Elective Angioplasty Safe at Hospitals Without Surgical Backup

CHICAGO – Clinical outcomes of elective percutaneous coronary intervention are similar at hospitals with or without on-site cardiac surgery, results of the CPORT-E trial show.

Mortality at 6 weeks was 0.9% at hospitals without on-site surgery, compared with 1% at those with on-site surgery, meeting the prespecified values for noninferiority.

At 9 months, major adverse cardiac event (MACE) rates were 12.1% and 11.2%, respectively. These also met the noninferiority criteria.

The need for target vessel revascularization (TVR) was slightly higher at hospitals without on-site cardiac surgery, but other adverse events such as bleeding, stroke, renal failure, and need for surgical revascularization were the same at hospitals with and without on-site surgery, Dr. Thomas Aversano reported at the annual meeting of the American College of Cardiology.

Session comoderator Dr. Robert Harrington, director of Duke Clinical Research Institute in Durham, N.C, asked whether every hospital should now offer elective PCI based on the results of the CPORT-E (Cardiovascular Patient Outcomes Research Team Nonprimary PCI) trial.

Dr. Aversano replied without hesitation "No, this study was not undertaken with the express idea of expansion of angioplasty programs. Really, the fundamental question was whether or not health care regulators, policy makers, and national organizations could use angioplasty in hospitals without on-site cardiac surgery as a tool. Is this possible? Is this safe?"

Invited discussant Dr. Gilles Montalescot, professor of cardiology at Hôpital Pitié-Salpétrière in Paris, said it’s always good for a study to confirm current practice, but that "the big difference is that you have excluded all high-risk patients and the temptation is to take all patients who come to the cath lab."

Dr. Aversano, the lead investigator of CPORT-E and associate professor of cardiology at Johns Hopkins University, Baltimore, emphasized that participating hospitals without on-site cardiac surgery undertook a formal PCI development program prior to study participation that took roughly 3-6 months to complete. It included detailed care plans and pathways, order sets, and training of staff in the care of PCI patients. Interventionalists were also required to meet criteria for competency developed by the ACC, the American Heart Association, and the Society for Cardiac Angiography and Interventions.

"What didn’t come out in the [online NEJM] article or the presentation is that these hospitals didn’t simply buy stents and guidewires and start doing this; it was a full development program," he said.

When asked whether the results could serve as a model for hospitals that may be considering offering PCI, Dr. Aversano said he was hesitant to make such a recommendation because each institution has its own unique political and logistical issues that prevent a "cookbook" approach.

ACC past president Dr. Ralph Brindis said results from the randomized trial support recent guideline changes by the ACC stating that it is reasonable for hospitals without cardiac surgery to perform elective PCI, not just emergency PCI.

"How policy makers at a state or government level utilize this in terms of offering PCI to local populations is yet to be determined," Dr. Brindis, clinical professor of medicine at the University of California, San Francisco, said in an interview. "Certainly every hospital shouldn’t be doing this, but there are issues of access in terms of having PCI available for our populations, particularly rural areas."

The 60 CPORT-E hospitals were located in 10 states and had a median annual PCI procedural volume of 150.

In all, 14,149 patients were randomly assigned to undergo PCI at a hospital without on-site cardiac surgery, and 4,718 were assigned to undergo PCI at a hospital with cardiac surgery, with 14,010 and 4,538 patients, respectively, ultimately undergoing the procedure. Patients were well matched, although prior PCI was more common among those randomized to hospitals without cardiac surgery (32% vs. 30.4%), Dr. Aversano said. Their average age was 64 years (N. Engl. J. Med. 2012 March 25 [doi: 10.1056/NEJMoa1114540]).

Staged procedures, meaning those performed on a different day than the initial cath lab visit, were more common at hospitals with on-site cardiac surgery than those without (68% vs. 26%), resulting in more catheterization laboratory visits (1.7 vs. 1.3).

Index PCI failure, however, was higher at hospitals without surgery on site (SOS) than those with SOS both per patient (3.4% vs. 2.5%) and per lesion (6.6% vs. 5.9%), he said. Use of bare metal stents was also higher at hospitals without SOS (24.2% vs. 23%).

At 9 months, there was no difference between hospitals without or with SOS in the composite elements of MACE including death (3.2% for both), Q-wave myocardial infarction (3.1% both) and TVR (6.5% vs. 5.4%, respectively), which included any unplanned PCI or coronary artery bypass grafting (CABG) after randomization.

Rates for hospitals without and with SOS were 5.2% vs. 5.3% for bleeding, 1.2% vs. 1.1% for vascular repair, 0.5% vs. 0.6% for stroke and 0.8% vs. 0.9% for renal insufficiency, respectively.

CABG was performed significantly more often at hospitals without SOS than those with SOS (2.3% vs. 1.5%).

An exploratory analysis of the intention-to-treat population that excluded CABG as part of TVR showed that MACE rates were 11.9% at hospitals without SOS and 10.5% at those with SOS.

An exploratory per protocol analysis also showed higher MACE rates at hospitals without SOS than at those with SOS (12% and 10.4% respectively), although these differences are within the range of noninferiority used in other recent stent trials, Dr. Aversano noted.

TVR may be higher in patients having PCI at hospitals without cardiac surgery because of a higher rate of bare metal stents used, which is a more conservative approach to PCI at relatively inexperienced hospitals, and a lack of a full complement of interventional devices, he suggested.

Johns Hopkins University and participating sites provided support for this trial. Dr. Brindis is a consultant to Ivivi Health Sciences. Dr. Harrington disclosed ties with numerous pharmaceutical companies. Dr. Aversano reported that he has no conflicts of interest.

CHICAGO – Clinical outcomes of elective percutaneous coronary intervention are similar at hospitals with or without on-site cardiac surgery, results of the CPORT-E trial show.

Mortality at 6 weeks was 0.9% at hospitals without on-site surgery, compared with 1% at those with on-site surgery, meeting the prespecified values for noninferiority.

At 9 months, major adverse cardiac event (MACE) rates were 12.1% and 11.2%, respectively. These also met the noninferiority criteria.

The need for target vessel revascularization (TVR) was slightly higher at hospitals without on-site cardiac surgery, but other adverse events such as bleeding, stroke, renal failure, and need for surgical revascularization were the same at hospitals with and without on-site surgery, Dr. Thomas Aversano reported at the annual meeting of the American College of Cardiology.

Session comoderator Dr. Robert Harrington, director of Duke Clinical Research Institute in Durham, N.C, asked whether every hospital should now offer elective PCI based on the results of the CPORT-E (Cardiovascular Patient Outcomes Research Team Nonprimary PCI) trial.

Dr. Aversano replied without hesitation "No, this study was not undertaken with the express idea of expansion of angioplasty programs. Really, the fundamental question was whether or not health care regulators, policy makers, and national organizations could use angioplasty in hospitals without on-site cardiac surgery as a tool. Is this possible? Is this safe?"

Invited discussant Dr. Gilles Montalescot, professor of cardiology at Hôpital Pitié-Salpétrière in Paris, said it’s always good for a study to confirm current practice, but that "the big difference is that you have excluded all high-risk patients and the temptation is to take all patients who come to the cath lab."

Dr. Aversano, the lead investigator of CPORT-E and associate professor of cardiology at Johns Hopkins University, Baltimore, emphasized that participating hospitals without on-site cardiac surgery undertook a formal PCI development program prior to study participation that took roughly 3-6 months to complete. It included detailed care plans and pathways, order sets, and training of staff in the care of PCI patients. Interventionalists were also required to meet criteria for competency developed by the ACC, the American Heart Association, and the Society for Cardiac Angiography and Interventions.

"What didn’t come out in the [online NEJM] article or the presentation is that these hospitals didn’t simply buy stents and guidewires and start doing this; it was a full development program," he said.

When asked whether the results could serve as a model for hospitals that may be considering offering PCI, Dr. Aversano said he was hesitant to make such a recommendation because each institution has its own unique political and logistical issues that prevent a "cookbook" approach.

ACC past president Dr. Ralph Brindis said results from the randomized trial support recent guideline changes by the ACC stating that it is reasonable for hospitals without cardiac surgery to perform elective PCI, not just emergency PCI.

"How policy makers at a state or government level utilize this in terms of offering PCI to local populations is yet to be determined," Dr. Brindis, clinical professor of medicine at the University of California, San Francisco, said in an interview. "Certainly every hospital shouldn’t be doing this, but there are issues of access in terms of having PCI available for our populations, particularly rural areas."

The 60 CPORT-E hospitals were located in 10 states and had a median annual PCI procedural volume of 150.

In all, 14,149 patients were randomly assigned to undergo PCI at a hospital without on-site cardiac surgery, and 4,718 were assigned to undergo PCI at a hospital with cardiac surgery, with 14,010 and 4,538 patients, respectively, ultimately undergoing the procedure. Patients were well matched, although prior PCI was more common among those randomized to hospitals without cardiac surgery (32% vs. 30.4%), Dr. Aversano said. Their average age was 64 years (N. Engl. J. Med. 2012 March 25 [doi: 10.1056/NEJMoa1114540]).

Staged procedures, meaning those performed on a different day than the initial cath lab visit, were more common at hospitals with on-site cardiac surgery than those without (68% vs. 26%), resulting in more catheterization laboratory visits (1.7 vs. 1.3).

Index PCI failure, however, was higher at hospitals without surgery on site (SOS) than those with SOS both per patient (3.4% vs. 2.5%) and per lesion (6.6% vs. 5.9%), he said. Use of bare metal stents was also higher at hospitals without SOS (24.2% vs. 23%).

At 9 months, there was no difference between hospitals without or with SOS in the composite elements of MACE including death (3.2% for both), Q-wave myocardial infarction (3.1% both) and TVR (6.5% vs. 5.4%, respectively), which included any unplanned PCI or coronary artery bypass grafting (CABG) after randomization.

Rates for hospitals without and with SOS were 5.2% vs. 5.3% for bleeding, 1.2% vs. 1.1% for vascular repair, 0.5% vs. 0.6% for stroke and 0.8% vs. 0.9% for renal insufficiency, respectively.

CABG was performed significantly more often at hospitals without SOS than those with SOS (2.3% vs. 1.5%).

An exploratory analysis of the intention-to-treat population that excluded CABG as part of TVR showed that MACE rates were 11.9% at hospitals without SOS and 10.5% at those with SOS.

An exploratory per protocol analysis also showed higher MACE rates at hospitals without SOS than at those with SOS (12% and 10.4% respectively), although these differences are within the range of noninferiority used in other recent stent trials, Dr. Aversano noted.

TVR may be higher in patients having PCI at hospitals without cardiac surgery because of a higher rate of bare metal stents used, which is a more conservative approach to PCI at relatively inexperienced hospitals, and a lack of a full complement of interventional devices, he suggested.

Johns Hopkins University and participating sites provided support for this trial. Dr. Brindis is a consultant to Ivivi Health Sciences. Dr. Harrington disclosed ties with numerous pharmaceutical companies. Dr. Aversano reported that he has no conflicts of interest.

CHICAGO – Clinical outcomes of elective percutaneous coronary intervention are similar at hospitals with or without on-site cardiac surgery, results of the CPORT-E trial show.

Mortality at 6 weeks was 0.9% at hospitals without on-site surgery, compared with 1% at those with on-site surgery, meeting the prespecified values for noninferiority.

At 9 months, major adverse cardiac event (MACE) rates were 12.1% and 11.2%, respectively. These also met the noninferiority criteria.

The need for target vessel revascularization (TVR) was slightly higher at hospitals without on-site cardiac surgery, but other adverse events such as bleeding, stroke, renal failure, and need for surgical revascularization were the same at hospitals with and without on-site surgery, Dr. Thomas Aversano reported at the annual meeting of the American College of Cardiology.

Session comoderator Dr. Robert Harrington, director of Duke Clinical Research Institute in Durham, N.C, asked whether every hospital should now offer elective PCI based on the results of the CPORT-E (Cardiovascular Patient Outcomes Research Team Nonprimary PCI) trial.

Dr. Aversano replied without hesitation "No, this study was not undertaken with the express idea of expansion of angioplasty programs. Really, the fundamental question was whether or not health care regulators, policy makers, and national organizations could use angioplasty in hospitals without on-site cardiac surgery as a tool. Is this possible? Is this safe?"

Invited discussant Dr. Gilles Montalescot, professor of cardiology at Hôpital Pitié-Salpétrière in Paris, said it’s always good for a study to confirm current practice, but that "the big difference is that you have excluded all high-risk patients and the temptation is to take all patients who come to the cath lab."

Dr. Aversano, the lead investigator of CPORT-E and associate professor of cardiology at Johns Hopkins University, Baltimore, emphasized that participating hospitals without on-site cardiac surgery undertook a formal PCI development program prior to study participation that took roughly 3-6 months to complete. It included detailed care plans and pathways, order sets, and training of staff in the care of PCI patients. Interventionalists were also required to meet criteria for competency developed by the ACC, the American Heart Association, and the Society for Cardiac Angiography and Interventions.

"What didn’t come out in the [online NEJM] article or the presentation is that these hospitals didn’t simply buy stents and guidewires and start doing this; it was a full development program," he said.

When asked whether the results could serve as a model for hospitals that may be considering offering PCI, Dr. Aversano said he was hesitant to make such a recommendation because each institution has its own unique political and logistical issues that prevent a "cookbook" approach.

ACC past president Dr. Ralph Brindis said results from the randomized trial support recent guideline changes by the ACC stating that it is reasonable for hospitals without cardiac surgery to perform elective PCI, not just emergency PCI.

"How policy makers at a state or government level utilize this in terms of offering PCI to local populations is yet to be determined," Dr. Brindis, clinical professor of medicine at the University of California, San Francisco, said in an interview. "Certainly every hospital shouldn’t be doing this, but there are issues of access in terms of having PCI available for our populations, particularly rural areas."

The 60 CPORT-E hospitals were located in 10 states and had a median annual PCI procedural volume of 150.

In all, 14,149 patients were randomly assigned to undergo PCI at a hospital without on-site cardiac surgery, and 4,718 were assigned to undergo PCI at a hospital with cardiac surgery, with 14,010 and 4,538 patients, respectively, ultimately undergoing the procedure. Patients were well matched, although prior PCI was more common among those randomized to hospitals without cardiac surgery (32% vs. 30.4%), Dr. Aversano said. Their average age was 64 years (N. Engl. J. Med. 2012 March 25 [doi: 10.1056/NEJMoa1114540]).

Staged procedures, meaning those performed on a different day than the initial cath lab visit, were more common at hospitals with on-site cardiac surgery than those without (68% vs. 26%), resulting in more catheterization laboratory visits (1.7 vs. 1.3).

Index PCI failure, however, was higher at hospitals without surgery on site (SOS) than those with SOS both per patient (3.4% vs. 2.5%) and per lesion (6.6% vs. 5.9%), he said. Use of bare metal stents was also higher at hospitals without SOS (24.2% vs. 23%).

At 9 months, there was no difference between hospitals without or with SOS in the composite elements of MACE including death (3.2% for both), Q-wave myocardial infarction (3.1% both) and TVR (6.5% vs. 5.4%, respectively), which included any unplanned PCI or coronary artery bypass grafting (CABG) after randomization.

Rates for hospitals without and with SOS were 5.2% vs. 5.3% for bleeding, 1.2% vs. 1.1% for vascular repair, 0.5% vs. 0.6% for stroke and 0.8% vs. 0.9% for renal insufficiency, respectively.

CABG was performed significantly more often at hospitals without SOS than those with SOS (2.3% vs. 1.5%).

An exploratory analysis of the intention-to-treat population that excluded CABG as part of TVR showed that MACE rates were 11.9% at hospitals without SOS and 10.5% at those with SOS.

An exploratory per protocol analysis also showed higher MACE rates at hospitals without SOS than at those with SOS (12% and 10.4% respectively), although these differences are within the range of noninferiority used in other recent stent trials, Dr. Aversano noted.

TVR may be higher in patients having PCI at hospitals without cardiac surgery because of a higher rate of bare metal stents used, which is a more conservative approach to PCI at relatively inexperienced hospitals, and a lack of a full complement of interventional devices, he suggested.

Johns Hopkins University and participating sites provided support for this trial. Dr. Brindis is a consultant to Ivivi Health Sciences. Dr. Harrington disclosed ties with numerous pharmaceutical companies. Dr. Aversano reported that he has no conflicts of interest.