April 6, 2020

Large Pooled Analysis Compares Long-Term Outcome Data in Women and Men After PCI

April 6, 2020—A large-scale, individual patient data–pooled analysis of contemporary percutaneous coronary intervention (PCI) trials evaluating the sex-related risk of 5-year cardiovascular outcomes after PCI found that women had a higher risk of major adverse cardiac events (MACE) and ischemia-driven target lesion revascularization (ID-TLR) compared with men. The study was published by Ioanna Kosmidou, MD, et al in Journal of the American College of Cardiology (JACC; 2020;75:1631–1640).

For the analysis, the investigators pooled patient-level data from 21 randomized PCI trials and assessed the association between sex and MACE (cardiac death, myocardial infarction, or ID-TLR) as well as its individual components at 5 years.

As summarized in JACC, women composed 27.8% (9,141 of 32,877 patients) of the study population for the pooled-data analysis.

Compared with men, the women in the study were older, with:

  • Higher body mass index
  • More frequent hypertension
  • More frequent diabetes
  • Less frequent history of surgical or percutaneous revascularization

Additionally, angiographic core laboratory analysis showed that lesions in women had smaller reference vessel diameter and shorter lesion length.

At 5 years, women compared with men had higher unadjusted rates of:

  • MACE (18.9% vs 17.7%; P = .003)
  • All-cause death (10.4% vs 8.7%; P = .0008)
  • Cardiac death (4.9% vs 4%; P = .003)
  • ID-TLR (10.9% vs 10.2%; P = .02)

By multivariable analysis, female sex was an independent predictor of MACE (hazard ratio [HR], 1.14; 95% confidence interval [CI], 1.01–1.3; P = .04) and ID-TLR (HR, 1.23; 95% CI, 1.05–1.44; P = .009).

However, female sex was not an independent predictor of all-cause death (HR, 0.91; 95% CI, 0.75–1.09; P = .3) or cardiac death (HR, 0.97; 95% CI, 0.73–1.29; P = .85), reported the investigators in JACC.


April 6, 2020

Shockwave Completes Enrollment in DISRUPT CAD III Pivotal Trial of Coronary Intravascular Lithotripsy

April 3, 2020

European Commission Postpones Medical Devices Regulation by 1 Year to Prioritize COVID-19 Response