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Meta-analysis of Randomized Trials

Adnan Kastrati, MD; Alban Dibra, MD; Sonja Eberle, Dipl Stat; Julinda Mehilli, MD; José Suárez de Lezo, MD; Jean-Jacque Goy, MD; Kurt Ulm, PhD; Albert Schömig, MD

JAMA. 2005;294:819-825.

Context  Placement of sirolimus-eluting stents or paclitaxel-eluting stents has emerged as the predominant percutaneous treatment strategy in patients with coronary artery disease (CAD). Whether there are any differences in efficacy and safety between these 2 drug-eluting stents is unclear.

Objective  To compare outcomes of sirolimus-eluting and paclitaxel-eluting coronary stents on the basis of data generated by randomized head-to-head clinical trials.

Data Sources  PubMed and the Cochrane Central Register of Controlled Trials, conference proceedings from major cardiology meetings, and Internet-based sources of information on clinical trials in cardiology from January 2003 to April 2005.

Study Selection  Randomized trials comparing the sirolimus-eluting stent with the paclitaxel-eluting stent in patients with CAD reporting the outcomes of interest (target lesion revascularization, angiographic restenosis, stent thrombosis, myocardial infarction [MI], death, and the composite of death or MI) during a follow-up of at least 6 months.

Data Extraction  Two reviewers independently identified studies and abstracted data on sample size, baseline characteristics, and outcomes of interest.

Data Synthesis  Six trials, including 3669 patients, met the selection criteria. No significant heterogeneity was found across trials. Target lesion revascularization, the primary outcome of interest, was less frequently performed in patients who were treated with the sirolimus-eluting stent (5.1%) vs the paclitaxel-eluting stent (7.8%) (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.49-0.84; P = .001). Similarly, angiographic restenosis was less frequently observed among patients assigned to the sirolimus-eluting stent (9.3%) vs the paclitaxel-eluting stent (13.1%) (OR, 0.68; 95% CI, 0.55-0.86; P = .001). Event rates for sirolimus-eluting vs paclitaxel-eluting stents were 0.9% and 1.1%, respectively, for stent thrombosis (P = .62); 1.4% and 1.6%, respectively, for death (P = .56); and 4.9% and 5.8%, respectively, for the composite of death or MI (P = .23).

Conclusions  Patients receiving sirolimus-eluting stents had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stents. Rates of death, death or MI, and stent thrombosis were similar.

Author Affiliations: Deutsches Herzzentrum (Drs Kastrati, Dibra, Mehilli, and Schömig) and Institut für Medizinische Statistik und Epidemiologie (Drs Eberle and Ulm), Technische Universität, Munich, Germany; Reina Sofia Hospital, Cordoba, Spain (Dr Suárez de Lezo); and Service of Cardiology, Clinique Cecil, Lausanne, Switzerland (Dr Goy).

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