Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
Department of Cardiology, Ziekenhuisgroep Twente, Almelo, the Netherlands.
J Am Coll Cardiol. 2013 Jun 18;61(24):2406-2416. doi: 10.1016/j.jacc.2013.04.005. Epub 2013 Apr 16.
The aim of this study was to assess the safety and efficacy of the implantation of Resolute zotarolimus-eluting stents (ZES) (Medtronic Inc., Santa Rosa, California) and Xience V everolimus-eluting stents (EES) (Abbott Vascular, Santa Clara, California) following strict discontinuation of dual antiplatelet therapy (DAPT) after 12 months.
Only limited long-term follow-up data are available from head-to-head comparisons of second-generation drug-eluting stents.
The randomized TWENTE (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente) trial is an investigator-initiated study performed in a population with many complex patients and lesions and only limited exclusion criteria. Patients were randomly assigned 1:1 to ZES (n = 697) or EES (n = 694).
Two-year follow-up information was available on all patients. The rate of continuation of DAPT beyond 12 months was very low (5.4%). The primary endpoint of target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization, did not differ between ZES and EES (10.8% vs. 11.6, p = 0.65), despite fewer target lesion revascularizations in patients with EES (2.6% vs. 4.9%, p = 0.03). The patient-oriented composite endpoint was similar (16.4% vs. 17.1%, p = 0.75). Two-year rates of definite or probable stent thrombosis were 1.2% and 1.4%, respectively (p = 0.63). Very late definite or probable stent thrombosis occurred only in 2 patients in each study arm (0.3% vs. 0.3%, p = 1.00).
After 2 years of follow-up and stringent discontinuation of DAPT beyond 12 months, Resolute ZES and Xience V EES showed similar results in terms of safety and efficacy for treating patients with a majority of complex lesions and off-label indications for drug-eluting stents. (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente [TWENTE]; NCT01066650).
本研究旨在评估在严格停用双联抗血小板治疗（DAPT）12 个月后，植入 Resolute 佐他莫司洗脱支架（ZES）（美敦力公司，加利福尼亚州圣罗莎）和依维莫司洗脱支架（EES）（雅培血管公司，加利福尼亚州圣克拉拉）的安全性和疗效。
仅有有限的第二代药物洗脱支架头对头比较的长期随访数据。
随机 TWENTE（真实世界 Endeavor Resolute 与 Xience V 药物洗脱支架研究在特温特）试验是一项由研究者发起的研究，在一个有许多复杂患者和病变的人群中进行，并且只有有限的排除标准。患者被随机分配 1:1 至 ZES（n=697）或 EES（n=694）。
所有患者均获得了 2 年随访信息。12 个月后继续 DAPT 的比率非常低（5.4%）。主要终点，即靶血管失败的复合终点，包括心源性死亡、靶血管相关心肌梗死和靶血管血运重建，在 ZES 和 EES 之间没有差异（10.8%比 11.6%，p=0.65），尽管 EES 组的靶病变血运重建较少（2.6%比 4.9%，p=0.03）。患者导向的复合终点相似（16.4%比 17.1%，p=0.75）。2 年时明确或可能的支架血栓形成率分别为 1.2%和 1.4%，差异无统计学意义（p=0.63）。非常晚期的明确或可能的支架血栓形成仅在每个研究臂各发生 2 例（0.3%比 0.3%，p=1.00）。
在 12 个月后严格停用 DAPT 并随访 2 年后，Resolute ZES 和 Xience V EES 在治疗大多数复杂病变和药物洗脱支架的适应证之外的患者的安全性和疗效方面表现相似。（真实世界 Endeavor Resolute 与 Xience V 药物洗脱支架研究在特温特[TWENTE]；NCT01066650）。
