Hybrid Coronary Revascularization In Diabetics Pilot Randomized Controlled Trial
Hadi Toeg, David Glineur, Alexander Dick, Michel LeMay, Marino Labinaz, Marc Ruel.
University of Ottawa Heart Insitiute, Ottawa, ON, Canada.
Objectives:The objective of this trial, which focuses on diabetic patients with multi-vessel coronary artery disease(CAD), is to evaluate whether performing minimally invasive bypass surgery(MICS-CABG) with the left internal thoracic artery(LITA) to the left anterior descending(LAD) coronary artery followed by placement of drug eluting stents(DES) in other affected coronary arteries(hybrid-revascularization[HCAR]) is more or less effective than CABG alone.
Methods:Enrollment began in December 2015(ClinicalTrials.gov Identifier:NCT02504762). Adult patients with diabetes, multivessel coronary artery disease (with involvement of the LAD), and angiographic lesion characteristics amenable to either percutaneous coronary intervention(PCI) or CABG were screened and enrolled in the study. Patients were randomized to either conventional off pump CABG or MICS-CABG with LITA to the LAD grafting followed by PCI within 3 days. The main objective of this study was to determine the number of consenting patients after 1 year of enrolment, protocol adherence, cross-over, and follow-up rates. After completion of this feasibility trial, patients will be enrolled into the main trial aimed at measuring major adverse cardiac and cerebrovascular events(MACCE) at 5 years.
Results:After 12 months of enrollment, 60 patients were screened and a total of 11 patients were enrolled. The potential reason for non-enrollment was perceived suboptimal PCI in non-LAD territories. Patients underwent either off-pump CABG(N=6) or HCAR(N=5). All patients were hypertensive, diabetic, and on maximal medical therapy(aspirin,beta-blocker,statin,ACE-inhibitor). HCAR patients underwent PCI after 1.2±0.4 days following MICS-CABG with placement of 2.2±1.1 DES per patient. Angiography demonstrated TIMI 3 flow in all LITA to LAD grafts. Length of hospital stay was shorter in the HCAR group(5 days) compared to the CABG group(7 days)(p=0.04). Protocol adherence and follow-up rates at a median of 6.3 months was 100%. Crossover/conversion to sternotomy, MACCE, and blood transfusion rates were 0% in both groups.
Conclusions:This is the first randomized controlled trial comparing conventional CABG to HCAR in diabetic patients with multivessel CAD. This feasibility study demonstrates that enrollment, crossover, and adherence to protocol rates are acceptable. The potential reason for non-enrollment is diffuse CAD felt to preclude PCI. HCAR patients demonstrated early discharge from hospital;moreover, both groups had no MACCE. Mid-term outcome data and myocardial perfusion imaging are underway.
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