PCI compared with anti-ischemic drug therapy reduced the long-term risk of major adverse cardiac events (HR 0.33; 95% CI 0.20-0.55; P<.001) in patients with recent MI and silent ischemia.
RCT (n=201)
Open-label
Randomized
Yes
Does percutaneous coronary intervention reduce major adverse cardiac events compared with drug therapy in asymptomatic patients with silent ischemia after a recent MI?
In asymptomatic patients with silent ischemia after a recent MI, PCI significantly reduced the long-term risk of major cardiac events compared with anti-ischemic drug therapy.
Effect estimate: HR 0.33 (95% CI 0.20-0.55)
Absolute Event Rate: 28.1% vs 63.8%
p-value: p=<.001
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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00387231.
Erné et al. (Tue,) conducted a rct in Silent ischemia after myocardial infarction (n=201). Percutaneous coronary intervention vs. Intensive anti-ischemic drug therapy was evaluated on Survival free of major adverse cardiac events defined as cardiac death, nonfatal MI, and/or symptom-driven revascularization (HR 0.33, 95% CI 0.20-0.55, p=<.001). PCI compared with anti-ischemic drug therapy reduced the long-term risk of major adverse cardiac events (HR 0.33; 95% CI 0.20-0.55; P<.001) in patients with recent MI and silent ischemia.