Effects of Percutaneous Coronary Interventions in Silent Ischemia After Myocardial Infarction The SWISSI II Randomized Controlled Trial
Paul Erne, MD; Andreas W. Schoenenberger, MD; Dieter Burckhardt, MD; Michel Zuber, MD; Wolfgang Kiowski, MD; Peter T. Buser, MD; Paul Dubach, MD; Therese J. Resink, PhD; Matthias Pfisterer, MD
JAMA. 2007;297:1985-1991.
Context The effect of a percutaneous coronary intervention (PCI) on the long-term prognosis of patients with silent ischemia after a myocardial infarction (MI) is not known.
Objective To determine whether PCI compared with drug therapy improves long-term outcome of asymptomatic patients with silent ischemia after an MI.
Design, Setting, and Participants Randomized, unblinded, controlled trial (Swiss Interventional Study on Silent Ischemia Type II [SWISSI II]) conducted from May 2, 1991, to February 25, 1997, at 3 public hospitals in Switzerland of 201 patients with a recent MI, silent myocardial ischemia verified by stress imaging, and 1- or 2-vessel coronary artery disease. Follow-up ended on May 23, 2006.
Interventions Percutaneous coronary intervention aimed at full revascularization (n = 96) or intensive anti-ischemic drug therapy (n = 105). All patients received 100 mg/d of aspirin and a statin.
Main Outcome Measures Survival free of major adverse cardiac events defined as cardiac death, nonfatal MI, and/or symptom-driven revascularization. Secondary measures included exercise-induced ischemia and resting left ventricular ejection fraction during follow-up.
Results During a mean (SD) follow-up of 10.2 (2.6) years, 27 major adverse cardiac events occurred in the PCI group and 67 events occurred in the anti-ischemic drug therapy group (adjusted hazard ratio, 0.33; 95% confidence interval, 0.20-0.55; P<.001), which corresponds to an absolute event reduction of 6.3% per year (95% confidence interval, 3.7%-8.9%; P<.001). Patients in the PCI group had lower rates of ischemia (11.6% vs 28.9% in patients in the drug therapy group at final follow-up; P = .03) despite fewer drugs. Left ventricular ejection fraction remained preserved in PCI patients (mean [SD] of 53.9% [9.9%] at baseline to 55.6% [8.1%] at final follow-up) and decreased significantly (P<.001) in drug therapy patients (mean [SD] of 59.7% [11.8%] at baseline to 48.8% [7.9%] at final follow-up). Conclusion Among patients with recent MI, silent myocardial ischemia verified by stress imaging, and 1- or 2-vessel coronary artery disease, PCI compared with anti-ischemic drug therapy reduced the long-term risk of major cardiac events. Conclusion Among patients with recent MI, silent myocardial ischemia verified by stress imaging, and 1- or 2-vessel coronary artery disease, PCI compared with anti-ischemic drug therapy reduced the long-term risk of major cardiac events.
COMMENTARIES:
For stable angina patients, the COURAGE trial found no advantage in any major cardiovascular endpoint for coronary stenting plus optimal medical therapy over medical therapy alone.
Another recent trial, the Open Artery Trial (OAT) reported at the American Heart Association meeting in November 2006, found no benefit for late percutaneous coronary intervention after heart attack over four years of follow up.
This study included a more select group of patients than the OAT study since all had viable myocardium.
"Taken together, these findings indicate a need for percutaneous coronary intervention after myocardial infarction only in the presence of symptomatic or silent ischemia but not without it," they wrote.
This trial was limited by lack of blinding (though all events were adjudicated by blinded physicians), a minority of female patients, and relatively small sample size.
LINKS: http://jama.ama-assn.org/cgi/content/short/297/18/1985?rss=1
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