Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale (EOC), Università della Svizzera Italiana, Lugano, Switzerland (M.V.).
Poland Miedziowe Centrum Zdrowia Lubin, Poland (A.W.).
Circulation. 2023 Sep 26;148(13):989-999. doi: 10.1161/CIRCULATIONAHA.123.065448. Epub 2023 Aug 25.
Limited information is available on the comparative efficacy and safety of different stent platforms in patients at high bleeding risk undergoing an abbreviated dual antiplatelet therapy duration after percutaneous coronary intervention (PCI). The aim of this study was to compare the safety and effectiveness of the biodegradable-polymer sirolimus-eluting stent with the durable-polymer zotarolimus-eluting stent in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after PCI.
The Bioflow-DAPT Study is an international, randomized, open-label trial conducted at 52 interventional cardiology hospitals in 18 countries from February 24, 2020, through September 20, 2021. Patients with a clinical indication to PCI because of acute or chronic coronary syndrome who fulfilled 1 or more criteria for high bleeding risk were eligible for enrollment. Patients were randomized to receive either biodegradable-polymer sirolimus-eluting stents or durable-polymer, slow-release zotarolimus-eluting stents after successful lesion preparation, followed by 1 month of dual antiplatelet therapy and thereafter single antiplatelet therapy. The primary outcome was the composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year, and was powered for noninferiority, with an absolute margin of 4.1% at 1-sided 5% alpha.
A total of 1948 patients at high bleeding risk were randomly assigned (1:1) to receive biodegradable-polymer sirolimus-eluting stents (969 patients) or durable-polymer zotarolimus-eluting stents (979 patients). At 1 year, the primary outcome was observed in 33 of 969 patients (3.6%) in the biodegradable-polymer sirolimus-eluting stent group and in 32 of 979 patients (3.4%) in the durable-polymer zotarolimus-eluting stent group (risk difference, 0.2 percentage points; upper boundary of the 1-sided 95% CI, 1.8; upper boundary of the 1-sided 97.5% CI, 2.1; <0.0001 for noninferiority for both tests).
Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis.
URL: https://www.
gov; Unique identifier: NCT04137510.
在接受经皮冠状动脉介入治疗（PCI）后接受缩短双联抗血小板治疗时间的高出血风险患者中，不同支架平台的疗效和安全性的比较信息有限。本研究旨在比较生物可降解聚合物西罗莫司洗脱支架与耐用聚合物佐他莫司洗脱支架在接受 1 个月双联抗血小板治疗的高出血风险患者中的安全性和有效性。
Bioflow-DAPT 研究是一项国际性、随机、开放标签试验，于 2020 年 2 月 24 日至 2021 年 9 月 20 日在 18 个国家的 52 家介入心脏病学医院进行。有因急性或慢性冠状动脉综合征而有 PCI 临床指征且符合 1 项或多项高出血风险标准的患者有资格入组。在成功准备病变后，患者被随机分配接受生物可降解聚合物西罗莫司洗脱支架或耐用聚合物、缓慢释放佐他莫司洗脱支架，随后接受 1 个月双联抗血小板治疗，然后接受单联抗血小板治疗。主要结局是 1 年时由心脏原因引起的死亡、心肌梗死或支架血栓形成的复合终点，该研究采用非劣效性设计，单侧 5%alpha 水平的绝对差值为 4.1%。
共有 1948 例高出血风险患者被随机分配（1:1）接受生物可降解聚合物西罗莫司洗脱支架（969 例）或耐用聚合物佐他莫司洗脱支架（979 例）。在 1 年时，生物可降解聚合物西罗莫司洗脱支架组 969 例患者中有 33 例（3.6%）发生主要结局，耐用聚合物佐他莫司洗脱支架组 979 例患者中有 32 例（3.4%）发生主要结局（风险差，0.2 个百分点；单侧 95%CI 的上限为 1.8；单侧 97.5%CI 的上限为 2.1；两个检验均<0.0001，非劣效性）。
在接受 PCI 后接受 1 个月双联抗血小板治疗的高出血风险患者中，与耐用聚合物佐他莫司洗脱支架相比，使用生物可降解聚合物西罗莫司洗脱支架在心脏原因引起的死亡、心肌梗死或支架血栓形成的复合终点方面不劣效。
网址：https://www.
gov；独特标识符：NCT04137510。
