全患者人群行经皮冠状动脉介入治疗后第一代或第二代药物洗脱支架或裸金属支架植入术后 2 年的结果：来自 PRODIGY 研究（支架内内膜增生分级后延长双联抗血小板治疗研究）的预先指定分析。
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 PRODIGY study (PROlonging Dual Antiplatelet Treatment After Grading stent-induced Intimal hyperplasia studY).
机构信息
Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
Cardiology Department, University of Ferrara, Ferrara, Italy.
出版信息
JACC Cardiovasc Interv. 2014 Jan;7(1):20-8. doi: 10.1016/j.jcin.2013.09.008. Epub 2013 Dec 11.
OBJECTIVES
This study sought to assess device-specific outcomes after implantation of bare-metal stents (BMS), zotarolimus-eluting Endeavor Sprint stents (ZES-S), paclitaxel-eluting stents (PES), or everolimus-eluting stents (EES) (Medtronic Cardiovascular, Santa Rosa, California) in all-comer patients undergoing percutaneous coronary intervention.
BACKGROUND
Few studies have directly compared second-generation drug-eluting stents with each other or with BMS.
METHODS
We randomized 2,013 patients to BMS, ZES-S, PES, or EES implantation. At 30 days, each stent group received up to 6 or 24 months of clopidogrel therapy. The key efficacy endpoint was the 2-year major 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 = 18.9, p = 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 = 16.9; p = 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. EES outperformed BMS also with respect to the safety endpoints with regard to definite or probable and definite, probable, or possible ST. (PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY [PRODIGY]; NCT00611286).
目的
本研究旨在评估在所有行经皮冠状动脉介入治疗的患者中，植入裸金属支架（BMS）、佐他莫司洗脱 Endeavor Sprint 支架（ZES-S）、紫杉醇洗脱支架（PES）或依维莫司洗脱支架（EES）（美敦力心血管，加利福尼亚州圣罗莎）后的器械特异性结局。
背景
很少有研究直接比较第二代药物洗脱支架之间或与 BMS 之间的情况。
方法
我们将 2013 名患者随机分为 BMS、ZES-S、PES 或 EES 植入组。在 30 天时，每个支架组接受长达 6 或 24 个月的氯吡格雷治疗。主要疗效终点是 2 年主要不良心脏事件（MACE），包括任何死亡、心肌梗死或靶血管血运重建，而明确或可能的支架血栓形成（ST）的累积发生率是主要安全性终点。
结果
99.7%的患者完成了 2 年的临床随访。EES 组的 MACE 发生率最低（19.2%；95%置信区间[CI]：16.0 至 22.8），BMS 组最高（32.1%；95%CI：28.1 至 36.3），PES 组和 ZES-S 组居中（26.2%；95%CI：22.5 至 30.2）和 27.8%（95%CI：24.1 至 31.9）（卡方检验=18.9，p=0.00029）。EES 组（1%；95%CI：0.4 至 2.2）2 年 ST 发生率与 ZES-S 组（1.4%；95%CI：0.7 至 2.8）相似，而低于 PES 组（4.6%；95%CI：3.1 至 6.8）和 BMS 组（3.6%；95%CI：2.4 至 5.6）（卡方=16.9；p=0.0001）。
结论
我们的研究表明，EES 组的累积 MACE 率（包括安全性和疗效终点）最低，BMS 组最高，PES 和 ZES-S 组居中。EES 在安全性终点（明确或可能以及明确、可能或可能的 ST）方面也优于 BMS。（PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY [PRODIGY]；NCT00611286）。
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