%0 Journal Article
%T Conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery: A randomized controlled trial (COMICS).
%A Angelini GD
%A Reeves BC
%A Culliford LA
%A Maishman R
%A Rogers CA
%A Anastasiadis K
%A Antonitsis P
%A Argiriadou H
%A Carrel T
%A Keller D
%A Liebold A
%A Ashkaniani F
%A El-Essawi A
%A Breitenbach I
%A Lloyd C
%A Bennett M
%A Cale A
%A Gunaydin S
%A Gunertem E
%A Oueida F
%A Yassin IM
%A Serrick C
%A Murkin JM
%A Rao V
%A Moscarelli M
%A Condello I
%A Punjabi P
%A Rajakaruna C
%A Deliopoulos A
%A Bone D
%A Lansdown W
%A Moorjani N
%A Dennis S
%J Perfusion
%V 0
%N 0
%D 2024 Jun 4
%M 38832503
%F 1.581
%R 10.1177/02676591241258054
%X <B>BACKGROUND: </B>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.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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).<BR><B>CONCLUSIONS: </B>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.