Clinical Outcomes of Primary Stenting versus Balloon Angioplasty in Patients with Myocardial Infarction: A Meta-analysis of Randomized Controlled Trials

Abstract

PURPOSE: To examine whether primary stenting as compared with primary balloon angioplasty reduces clinical outcomes in patients with myocardial infarction. METHODS: Major medical databases from 1979 to March 2002 were searched for randomized controlled trials that compared primary stenting with balloon angioplasty in patients with myocardial infarction. Two independent reviewers selected and extracted data from identified trials. The outcomes were mortality at 30 days, 6 months, and 12 months; recurrent events; and bleeding. RESULTS: Nine trials with a total of 4433 patients fulfilled the inclusion criteria. The odds ratios for mortality after stenting as compared with balloon angioplasty were 1.17 (95% confidence interval [CI]: 0.78 to 1.74) at 30 days, 1.07 (95% CI: 0.76 to 1.52) at 6 months, and 1.09 (95% CI: 0.80 to 1.50) at 12 months (P for heterogeneity Ͼ0.1 for each comparison). The odds ratios for reinfarction after stenting as compared with balloon angioplasty were 0.52 (95% CI: 0.31 to 0.87) at 30 days, 0.67 (95% CI: 0.45 to 1.00) at 6 months, and 0.67 (95% CI: 0.45 to 0.99) at 12 months; for target vessel revascularization, they were 0.46 (95% CI: 0.34 to 0.61) at 30 days, 0.42 (95% CI: 0.35 to 0.51) at 6 months, and 0.48 (95% CI: 0.39 to 0.59) at 12 months (P for heterogeneity Ͼ0.1 for all estimates with the exception of reinfarction at 12 months where P ϭ 0.08). The odds ratio for postinterventional bleeding complications after stenting as compared with balloon angioplasty was 1.34 (95% CI: 0.95 to 1.88; P for heterogeneity Ͼ0.1). CONCLUSION: Compared with balloon angioplasty, primary stenting is not associated with lower mortality, but is associated with a lower risk of reinfarction and target vessel revascularization. Am J Med. 2004;116:253-262. ©2004 by Excerpta Medica Inc. I n patients with myocardial infarction, balloon angioplasty reduces short-term death, nonfatal myocardial infarction, and stroke when compared with thrombolytic reperfusion (1). Still, the clinical efficacy of balloon angioplasty is limited by the development of late restenosis in up to 50% of patients, and by recurrent myocardial infarction in 3% to 5% of patients (2-5). Primary stenting may offer additional benefits. However, a recent meta-analysis of clinical trials found no difference in mortality and reinfarction rates among patients undergoing stenting or balloon angioplasty (6). We conducted a meta-analysis based on published and unpublished trial data to investigate whether primary stenting as compared with balloon angioplasty reduces mortality, recurrent events, and the risk of bleeding in patients with myocardial infarction. METHODS Data Search and Trial Selection We searched MEDLINE, EMBASE, Pascal, Index Medicus, the Cochrane Library, and abstracts from cardiology conferences from 1979 to March 2002 to identify all randomized controlled trials that compared primary stenting with balloon angioplasty in patients with myocardial infarction. We used the following search terms: angioplasty transluminal percutaneous coronary, stents, randomized controlled trials, clinical trials, coronary artery dilatation, transluminal coronary angioplasty, and random. We also searched all references of relevant articles for additional trials. If necessary, authors of identified trials were contacted for additional information