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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.

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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