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Sirolimus-Eluting Stents vs Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease: 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(7):819-825. doi:10.1001/jama.294.7.819.
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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.

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Figure 1. Odds Ratios of Target Lesion Revascularization Associated With Sirolimus-Eluting Stent vs Paclitaxel-Eluting Stent
Graphic Jump Location

SES indicates sirolimus-eluting stent; PES, paclitaxel-eluting stent; CI, confidence interval. The size of the data marker is proportional to the weight of the individual studies, measured as the inverse of the variance in the study by the Mantel-Haenszel procedure.

Figure 2. Odds Ratios of Angiographic Restenosis Associated With Sirolimus-Eluting Stent vs Paclitaxel-Eluting Stent
Graphic Jump Location

SES indicates sirolimus-eluting stent; PES, paclitaxel-eluting stent; CI, confidence interval. Follow-up angiography was not performed in the TAXI trial.28 The size of the data marker is proportional to the weight of the individual studies, measured as the inverse of the variance in the study by the Mantel-Haenszel procedure.

Figure 3. Odds Ratios of Stent Thrombosis Associated With Sirolimus-Eluting Stent vs Paclitaxel-Eluting Stent
Graphic Jump Location

SES indicates sirolimus-eluting stent; PES, paclitaxel-eluting stent; CI, confidence interval. The size of the data marker is proportional to the weight of the individual studies, measured as the inverse of the variance in the study by the Mantel-Haenszel procedure.

Figure 4. Odds Ratios of Death Associated With Sirolimus-Eluting Stent vs Paclitaxel-Eluting Stent
Graphic Jump Location

SES indicates sirolimus-eluting stent; PES, paclitaxel-eluting stent; CI, confidence interval. The size of the data marker is proportional to the weight of the individual studies, measured as the inverse of the variance in the study by the Mantel-Haenszel procedure.

Figure 5. Odds Ratios of the Composite of Death or Myocardial Infarction Associated With Sirolimus-Eluting Stent vs Paclitaxel-Eluting Stent
Graphic Jump Location

SES indicates sirolimus-eluting stent; PES, paclitaxel-eluting stent; CI, confidence interval. The size of the data marker is proportional to the weight of the individual studies, measured as the inverse of the variance in the study by the Mantel-Haenszel procedure.

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