Abstract
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.
Highlights
Materials and MethodsTreatment was within 7 days from randomization
Vladimir Ganyukov,1 Nikita Kochergin,1 Aleksandr Shilov,1 Roman Tarasov,1 Jan Skupien,2 Wojciech Szot,2,3 Aleksandr Kokov,1 Vadim Popov,4 Kirill Kozyrin,1 Olga Barbarash,1 Leonid Barbarash,1 and Piotr Musialek 2,5
In a randomized clinical trial, residual myocardial ischemia (RI) and clinical outcomes of MV-coronary artery disease (CAD) revascularization using coronary artery bypass grafting (CABG), hybrid coronary revascularization (HCR), or MV-percutaneous intervention (PCI)
Summary
Treatment was within 7 days from randomization Prior to this trial, the study team had built experience in performing the trial procedures (yearly volume of over 700 CABG with over 100 LIMA-LAD MIDCAB, and over 800 PCIs). Revascularization, Pharmacological Treatment, and Angiographic Follow-Up. For the CABG procedure, venous revascularization (except LIMA to LAD) was performed according to routine practice in the study centre. Any potential angiography (±PCI) performed for clinical reason(s) prior to the study primary follow-up point had no influence on adhering to protocol-mandated angiographic control at 12 ± 1 months. RI differences between the study arms (with CABG taken as reference) were tested against a prespecified noninferiority margin of 4.2 percentage points based on literature data of the clinically relevant threshold of RI difference (see Appendix D).
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