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第一代、第二代药物洗脱支架以及裸金属支架植入用于接受经皮冠状动脉介入治疗的患者:预先设定的针对PROGIGY研究的分析

Two-Year Outcomes After First- or Second-Generation Drug-Eluting or Bare-Metal Stent Implantation in All-Comer Patients Undergoing Percutaneous Coronary Intervention: A Pre-specified Analysis From the PROlonging Dual Antiplatelet Treatment After Grading stent-induced Intimal hyperplasia studY (PRODIGY)

来源:爱思唯尔 发布时间:2014-1-4
期刊: JACC: Cardiovascular Interventions2013年12月期卷

 

Objectives

This study sought to assess device-specific outcomes after implantation of bare-metal stents (BMSs), zotarolimus-eluting Endeavor Sprint stents (ZES-Ss), paclitaxel-eluting stents (PESs), or everolimus-eluting stents (EESs) (Medtronic Cardiovascular, Santa Rosa, CA) in all-comer patients undergoing percutaneous coronary intervention.

 

Background

Few studies have directly compared second-generation drug-eluting stents with each other or with BMSs.

 

Methods

We randomized 2,013 patients to BMS, ZES-Ss, PES, or EES implantation. At 30 days, each stent group received up to 6 or 24months of clopidogrel therapy. The key efficacy endpointwas the 2-yearmajor adverse cardiac event (MACE) including any death, myocardial infarction, or target vessel revascularization, whereas the cumulative rate of definite or probable stent thrombosis (ST) was the key safety endpoint.

 

Results

Clinical follow-up at 2 years was complete for 99.7% of patients. The MACE rate was lowest in EES (19.2%; 95% confidence interval [CI]: 16.0 to 22.8), highest in BMS (32.1%; 95% CI: 28.1 to 36.3), and intermediate in PES (26.2%; 95% CI: 22.5 to 30.2) and ZES-S (27.8%; 95% CI: 24.1 to 31.9) groups (chi-square test ¼ 18.9, p ¼ 0.00029). The 2-year incidence of ST in the EES group (1%; 95% CI: 0.4 to 2.2) was similar to that in the ZES-S group (1.4%; 95% CI: 0.7 to 2.8), whereas it was lower compared with the PES (4.6%, 95% CI: 3.1 to 6.8) and BMS (3.6%; 95% CI: 2.4 to 5.6) groups (chi-square ¼ 16.9; p ¼ 0.0001).

 

Conclusions

Our study shows that cumulative MACE rate, encompassing both safety and efficacy endpoints, was lowest for EES, highest for BMS, and intermediate for PES and ZES-S groups. EESs outperformed BMSs also with respect to the safety endpoints with regard to definite or probable and definite, probable, or possible ST.

 

主要结论:对于重大心血管不良事件,依维莫司药物洗脱支架最低,裸金属支架最高,紫杉醇洗脱支架和咗他莫司洗脱支架居中。与裸金属支架相比,依维莫司药物洗脱支架的安全性更佳。

 

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