Department of Cardiology, Maasstad Ziekenhuis, Rotterdam, Netherlands.
Lancet. 2010 Jan 16;375(9710):201-9. doi: 10.1016/S0140-6736(09)62127-9. Epub 2010 Jan 7.
Everolimus-eluting and paclitaxel-eluting stents, compared with bare metal stents, reduced the risk of restenosis in clinical trials with strict inclusion and exclusion criteria. We compared the safety and efficacy of the second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice.
We randomly assigned 1800 consecutive patients (aged 18-85 years) undergoing percutaneous coronary intervention at one centre to treatment with everolimus-eluting or paclitaxel-eluting stents. The primary endpoint was a composite of safety and efficacy (all-cause mortality, myocardial infarction, and target vessel revascularisation) within 12 months. Patients were not told which stent they had been allocated. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01016041.
Follow-up was completed in 1797 patients. The primary endpoint occurred in 56 (6%) of 897 patients in the everolimus-eluting stent group versus 82 (9%) of 903 in the paclitaxel-eluting stent group (relative risk 0.69 [95% CI 0.50-0.95], p value for superiority=0.02). The difference was attributable to a lower rate of stent thrombosis (6 [<1%] vs 23 [3%], 0.26 [0.11-0-64], p=0.002), myocardial infarction (25 [3%] vs 48 [5%], 0.52 [0.33-0.84], p=0.007), and target vessel revascularisation (21 [2%] vs 54 [6%], 0.39 [0.24-0.64], p=0.0001). Cardiac death, non-fatal myocardial infarction, or target lesion revascularisation occurred in 44 [5%] patients in the everolimus-eluting stent group versus 74 [8%] patients in the paclitaxel-eluting stent group, p value for superiority was 0.005.
The everolimus-eluting stent is better than the second generation paclitaxel-eluting stent in unselected patients in terms of safety and efficacy. On the basis of our results, we suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice.
Unrestricted grants from Abbott Vascular and Boston Scientific.
依维莫司洗脱支架和紫杉醇洗脱支架与裸金属支架相比，在纳入和排除标准严格的临床试验中降低了再狭窄的风险。我们比较了第二代依维莫司洗脱支架和紫杉醇洗脱支架在真实临床实践中的安全性和疗效。
我们在一个中心将 1800 例连续接受经皮冠状动脉介入治疗的患者随机分为依维莫司洗脱支架组或紫杉醇洗脱支架组。主要终点为 12 个月内的安全性和疗效复合终点（全因死亡率、心肌梗死和靶血管血运重建）。患者不知道自己被分配了哪种支架。分析采用意向治疗。该试验在 ClinicalTrials.gov 注册，编号为 NCT01016041。
1797 例患者完成了随访。依维莫司洗脱支架组 897 例患者中有 56 例（6%）发生主要终点事件，紫杉醇洗脱支架组 903 例患者中有 82 例（9%）（相对风险 0.69 [95%CI 0.50-0.95]，p 值为优效性=0.02）。差异归因于支架血栓形成发生率较低（6 例[＜1%]比 23 例[3%]，0.26 [0.11-0-64]，p=0.002）、心肌梗死发生率较低（25 例[3%]比 48 例[5%]，0.52 [0.33-0.84]，p=0.007）和靶血管血运重建发生率较低（21 例[2%]比 54 例[6%]，0.39 [0.24-0.64]，p=0.0001）。依维莫司洗脱支架组 44 例（5%）患者发生心脏死亡、非致死性心肌梗死或靶病变血运重建，紫杉醇洗脱支架组 74 例（8%）患者发生（p 值为优效性=0.005）。
依维莫司洗脱支架在安全性和疗效方面优于第二代紫杉醇洗脱支架，适用于未经选择的患者。基于我们的结果，我们建议在日常临床实践中不再使用紫杉醇洗脱支架。
雅培血管和波士顿科学公司的无限制拨款。
