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.
RCT Entities:
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.
Authors: Arthur Nasis; Brian S Ko; Michael C Leung; Paul R Antonis; Dee Nandurkar; Dennis T Wong; Leo Kyi; James D Cameron; John M Troupis; Ian T Meredith; Sujith K Seneviratne Journal: Eur Radiol Date: 2013-02-21 Impact factor: 5.315
Authors: Santanu Guha; Rishi Sethi; Saumitra Ray; Vinay K Bahl; S Shanmugasundaram; Prafula Kerkar; Sivasubramanian Ramakrishnan; Rakesh Yadav; Gaurav Chaudhary; Aditya Kapoor; Ajay Mahajan; Ajay Kumar Sinha; Ajit Mullasari; Akshyaya Pradhan; Amal Kumar Banerjee; B P Singh; J Balachander; Brian Pinto; C N Manjunath; Chandrashekhar Makhale; Debabrata Roy; Dhiman Kahali; Geevar Zachariah; G S Wander; H C Kalita; H K Chopra; A Jabir; JagMohan Tharakan; Justin Paul; K Venogopal; K B Baksi; Kajal Ganguly; Kewal C Goswami; M Somasundaram; M K Chhetri; M S Hiremath; M S Ravi; Mrinal Kanti Das; N N Khanna; P B Jayagopal; P K Asokan; P K Deb; P P Mohanan; Praveen Chandra; Col R Girish; O Rabindra Nath; Rakesh Gupta; C Raghu; Sameer Dani; Sandeep Bansal; Sanjay Tyagi; Satyanarayan Routray; Satyendra Tewari; Sarat Chandra; Shishu Shankar Mishra; Sibananda Datta; S S Chaterjee; Soumitra Kumar; Soura Mookerjee; Suma M Victor; Sundeep Mishra; Thomas Alexander; Umesh Chandra Samal; Vijay Trehan Journal: Indian Heart J Date: 2017-03-23
Authors: Gregg W Stone; Judith S Hochman; David O Williams; William E Boden; T Bruce Ferguson; Robert A Harrington; David J Maron Journal: J Am Coll Cardiol Date: 2015-11-23 Impact factor: 24.094