scholarly journals 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)

2020 ◽  
Vol 2020 ◽  
pp. 1-11 ◽  
Author(s):  
Vladimir Ganyukov ◽  
Nikita Kochergin ◽  
Aleksandr Shilov ◽  
Roman Tarasov ◽  
Jan Skupien ◽  
...  

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.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Ganyukov ◽  
N Kochergin ◽  
A Shilov ◽  
R Tarasov ◽  
J Skupien ◽  
...  

Abstract Aim Optimal revascularization strategy in multi-vessel (MV) coronary artery disease (CAD) eligible for percutaneous intervention (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. Materials and 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. The primary endpoint was SPECT at 12 months (primary endpoint of RI that the trial was powered for; a measure of revascularization mid-term efficacy and an independent predictor of long-term prognosis). The secondary endpoint was 3-year MACCE. Results Baseline characteristics were similar between the study arms. 5 (9.8%) patients in the HCR group required conversion to CABG. Data are given respectively for the CABG, HCR and MV-PCI arm. Incomplete revascularization rate was 8.0% vs. 7.7% vs. 5.7% (p=0.86). At 12 months, RI was 5 (2,9)% vs. 5 (3,7)% vs. 6 (3,10)% (median; Q1,Q3) with non-inferiority p values of 0.0006 (HCR vs. CABG) and 0.016 (MV-PCI vs. CABG). 3-year MACCE rate was similar (34.7% vs. 27.1% vs. 38%; p=0.18). Conclusion In patients with MV-CAD amenable to CABG, HCR, and MV-PCI, endpoints of residual myocardial ischemia at 12 months and 3-year MACCE were similar. ClinicalTrials: gov identifier: NCT01699048 Funding Acknowledgement Type of funding source: None


2010 ◽  
Vol 24 (4) ◽  
pp. 319-327 ◽  
Author(s):  
Dominique Hansen ◽  
Paul Dendale ◽  
Anita Raskin ◽  
Annick Schoonis ◽  
Jan Berger ◽  
...  

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