Association between bleeding and mortality among women and men with high-risk acute coronary syndromes: insights from the Early versus Delayed, Provisional Eptifibatide in Acute Coronary Syndromes (EARLY ACS) trial.

Abstract

BACKGROUND:

Female sex is an established risk factor for bleeding, which is an important safety end point in patients presenting with non-ST-segment elevation acute coronary syndromes (NSTE ACS). However, it is unknown whether the association between bleeding and mortality is modulated by sex in this patient population.

METHODS:

We examined the interaction between sex and bleeding and 30-day mortality outcomes among 2,975 women and 6,431 men with high-risk NSTE ACS enrolled in the EARLY ACS trial. The Global Utilization of Strategies to Open Occluded Arteries (GUSTO) criteria were used to identify moderate or severe bleeds.

RESULTS:

Women were older and had more comorbid disease compared with men. Bleeding rates were higher among women (8.2%) than among men (5.5%; P < .01). However, the association of bleeding and 30-day mortality was stronger among men (odds ratio 5.8, 95% CI 3.9-8.8) than among women (odds ratio 1.5, 95% CI 0.8-2.9; sex * bleeding interaction P < .01). Sex differences in the association of bleeding and mortality persisted in a landmark analysis of 120-hour survivors.

CONCLUSIONS:

In a contemporary high-risk NSTE ACS cohort, women had higher bleeding rates than did men. Paradoxically, the association between bleeding and mortality was worse among men than among women.

• Authors: Padma Kaul, Jean-François Tanguay, L Kristin Newby, Judith S Hochman, Cynthia M Westerhout, Robert M Califf, Pierluigi Tricoci, C Michael Gibson, Robert P Giugliano, Robert A Harrington, Frans Van de Werf, Paul W Armstrong
• Journal: American heart journal (Am Heart J) Vol. 166 Issue 4 Pg. 723-8 (Oct 2013) ISSN: 1097-6744 [Electronic] United States
• PMID: 24093853 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2013.

Chemical References

• Peptides
• Platelet Aggregation Inhibitors
• Platelet Glycoprotein GPIIb-IIIa Complex
• Eptifibatide

Topics

• Acute Coronary Syndrome (mortality, physiopathology, therapy)
• Aged
• Dose-Response Relationship, Drug
• Double-Blind Method
• Electrocardiography
• Eptifibatide
• Female
• Hemorrhage (chemically induced, epidemiology)
• Humans
• Incidence
• Male
• Middle Aged
• Peptides (administration & dosage, adverse effects, therapeutic use)
• Percutaneous Coronary Intervention (methods)
• Platelet Aggregation Inhibitors (administration & dosage, adverse effects, therapeutic use)
• Platelet Glycoprotein GPIIb-IIIa Complex (antagonists & inhibitors)
• Risk Factors
• Sex Distribution
• Sex Factors
• Survival Rate (trends)