Abstract：
BACKGROUND: The 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.
METHODS: This 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.
RESULTS: The 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).
CONCLUSIONS: MiECC 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.
METHODS: This 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.
RESULTS: The 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).
CONCLUSIONS: MiECC 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.
摘要：
背景：该试验假设微创体外循环（MiECC）降低了需要体外循环而不停止循环的心脏手术后严重不良事件（SAE）的风险。
方法：这是一个多中心，14个心脏手术中心的国际随机对照试验，包括年龄≥18岁和<85岁的择期或紧急单纯性冠状动脉旁路移植术（CABG）患者，孤立性主动脉瓣置换术（AVR）手术，或CABG+AVR手术。参与者被随机分配到MiECC或常规体外循环（CECC），按中心和操作分层。主要结果是手术后30天内12次SAE的复合结果，假设MiECC降低的风险。次要结果包括：其他SAE；全因死亡率；输血；重症监护和医院出院时间；健康相关生活质量。分析是在改良的意向治疗基础上进行的。
结果：由于COVID-19大流行，试验提前终止；1071名参与者(896名孤立的CABG，97隔离AVR，69CABG+AVR），中位年龄66岁，中位EuroSCOREII1.24被随机分配（535至MiECC，536至CECC)。26名参与者在随机分组后退出，干预前22和干预后4。517例（9.7％）随机分配给MiECC组和69/522例（13.2％）随机分配给CECC组的主要结果（风险比=0.732，95％置信区间（95％CI）=0.556至0.962，p=0.025）。任何不影响主要结局的SAE的风险也同样降低（风险比=0.791，95%CI0.530至1.179，p=0.250）。
结论：MiECC可将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。因为试验在没有达到目标样本量的情况下提前终止，MiECC的这些潜在好处是不确定的。
方法：这是一个多中心，14个心脏手术中心的国际随机对照试验，包括年龄≥18岁和<85岁的择期或紧急单纯性冠状动脉旁路移植术（CABG）患者，孤立性主动脉瓣置换术（AVR）手术，或CABG+AVR手术。参与者被随机分配到MiECC或常规体外循环（CECC），按中心和操作分层。主要结果是手术后30天内12次SAE的复合结果，假设MiECC降低的风险。次要结果包括：其他SAE；全因死亡率；输血；重症监护和医院出院时间；健康相关生活质量。分析是在改良的意向治疗基础上进行的。
结果：由于COVID-19大流行，试验提前终止；1071名参与者(896名孤立的CABG，97隔离AVR，69CABG+AVR），中位年龄66岁，中位EuroSCOREII1.24被随机分配（535至MiECC，536至CECC)。26名参与者在随机分组后退出，干预前22和干预后4。517例（9.7％）随机分配给MiECC组和69/522例（13.2％）随机分配给CECC组的主要结果（风险比=0.732，95％置信区间（95％CI）=0.556至0.962，p=0.025）。任何不影响主要结局的SAE的风险也同样降低（风险比=0.791，95%CI0.530至1.179，p=0.250）。
结论：MiECC可将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。因为试验在没有达到目标样本量的情况下提前终止，MiECC的这些潜在好处是不确定的。
