Results Of The Hybrid Coronary Revascularization In Diabetics (hycards) Pilot Randomized Controlled Trial
Marc Ruel, Hadi Toeg, Aun-Yeong Chong, Alexander Dick, David Glineur, Marino Labinaz
University of Ottawa Heart Institute, Ottawa, ON, Canada
Objective: This pilot randomized controlled trial aimed to determine the feasibility of a definitive study comparing a hybrid revascularization strategy (MICS CABG + PCI) to conventional CABG for the treatment of multivessel CAD in patients with diabetes mellitus.
Methods: The trial was registered at www.clinicaltrials.gov as NCT02504762. Patients with diabetes and multivessel CAD involving the left anterior descending (LAD) artery and at least 1 other coronary territory (stenosis ≥ 70% in an artery ≥ 1.5 mm) were randomized to undergo either MICS CABG to the LAD + PCI to the other stenosed vessels (Hybrid group) or complete revascularization via sternotomy (Conventional group). Feasibility endpoints included ≥ 95% participant adherence to the randomly allocated revascularization method; ≤ 5% procedural crossovers; and achievement of enrolment by a single surgeon over 2 years. Potential efficacy differences were examined with major adverse cardiovascular events; Seattle Angina Questionnaire (SAQ) at baseline, 1 month, 6 months and 1 year; and Rest/Stress myocardial perfusion imaging at 1 year.
Results: Enrollment (N=20) was completed between 2015 and 2018, from a total of 34 eligible patients screened. Enrolled patients were aged 67 ± 7 years and included 4 (20%) females. There was 1 (5%) procedural crossover from the Hybrid to the Conventional group prior to treatment initiation. All treatments were completed during 1 index hospitalization. No periprocedural death, myocardial infarction or stroke occurred. Clinical follow-up was complete to a median of 20 (max. 37) months. One patient in the Conventional group died 14 months postoperatively due to gastrointestinal cancer. No myocardial infarction or stroke occurred. Two patients in the Hybrid group required repeat revascularization at 3 days and 13 months postoperatively. Two other Hybrid patients experienced spontaneous bleeding events. Functionally, patients in the Hybrid group reported a better capacity to garden, carry groceries or vacuum (P=0.04) at 1 month postoperatively. No differences in SAQ were observed at 6 or 12 months postoperatively. There was no difference in myocardial perfusion or left ventricular function at 1 year.
Conclusions: This pilot trial of hybrid coronary revascularization is, to our knowledge, the first to have been completed exclusively in patients with diabetes. The trial successfully met its feasibility and protocol adherence endpoints. There was no clinical outcome difference between the Hybrid and Conventional therapies, with the possible exception of earlier recovery and numerically higher incidence of repeat revascularization in the Hybrid group.
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