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EXPEDITED PUBLICATION

A Meta-Analysis of 16 Randomized Trials of Sirolimus-Eluting Stents Versus Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease

Albert Schömig, MD^_*,_*, Alban Dibra, MD^_*, Stephan Windecker, MD, Julinda Mehilli, MD^_*, José Suárez de Lezo, MD, Christoph Kaiser, MD, Seung-Jung Park, MD^||, Jean-Jacque Goy, MD, Jae-Hwan Lee, MD^¶, Emilio Di Lorenzo, MD^#, Jinjin Wu, MD^_*, Peter Jüni, MD^_**, Matthias E. Pfisterer, MD, Bernhard Meier, MD and Adnan Kastrati, MD^_*

^_* Deutsches Herzzentrum, Technische Universität, Munich, Germany
Department of Cardiology, University Hospital Bern, Bern, Switzerland
Reina Sofia Hospital, University of Córdoba, Córdoba, Spain
University of Basel, Basel, Switzerland
^|| Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
^¶ Cardiovascular Center in Chungnam National University Hospital, Daejeon, Korea
^# A.O.R.N. "S. G. Moscati," Avellino, Italy
^_** Department of Social and Preventive Medicine, University Hospital Bern, Bern, Switzerland
Service of Cardiology, Clinique Cecil, Lausanne, Switzerland.

Manuscript received May 31, 2007; revised manuscript received June 15, 2007, accepted June 26, 2007.

^_* Reprint requests and correspondence: Dr. Albert Schömig, Deutsches Herzzentrum, Lazarettstr. 36, 80636 Munich, Germany. (Email: aschoemig{at}dhm.mhn.de).

Objectives: Our purpose was to make a synthesis of the available evidence on the relative efficacy and safety of 2 drug-eluting stents (DES)—sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES)—in patients with coronary artery disease.

Background: It is not known whether there are differences in late outcomes between the 2 most commonly used DES: SES and PES.

Methods: Sixteen randomized trials of SES versus PES with a total number of 8,695 patients were included in this meta-analysis. A full set of individual outcome data from 5,562 patients was also available. Mean follow-up period ranged from 9 to 37 months. The primary efficacy end point was the need for reintervention (target lesion revascularization). The primary safety end point was stent thrombosis. Secondary end points were death and recurrent myocardial infarction (MI).

Results: No significant heterogeneity was found across trials. Compared with PES, SES significantly reduced the risk of reintervention (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.63 to 0.87, p < 0.001) and stent thrombosis (HR 0.66; 95% CI 0.46 to 0.94, p = 0.02) without significantly impacting on the risk of death (HR 0.92; 95% CI 0.74 to 1.13, p = 0.43) or MI (HR 0.84; 95% CI 0.69 to 1.03, p = 0.10).

Conclusions: Sirolimus-eluting stents are superior to PES in terms of a significant reduction of the risk of reintervention and stent thrombosis. The risk of death was not significantly different between the 2 DES, but there was a trend toward a higher risk of MI with PES, especially after the first year from the procedure.

Abbreviations and Acronyms   CI = confidence interval   DES = drug-eluting stent(s)   HR = hazard ratio   MI = myocardial infarction   PES = paclitaxel-eluting stent(s)   SES = sirolimus-eluting stent(s)

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