Hybrid Coronary Revascularization versus Standards: The HREVS Randomized Clinical Trial

Vladimir Ganyukov ¹, Nikita Kochergin ¹, Alexander Shilov ¹, Wojciech Szot ², Vadim Popov ³, Jan Scupien ², Kirill Kozyrin ¹, Roman Tarasov ¹, Leonid Barbarash ¹, Olga Barbarash ¹, Piotr Musialek ²

¹ State Research Institute for Complex Issues of Cardiovascular Disease, Kemerovo, Russia; ² Dept. of Cardiac Vascular Diseases and Dept. of Nuclear Medicine, John Paul II Hospital, Jagiellonian University, Krakow, Poland; ³ Federal State Budgetary Institution A.V. Vishnevsky Institute of Surgery, Moscow, Russia;

Date, time and location: 2018.05.25 15:30, Congress Hall, 2F–A

Abstract

Objective: To evaluate, in a randomized study, residual myocardial ischemia (RI) and clinical outcomes of multivessel coronary artery disease (MV-CAD) revascularization using different strategies.

Background: Optimal coronary revascularization (CR) method in MV-CAD continues to be debated.

Methods: Consecutive MV-CAD patients (n=155) were randomized (1:1:1) to conventional coronary artery bypass grafting (CABG) (left internal mammary artery- left anterior descending artery (LIMA-LAD) plus venous grafts) or multivessel percutaneous coronary intervention (PCI) (everolimus-eluting stents) or hybrid CR (HCR; minimally invasive direct coronary bypass (MIDCAB) LIMA-LAD plus PCI for remaining vessel/s) following Heart Team agreement on equal technical and clinical feasibility of each strategy. Single-photon emission computed tomography (SPECT) at 12 months (primary endpoint of RI; an independent predictor of long-term prognosis) was followed by control angiography.

Analysis was intention-to-treat.

Results: Study groups baseline characteristics were similar. Incomplete revascularization rate was 3.7% vs. 2.7% vs. 2.1% (p=0.71).  Hospital stay was 13.8 vs. 13.5 vs. 4.5 days (p<0.001) and sick-leave duration was 23 vs. 16 vs. 8 weeks (p<0.001) (respectively CABG, HCR and PCI). Mean RI (95%CI) was 6.7(4.6, 8.8) vs. 6.4(4.3, 8.5) vs. 7.9(5.9, 9.8) with between group differences neither exceeding non-inferiority margin (p=0.039 for meeting non-inferiority) nor statistically significant on superiority analysis (p for superiority 0.46). MACCE rate at 12 months was 12% (CABG) vs. 13.4% (HCR) vs. 13.2% (PCI) (p=0.083), including clinically-driven repeat revascularization in 2.0% vs. 1.9% vs. 5.7% (p=0.54). Target vessel/graft failure occurred in 12.0% vs. 17.3% vs. 11.3% (p=0.62). 

Conclusion: At 12 months, RI and MACCE was similar with the 3 revascularization methods. MV-CAD PCI, using 2^nd generation drug-eluting stents, was associated with a shorter hospital stay and shorter sick-leave duration. Extended follow-up will determine longer-term outcomes.

(Hybrid REvascularization Versus Standards, HREVS, NCT01699048)