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INTRODUCTION

Percutaneous coronary intervention for complex coronary disease is associated with a high risk of cardiogenic shock. This can cause harm and limit the quality of revascularization achieved, especially when left ventricular function is impaired at the outset. Elective percutaneous left ventricular unloading is increasingly used to mitigate adverse events in patients undergoing high-risk percutaneous coronary intervention, but this strategy has fiscal and clinical costs and is not supported by robust evidence.

METHODS

CHIP-BCIS3 (Controlled Trial of High-Risk Coronary Intervention With Percutaneous Left Ventricular Unloading) is a prospective, multicenter, open-label randomized controlled trial that aims to determine whether a strategy of elective percutaneous left ventricular unloading is superior to standard care (no planned mechanical circulatory support) in patients undergoing nonemergent high-risk percutaneous coronary intervention. Patients are eligible for recruitment if they have severe left ventricular systolic dysfunction, extensive coronary artery disease, and are due to undergo complex percutaneous coronary intervention (to the left main stem with calcium modification or to a chronic total occlusion with a retrograde approach). Cardiogenic shock and acute ST-segment-elevation myocardial infarction are exclusions. The primary outcome is a hierarchical composite of all-cause death, stroke, spontaneous myocardial infarction, cardiovascular hospitalization, and periprocedural myocardial infarction, analyzed using the win ratio. Secondary outcomes include completeness of revascularization, major bleeding, vascular complications, health economic analyses, and health-related quality of life. A sample size of 250 patients will have in excess of 80% power to detect a hazard ratio of 0.62 at a minimum of 12 months, assuming 150 patients experience an event across all follow-up.

CONCLUSIONS

To date, 169 patients have been recruited from 21 National Health Service hospitals in the United Kingdom, with recruitment expected to complete in 2024.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT05003817.

简介

复杂冠状动脉疾病的经皮冠状动脉介入治疗与心源性休克的风险较高相关。这可能会造成伤害，并限制血运重建的质量，尤其是在最初左心室功能受损的情况下。选择性经皮左心室减压术越来越多地用于减轻高危经皮冠状动脉介入治疗患者的不良事件，但这种策略存在财政和临床成本，并且没有得到强有力的证据支持。

方法

CHIP-BCIS3（高危冠状动脉介入治疗中经皮左心室减压术的对照试验）是一项前瞻性、多中心、开放标签随机对照试验，旨在确定在接受非紧急高危经皮冠状动脉介入治疗的患者中，选择性经皮左心室减压术策略是否优于标准治疗（无计划机械循环支持）。如果患者有严重的左心室收缩功能障碍、广泛的冠状动脉疾病，并且要进行复杂的经皮冠状动脉介入治疗（左主干伴钙修饰或逆行慢性完全闭塞），则符合入组条件。心源性休克和急性 ST 段抬高型心肌梗死是排除标准。主要结局是全因死亡、中风、自发性心肌梗死、心血管住院和围手术期心肌梗死的分层复合，使用赢率进行分析。次要结局包括血运重建的完整性、大出血、血管并发症、卫生经济学分析和健康相关生活质量。如果在所有随访中，预计 250 例患者中有 150 例出现事件，则将有超过 80%的效力检测 12 个月时风险比为 0.62 的情况，假设 169 例患者中有 250 例患者入组。