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冠状动脉窦狭窄治疗慢性难治性心绞痛的安全性和有效性:来自 RESOURCE 研究的新发现。

Safety and efficacy of coronary sinus narrowing in chronic refractory angina: Insights from the RESOURCE study.

机构信息

Interventional Cardiology Unit, GVM Care & Research Maria Cecilia Hospital, Cotignola, Italy.

Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands.

出版信息

Int J Cardiol. 2021 Aug 15;337:29-37. doi: 10.1016/j.ijcard.2021.05.034. Epub 2021 May 21.

Abstract

INTRODUCTION

Refractory angina (RA) is considered the end-stage of coronary artery disease, and often has no interventional treatment options. Coronary sinus Reducer (CSR) is a recent addition to the therapeutic arsenal, but its efficacy has only been evaluated on small populations. The RESOURCE registry provides further insights into this therapy.

METHODS

The RESOURCE is an observational, retrospective registry that includes 658 patients with RA from 20 centers in Europe, United Kingdom and Israel. Prespecified endpoints were the amelioration of anginal symptoms evaluated with the Canadian Cardiovascular Society (CCS) score, the rates of procedural success and complications, and MACEs as composite of all-cause mortality, acute coronary syndromes, and stroke.

RESULTS

At a median follow-up of 502 days (IQR 225-1091) after CSR implantation, 39.7% of patients improved by ≥2 CCS classes (primary endpoint), and 76% by ≥1 class. Procedural success was achieved in 96.7% of attempts, with 3% of procedures aborted mostly for unsuitable coronary sinus anatomy. Any complication occurred in 5.7% of procedures, but never required bailout surgery nor resulted in intra- or periprocedural death or myocardial infarction. One patient developed periprocedural stroke after inadvertent carotid artery puncture. At the last available follow-up, overall mortality and MACE were 10.4% and 14.6% respectively. At one, three and five years, mortality rate at Kaplan-Meier analysis was 4%, 13.7%, and 23.4% respectively.

CONCLUSIONS

CSR implantation is safe and reduces angina in patients with refractory angina.

摘要

引言

难治性心绞痛(RA)被认为是冠状动脉疾病的终末期,通常没有介入治疗选择。冠状窦缩窄器(CSR)是最近加入的治疗武器,但它的疗效仅在小人群中进行了评估。RESOURCE 登记处提供了对这种治疗方法的进一步了解。

方法

RESOURCE 是一项观察性、回顾性登记处,包括来自欧洲、英国和以色列的 20 个中心的 658 例 RA 患者。预先指定的终点是加拿大心血管学会(CCS)评分评估的心绞痛症状改善、程序成功率和并发症率,以及复合全因死亡率、急性冠状动脉综合征和中风的 MACEs。

结果

在 CSR 植入后的中位随访 502 天(IQR 225-1091)后,39.7%的患者CCS 评分至少改善了 2 个等级(主要终点),76%的患者至少改善了 1 个等级。96.7%的尝试实现了程序成功,3%的程序因冠状窦解剖结构不合适而中止。任何并发症的发生率为 5.7%,但从未需要紧急手术,也未导致围手术期死亡或心肌梗死。1 例患者因颈动脉意外穿刺后发生围手术期中风。在最后一次可用随访时,总死亡率和 MACE 分别为 10.4%和 14.6%。在 Kaplan-Meier 分析中,1 年、3 年和 5 年的死亡率分别为 4%、13.7%和 23.4%。

结论

CSR 植入术安全,可减轻难治性心绞痛患者的心绞痛。

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