Author + information
- Received November 20, 2017
- Revision received March 19, 2018
- Accepted March 27, 2018
- Published online July 2, 2018.
- Patrick W. Serruys, MD, PhDa,∗∗ (, )
- Rafael Cavalcante, MD, PhDb,∗,
- Carlos Collet, MDc,d,
- Arie Pieter Kappetein, MD, PhDb,
- Joseph F. Sabik III, MDe,
- Adrian P. Banning, MD, PhDf,
- David P. Taggart, MD, PhDf,
- Manel Sabaté, MD, PhDg,
- Jose Pomar, MDg,
- Piet W. Boonstra, MDh,
- Nicholas J. Lembo, MDi,
- Yoshinobu Onuma, MD, PhDj,
- Charles A. Simonton, MDk,
- Marie-Claude Morice, MDl,
- Thomas McAndrew, PhDm,
- Ovidiu Dressler, MDm and
- Gregg W. Stone, MDm
- aImperial College London, London, United Kingdom
- bErasmus Medical Center, Rotterdam, the Netherlands
- cAcademic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
- dDepartment of Cardiology, Universitair Ziekenhuis Brussel, Brussels, Belgium
- eThe Cleveland Clinic Foundation, Cleveland, Ohio
- fOxford University Hospitals, Oxford, United Kingdom
- gHospital Clinico y Provincial de Barcelona, Barcelona, Spain
- hMedisch Centrum Leeuwarden, Leeuwarden, the Netherlands
- iPiedmont Hospital Atlanta, Atlanta, Georgia
- jCardialysis BV, Rotterdam, the Netherlands
- kAbbott Vascular, Santa Clara, California
- lRamsay Générale de Santé, Hopital Privé Jacques Cartier, Massy, France
- mNew York Presbyterian Hospital, Columbia University Medical Center, and the Cardiovascular Research Foundation, New York, New York
- ↵∗Address for correspondence:
Dr. Patrick W. Serruys, Erasmus University, Westblak 98, 3012 KM Rotterdam, the Netherlands.
Objectives The aim of the present study was to assess outcomes after coronary artery bypass grafting surgery (CABG) and percutaneous coronary intervention (PCI) according to sex in a large randomized trial of patients with unprotected left main disease.
Background In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, sex had a significant interaction effect with revascularization strategy, and women had an overall higher mortality when treated with PCI than CABG.
Methods The EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial was a multinational randomized trial that compared PCI with everolimus-eluting stents and CABG in patients with unprotected left main disease. The primary endpoint was the composite of all-cause death, myocardial infarction, or stroke at 3 years.
Results Of 1,905 patients randomized, 1,464 (76.9%) were men and 441 (23.1%) were women. Compared with men, women were older; had higher prevalence rates of hypertension, hyperlipidemia, and diabetes; and were less commonly smokers but had lower coronary anatomic burden and complexity (mean SYNTAX score 24.2 vs. 27.2, p < 0.001). By multivariate analysis, sex was not independently associated with either the primary endpoint (hazard ratio [HR]: 1.10; 95% confidence interval [CI]: 0.82 to 1.48; p = 0.53) or all-cause death (HR: 1.39; 95% CI: 0.92 to 2.10; p = 0.12) at 3 years. At 30 days, all-cause death, myocardial infarction, or stroke had occurred in 8.9% of woman treated with PCI, 6.2% of women treated with CABG, 3.6% of men treated with PCI, and 8.4% of men treated with CABG (p for interaction = 0.003). The 3-year rate of the composite primary endpoint was 19.7% in women treated with PCI, 14.6% in women treated with CABG, 13.8% in men treated with PCI, and 14.7% in men treated with CABG (p for interaction = 0.06). These differences were driven by higher periprocedural rates of myocardial infarction in women after PCI and in men after CABG.
Conclusions In patients with unprotected left main disease in the EXCEL trial, sex was not an independent predictor of adverse outcomes after revascularization. However, women undergoing PCI had a trend toward worse outcomes, a finding related to associated comorbidities and increased periprocedural complications. Further studies are required to determine the optimal revascularization modality in women with complex coronary artery disease.
↵∗ Drs. Serruys and Cavalcante contributed equally to this report.
Dr. Cavalcante is an employee of Boston Scientific. Dr. Lembo has received fees for lectures and for serving on advisory boards from Abbott Vascular, Boston Scientific, and Medtronic. Dr. Simonton is an employee of Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 20, 2017.
- Revision received March 19, 2018.
- Accepted March 27, 2018.
- 2018 American College of Cardiology Foundation