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Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months versus aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicenter, open-label, randomized superiority trial Causes, Timing, and Impact of Dual Antiplatelet Therapy Interruption for Surgery (from the Patterns of Non-adherence to Anti-platelet Regimens In Stented Patients Registry) ACC/AHA Versus ESC Guidelines on Dual Antiplatelet Therapy JACC Guideline Comparison: JACC State-of-the-Art Review Benefit of switching dual antiplatelet therapy after acute coronary syndrome: the TOPIC (timing of platelet inhibition after acute coronary syndrome) randomized study Safety of six-month dual antiplatelet therapy after second-generation drug-eluting stent implantation: OPTIMA-C Randomised Clinical Trial and OCT Substudy 6- Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents in Patients Nonresistant to Aspirin Final Results of the ITALIC Trial (Is There a Life for DES After Discontinuation of Clopidogrel) Dual-antiplatelet treatment beyond 1 year after drug-eluting stent implantation (ARCTIC-Interruption): a randomised trial Low-Dose Aspirin Discontinuation and Risk of Cardiovascular Events: A Swedish Nationwide, Population-Based Cohort Study Rationale and design of a prospective substudy of clinical endpoint adjudication processes within an investigator-reported randomised controlled trial in patients with coronary artery disease: the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY)

Clinical TrialVolume 11, Issue 13, July 2018

JOURNAL:JACC Cardiovasc Interv. Article Link

Outcomes After Coronary Stenting or Bypass Surgery for Men and Women With Unprotected Left Main Disease: The EXCEL Trial

PW Serruys, R Cavalcante, GW Stone et al. Keywords: coronary artery bypass graft; female; male; PCI; sex; SYNTAX score

ABSTRACT


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.


BACKGOURND - 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.