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.

中文翻译：

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冠状窦狭窄治疗难治性心绞痛：REDUCER-I 多中心“真实世界”观察性研究主要终点分析。


背景 难治性心绞痛患者通常不符合血运重建的条件，并且尽管进行了最佳药物治疗，但生活质量仍然很差。在 COSIRA （治疗难治性心绞痛的冠状窦缩小剂） 随机假对照试验中，冠状窦 （CS） 复位剂 （Shockwave Medical Inc） 治疗难治性心绞痛是安全有效的。目的 本研究旨在对完整的 REDUCER-I （Neovasc Reducer System） 研究队列进行主要终点分析。方法 REDUCER-I 是一项非随机的“真实世界”研究，对象为在 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 个月时加拿大心血管学会 （CCS） 等级的改善。主要安全终点是 30 天内的主要不良心脏事件和设备或手术相关的严重不良事件。研究随访计划持续 5 年，此处包括一些 3 年的中期分析。结果 2016—2023年共纳入400例患者，其中男性占78.0%（312/400），既往心肌梗死占54.3%（216/398），血运重建既往占73.6%（293/398），CCS III/IV分级占72.0%（280/389）。主要不良心脏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。6 个月时，69.8% （240/344） 的患者改善了 ≥1 级 CCS。6 个月时，6 分钟步行距离提高了 34.1 ± 85.8 m（P < 0.0001）。中期 3 年结果显示 CCS 分级和西雅图心绞痛问卷生活质量改善持续 （P < 0.0001）。 结论 REDUCER-I 研究的完整主要终点分析显示，难治性心绞痛患者接受了 CS Reducer 安全有效的治疗。心绞痛和生活质量的改善似乎持续 3 年。