Outcomes, Health Policy, and Managed Care Impact of coronary artery stents on mortality and nonfatal myocardial infarction: Meta-analysis of randomized trials comparing a strategy of routine stenting with that of balloon angioplasty Jassim Al Suwaidi, MB, ChB, a David R. Holmes, Jr, MD, b Amar M. Salam, MB, BS, MRCP, a Ryan Lennon, MS, c and Peter B. Berger, MD b Doha, Qatar, and Rochester, Minn Background A strategy of routine stenting has been shown to reduce the need for target-vessel revascularization compared with a strategy of balloon angioplasty alone; however, the impact on mortality and frequency of nonfatal myo- cardial infarction is unclear. The aim of this study was to provide a quantitative comparison of the impact of coronary stenting on the rates of mortality and myocardial infarction with that of balloon angioplasty with provisional stenting. Methods We performed a meta-analysis of randomized trials comparing routine coronary stenting to percutaneous trans- luminal coronary angioplasty (PTCA), including only those trials that used combination antiplatelet therapy (aspirin and a thien- opyridine) as an adjuvant to stenting. Such trials included: the Belegian Netherlands Stent Study (BENESTENT) II, Optimal Coro- nary Balloon Angioplasty With Provisional Stenting Versus Primary Stent (OCBAS), Balloon Optimization vs Stent Study (BOSS), Evaluation of Platelet IIb/IIIa Inhibitor for Stenting (EPISTENT), Optimum Percutaneous Transluminal Coronary Angioplasty Com- pared With Routine Stent Strategy (OPUS-1), French Optimal Stenting Trial (FROST), Angioplasty or Stent (AS), and Doppler Endpoint Stenting International Investigation (DESTINI) trials for de novo coronary artery lesions; the Stent vs Percutaneous An- gioplasty in Chronic Total Occlusion (SPACTO), Total Occlusion Study of Canada (TOSCA), Stent or Angioplasty after Recana- lization of Chronic Coronary Occlusions (SARECCO), and Mayo-Japan Investigation for Chronic Total Occlusion (MAJIC) trials for coronary occlusions; the Primary Angioplasty Versus Stent Implantation in Acute Myocardial Infarction (PASTA), Gianturco- Roubin in Acute Myocardial Infarction (GRAMI), Florence Randomized Elective Stenting in Acute Coronary Occlusions (FRESCO), Immediate Coronary Angioplasty with Elective Wiktor Stent Implantation Compared with Conventional Balloon An- gioplasty in Acute Myocardial Infarction (STENTUIM-2), Stent Primary Angioplasty in MI (Stent-PAMI), Zwolle, and Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trials for acute ST-segment elevation myocardial infarction; and the Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries (ISAR-SMART), Park, Stenting in Small Arteries (SISA), and Bestent in Small Arteries (BESMART) trials for small vessels. Results The 23 trials enrolled 10,347 patients, with 5130 patients randomized to receive stent and 5217 patients randomized to receive balloon angioplasty. A total of 902 (17 %) of patients crossed over from a strategy of balloon an- gioplasty to stent placement because of the inability to achieve a satisfactory result with a balloon. No significant differ- ence was observed between the stent group and PTCA group in the rates of death or myocardial infarction, despite a sig- nificant reduction in the frequency of major adverse cardiac events (odds ratio, 0.59; 95% CI, 0.50 – 0.70; P .001), which was driven entirely by a reduction in target vessel revascularization. Conclusions An initial strategy of stent placement versus balloon angioplasty with provisional stenting is associated with a similar mortality rate and frequency of nonfatal myocardial infarction after a mean follow-up period of 12.8 months. Patients who underwent stent placement had a significantly lower risk of major adverse cardiac events only when target revascularization is included as an end point. (Am Heart J 2004;147:815–22.) See related Editorial on page 756. The introduction of coronary stents has been the most important advancement in the percutaneous treatment of coronary artery disease since the advent of balloon angioplasty. Intracoronary stents not only increase procedural success rates, but also increase the From the a Department of Cardiology and Cardiovascular Surgery, Hamad General Hospital and Hamad Medical Corporation, Doha, Qatar, and b Division of Cardiovas- cular Diseases and Department of Internal Medicine and c Section of Biostatistics, Mayo Clinic and Foundation, Rochester, Minn. Submitted November 11, 2002; accepted November 26, 2003. Reprint requests: Peter B. Berger, MD, Duke University Medical Center and the Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715 . E-mail: berger.peter@duke.edu 0002-8703/$ - see front matter © 2004, Elsevier Inc. All rights reserved. doi:10.1016/j.ahj.2003.11.025 Clinical Investigations