NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.
Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.
Catheter Cardiovasc Interv. 2020 May 1;95(6):1067-1073. doi: 10.1002/ccd.28392. Epub 2019 Jul 13.
To assess the long-term safety and efficacy of the Resolute zotarolimus-eluting stent (R-ZES).
The R-ZES has been associated with low rates of adverse events over short-intermediate term follow-up. However, reliable assessment of the safety and efficacy of any implanted device requires long-term evaluation.
The RESOLUTE US trial was a prospective, observational study conducted at 116 U.S. sites and enrolled patients with de novo coronary lesions. Patients were followed clinically for 5 years with independent event adjudication and data monitoring.
A total of 1,402 patients (1,573 lesions) were enrolled; 34% had diabetes mellitus and 75% had ACC type B2/C lesions. The 5-year rate of target lesion failure (TLF) was 12.3%, target lesion revascularization was 6.5%, target vessel myocardial infarction was 3.2%, and cardiac death was 4.1%. Dual antiplatelet therapy usage was 94% at 1 year and 47% at 5 years, with a 0.1% and 0.5% respective incidence of definite or probable stent thrombosis. The 5-year rate of TLF was 16.9% among patients with diabetes mellitus and 14.7% in patients with at least one small (≤2.5 mm) vessel treated. Covariates independently associated with 5-year TLF in multivariable analysis included diabetes mellitus (odds ratio [OR] 1.89, p < .001), prior coronary artery bypass grafting (OR 2.28, p < .001), prior myocardial infarction (OR 1.85, p = .002), and smaller reference vessel diameter (OR 1.75, p = .004).
Results from the fully adjudicated and monitored RESOLUTE US trial demonstrate long-term 5-year safety and efficacy of the R-ZES stent among a relatively low-risk population of patients, including a 0.5% rate of stent thrombosis at 5 years.
评估 Resolute 佐他莫司洗脱支架（R-ZES）的长期安全性和有效性。
在短中期随访中，R-ZES 与较低的不良事件发生率相关。然而，对任何植入设备的安全性和有效性的可靠评估都需要长期评估。
RESOLUTE US 试验是一项在美国 116 个地点进行的前瞻性观察性研究，入组了患有新发冠状动脉病变的患者。患者接受了 5 年的临床随访，包括独立的事件评估和数据监测。
共入组了 1402 例患者（1573 处病变）；34%的患者患有糖尿病，75%的患者存在 ACC 类型 B2/C 病变。5 年靶病变失败（TLF）率为 12.3%，靶病变血运重建率为 6.5%，靶血管心肌梗死率为 3.2%，心脏死亡率为 4.1%。双联抗血小板治疗的使用率在 1 年时为 94%，在 5 年时为 47%，分别有 0.1%和 0.5%的患者发生明确或可能的支架血栓形成。在糖尿病患者中，5 年 TLF 率为 16.9%，在至少有一处小血管（≤2.5mm）治疗的患者中，该比例为 14.7%。多变量分析中与 5 年 TLF 独立相关的因素包括糖尿病（比值比[OR] 1.89，p<.001）、既往冠状动脉旁路移植术（OR 2.28，p<.001）、既往心肌梗死（OR 1.85，p=0.002）和较小的参考血管直径（OR 1.75，p=0.004）。
RESOLUTE US 试验的完全裁定和监测结果显示，在相对低危的患者人群中，R-ZES 支架具有长期的 5 年安全性和有效性，5 年时的支架血栓形成率为 0.5%。
