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Potent P2Y12 Inhibitors in Men vs. Women
Study Questions:
Do men and women with coronary artery disease (CAD) derive similar benefit from potent P2Y12 inhibitors?
Methods:
This was a meta-analysis of phase III or IV randomized trials, which examined potent P2Y12 inhibitors including prasugrel, ticagrelor, and intravenous cangrelor. A search of all studies published between January 2006 and June 2016 was completed using MEDLINE, PubMed, ClinicalTrials.gov, and Cochrane databases. Trials were included if an active or placebo-treated arm was used as a comparator group. Exclusion criteria included use of potent P2Y12 inhibitors for both the intervention and comparator groups, and/or if clinical efficacy or safety outcomes were not reported. The primary outcome of interest for each trial was major adverse cardiovascular events (MACE). For this meta-analysis, additional outcomes examined included safety as prespecified by TIMI (Thrombolysis in Myocardial Infarction) major bleeding, minor bleeding (both noncoronary artery bypass grafting related), all-cause mortality, and intracranial hemorrhage.
Results:
A total of 1,822 potential titles were identified, from which 26 randomized controlled trials were further reviewed. A total of seven trials met all the inclusion criteria. Six trials used an active comparator (clopidogrel) and one trial (PEGASUS-TIMI 54) used a placebo comparator arm. These seven trials included a total of 24,494 women and 63,346 men. Potent P2Y12 inhibitors significantly reduced the risk of MACE by 14% in women (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.78-0.94) and by 15% in men (HR, 0.85; 95% CI, 0.80-0.90; p interaction = 0.93). Treatment reduced the risk of MI by 13% in women (HR, 0.87; 95% CI, 0.78-0.96) and 16% in men (HR, 0.84; 95% CI, 0.77-0.91; p interaction = 0.65). Also reduced was the risk of stent thrombosis by 51% in women (HR, 0.49; 95% CI, 0.37-0.65) and 41% in men (HR, 0.59; 95% CI, 0.42-0.84; p interaction = 0.85). Although not statistically significant, a trend toward benefit was observed for cardiovascular death in women (HR, 0.87; 95% CI, 0.76-1.01), which was observed in men (HR, 0.85; 95% CI, 0.77-0.95; p interaction = 0.86). The potent P2Y12 inhibitors increased major bleeding in women (HR, 1.28; 95% CI, 0.87-1.88) and men (HR, 1.52; 95% CI, 1.12-2.07; p interaction = 0.62).
Conclusions:
The authors concluded that in randomized trials, the efficacy and safety of the potent P2Y12 inhibitors were comparable between men and women. Given these data, sex should not influence patient selection for the administration of potent P2Y12 inhibitors.
Perspective:
This meta-analysis supports the use of potent P2Y12 inhibitors in women and men with CAD. Of note, there was no significant difference in bleeding between men and women.
Keywords: Acute Coronary Syndrome, Adenosine, Coronary Artery Disease, Hemorrhage, Intracranial Hemorrhages, Myocardial Infarction, Patient Selection, Primary Prevention, Purinergic P2Y Receptor Antagonists, Platelet Aggregation Inhibitors, Sex Characteristics, Stents, Thrombosis, Ticlopidine, Treatment Outcome
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