Sex Differences in Outcomes After Contemporary Percutaneous Coronary Intervention: Insights From the PENDULUM...

Sex differences in clinical outcomes remain controversial in patients treated with a drug-eluting stent (DES).

The purpose of this study was to investigate whether the effects of sex differences on ischemic and bleeding outcomes vary by bleeding risk in patients undergoing contemporary percutaneous coronary intervention (PCI) with a second-generation DES and predominant use of potent P2Y₁₂ inhibitors.

The PENDULUM (Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event) registry was a prospective, multicenter, PCI registry in Japan. The primary endpoints were major adverse cardiac and cerebrovascular events (MACCE) and major bleeding (Bleeding Academic Research Consortium types 3 and 5) 30 months after the index PCI.

Of the 6,266 patients included in this subgroup analysis, 1,357 patients (21.7%) were women. The incidences of MACCE and major bleeding at 30 months were similar between the sexes (MACCE: 9.4% vs 9.4%, HR: 1.00 [95% CI: 0.82-1.22]; P = 1.000; major bleeding: 4.2% vs 4.5%, HR: 1.07 [95% CI: 0.81-1.43]; P = 0.628). After adjustment, female sex was associated with lower incidences of MACCE at 30 months (adjusted HR: 0.65 [95% CI: 0.51-0.82]; P < 0.001). There was no interaction between sex and high bleeding risk for MACCE and major bleeding at 30-month follow-up (P for interaction = 0.926 and 0.617, respectively).

Female sex is an independent predictor of lower ischemic outcomes but not bleeding outcomes at 30 months in patients undergoing contemporary PCI with a second-generation DES and predominant use of potent P2Y₁₂ inhibitors. There was no interaction between high bleeding risk and sex for ischemic and bleeding outcomes. (Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event; UMIN000020332).