Conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery: A randomized controlled trial (COMICS)
Gianni D. Angelini, Barnaby C Reeves, Lucy Culliford, Rachel Maishman, Chris Rogers, Kyriakos Anastasiadis, Polychronis Antonitsis, Helena Argiriadou, Thierry Carrel, Dorothée Keller, Andreas Liebold, Fatma Ashkaniani, Aschraf El‐Essawi, Ingo Breitenbach, Clinton Lloyd, Mark J. Bennett, Alex Cale, Serdar Günaydın, Eren Günertem, Farouk Oueida, Ibrahim M. Yassin, Cyril Serrick, John M. Murkin, Vivek Rao, Marco Moscarelli, Ignazzo Condello, Prakash P Punjabi, Cha Rajakaruna, Apostolos Deliopoulos, Daniel Bone, William Lansdown, Narain Moorjani, Sarah Dennis
Abstract
Introduction 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.