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Association of Sex With Outcomes in PCI Patients
Study Questions:
What is the association of sex with patient outcomes at 2 years after contemporary percutaneous coronary intervention (PCI) and with the efficacy and safety of two antiplatelet strategies?
Methods:
The investigators conducted a prespecified subgroup analysis of the investigator-initiated, prospective, randomized GLOBAL LEADERS study evaluating two strategies of antiplatelet therapy after PCI in an unselected population including 130 secondary/tertiary care hospitals in different countries. The main study enrolled 15,991 unselected patients undergoing PCI between July 2013 and November 2015. Patients had an outpatient clinic visit at 30 days and 3, 6, 12, 18, and 24 months after the index procedure. Eligible patients were randomized to either the experimental or reference antiplatelet strategy. The experimental strategy consisted of 1 month of dual antiplatelet therapy (DAPT) followed by 23 months of ticagrelor monotherapy, while the reference strategy was comprised of 12 months of DAPT followed by 12 months of aspirin monotherapy. The primary efficacy endpoint was the composite of all-cause mortality and new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding. The association of sex with the outcomes was assessed in the unadjusted and adjusted Cox proportional hazards model.
Results:
Of the 15,968 patients included in this study, 3,714 (23.3%) were women. The risk of the primary endpoint at 2 years was similar between women and men (adjusted hazard ratio [HR], 1.00; 95% confidence interval [CI], 0.83-1.20). Compared with men, women had a higher risk of BARC type 3 or 5 bleeding (adjusted HR, 1.32; 95% CI, 1.04-1.67) and hemorrhagic stroke at 2 years (adjusted HR, 4.76; 95% CI, 1.92-11.81). At 2 years, there was no between-sex difference in the efficacy and safety of the two antiplatelet strategies. At 1 year, compared with DAPT, ticagrelor monotherapy was associated with a lower risk of bleeding in men (HR, 0.72; 95% CI, 0.53-0.98), but not in women (HR, 1.23; 95% CI, 0.80-1.89; p for interaction = 0.045).
Conclusions:
The authors concluded that compared with men, women experienced a higher risk of bleeding and hemorrhagic stroke after PCI.
Perspective:
This subgroup study reports that women experienced a similar risk of ischemic events compared with men at 2 years after PCI after adjustment for confounders, but women had a higher rate of hemorrhagic stroke and BARC 3 or 5 bleeding compared with men at 2 years after PCI. Furthermore, compared with DAPT, ticagrelor monotherapy was associated with a lower risk of bleeding at 1 year in men but not in women, suggesting that the effect of antiplatelet strategy on bleeding may be different between the sexes. Of note, female sex has been identified as an independent predictor for premature ticagrelor cessation, largely owing to bleeding or dyspnea. Thus, physicians should carefully weigh the risk and benefit of using ticagrelor in women, particularly in light of the fact that ticagrelor monotherapy was not associated with a lower risk of bleeding in women in this study.
Keywords: Acute Coronary Syndrome, Adenosine, Ambulatory Care Facilities, Aspirin, Dyspnea, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Secondary Prevention, Sex Characteristics, Tertiary Care Centers
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