title: Long-term forecasting and comparison of mortality in the Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial: prospective validation of the SYNTAX Score II.
abstract: OBJECTIVE
  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.
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Erasmus University Medical Center, s-Gravendijkwal 230, Rotterdam 3015, The Netherlands Heart Institute (InCor), University of São Paulo Medical School, Sao Paulo, Brazil.
authors.forename: Carlos M
authors.initials: CM
authors.lastname: Campos
authors.affiliation: Erasmus University Medical Center, s-Gravendijkwal 230, Rotterdam 3015, The Netherlands.
authors.forename: David
authors.initials: D
authors.lastname: van Klaveren
authors.affiliation: Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, Manchester, UK.
authors.forename: Vasim
authors.initials: V
authors.lastname: Farooq
authors.affiliation: Abbott Vascular, Santa Clara, CA, USA.
authors.forename: Charles A
authors.initials: CA
authors.lastname: Simonton
authors.affiliation: Erasmus University Medical Center, s-Gravendijkwal 230, Rotterdam 3015, The Netherlands.
authors.forename: Arie-Pieter
authors.initials: AP
authors.lastname: Kappetein
authors.affiliation: Department of Cardiothoracic Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, USA.
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Sabik
authors.affiliation: Erasmus University Medical Center, s-Gravendijkwal 230, Rotterdam 3015, The Netherlands.
authors.forename: Ewout W
authors.initials: EW
authors.lastname: Steyerberg
authors.affiliation: Columbia University Medical Center, New York, NY, USA Cardiovascular Research Foundation, New York, NY, USA.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.affiliation: 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.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000368:Aged; D001026:Coronary Artery Bypass / Q000379:methods* / Q000401:mortality; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D020000:Decision Support Systems, Clinical; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization / Q000379:methods / Q000401:mortality; D062645:Percutaneous Coronary Intervention / Q000379:methods* / Q000401:mortality; D016491:Peripheral Vascular Diseases / Q000150:complications / Q000401:mortality; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000401:mortality; D012720:Severity of Illness Index
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus
keywords: Coronary artery bypass surgery; Drug-eluting stents; Left main; Mortality; Percutaneous coronary intervention; SYNTAX Score II; SYNTAX score