not have a clearly identifiable infarct-related artery. In addition, to qualify for entry, the patient’s infarct-related artery had to have been successfully treated by PCI and they had to have at least one other coronary artery with at least 50% stenosis judged treatable by PCI. Patients with coronary anatomy more appropriately treated with bypass surgery were excluded. The enrolled patients averaged 62 years of age, about three-quarters were men, and about 18% had diabetes. Roughly two-thirds had a second coronary artery with a greater than 50% stenosis, and the remaining patients had two coronary arteries with a significant lesion.
After successful treatment of the infarct-producing artery, patients with additional, significant lesions judged appropriate for PCI were randomized to either have their other significant lesions treated during the same procedure or to undergo no further intervention. This resulted in an average of 1.36 additional arteries undergoing PCI in the 234 patients randomized to the more aggressive protocol.
Following the PCI procedures, all patients received standard medical treatment: daily treatment with aspirin and a second antiplatelet drug, clopidogrel (Plavix), prasugrel (Effient), or ticagrelor (Brilinta). About 95% of patients in both study arms also received treatment with a statin, and about 90% received a beta-blocker and an angiotensin-converting enzyme inhibitor.
During an average follow-up of 23 months, the combined rate of death from cardiac causes, nonfatal MI, or refractory angina – the study’s primary endpoint – occurred in 9% of the patients randomized to immediate PCI of their noninfarct-related stenoses and in 23% of the 231 patients in the control arm, a statistically significant difference. The 14-percentage-point absolute reduction in endpoints translated into a 65% relative risk reduction. The rate of cardiac death or nonfatal MI was 5% in the patients who received added PCI while in the catheterization laboratory and 12% among those only treated in their infarct-related artery, also a statistically significant difference.
Additional analyses also showed statistically significantly lower rates of both nonfatal MI and refractory angina in the patients treated in multiple arteries when these endpoints were tallied individually and a strong trend toward fewer cardiac deaths in these patients as well. Kaplan-Meier analysis showed that the risk reduction in the preventive-PCI group was evident after 6 months of follow-up and then increased with continued follow-up.
These results were not materially affected by patient age, sex, diabetes status, infarct location, or the number of coronary arteries with significant stenoses. In addition, the complication rates, including procedure-related strokes, bleeding requiring transfusions or surgery, and contrast-induced nephropathy requiring dialysis, were similar in the two study arms.
The results were consistent with reports from two prior randomized trials that also assessed the value of preventive PCI in patients with acute STEMI, but in fewer patients. One of these prior studies involved a total of 69 patients (Int. J. Cardiovasc. Intervent. 2004;6:128-33), and the second enrolled a total of 214 patients (Heart 2010;96:662-7); both were limited by a lack of statistical power, and both relied on repeat revascularization as an endpoint, which may be subject to bias, Dr. Wald said.
Dr. Wald said that he a director for and shareholder in Polypill Ltd.
On Twitter @mitchelzoler
Based on this report from the PRAMI trial, we can no longer assume that secondary lesions in acute myocardial infarction are innocent until proven guilty.
It has been a core belief in interventional cardiology that percutaneous coronary intervention in noninfarct lesions does not prevent death and MI. Cardiologists have refrained from treating anything but the infarct lesion acutely, and they usually withhold further treatment unless a patient is symptomatic.
But patients with acute ST-segment elevation MI have a substantial risk for early, recurrent events, in contrast to patients with stable angina. Why? Coronary artery disease is accompanied by systemic abnormalities in coagulation, inflammation, and endothelial function, with multiple inflamed lesions. Patients with acute coronary syndrome have prominent, systemic derangements in these processes. The aggressive, acute treatment used in PRAMI may have stabilized these not-so-innocent lesions.
The PRAMI findings suggest that there are no healthy coronary arteries in a patient with acute STEMI. Does this mean that these patients need extensive revascularization? It is plausible that the risk from noninfarct lesions is independent of their hemodynamic severity.
The strategy employed in this study differs markedly from current practice. Guidelines have cautioned against treating multiple vessels during acute STEMI, particularly when the secondary sites are not clearly causing ongoing hemodynamic instability. The PRAMI results suggest that widening the scope of interventional therapy in acute STEMI patients is a promising new approach to management.
Dr. Laura Mauri is an interventional cardiologist at Brigham and Women’s Hospital, professor of medicine at Harvard University, and chief scientific officer of the Harvard Clinical Research Institute in Boston. She has been a consultant to Biotronik, has been on an advisory board of St. Jude, and she has received research grants from seven other drug or device-manufacturing companies. She made these comments in an editorial that accompanied the published version of the PRAMI report (N. Engl. J. Med. 2013 [doi:10.1056/NEJMe1309383]).
Based on this report from the PRAMI trial, we can no longer assume that secondary lesions in acute myocardial infarction are innocent until proven guilty.
It has been a core belief in interventional cardiology that percutaneous coronary intervention in noninfarct lesions does not prevent death and MI. Cardiologists have refrained from treating anything but the infarct lesion acutely, and they usually withhold further treatment unless a patient is symptomatic.
But patients with acute ST-segment elevation MI have a substantial risk for early, recurrent events, in contrast to patients with stable angina. Why? Coronary artery disease is accompanied by systemic abnormalities in coagulation, inflammation, and endothelial function, with multiple inflamed lesions. Patients with acute coronary syndrome have prominent, systemic derangements in these processes. The aggressive, acute treatment used in PRAMI may have stabilized these not-so-innocent lesions.
The PRAMI findings suggest that there are no healthy coronary arteries in a patient with acute STEMI. Does this mean that these patients need extensive revascularization? It is plausible that the risk from noninfarct lesions is independent of their hemodynamic severity.
The strategy employed in this study differs markedly from current practice. Guidelines have cautioned against treating multiple vessels during acute STEMI, particularly when the secondary sites are not clearly causing ongoing hemodynamic instability. The PRAMI results suggest that widening the scope of interventional therapy in acute STEMI patients is a promising new approach to management.
Dr. Laura Mauri is an interventional cardiologist at Brigham and Women’s Hospital, professor of medicine at Harvard University, and chief scientific officer of the Harvard Clinical Research Institute in Boston. She has been a consultant to Biotronik, has been on an advisory board of St. Jude, and she has received research grants from seven other drug or device-manufacturing companies. She made these comments in an editorial that accompanied the published version of the PRAMI report (N. Engl. J. Med. 2013 [doi:10.1056/NEJMe1309383]).
Based on this report from the PRAMI trial, we can no longer assume that secondary lesions in acute myocardial infarction are innocent until proven guilty.
It has been a core belief in interventional cardiology that percutaneous coronary intervention in noninfarct lesions does not prevent death and MI. Cardiologists have refrained from treating anything but the infarct lesion acutely, and they usually withhold further treatment unless a patient is symptomatic.
But patients with acute ST-segment elevation MI have a substantial risk for early, recurrent events, in contrast to patients with stable angina. Why? Coronary artery disease is accompanied by systemic abnormalities in coagulation, inflammation, and endothelial function, with multiple inflamed lesions. Patients with acute coronary syndrome have prominent, systemic derangements in these processes. The aggressive, acute treatment used in PRAMI may have stabilized these not-so-innocent lesions.
The PRAMI findings suggest that there are no healthy coronary arteries in a patient with acute STEMI. Does this mean that these patients need extensive revascularization? It is plausible that the risk from noninfarct lesions is independent of their hemodynamic severity.
The strategy employed in this study differs markedly from current practice. Guidelines have cautioned against treating multiple vessels during acute STEMI, particularly when the secondary sites are not clearly causing ongoing hemodynamic instability. The PRAMI results suggest that widening the scope of interventional therapy in acute STEMI patients is a promising new approach to management.
Dr. Laura Mauri is an interventional cardiologist at Brigham and Women’s Hospital, professor of medicine at Harvard University, and chief scientific officer of the Harvard Clinical Research Institute in Boston. She has been a consultant to Biotronik, has been on an advisory board of St. Jude, and she has received research grants from seven other drug or device-manufacturing companies. She made these comments in an editorial that accompanied the published version of the PRAMI report (N. Engl. J. Med. 2013 [doi:10.1056/NEJMe1309383]).
AMSTERDAM – In patients with acute ST-segment elevation myocardial infarction, stenting of significant coronary stenoses not responsible for the infarction as well as the infarct-producing lesion led to substantially better outcomes than an intervention that only targeted the infarct-related stenosis in a randomized, multicenter trial with 465 patients.
The results appeared to refute the prevailing recommendation from cardiology societies to limit the percutaneous coronary intervention (PCI) done during acute treatment of ST-segment elevation myocardial infarction (STEMI) to the infarct-related lesion, especially when the secondary lesions are not clearly causing ongoing hemodynamic instability.
The new findings "make it clear that preventive PCI is a better strategy than restricting a further intervention to those patients with refractory angina or a subsequent myocardial infarction," Dr. David S. Wald reported on Sept. 1 at the annual congress of the European Society of Cardiology. Simultaneous with Dr. Wald’s report, the results appeared in an article published online (N. Engl. J. Med. 2013 [doi:10.156/NEJMoa1305520]).
Current guidelines on management of STEMI recommend PCI for the infarct-related artery only (Eur. Heart J. 2012;33:2569-619; Circulation 2013;127:529-55), primarily because, until now, scant evidence existed that a different strategy helped patients. "This uncertainty has led to variations in practice, with some cardiologists performing immediate preventive PCI in spite of the guidelines, some delaying preventive PCI until recovery from the acute episode, and others limiting the procedure to patients with recurrent symptoms or evidence of ischemia," noted Dr. Wald, an interventional cardiologist at the Wolfson Institute of Preventive Medicine of the Queen Mary University of London.
Dr. Wald acknowledged, however, that his study did not address whether patients would be better served by a staged approach that delayed preventive PCI of significant, noninfarct related stenoses in a second PCI procedure, whether the benefits extend to treating noninfarct stenoses that occlude less than half of a coronary artery, and whether a similar strategy would help patients with non-ST–elevation MI (NSTEMI).
The Preventive Angioplasty in Acute Myocardial Infarction (PRAMI) trial enrolled consecutive patients of any age at five U.K. centers during April 2008 to January 2013. The study focused on STEMI patients because patients with a NSTEMI often do not have a clearly identifiable infarct-related artery. In addition, to qualify for entry, the patient’s infarct-related artery had to have been successfully treated by PCI and they had to have at least one other coronary artery with at least 50% stenosis judged treatable by PCI. Patients with coronary anatomy more appropriately treated with bypass surgery were excluded. The enrolled patients averaged 62 years of age, about three-quarters were men, and about 18% had diabetes. Roughly two-thirds had a second coronary artery with a greater than 50% stenosis, and the remaining patients had two coronary arteries with a significant lesion.
After successful treatment of the infarct-producing artery, patients with additional, significant lesions judged appropriate for PCI were randomized to either have their other significant lesions treated during the same procedure or to undergo no further intervention. This resulted in an average of 1.36 additional arteries undergoing PCI in the 234 patients randomized to the more aggressive protocol.
Following the PCI procedures, all patients received standard medical treatment: daily treatment with aspirin and a second antiplatelet drug, clopidogrel (Plavix), prasugrel (Effient), or ticagrelor (Brilinta). About 95% of patients in both study arms also received treatment with a statin, and about 90% received a beta-blocker and an angiotensin-converting enzyme inhibitor.
During an average follow-up of 23 months, the combined rate of death from cardiac causes, nonfatal MI, or refractory angina – the study’s primary endpoint – occurred in 9% of the patients randomized to immediate PCI of their noninfarct-related stenoses and in 23% of the 231 patients in the control arm, a statistically significant difference. The 14-percentage-point absolute reduction in endpoints translated into a 65% relative risk reduction. The rate of cardiac death or nonfatal MI was 5% in the patients who received added PCI while in the catheterization laboratory and 12% among those only treated in their infarct-related artery, also a statistically significant difference.
Additional analyses also showed statistically significantly lower rates of both nonfatal MI and refractory angina in the patients treated in multiple arteries when these endpoints were tallied individually and a strong trend toward fewer cardiac deaths in these patients as well. Kaplan-Meier analysis showed that the risk reduction in the preventive-PCI group was evident after 6 months of follow-up and then increased with continued follow-up.
These results were not materially affected by patient age, sex, diabetes status, infarct location, or the number of coronary arteries with significant stenoses. In addition, the complication rates, including procedure-related strokes, bleeding requiring transfusions or surgery, and contrast-induced nephropathy requiring dialysis, were similar in the two study arms.
The results were consistent with reports from two prior randomized trials that also assessed the value of preventive PCI in patients with acute STEMI, but in fewer patients. One of these prior studies involved a total of 69 patients (Int. J. Cardiovasc. Intervent. 2004;6:128-33), and the second enrolled a total of 214 patients (Heart 2010;96:662-7); both were limited by a lack of statistical power, and both relied on repeat revascularization as an endpoint, which may be subject to bias, Dr. Wald said.
Dr. Wald said that he a director for and shareholder in Polypill Ltd.
On Twitter @mitchelzoler
AMSTERDAM – In patients with acute ST-segment elevation myocardial infarction, stenting of significant coronary stenoses not responsible for the infarction as well as the infarct-producing lesion led to substantially better outcomes than an intervention that only targeted the infarct-related stenosis in a randomized, multicenter trial with 465 patients.
The results appeared to refute the prevailing recommendation from cardiology societies to limit the percutaneous coronary intervention (PCI) done during acute treatment of ST-segment elevation myocardial infarction (STEMI) to the infarct-related lesion, especially when the secondary lesions are not clearly causing ongoing hemodynamic instability.
The new findings "make it clear that preventive PCI is a better strategy than restricting a further intervention to those patients with refractory angina or a subsequent myocardial infarction," Dr. David S. Wald reported on Sept. 1 at the annual congress of the European Society of Cardiology. Simultaneous with Dr. Wald’s report, the results appeared in an article published online (N. Engl. J. Med. 2013 [doi:10.156/NEJMoa1305520]).
Current guidelines on management of STEMI recommend PCI for the infarct-related artery only (Eur. Heart J. 2012;33:2569-619; Circulation 2013;127:529-55), primarily because, until now, scant evidence existed that a different strategy helped patients. "This uncertainty has led to variations in practice, with some cardiologists performing immediate preventive PCI in spite of the guidelines, some delaying preventive PCI until recovery from the acute episode, and others limiting the procedure to patients with recurrent symptoms or evidence of ischemia," noted Dr. Wald, an interventional cardiologist at the Wolfson Institute of Preventive Medicine of the Queen Mary University of London.
Dr. Wald acknowledged, however, that his study did not address whether patients would be better served by a staged approach that delayed preventive PCI of significant, noninfarct related stenoses in a second PCI procedure, whether the benefits extend to treating noninfarct stenoses that occlude less than half of a coronary artery, and whether a similar strategy would help patients with non-ST–elevation MI (NSTEMI).
The Preventive Angioplasty in Acute Myocardial Infarction (PRAMI) trial enrolled consecutive patients of any age at five U.K. centers during April 2008 to January 2013. The study focused on STEMI patients because patients with a NSTEMI often do not have a clearly identifiable infarct-related artery. In addition, to qualify for entry, the patient’s infarct-related artery had to have been successfully treated by PCI and they had to have at least one other coronary artery with at least 50% stenosis judged treatable by PCI. Patients with coronary anatomy more appropriately treated with bypass surgery were excluded. The enrolled patients averaged 62 years of age, about three-quarters were men, and about 18% had diabetes. Roughly two-thirds had a second coronary artery with a greater than 50% stenosis, and the remaining patients had two coronary arteries with a significant lesion.
After successful treatment of the infarct-producing artery, patients with additional, significant lesions judged appropriate for PCI were randomized to either have their other significant lesions treated during the same procedure or to undergo no further intervention. This resulted in an average of 1.36 additional arteries undergoing PCI in the 234 patients randomized to the more aggressive protocol.
Following the PCI procedures, all patients received standard medical treatment: daily treatment with aspirin and a second antiplatelet drug, clopidogrel (Plavix), prasugrel (Effient), or ticagrelor (Brilinta). About 95% of patients in both study arms also received treatment with a statin, and about 90% received a beta-blocker and an angiotensin-converting enzyme inhibitor.
During an average follow-up of 23 months, the combined rate of death from cardiac causes, nonfatal MI, or refractory angina – the study’s primary endpoint – occurred in 9% of the patients randomized to immediate PCI of their noninfarct-related stenoses and in 23% of the 231 patients in the control arm, a statistically significant difference. The 14-percentage-point absolute reduction in endpoints translated into a 65% relative risk reduction. The rate of cardiac death or nonfatal MI was 5% in the patients who received added PCI while in the catheterization laboratory and 12% among those only treated in their infarct-related artery, also a statistically significant difference.
Additional analyses also showed statistically significantly lower rates of both nonfatal MI and refractory angina in the patients treated in multiple arteries when these endpoints were tallied individually and a strong trend toward fewer cardiac deaths in these patients as well. Kaplan-Meier analysis showed that the risk reduction in the preventive-PCI group was evident after 6 months of follow-up and then increased with continued follow-up.
These results were not materially affected by patient age, sex, diabetes status, infarct location, or the number of coronary arteries with significant stenoses. In addition, the complication rates, including procedure-related strokes, bleeding requiring transfusions or surgery, and contrast-induced nephropathy requiring dialysis, were similar in the two study arms.
The results were consistent with reports from two prior randomized trials that also assessed the value of preventive PCI in patients with acute STEMI, but in fewer patients. One of these prior studies involved a total of 69 patients (Int. J. Cardiovasc. Intervent. 2004;6:128-33), and the second enrolled a total of 214 patients (Heart 2010;96:662-7); both were limited by a lack of statistical power, and both relied on repeat revascularization as an endpoint, which may be subject to bias, Dr. Wald said.
Dr. Wald said that he a director for and shareholder in Polypill Ltd.
On Twitter @mitchelzoler
AT THE ESC CONGRESS 2013
Major finding: Preventive PCI of significant, noninfarct-related coronary stenoses in acute STEMI cut the combined rate of death from cardiac causes, nonfatal MI, or refractory angina by 14 percentage points, compared with controls – a 65% relative risk reduction.
Data source: A multicenter, randomized trial with 465 patients.
Disclosures: Dr. Wald said that he a director for and shareholder in Polypill Ltd.
