Angelini Gianni D, Reeves Barnaby C, Culliford Lucy A, Maishman Rachel, Rogers Chris A, Anastasiadis Kyriakos, Antonitsis Polychronis, Argiriadou Helena, Carrel Thierry, Keller Dorothée, Liebold Andreas, Ashkaniani Fatma, El-Essawi Aschraf, Breitenbach Ingo, Lloyd Clinton, Bennett Mark, Cale Alex, Gunaydin Serdar, Gunertem Eren, Oueida Farouk, Yassin Ibrahim M, Serrick Cyril, Murkin John M, Rao Vivek, Moscarelli Marco, Condello Ignazzo, Punjabi Prakash, Rajakaruna Cha, Deliopoulos Apostolos, Bone Daniel, Lansdown William, Moorjani Narain, Dennis Sarah
Bristol Medical School, University of Bristol, Bristol, UK.
Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece.
Perfusion. 2025 Apr;40(3):730-741. doi: 10.1177/02676591241258054. Epub 2024 Jun 4.
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, = 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, = 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.
引言
该试验假设，在需要体外循环且无循环骤停的心脏手术中，微创体外循环（MiECC）可降低严重不良事件（SAE）的风险。
方法
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，纳入年龄≥18岁且<85岁，接受择期或急诊单纯冠状动脉旁路移植术（CABG）、单纯主动脉瓣置换术（AVR）或CABG + AVR手术的患者。参与者按中心和手术类型分层，随机分为MiECC组或传统体外循环（CECC）组。主要结局是术后30天内12种术后SAE的复合结局，试验假设MiECC可降低其风险。次要结局包括：其他SAE；全因死亡率；血液制品输注；重症监护病房和医院出院时间；健康相关生活质量。分析采用改良意向性分析。
结果
由于COVID-19大流行，试验提前终止；1071名参与者（896例单纯CABG，97例单纯AVR，69例CABG + AVR）被随机分组，年龄中位数66岁，欧洲心脏手术风险评估系统（EuroSCORE）II中位数为1.24（535例分入MiECC组，536例分入CECC组）。26名参与者在随机分组后退出，22名在干预前，4名在干预后。随机分入MiECC组的517名参与者中有50名（9.7%），随机分入CECC组的522名参与者中有69名（13.2%）发生主要结局（风险比=0.732，95%置信区间（95%CI）=0.556至0.962，P=0.025）。未导致主要结局的任何SAE的风险也同样降低（风险比=0.791，95%CI 0.530至1.179，P=0.250）。
结论
MiECC可使主要结局事件的相对风险降低约25%。其他SAE的风险也同样降低。由于试验提前终止，未达到目标样本量，MiECC的这些潜在益处尚不确定。
