Conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery: A randomized controlled trial (COMICS).

IF 1.1 4区 医学 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS
Perfusion-Uk Pub Date : 2025-04-01 Epub Date: 2024-06-04 DOI:10.1177/02676591241258054
Gianni D Angelini, Barnaby C Reeves, Lucy A Culliford, Rachel Maishman, Chris A Rogers, Kyriakos Anastasiadis, Polychronis Antonitsis, Helena Argiriadou, Thierry Carrel, Dorothée Keller, Andreas Liebold, Fatma Ashkaniani, Aschraf El-Essawi, Ingo Breitenbach, Clinton Lloyd, Mark Bennett, Alex Cale, Serdar Gunaydin, Eren Gunertem, Farouk Oueida, Ibrahim M Yassin, Cyril Serrick, John M Murkin, Vivek Rao, Marco Moscarelli, Ignazzo Condello, Prakash Punjabi, Cha Rajakaruna, Apostolos Deliopoulos, Daniel Bone, William Lansdown, Narain Moorjani, Sarah Dennis
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引用次数: 0

Abstract

IntroductionThe trial hypothesized that minimally invasive extra-corporeal circulation (MiECC) reduces the risk of serious adverse events (SAEs) after cardiac surgery operations requiring extra-corporeal circulation without circulatory arrest.MethodsThis is a multicentre, international randomized controlled trial across fourteen cardiac surgery centres including patients aged ≥18 and <85 years undergoing elective or urgent isolated coronary artery bypass grafting (CABG), isolated aortic valve replacement (AVR) surgery, or CABG + AVR surgery. Participants were randomized to MiECC or conventional extra-corporeal circulation (CECC), stratified by centre and operation. The primary outcome was a composite of 12 post-operative SAEs up to 30 days after surgery, the risk of which MiECC was hypothesized to reduce. Secondary outcomes comprised: other SAEs; all-cause mortality; transfusion of blood products; time to discharge from intensive care and hospital; health-related quality-of-life. Analyses were performed on a modified intention-to-treat basis.ResultsThe trial terminated early due to the COVID-19 pandemic; 1071 participants (896 isolated CABG, 97 isolated AVR, 69 CABG + AVR) with median age 66 years and median EuroSCORE II 1.24 were randomized (535 to MiECC, 536 to CECC). Twenty-six participants withdrew after randomization, 22 before and four after intervention. Fifty of 517 (9.7%) randomized to MiECC and 69/522 (13.2%) randomized to CECC group experienced the primary outcome (risk ratio = 0.732, 95% confidence interval (95% CI) = 0.556 to 0.962, p = 0.025). The risk of any SAE not contributing to the primary outcome was similarly reduced (risk ratio = 0.791, 95% CI 0.530 to 1.179, p = 0.250).ConclusionsMiECC reduces the relative risk of primary outcome events by about 25%. The risk of other SAEs was similarly reduced. Because the trial terminated early without achieving the target sample size, these potential benefits of MiECC are uncertain.

心脏手术患者接受传统体外循环还是微创体外循环?随机对照试验(COMICS)。
简介:试验假设微创体外循环(MiECC)可降低心脏外科手术后发生严重不良事件(SAE)的风险:这是一项多中心国际随机对照试验,涉及 14 个心脏外科中心,包括年龄≥18 岁的患者和结果:试验因 COVID-19 大流行而提前结束;1071 位参与者(896 位单独 CABG、97 位单独 AVR、69 位 CABG + AVR)被随机分配(535 位分配至 MiECC,536 位分配至 CECC),中位年龄为 66 岁,中位 EuroSCORE II 为 1.24。26 名参与者在随机化后退出,22 名在干预前退出,4 名在干预后退出。在随机接受 MiECC 治疗的 517 人中,有 50 人(9.7%)出现了主要结果;在随机接受 CECC 治疗的 522 人中,有 69 人(13.2%)出现了主要结果(风险比 = 0.732,95% 置信区间 (95% CI) = 0.556 至 0.962,P = 0.025)。不导致主要结果的任何 SAE 的风险也同样降低(风险比 = 0.791,95% CI 0.530 至 1.179,p = 0.250):MiECC可将主要结局事件的相对风险降低约25%。结论:MiECC 将主要结果事件的相对风险降低了约 25%,其他 SAE 的风险也同样降低。由于试验未达到目标样本量而提前终止,因此MiECC的这些潜在益处尚不确定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Perfusion-Uk
Perfusion-Uk 医学-外周血管病
CiteScore
3.00
自引率
8.30%
发文量
203
审稿时长
6-12 weeks
期刊介绍: Perfusion is an ISI-ranked, peer-reviewed scholarly journal, which provides current information on all aspects of perfusion, oxygenation and biocompatibility and their use in modern cardiac surgery. The journal is at the forefront of international research and development and presents an appropriately multidisciplinary approach to perfusion science.
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