Results of an analysis of more than 20 randomized trials indicates women are at a greater risk of MACE and all-cause mortality than men following PCI.
Gregg Stone, MD
A new analysis is shedding light on the differences in outcomes and adverse events seen between men and women undergoing percutaneous coronary intervention (PCI).
Results of the analysis, which included data from more than 30,000 patients, indicated women had a greater risk of suffering a major adverse cardiovascular event (MACE) and female sex independently increased risk of MACE by 14% compared to men.
In an effort to further examine sex-related outcomes following PCI, an international team of investigators—led by Greg Stone, MD, of the Icahn School of Medicine at Mount Sinai—conducted an analysis of patient-level data from randomized PCI trials. With this in mind, investigators identified 21 randomized trials from 2000-2013 that enrolled patients with coronary artery disease (CAD) undergoing PCI with bare-metal stents (BMS) or first- or second-generation drug-eluting stents (DES).
The primary endpoint for the analysis was MACE—defined as a composite outcome of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization (ID-TLR). Secondary endpoints included MACE at 30 days and the individual components of MACE, stent thrombosis, and ischemia-driven target-vessel revascularization (ID-TVR) at 30 days and 5 years.
From the 21 trials included, investigators identified a cohort of 32,877 patients who underwent PCI for obstructive CAD, of which 9141 were women. Investigators pointed out women were more older, less likely to be Caucasian, had higher BMI, and had higher left ventricular ejection fraction (LVEF) than their male counterparts.
Additionally, women had more frequent history of hypertension, diabetes, and hyperlipidemia but a lower frequency of history of smoking, prior MI, and prior percutaneous or surgical revascularization. Investigators also noted that women were more commonly treated for stable angina while men were more frequently presented with ST-segment elevation or non-ST-segment elevation MI.
Results of the analysis indicated women had a higher unadjusted rate of MACE (18.9% vs 17.7%; P = .003), cardiac death (10.4% vs 8.7%; P = .0008), and ID-TLR (10.9% vs 10.2%; P = .02) at 5 years compared with men. Results of a multivariable analysis indicated female sex was an independent predictor of MACE (HR 1.14; 95% CI, 1.01-1.30; P = .04) and ID-TLR (HR 1.23; 95% CI, 1.05-1.44; P = .009) but not for cardiac (HR 0.97; 95% CI, 0.73-1.29; P = .85). or all-cause (HR 0.91; 95% CI, 0.75-1.09; P = .30) mortality.
Investigators noted multiple limtiations within their study. These limtations included imbalances in baseline clinical and angiographic characteristics between men and women, immediate procedure-related complications were not consistently captured, and the inability to exclude a potential effect of these and other unmeasured confounders.
In a related editorial to the findings, Michelle O’Donoghue, MD, MPH, of the TIMI Study Group at Brigham and Women’s Hospital, and Amy Sarma, MD, of the Cardiovascular Division at Massachusetts General Hospital, commended the investigators and noted the study results highlight the need for evidence-based therapies for women undergoing PCI.
“The current findings build upon prior studies on potential differences in the pathobiology and natural history of coronary disease in women versus men,” wrote O’Donoghue and Sarma.
“Despite a lower atherosclerotic disease burden and reduced target lesion complexity, women remain at high risk of MACE after PCI, which underscores the need for use of appropriate evidence-based therapies in this population.”
The study, “Long-Term Outcomes in Women and Men Following Percutaneous Coronary Intervention,” was published online in the Journal of the American College of Cardiology.