Randomized Clinical Trial of Surgical vs. Percutaneous vs. Hybrid Revascularization in Multivessel Coronary Artery Disease: Residual Myocardial Ischemia and Clinical Outcomes at One Year—Hybrid coronary REvascularization Versus Stenting or Surgery (HREVS)‎

الملخص EN

Aim.

Optimal revascularization strategy in multivessel (MV) coronary artery disease (CAD) eligible for percutaneous management (PCI) and surgery remains unresolved.

We evaluated, in a randomized clinical trial, residual myocardial ischemia (RI) and clinical outcomes of MV-CAD revascularization using coronary artery bypass grafting (CABG), hybrid coronary revascularization (HCR), or MV-PCI.

Methods.

Consecutive MV-CAD patients (n = 155) were randomized (1 : 1 : 1) to conventional CABG (LIMA-LAD plus venous grafts) or HCR (MIDCAB LIMA-LAD followed by PCI for remaining vessels) or MV-PCI (everolimus-eluting CoCr stents) under Heart Team agreement on equal technical and clinical feasibility of each strategy.

SPECT at 12 months (primary endpoint of RI that the trial was powered for; a measure of revascularization midterm efficacy and an independent predictor of long-term prognosis) preceded routine angiographic control.

Results.

Data are given, respectively, for the CABG, HCR, and MV-PCI arms.

Incomplete revascularization rate was 8.0% vs.

7.7% vs.

5.7% (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).

At 12 months, RI was 5 (2, 9)% vs.

5 (3, 7)% vs.

6 (3, 10)% (median; Q1, Q3) with noninferiority p values of 0.0006 (HCR vs.

CABG) and 0.016 (MV-PCI vs.

CABG).

Rates of angiographic graft stenosis/occlusion or in-segment restenosis were 20.4% vs.

8.2% vs.

5.9% (p=0.05).

Clinical target vessel/graft failure occurred in 12.0% vs.

11.5% vs.

11.3% (p=0.62).

Major adverse cardiac and cerebral event (MACCE) rate was similar (12% vs.

13.4% vs.

13.2%; p=0.83).

Conclusion.

In this first randomized controlled study comparing CABG, HCR, and MV-PCI, residual myocardial ischemia and MACCE were similar at 12 months.

There was no midterm indication of any added value of HCR.

Hospital stay and sick-leave duration were shortest with MV-PCI.

While longer-term follow-up is warranted, these findings may impact patient and physician choices and healthcare resources utilization.

This trial is registered with NCT01699048.