Carlos M Campos1, David van Klaveren2, Vasim Farooq3, Charles A Simonton4, Arie-Pieter Kappetein2, Joseph F Sabik5, Ewout W Steyerberg2, Gregg W Stone6, Patrick W Serruys7. 1. Erasmus University Medical Center, s-Gravendijkwal 230, Rotterdam 3015, The Netherlands Heart Institute (InCor), University of São Paulo Medical School, Sao Paulo, Brazil. 2. Erasmus University Medical Center, s-Gravendijkwal 230, Rotterdam 3015, The Netherlands. 3. Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, Manchester, UK. 4. Abbott Vascular, Santa Clara, CA, USA. 5. Department of Cardiothoracic Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, USA. 6. Columbia University Medical Center, New York, NY, USA Cardiovascular Research Foundation, New York, NY, USA. 7. Erasmus University Medical Center, s-Gravendijkwal 230, Rotterdam 3015, The Netherlands International Centre for Circulatory Health, NHLI, Imperial College London, London, UK patrick.w.j.c.serruys@gmail.com.
Abstract
AIMS: To prospectively validate the SYNTAX Score II and forecast the outcomes of the randomized Evaluation of the Xience Everolimus-Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) Trial. METHODS AND RESULTS: Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization is a prospective, randomized multicenter trial designed to establish the efficacy and safety of percutaneous coronary intervention (PCI) with the everolimus-eluting stent compared with coronary artery bypass graft (CABG) surgery in subjects with unprotected left-main coronary artery (ULMCA) disease and low-intermediate anatomical SYNTAX scores (<33). After completion of patient recruitment in EXCEL, the SYNTAX Score II was prospectively applied to predict 4-year mortality in the CABG and PCI arms. The 95% prediction intervals (PIs) for mortality were computed using simulation with bootstrap resampling (10 000 times). For the entire study cohort, the 4-year predicted mortalities were 8.5 and 10.5% in the PCI and CABG arms, respectively [odds ratios (OR) 0.79; 95% PI 0.43-1.50). In subjects with low (≤22) anatomical SYNTAX scores, the predicted OR was 0.69 (95% PI 0.34-1.45); in intermediate anatomical SYNTAX scores (23-32), the predicted OR was 0.93 (95% PI 0.53-1.62). Based on 4-year mortality predictions in EXCEL, clinical characteristics shifted long-term mortality predictions either in favour of PCI (older age, male gender and COPD) or CABG (younger age, lower creatinine clearance, female gender, reduced left ventricular ejection fraction). CONCLUSION: The SYNTAX Score II indicates at least an equipoise for long-term mortality between CABG and PCI in subjects with ULMCA disease up to an intermediate anatomical complexity. Both anatomical and clinical characteristics had a clear impact on long-term mortality predictions and decision making between CABG and PCI. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: To prospectively validate the SYNTAX Score II and forecast the outcomes of the randomized Evaluation of the Xience Everolimus-Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) Trial. METHODS AND RESULTS: Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization is a prospective, randomized multicenter trial designed to establish the efficacy and safety of percutaneous coronary intervention (PCI) with the everolimus-eluting stent compared with coronary artery bypass graft (CABG) surgery in subjects with unprotected left-main coronary artery (ULMCA) disease and low-intermediate anatomical SYNTAX scores (<33). After completion of patient recruitment in EXCEL, the SYNTAX Score II was prospectively applied to predict 4-year mortality in the CABG and PCI arms. The 95% prediction intervals (PIs) for mortality were computed using simulation with bootstrap resampling (10 000 times). For the entire study cohort, the 4-year predicted mortalities were 8.5 and 10.5% in the PCI and CABG arms, respectively [odds ratios (OR) 0.79; 95% PI 0.43-1.50). In subjects with low (≤22) anatomical SYNTAX scores, the predicted OR was 0.69 (95% PI 0.34-1.45); in intermediate anatomical SYNTAX scores (23-32), the predicted OR was 0.93 (95% PI 0.53-1.62). Based on 4-year mortality predictions in EXCEL, clinical characteristics shifted long-term mortality predictions either in favour of PCI (older age, male gender and COPD) or CABG (younger age, lower creatinine clearance, female gender, reduced left ventricular ejection fraction). CONCLUSION: The SYNTAX Score II indicates at least an equipoise for long-term mortality between CABG and PCI in subjects with ULMCA disease up to an intermediate anatomical complexity. Both anatomical and clinical characteristics had a clear impact on long-term mortality predictions and decision making between CABG and PCI. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Si Eun Lee; Kyunghwa Han; Jin Hur; Young Jin Kim; Hye-Jeong Lee; Yoo Jin Hong; Dong Jin Im; Byoung Wook Choi Journal: Eur Radiol Date: 2017-12-08 Impact factor: 5.315
Authors: Sérgio Madeira; Luís Raposo; João Brito; Ricardo Rodrigues; Pedro Gonçalves; Rui Teles; Henrique Gabriel; Francisco Machado; Manuel Almeida; Miguel Mendes Journal: Arq Bras Cardiol Date: 2016-03-22 Impact factor: 2.000