比较生物可吸收聚合物西罗莫司洗脱支架和永久性聚合物依维莫司洗脱支架治疗多支冠状动脉疾病患者的长期临床结局：CENTURY II 随机临床试验 5 年结果。

Comparison of long-term clinical outcomes in multivessel coronary artery disease patients treated either with bioresoarbable polymer sirolimus-eluting stent or permanent polymer everolimus-eluting stent: 5-year results of the CENTURY II randomized clinical trial.

机构信息

Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.

Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France.

出版信息

Catheter Cardiovasc Interv. 2020 Feb;95(2):175-184. doi: 10.1002/ccd.28224. Epub 2019 Apr 29.

OBJECTIVES

To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial.

BACKGROUND

The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient.

METHODS

Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months.

RESULTS

In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar.

CONCLUSIONS

These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.

目的

在 CENTURY II 试验中，评估载有生物可吸收聚合物（BP-SES；Ultimaster）的西罗莫司洗脱支架（SES）与依维莫司洗脱、永久性聚合物支架（PP-EES；Xience）相比，在多支血管病变（MVD）患者这一预设亚组中的长期安全性和疗效。

背景

在高危亚组（如 MVD 患者）中使用冠状动脉支架的情况越来越多。然而，临床证据，包括不同新一代药物洗脱支架疗效和安全性的长期比较分析，仍然不足。

方法

在 CENTURY II 前瞻性、随机、单盲、多中心试验中，共纳入 1119 例患者（意向治疗），其中 MVD 患者亚组 456 例，采用分层随机化方法，分别接受 BP-SES（n=225）或 PP-EES（n=231）治疗。该研究的主要终点是 9 个月时无靶病变失败（TLF：心脏死亡、靶血管相关心肌梗死[MI]和临床靶病变血运重建的复合终点）。

结果

在该 MVD 子研究中，治疗组之间患者、病变和手术特征基线相似。在 1 年和 5 年时，BP-SES 和 PP-EES 的 TLF 发生率均较低且相似（5.3% vs. 7.8%；p=0.29 和 10.2% vs. 13.4%；p=0.29），明确或可能的支架血栓形成发生率也相似（0.4% vs. 1.3%；p=0.33 和 0.9% vs. 1.7%；p=0.43）。心脏死亡和 MI 的复合终点以及患者导向的任何死亡、MI 和冠状动脉血运重建的复合终点也相似。