Safety and efficacy of the latest generation biodegradable polymer-coated ultrathin sirolimus-eluting stent in the treatment of coronary artery disease in a European all-comer population with or without high bleeding risk: The Cruz HBR Registry.

IF 1.4 4区 医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Minerva cardiology and angiology Pub Date : 2024-08-01 Epub Date: 2024-05-27 DOI:10.23736/S2724-5683.24.06462-7
David M Leistner, Rajiv Rampat, Michael Haude, Thomas Schmitz, Abdelhakim Allali, Helge Möllmann, Barbara E Stähli, Tanja K Rudolph, Alexander Lauten, René Koning, Kris Bogaerts, Krishnankutty Sudhir, Christoph Naber
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Abstract

Background: The latest generation ultrathin Supraflex Cruz (Sahajanand Medical Technologies Limited, Surat, India) sirolimus-eluting stent (SES) has shown early healing properties and represents an attractive percutaneous coronary intervention (PCI) device in a high bleeding risk (HBR) population. The aim of this Cruz HBR registry was to assess safety and efficacy of the Supraflex Cruz SES in a large cohort of all-comer patients, of whom about one third were patients at HBR.

Methods: Patients undergoing PCI were enrolled in this prospective, multi-centre, open label registry and stratified into non-HBR and HBR groups. The primary endpoint was a device-oriented composite endpoint (DOCE), a composite of cardiovascular death, myocardial infarction not clearly attributable to a non-target vessel and clinically driven target lesion revascularization within 12 months after PCI. The predefined aims were to show non-inferiority of the non-HBR group to the Supraflex arm of the TALENT Trial, and of the HBR group to polymer-free biolimus-coated stent arm of LEADERS FREE Trial.

Results: A total of 1203 patients were enrolled across 26 European centers, including a significant proportion (38.7%; N.=466) of HBR patients. A total of 1745 lesions were treated in 1203 patients and 2235 stents were implanted. The DOCE occurred within the total cohort in 5.8% of patients with a significant difference between HBR patients and non-HBR patients (8.1% vs. 4.4%; P<0.001). All-cause mortality at 12 months was significantly (P<0.0001) different among HBR (9.0%) and non-HBR patients (1.7%), respectively. At 12 months, the overall incidence of definite and probable stent thrombosis was 1.0%. Major bleeding occurred in 5.9% patients of the HBR group. These results met the non-inferiority criteria with respect to the TALENT trial for the non-HBR group (P<0.0001), and the LEADERS FREE trial for the HBR group (P<0.0001).

Conclusions: The Cruz HBR registry confirms that PCI with the Supraflex Cruz SES is associated with a favorable clinical outcome in an all-comer population, including complex patients with HBR.

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最新一代生物可降解聚合物涂层超薄西罗莫司洗脱支架治疗冠状动脉疾病的安全性和有效性:欧洲所有有或没有高出血风险的人群:克鲁兹 HBR 登记。
背景:最新一代超薄 Supraflex Cruz(Sahajanand 医疗技术有限公司,印度苏拉特)西罗莫司洗脱支架(SES)显示出了早期愈合特性,是高出血风险(HBR)人群中极具吸引力的经皮冠状动脉介入(PCI)设备。这项 Cruz HBR 登记的目的是评估 Supraflex Cruz SES 在一大批所有患者(其中约三分之一是 HBR 患者)中的安全性和有效性:接受 PCI 治疗的患者被纳入这项前瞻性、多中心、开放标签注册研究,并被分为非 HBR 组和 HBR 组。主要终点是以设备为导向的复合终点(DOCE),即PCI术后12个月内心血管死亡、非目标血管所致心肌梗死和临床驱动的目标病变血运重建的复合终点。预定目标是证明非HBR组与TALENT试验的Supraflex组和HBR组与LEADERS FREE试验的不含聚合物的biolimus涂层支架组无劣效性:26个欧洲中心共招募了1203名患者,其中包括相当一部分(38.7%;N.=466)HBR患者。1203名患者共治疗了1745个病灶,植入了2235个支架。在所有患者中,5.8%的患者发生了DOCE,HBR患者和非HBR患者之间存在显著差异(8.1%对4.4%;PC结论:Cruz HBR 登记证实,使用 Supraflex Cruz SES 进行 PCI 与所有患者(包括复杂的 HBR 患者)的良好临床预后相关。
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来源期刊
Minerva cardiology and angiology
Minerva cardiology and angiology CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
2.60
自引率
18.80%
发文量
118
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