The EXCEL trial did not find the sex of patients with left main coronary artery disease to be an independent predictor of adverse events after revascularization. However, women who underwent angioplasty had a trend towards worse outcomes, a finding that might be related to comorbidities and somewhat increased chances of peri-procedural complications.

In its formal conclusions, this trial tells us that further studies are required to determine the best revascularization strategy in women with complex coronary artery disease. However, these additional studies are unlikely to be conducted in the short or medium term; in consequence, in daily clinical practice, we can make decisions without any regard to sex.

All of that comes to dethrone the teachings of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, in which women clearly showed higher mortality rates with angioplasty compared with surgery.

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The EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, which is more modern, randomized patients with left main disease to angioplasty with everolimus-eluting stent Xience or myocardial revascularization surgery, and followed them for 3 years with a combined endpoint of death, infarction, or stroke.

Out of 1905 patients included, 1464 were male (76.9%) and 441 were female (23.1%).

These women enrolled were older and had more risk factors (including diabetes) although their coronary lesions were less complex (mean SYNTAX score 24.2 vs. 27.2, p < 0.0001).

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In a multivariate analysis, sex was not an independent predictor for the primary endpoint (hazard ratio [HR]: 1.10; 95% confidence interval [CI]: 0.82 to 1.48; p = 0.53) or death (HR: 1.39; 95% CI: 0.92 to 2.10; p = 0.12) at 3 years.

In the 30-day cut-off, the composite of death, infarction, or stroke occurred in 8.9% of women who underwent angioplasty, 6.2% of women who underwent surgery, 3.6% of men who underwent angioplasty, and 8.4% of men who underwent surgery (p for interaction = 0.003).

At 3 years, these differences were mitigated and interactions stopped being significant (p = 0.06) both between men and women, and between revascularization strategies. The numerical differences observed were driven by higher peri-procedural infarction rates in women who underwent angioplasty and by the same event in men who underwent surgery.

Original title: Outcomes After Coronary Stenting or Bypass Surgery for Men and Women with Unprotected Left Main Disease. The EXCEL Trial.

Reference: Patrick W. Serruys et al. (J Am Coll Cardiol Intv 2018;11:1234–43).

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