scholarly journals Randomized clinical trial of surgical vs. percutaneous vs. hybrid revasculatization in multivessel coronary artery disease: 3 years follow-up (the HREVS Trial)

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

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.


2018 ◽  
Vol 115 (1) ◽  
pp. 119-129 ◽  
Author(s):  
Tadao Aikawa ◽  
Masanao Naya ◽  
Masahiko Obara ◽  
Osamu Manabe ◽  
Keiichi Magota ◽  
...  

Abstract Aims Coronary flow reserve (CFR) is an integrated measure of the entire coronary vasculature, and is a powerful prognostic marker in coronary artery disease (CAD). The extent to which coronary revascularization can improve CFR is unclear. This study aimed to evaluate the impact of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) on CFR in patients with stable CAD. Methods and results In a prospective, multicentre observational study, CFR was measured by 15O-water positron emission tomography as the ratio of stress to rest myocardial blood flow at baseline and 6 months after optimal medical therapy (OMT) alone, PCI, or CABG. Changes in the SYNTAX and Leaman scores were angiographically evaluated as indicators of completeness of revascularization. Follow-up was completed by 75 (25 OMT alone, 28 PCI, and 22 CABG) out of 82 patients. The median SYNTAX and Leaman scores, and baseline CFR were 14.5 [interquartile range (IQR): 8–24.5], 5.5 (IQR: 2.5–12.5), and 1.94 (IQR: 1.67–2.66), respectively. Baseline CFR was negatively correlated with the SYNTAX (ρ = −0.40, P < 0.001) and Leaman scores (ρ = −0.33, P = 0.004). Overall, only CABG was associated with a significant increase in CFR [1.67 (IQR: 1.14–1.96) vs. 1.98 (IQR: 1.60–2.39), P < 0.001]. Among patients with CFR <2.0 (n = 41), CFR significantly increased in the PCI [1.70 (IQR: 1.42–1.79) vs. 2.21 (IQR: 1.78–2.49), P = 0.002, P < 0.001 for interaction between time and CFR] and CABG groups [1.28 (IQR: 1.13–1.80) vs. 1.86 (IQR: 1.57–2.22), P < 0.001]. The reduction in SYNTAX or Leaman scores after PCI or CABG was independently associated with the percent increase in CFR after adjusting for baseline characteristics (P = 0.012 and P = 0.011, respectively). Conclusion Coronary revascularization ameliorated reduced CFR in patients with obstructive CAD. The degree of improvement in angiographic CAD burden by revascularization was correlated with magnitude of improvement in CFR.


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

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