Performing angioplasty and stenting on nonculprit lesions during primary percutaneous coronary interventions appeared to lower the risk of major post-procedure events markedly, researchers reported.
Patients treated with the preventive angioplasty strategy had a 65% reduction (hazard ratio 0.35, 95% CI 0.21-0.58; P<0.001) in the risk of the composite primary outcome of cardiac death, nonfatal myocardial infarction, or refractory angina compared with patients who did not receive the preventive strategy, said David Wald, MD, MBBS, reader in cardiology and consultant cardiologist at the , Barts and the London School of Medicine.
Action Points
- Performing angioplasty and stenting on nonculprit lesions during primary appeared to lower the risk of major post-procedure events markedly.
- Note that if the study results are confirmed, it will change practice and probably cause more extensive stenting to be required at the time of PCI among patients with a ST-elevation acute MI.
In the study, 21 of 234 patients receiving preventive angioplasty experienced the composite endpoint, compared with 53 of 231 patients who only had the culprit lesion treated.
"When we looked at just cardiac death and nonfatal myocardial infarction -- the two most severe events in the composite -- the results were similar," Wald said at a press briefing at the meeting in Amsterdam. The PRAMI results were reported online in the New England Journal of Medicine.
He and colleagues reported a 64% reduction in the risk of those two events. Overall, 11 patients who underwent the preventive angioplasty strategy in the Preventive Angioplasty in Acute Myocardial Infarction (PRAMI) trial experienced cardiac death or nonfatal myocardial infarction (HR 0.36, 95% CI 0.18-0.73; P=0.004) compared with 27 events among those patients receiving the less extensive therapy.
Four of those deaths in the extensively treated group were due to cardiac death and seven nonfatal myocardial infarcts were observed. Among those not treated, 10 died from cardiac reasons; 20 had nonfatal myocardial infarcts.
"In patients with ST-segment elevated myocardial infarction (STEMI) and multivessel coronary artery disease undergoing infarct-artery percutaneous coronary intervention, preventive percutaneous coronary intervention in non-infarct coronary arteries with major stenosis significantly reduced the risk of adverse cardiovascular events as compared with percutaneous coronary intervention limited to the infarct artery," Wald reported.
Michel Bertrand, MD, emeritus professor of medicine at the University of Lille in France, told 51˶ that he had misgivings about the idea of stenting multiple lesions at the time of treatment of an acute myocardial infarct. "It might be dangerous for the patient because it certainly increases the time of the procedure," he said. "In the setting of acute myocardial infarction it is easier to treat the culprit lesion and then perhaps later treat the other lesions. You can accumulate the risk and increase the risk of procedural problems" by doing too much at one time.
Bertrand added that he doesn't believe that the multiple stenting procedure is ready for wider adoption. "I would like to have more information, especially regarding stent procedures," he said. "It is not the same in doing the procedure when the patient is having a heart attack or when you are doing the procedure when the patient is in a better condition."
On the other hand, William O'Neill, MD, medical director of the Center for Structural Heart Disease at Henry Ford Hospital, Detroit, said, "This study is the first to conclusively show that preventative stenting improves outcomes in any setting.
"It suggests," he told 51˶, "that the process which triggered the STEMI [inflammation] is a widespread arteritis. The study needs to be confirmed and if the findings hold, it will change practice and cause more extensive stenting to be required."
In the study, Wald and colleagues enrolled patients after they had undergone percutaneous coronary intervention which was considered successful in treatment of the infarct-related lesion and doctors observed lesions of 50% or more in one or more coronary arteries other than the infarct artery, and that these stenoses were deemed treatable by angioplasty procedures.
Wald said the goal was to randomize 600 patients, but the data and safety monitoring board found favorable results in an interim analysis conducted when 465 patients had been treated and recommended that the trial be halted at that point.
Mean age of the patients was 62 years; three-fourths were men. Wald said that a mean of 1.5 stents were implanted in the artery where the culprit lesion was located; in the preventive-intervention group, a mean of 1.4 stents were implanted in other arteries.
From the American Heart Association:
Disclosures
The study was supported by Barts and the London Charity.
Wald disclosed commercial interests with Polypill, Inc.
Mauri disclosed commercial interests with Abbott, Boston Scientific, Cordis, Medtronic, Eli Lilly, Daiichi-Sankyo, Bristol-Myers Squibb, Sanofi, Biotronik, and St. Jude.
O'Neill disclosed financial interests with Medtronic.
Antman has a research grant from Daiichi-Sankyo through Brigham and Women's Hospital.
Primary Source
New England Journal of Medicine
Mauri L, et al "Nonculprit lesions -- innocent or guilty by association" New Engl J Med 2013; DOI: 10.1056/NEJMe1309383.
Secondary Source
New England Journal of Medicine
Wald D, et al "Randomized trial of preventive angioplasty in myocardial infarction" New Engl J Med 2013; DOI: 10.1056/NEJMoa1305520.