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Sirolimus-Eluting and Paclitaxel-Eluting Stent for Coronary Revascularization
Interventional Cardiology
Sirolimus-Eluting Stents vs Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease: Metaanalysis of Randomized Trials
Abstracts Sirolimus-Eluting and Paclitaxel-Eluting Stent for Coronary Revascularization
Kastrati A, Dibra A, Eberle S, et al. JAMA 2005;294:819 –25. Study Question: To compare outcomes of sirolimus-eluting and paclitaxel-eluting coronary stents on the basis of data generated by randomized head-to-head clinical trials. Methods: The study was a meta-analysis. The researchers pooled 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. Results: 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⫽0.001). 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⫽0.001). Event rates for sirolimus-eluting vs. paclitaxel-eluting stents were 0.9% and 1.1%, respectively, for stent thrombosis (p⫽0.62); 1.4% and 1.6%, respectively, for death (p⫽0.56); and 4.9% and 5.8%, respectively, for the composite of death or MI (p⫽0.23). Conclusions: The investigators concluded that patients receiving sirolimus-eluting stents had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stents. Perspective: The results of this meta-analysis suggest that in patients with CAD presenting with various clinical and angiographic risk profiles, sirolimus-eluting stents appear better than paclitaxel-eluting stents in reducing the risk of restenosis. The studies included in the metaanalysis are individually small and open-label studies, and the largest individual study, the REALITY trial, failed to show any significant difference in restenosis between the two drug-eluting stents. Moreover, the field of drugeluting stents is rapidly evolving, and newer-generation stents will be made available in the next few months. Both currently available drug-eluting stents have been shown to be very effective in reducing clinical restenosis, and an appropriately designed and adequately powered trial is needed to show definitive advantages of one type of drug-eluting stent over others prior to changing clinical practice. Debabrata Mukherjee
Windecker S, Remondino A, Eberli FR, et al. N Engl J Med 2005;353:653– 62. Study Question: To compare the safety and efficacy of sirolimus and paclitaxel stents in patients undergoing percutaneous coronary intervention. Methods: Investigators conducted a randomized, controlled, single-blind trial comparing sirolimus-eluting stents with paclitaxel-eluting stents in 1012 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (MACE; death from cardiac causes, myocardial infarction [MI] and ischemia-driven revascularization of the target lesion) by 9 months. Follow-up angiography was completed in 540 of 1012 patients (53.4%). Results: The two groups had similar baseline clinical and angiographic characteristics. The rate of MACE at 9 months was 6.2% in the sirolimus-stent group and 10.8% in the paclitaxel-stent group (hazard ratio [HR] 0.56; 95% confidence interval [CI] 0.36 – 0.86; p⫽0.009). The difference was driven by a lower rate of target-lesion revascularization in the sirolimus-stent group than in the paclitaxel-stent group (4.8% vs. 8.3%; HR 0.56; 95% CI, 0.34 – 0.93; p⫽0.03). Rates of death from cardiac causes were 0.6% in the sirolimus-stent group and 1.6% in the paclitaxel-stent group (p⫽0.15); the rates of MI were 2.8% and 3.5%, respectively (p⫽0.49); and the rates of angiographic restenosis were 6.6% and 11.7%, respectively (p⫽0.02). Conclusions: The investigators concluded that, compared with paclitaxel-eluting stents, use of sirolimus-eluting stents results in fewer MACE, primarily by decreasing the rates of clinical and angiographic restenosis. Perspective: The study suggests that compared with polymer-based paclitaxel-eluting stents, sirolimus-eluting stents resulted in fewer MACE at 9 months, primarily by decreasing the rates of clinical and angiographic restenosis. This is a well-designed, clinically relevant trial with the limitations of being single-center with a relatively small sample size. One needs to remember that a similar comparative study with a larger sample size, the REALITY trial, failed to show a restenosis benefit with sirolimus compared to paclitaxel-eluting stents. Moreover, this is a rapidly evolving field with second-generation drug-eluting stents to be made available in the next few months. Larger, adequately powered, trials are needed to show whether a clinically significant difference exists between the different drug-eluting stents. Debabrata Mukherjee
ACC CURRENT JOURNAL REVIEW November 2005
47
Sirolimus-Eluting Stents vs Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease: Metaanalysis of Randomized Trials
Abstracts Sirolimus-Eluting and Paclitaxel-Eluting Stent for Coronary Revascularization
Kastrati A, Dibra A, Eberle S, et al. JAMA 2005;294:819 –25. Study Question: To compare outcomes of sirolimus-eluting and paclitaxel-eluting coronary stents on the basis of data generated by randomized head-to-head clinical trials. Methods: The study was a meta-analysis. The researchers pooled 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. Results: 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⫽0.001). 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⫽0.001). Event rates for sirolimus-eluting vs. paclitaxel-eluting stents were 0.9% and 1.1%, respectively, for stent thrombosis (p⫽0.62); 1.4% and 1.6%, respectively, for death (p⫽0.56); and 4.9% and 5.8%, respectively, for the composite of death or MI (p⫽0.23). Conclusions: The investigators concluded that patients receiving sirolimus-eluting stents had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stents. Perspective: The results of this meta-analysis suggest that in patients with CAD presenting with various clinical and angiographic risk profiles, sirolimus-eluting stents appear better than paclitaxel-eluting stents in reducing the risk of restenosis. The studies included in the metaanalysis are individually small and open-label studies, and the largest individual study, the REALITY trial, failed to show any significant difference in restenosis between the two drug-eluting stents. Moreover, the field of drugeluting stents is rapidly evolving, and newer-generation stents will be made available in the next few months. Both currently available drug-eluting stents have been shown to be very effective in reducing clinical restenosis, and an appropriately designed and adequately powered trial is needed to show definitive advantages of one type of drug-eluting stent over others prior to changing clinical practice. Debabrata Mukherjee
Windecker S, Remondino A, Eberli FR, et al. N Engl J Med 2005;353:653– 62. Study Question: To compare the safety and efficacy of sirolimus and paclitaxel stents in patients undergoing percutaneous coronary intervention. Methods: Investigators conducted a randomized, controlled, single-blind trial comparing sirolimus-eluting stents with paclitaxel-eluting stents in 1012 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (MACE; death from cardiac causes, myocardial infarction [MI] and ischemia-driven revascularization of the target lesion) by 9 months. Follow-up angiography was completed in 540 of 1012 patients (53.4%). Results: The two groups had similar baseline clinical and angiographic characteristics. The rate of MACE at 9 months was 6.2% in the sirolimus-stent group and 10.8% in the paclitaxel-stent group (hazard ratio [HR] 0.56; 95% confidence interval [CI] 0.36 – 0.86; p⫽0.009). The difference was driven by a lower rate of target-lesion revascularization in the sirolimus-stent group than in the paclitaxel-stent group (4.8% vs. 8.3%; HR 0.56; 95% CI, 0.34 – 0.93; p⫽0.03). Rates of death from cardiac causes were 0.6% in the sirolimus-stent group and 1.6% in the paclitaxel-stent group (p⫽0.15); the rates of MI were 2.8% and 3.5%, respectively (p⫽0.49); and the rates of angiographic restenosis were 6.6% and 11.7%, respectively (p⫽0.02). Conclusions: The investigators concluded that, compared with paclitaxel-eluting stents, use of sirolimus-eluting stents results in fewer MACE, primarily by decreasing the rates of clinical and angiographic restenosis. Perspective: The study suggests that compared with polymer-based paclitaxel-eluting stents, sirolimus-eluting stents resulted in fewer MACE at 9 months, primarily by decreasing the rates of clinical and angiographic restenosis. This is a well-designed, clinically relevant trial with the limitations of being single-center with a relatively small sample size. One needs to remember that a similar comparative study with a larger sample size, the REALITY trial, failed to show a restenosis benefit with sirolimus compared to paclitaxel-eluting stents. Moreover, this is a rapidly evolving field with second-generation drug-eluting stents to be made available in the next few months. Larger, adequately powered, trials are needed to show whether a clinically significant difference exists between the different drug-eluting stents. Debabrata Mukherjee
ACC CURRENT JOURNAL REVIEW November 2005
47