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
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
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
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.
Kastrati A, Dibra A, Eberle S, et al. Sirolimus-Eluting Stents vs Paclitaxel-Eluting Stents in Patients With
Coronary Artery Disease: Meta-analysis of Randomized Trials. JAMA. 2005;294(7):819–825. doi:10.1001/jama.294.7.819
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