Sirolimus-coated balloon in acute and chronic coronary syndromes: the PEACE study, a subanalysis of the EASTBOURNE registry

IF 7.2 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Revista española de cardiología (English ed.) Pub Date : 2024-07-01 DOI:10.1016/j.rec.2023.11.010
Alessandra Laricchia , Irene Bossi , Roberto A. Latini , Chuey Y. Lee , Ignacio S. Pérez , Fabrizio Tomai , Amin A. Nuruddin , Dario Buccheri , Giuseppe Seresini , Raymundo Ocaranza , Gunasekaran Sengottvelu , Nicola Pesenti , Antonio Mangieri , Bernardo Cortese , on behalf of the EASTBOURNE investigators
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Abstract

Introduction and objectives

The PEACE study (Performance of a sirolimus-eluting balloon strategy in acute and chronic coronary syndromes) investigated for the first time whether a sirolimus-coated balloon (SCB) (Magic Touch, Concept Medical, India) is associated with different outcomes depending on whether it is used in acute coronary syndromes (ACS) or chronic coronary syndromes (CCS).

Methods

This was a post-hoc analysis from the all-comers EASTBOURNE Registry (NCT03085823). Out of 2083 patients enrolled, an SCB was used to treat 968 (46.5%) ACS and 1115 (53.5%) CCS patients. The primary endpoint was target lesion revascularization at 12 months, while secondary endpoints were angiographic success and major adverse cardiovascular events.

Results

Baseline demographics, mean reference vessel diameter and mean lesion length were comparable between ACS and CCS. Predilatation was more commonly performed in ACS (P = .007). SCB was inflated at a standard pressure in both groups with a slight trend toward longer inflation time in ACS. Angiographic success was high in both groups (ACS 97.4% vs CCS 97.7%, P = .820) with limited bailout stenting. Similarly, at 12 months the cumulative incidence of target lesion revascularization (ACS 6.6% vs CCS 5.2%, P = .258) was comparable between ACS and CCS. Conversely, a higher rate of major adverse cardiovascular events in acute presenters was mainly driven by myocardial infarction recurrencies (ACS 10.4% vs CCS 8.3%, P = .009). In-stent restenosis showed a higher proportion of target lesion revascularization and major adverse cardiovascular events than de novo lesions, independently of the type of presentation at the index procedure.

Conclusions

This SCB shows good performance in terms of acute and 1-year outcomes independently of the clinical presentation.

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西罗莫司包被球囊治疗急性和慢性冠状动脉综合征:伊斯特伯恩登记的亚分析。
简介和目的:PEACE研究(西罗莫司洗脱球囊策略在急慢性冠状动脉综合征中的性能)首次调查了西罗莫司涂层球囊(SCB) (Magic Touch, Concept Medical,印度)是否与不同的结果相关,取决于它是用于急性冠状动脉综合征(ACS)还是慢性冠状动脉综合征(CCS)。方法:这是一项来自伊斯特伯恩注册中心(NCT03085823)的事后分析。在入选的2083例患者中,SCB用于治疗968例(46.5%)ACS患者和1115例(53.5%)CCS患者。主要终点是12个月时的目标病变血运重建,而次要终点是血管造影成功和主要不良心血管事件。结果:ACS和CCS的基线人口统计学、平均参考血管直径和平均病变长度具有可比性。预扩张在ACS患者中更为常见(P = .007)。两组SCB均在标准压力下充气,ACS组SCB充气时间稍长。两组的血管造影成功率都很高(ACS 97.4% vs CCS 97.7%, P = 0.820)。同样,在12个月时,ACS和CCS的目标病变血供重建累积发生率(ACS为6.6%,CCS为5.2%,P = 0.258)具有可比性。相反,急性患者主要心血管不良事件发生率较高主要是由心肌梗死复发所致(ACS 10.4% vs CCS 8.3%, P = 0.009)。支架内再狭窄的目标病变血运重建和主要不良心血管事件的比例高于新生病变,与指数手术时的表现类型无关。结论:这种SCB在独立于临床表现的急性和1年预后方面表现良好。
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