Association of spontaneous and procedure-related bleeds with short- and long-term mortality after acute coronary syndromes: an analysis from the PLATO trial

EuroIntervention. 2015 Nov;11(7):737-45. doi: 10.4244/EIJY14M09_11.

Abstract

Aims: We sought to describe the differential effect of bleeding events in acute coronary syndromes (ACS) on short- and long-term mortality according to their type and severity.

Methods and results: The PLATO trial randomised 18,624 ACS patients to clopidogrel or ticagrelor. Post-randomisation bleeding events were captured according to bleeding type (spontaneous or procedure-related), with PLATO, TIMI, and GUSTO definitions. The association of bleeding events with subsequent short-term (<30 days) and long-term (>30 days) all-cause mortality was assessed using time-dependent Cox proportional hazard models. A model was fitted to compare major and minor bleeding for mortality prediction. Of 18,624 patients, 2,189 (11.8%) had at least one PLATO major bleed (mean follow-up 272.2±123.5 days). Major bleeding was associated with higher short-term mortality (adjusted hazard ratio [HR] 9.28; 95% confidence interval [CI]: 7.50-11.48) but not with long-term mortality (adjusted HR 1.28; 95% CI: 0.93-1.75). Spontaneous bleeding was associated with short-term (adjusted HR 14.59; 95% CI: 11.14-19.11) and long-term (adjusted HR 3.38; 95% CI: 2.26-5.05) mortality. Procedure-related bleeding was associated with short-term mortality (adjusted HR 5.29; 95% CI: 4.06-6.87): CABG-related and non-coronary-procedure-related bleeding were associated with a higher short-term mortality, whereas PCI or angiography-related bleeding was not associated with either short- or long-term mortality. Similar results were obtained using the GUSTO and TIMI bleeding definitions.

Conclusions: Major bleeding is associated with high subsequent mortality in ACS. However, this association is much stronger in the first 30 days and is strongest for spontaneous (vs. procedure-related) bleeding.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Coronary Syndrome / diagnostic imaging
  • Acute Coronary Syndrome / mortality
  • Acute Coronary Syndrome / therapy*
  • Adenosine / adverse effects
  • Adenosine / analogs & derivatives
  • Aged
  • Clopidogrel
  • Coronary Angiography / adverse effects*
  • Coronary Artery Bypass / adverse effects*
  • Coronary Artery Bypass / mortality
  • Double-Blind Method
  • Female
  • Hemorrhage / chemically induced
  • Hemorrhage / diagnosis
  • Hemorrhage / etiology*
  • Hemorrhage / mortality
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention / adverse effects*
  • Percutaneous Coronary Intervention / mortality
  • Platelet Aggregation Inhibitors / adverse effects
  • Postoperative Hemorrhage / etiology
  • Postoperative Hemorrhage / mortality
  • Predictive Value of Tests
  • Proportional Hazards Models
  • Risk Assessment
  • Risk Factors
  • Severity of Illness Index
  • Ticagrelor
  • Ticlopidine / adverse effects
  • Ticlopidine / analogs & derivatives
  • Time Factors
  • Treatment Outcome

Substances

  • Platelet Aggregation Inhibitors
  • Clopidogrel
  • Ticagrelor
  • Adenosine
  • Ticlopidine