Stettler Christoph, Wandel Simon, Allemann Sabin, Kastrati Adnan, Morice Marie Claude, Schömig Albert, Pfisterer Matthias E, Stone Gregg W, Leon Martin B, de Lezo José Suarez, Goy Jean-Jacques, Park Seung-Jung, Sabaté Manel, Suttorp Maarten J, Kelbaek Henning, Spaulding Christian, Menichelli Maurizio, Vermeersch Paul, Dirksen Maurits T, Cervinka Pavel, Petronio Anna Sonia, Nordmann Alain J, Diem Peter, Meier Bernhard, Zwahlen Marcel, Reichenbach Stephan, Trelle Sven, Windecker Stephan, Jüni Peter
Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.
Whether the two drug-eluting stents approved by the US Food and Drug Administration-a sirolimus-eluting stent and a paclitaxel-eluting stent-are associated with increased risks of death, myocardial infarction, or stent thrombosis compared with bare-metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents.
We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with bare-metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18,023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a network meta-analysis with a mixed-treatment comparison method to combine direct within-trial comparisons between stents with indirect evidence from other trials while maintaining randomisation.
Mortality was similar in the three groups: hazard ratios (HR) were 1.00 (95% credibility interval 0.82-1.25) for sirolimus-eluting versus bare-metal stents, 1.03 (0.84-1.22) for paclitaxel-eluting versus bare-metal stents, and 0.96 (0.83-1.24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0.81, 95% credibility interval 0.66-0.97, p=0.030 vs bare-metal stents; 0.83, 0.71-1.00, p=0.045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2.11, 95% credibility interval 1.19-4.23, p=0.017 vs bare-metal stents; 1.85, 1.02-3.85, p=0.041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with bare-metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0.70, 0.56-0.84; p=0.0021).
The risks of mortality associated with drug-eluting and bare-metal stents are similar. Sirolimus-eluting stents seem to be clinically better than bare-metal and paclitaxel-eluting stents.
美国食品药品监督管理局批准的两种药物洗脱支架——西罗莫司洗脱支架和紫杉醇洗脱支架——与裸金属支架相比，是否会增加死亡、心肌梗死或支架血栓形成的风险尚不确定。我们的目的是比较这些支架的安全性和有效性。
我们检索了从开始到2007年3月的相关资料，并联系了研究人员和制造商，以确定在冠心病患者中比较药物洗脱支架与裸金属支架，或直接比较西罗莫司洗脱支架与紫杉醇洗脱支架的随机对照试验。安全性结局包括死亡率、心肌梗死和明确的支架血栓形成；有效性结局是靶病变血运重建。我们纳入了38项试验（18023例患者），随访时间长达4年。试验人员和制造商提供了29项试验的临床结局额外数据。我们采用混合治疗比较方法进行网络荟萃分析，以将支架之间的直接试验内比较与来自其他试验的间接证据相结合，同时保持随机化。
三组的死亡率相似：西罗莫司洗脱支架与裸金属支架相比，风险比（HR）为1.00（95%可信区间0.82 - 1.25）；紫杉醇洗脱支架与裸金属支架相比，HR为1.03（0.84 - 1.22）；西罗莫司洗脱支架与紫杉醇洗脱支架相比，HR为0.96（0.83 - 1.24）。西罗莫司洗脱支架与心肌梗死风险最低相关（HR 0.81，95%可信区间0.66 - 0.97，与裸金属支架相比p = 0.030；0.83，0.71 - 1.00，与紫杉醇洗脱支架相比p = 0.045）。明确的支架血栓形成风险（0天至4年）无显著差异。然而，紫杉醇洗脱支架晚期明确的支架血栓形成风险（>30天）增加（HR 2.11，95%可信区间1.19 - 4.23，与裸金属支架相比p = 0.017；1.85，1.02 - 3.85，与西罗莫司洗脱支架相比p = 0.041）。与裸金属支架相比，药物洗脱支架在靶病变血运重建方面的降低在西罗莫司洗脱支架中比在紫杉醇洗脱支架中更明显（0.70，0.56 - 0.84；p = 0.0021）。
药物洗脱支架和裸金属支架相关的死亡风险相似。西罗莫司洗脱支架在临床上似乎优于裸金属支架和紫杉醇洗脱支架。
