Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.
Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France.
Catheter Cardiovasc Interv. 2020 Feb;95(2):175-184. doi: 10.1002/ccd.28224. Epub 2019 Apr 29.
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.
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.
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.
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.
These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.
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。
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。
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）。
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。
这些结果证实了在这一高危患者人群中，研究用生物可吸收聚合物支架具有良好的长期安全性和疗效。
