Hironori Hara1, Kuniaki Takahashi2, David van Klaveren3, Rutao Wang4, Scot Garg5, Masafumi Ono1, Hideyuki Kawashima1, Chao Gao4, Michael Mack6, David R Holmes7, Marie-Claude Morice8, Stuart J Head9, Arie Pieter Kappetein9, Daniel J F M Thuijs9, Yoshinobu Onuma10, Thilo Noack11, Friedrich W Mohr11, Piroze M Davierwala11, Patrick W Serruys12. 1. Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Department of Cardiology, National University of Ireland, Galway, Galway, Ireland. 2. Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. 3. Department of Public Health, Center for Medical Decision Making, Erasmus MC, Rotterdam, the Netherlands; Predictive Analytics and Comparative Effectiveness Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts. 4. Department of Cardiology, National University of Ireland, Galway, Galway, Ireland; Department of Cardiology, Radboud University, Nijmegen, the Netherlands. 5. Department of Cardiology, Royal Blackburn Hospital, Blackburn, United Kingdom. 6. Department of Cardiothoracic Surgery, Baylor Scott and White Healthcare, Dallas, Texas. 7. Department of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, Minnesota. 8. Département of Cardiologie, Hôpital privé Jacques Cartier, Générale de Santé Massy, France. 9. Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, the Netherlands. 10. Department of Cardiology, National University of Ireland, Galway, Galway, Ireland. 11. University Department of Cardiac Surgery, Heart Centre Leipzig, Leipzig, Germany. 12. Department of Cardiology, National University of Ireland, Galway, Galway, Ireland; National Heart and Lung Institute, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.
Abstract
BACKGROUND: The poorer prognosis of coronary artery disease in females compared with males is related mainly to differences in baseline characteristics. In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, the effect of treatment with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting surgery (CABG) on mortality at 5 years differed significantly between females and males; however, the optimal revascularization beyond 5 years according to sex has not been evaluated. OBJECTIVES: The aim of this study was to investigate the impact of sex on mortality and sex-treatment interaction at 10 years. METHODS: The SYNTAXES (SYNTAX Extended Survival) study evaluated vital status up to 10 years in 1,800 patients with de novo 3-vessel and/or left main coronary artery disease randomized to treatment with PCI or CABG in the SYNTAX trial. All-cause death at 10 years was separately evaluated in female and male patients with complex coronary artery disease. RESULTS:Of 1,800 patients, 402 (22.3%) were female and 1,398 (77.7%) were males. Females had a higher 10-year mortality rate compared with males (32.8% vs. 24.7%; log-rank p = 0.002), but female sex was not an independent predictor of mortality (adjusted hazard ratio: 1.02; 95% confidence interval: 0.76 to 1.36). Mortality at 10 years tended to be lower after CABG than after PCI, with a similar treatment effect for female and male patients (adjusted hazard ratio for females: 0.90 [95% confidence interval: 0.54 to 1.51]; adjusted hazard ratio for males: 0.76 [95% confidence interval: 0.56 to 1.02]; p for interaction = 0.952). CONCLUSIONS: Female sex was not an independent predictor of mortality at 10 years in patients with complex coronary artery disease. The interaction between sex and treatment with PCI or CABG that was observed at 5 years was no longer present at 10 years. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES], NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX], NCT00114972).
RCT Entities:
BACKGROUND: The poorer prognosis of coronary artery disease in females compared with males is related mainly to differences in baseline characteristics. In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, the effect of treatment with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting surgery (CABG) on mortality at 5 years differed significantly between females and males; however, the optimal revascularization beyond 5 years according to sex has not been evaluated. OBJECTIVES: The aim of this study was to investigate the impact of sex on mortality and sex-treatment interaction at 10 years. METHODS: The SYNTAXES (SYNTAX Extended Survival) study evaluated vital status up to 10 years in 1,800 patients with de novo 3-vessel and/or left main coronary artery disease randomized to treatment with PCI or CABG in the SYNTAX trial. All-cause death at 10 years was separately evaluated in female and male patients with complex coronary artery disease. RESULTS: Of 1,800 patients, 402 (22.3%) were female and 1,398 (77.7%) were males. Females had a higher 10-year mortality rate compared with males (32.8% vs. 24.7%; log-rank p = 0.002), but female sex was not an independent predictor of mortality (adjusted hazard ratio: 1.02; 95% confidence interval: 0.76 to 1.36). Mortality at 10 years tended to be lower after CABG than after PCI, with a similar treatment effect for female and male patients (adjusted hazard ratio for females: 0.90 [95% confidence interval: 0.54 to 1.51]; adjusted hazard ratio for males: 0.76 [95% confidence interval: 0.56 to 1.02]; p for interaction = 0.952). CONCLUSIONS: Female sex was not an independent predictor of mortality at 10 years in patients with complex coronary artery disease. The interaction between sex and treatment with PCI or CABG that was observed at 5 years was no longer present at 10 years. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES], NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX], NCT00114972).
Authors: Monica Parry; Harriette G C Van Spall; Kerri-Anne Mullen; Sharon L Mulvagh; Christine Pacheco; Tracey J F Colella; Marie-Annick Clavel; Shahin Jaffer; Heather J A Foulds; Jasmine Grewal; Marsha Hardy; Jennifer A D Price; Anna L E Levinsson; Christine A Gonsalves; Colleen M Norris Journal: CJC Open Date: 2022-04-19