冠状动脉窦狭窄治疗难治性心绞痛:REDUCER-I 多中心 "真实世界 "观察研究的主要终点分析。

IF 11.7 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS JACC. Cardiovascular interventions Pub Date : 2024-12-23 Epub Date: 2024-11-06 DOI:10.1016/j.jcin.2024.08.047
Stefan Verheye, Tim P van de Hoef, Ranil de Silva, Jan-Peter van Kuijk, Jonathan Byrne, Matteo Montorfano, Eva Buschmann, Matthias Dupont, Nick E J West, Shmuel Banai
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引用次数: 0

摘要

背景:难治性心绞痛患者通常不符合血管重建的条件,尽管接受了最佳的药物治疗,但生活质量仍然很差。在 COSIRA(冠状窦减压治疗难治性心绞痛)随机假对照试验中,冠状窦(CS)减压器(冲击波医疗公司)治疗难治性心绞痛安全有效:本研究旨在对完整的 REDUCER-I(Neovasc 减压系统观察性研究)研究队列进行主要终点分析:REDUCER-I 是一项非随机的 "真实世界 "研究,研究对象是在 9 个欧洲国家的 25 个中心接受 CS Reducer 治疗的难治性心绞痛患者。主要有效性终点是 6 个月后加拿大心血管协会(CCS)分级的改善。主要安全性终点是 30 天内的主要心脏不良事件以及与器械或手术相关的严重不良事件。研究计划随访5年,这里包括一些3年中期分析:从2016年到2023年,共有400名患者入组,其中包括78.0%(312/400)的男性患者、54.3%(216/398)的既往心肌梗死患者、73.6%(293/398)的既往血管重建患者和72.0%(280/389)的CCS III/IV级患者。重大心脏不良事件和严重不良事件发生率分别为 1.6%(95% CI:0.7-3.6)和 1.1%(4/371),30 天内无死亡病例。6个月时,69.8%(240/344)的患者病情改善≥1个CCS等级。6 个月时,六分钟步行距离缩短了 34.1 ± 85.8 米(P < 0.0001)。3年中期结果显示,CCS分级和西雅图心绞痛问卷调查显示的生活质量改善是持续性的(P < 0.0001):REDUCER-I研究的完整主要终点分析表明,难治性心绞痛患者可以安全有效地接受CS Reducer治疗。心绞痛和生活质量的改善似乎持续了 3 年。
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Coronary Sinus Narrowing for Treating Refractory Angina: REDUCER-I Multicenter "Real-World" Observational Study Primary Endpoint Analysis.

Background: Patients with refractory angina are often ineligible for revascularization and have poor quality of life despite optimal medical therapy. The coronary sinus (CS) Reducer (Shockwave Medical Inc) was safe and effective in the treatment of refractory angina in the COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) randomized sham-controlled trial.

Objectives: This study sought to perform the primary endpoint analysis of the complete REDUCER-I (An Observational Study of the Neovasc Reducer System) study cohort.

Methods: REDUCER-I is a nonrandomized, "real-world" study of patients with refractory angina treated with the CS Reducer conducted at 25 centers from 9 European countries. The primary effectiveness endpoint was an improvement in Canadian Cardiovascular Society (CCS) class at 6 months. The primary safety endpoints were major adverse cardiac events and device- or procedure-related serious adverse events through 30 days. Study follow-up is planned through 5 years with some interim 3-year analyses included here.

Results: From 2016 to 2023, 400 patients were enrolled, including 78.0% (312/400) male patients, 54.3% (216/398) with previous myocardial infarction, 73.6% (293/398) with previous revascularization, and 72.0% (280/389) CCS class III/IV. Major adverse cardiac event and serious adverse event rates were 1.6% (95% CI: 0.7-3.6) and 1.1% (4/371), respectively, with no deaths within 30 days. At 6 months, 69.8% (240/344) of patients improved by ≥1 CCS class. Six-minute walk distances improved by 34.1 ± 85.8 m at 6 months (P < 0.0001). Interim 3-year results showed CCS class and Seattle Angina Questionnaire quality of life improvements were sustained (P < 0.0001).

Conclusions: The complete primary endpoint analysis of the REDUCER-I study shows patients with refractory angina were safely and effectively treated with the CS Reducer. Improvements in angina and quality of life appear sustained through 3 years.

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来源期刊
JACC. Cardiovascular interventions
JACC. Cardiovascular interventions CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
11.60
自引率
8.80%
发文量
756
审稿时长
4-8 weeks
期刊介绍: JACC: Cardiovascular Interventions is a specialist journal launched by the Journal of the American College of Cardiology (JACC). It covers the entire field of interventional cardiovascular medicine, including cardiac, peripheral, and cerebrovascular interventions. The journal publishes studies that will impact the practice of interventional cardiovascular medicine, including clinical trials, experimental studies, and in-depth discussions by respected experts. To enhance visual understanding, the journal is published both in print and electronically, utilizing the latest technologies.
期刊最新文献
Crushed Pigtail Sign: A Specific X-Ray Sign of Impella Malrotation. The Double Bioadaptors Culotte (ADAPT-CULOTTE) Technique: From Bench Testing to the First-in-Human Longitudinal Imaging Analysis. Alleviating Refractory Angina Through Coronary Sinus Narrowing: Consistent Benefits and the Pursuit of Mechanistic Insights. Coronary Sinus Narrowing for Treating Refractory Angina: REDUCER-I Multicenter "Real-World" Observational Study Primary Endpoint Analysis. Coronary Sinus Reducer Improves Angina, Quality of Life, and Coronary Flow Reserve in Microvascular Dysfunction.
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