Short- and long-term mortality following bleeding events in patients undergoing percutaneous coronary intervention: insights from four validated bleeding scales in the CHAMPION trials

EuroIntervention. 2018 Feb 2;13(15):e1841-e1849. doi: 10.4244/EIJ-D-17-00723.

Abstract

Aims: The aim of this study was to determine the prognostic significance of periprocedural bleeding based on various definitions on 30-day and one-year all-cause mortality in patients undergoing routine or urgent percutaneous coronary intervention (PCI).

Methods and results: In this exploratory analysis of 25,107 patients enrolled in the three phase-3 CHAMPION trials, we assessed the prognostic impact of four bleeding scales (GUSTO, TIMI, ACUITY, and BARC) at 48 hrs. Follow-up all-cause mortality data were available at 30 days in all three trials, and at one year in CHAMPION PCI and CHAMPION PLATFORM. Bleeding rates within 48 hrs of PCI were variably identified by each clinical definition (range: <0.5% to >3.5%). Severe/major bleeding, measured by all bleeding scales, and blood transfusion requirement were independently associated with increased mortality at 30 days and one year after PCI (p<0.001 for all associations). Mild/minor bleeding was not independently predictive of one-year mortality (p>0.07 for all associations). Each bleeding definition demonstrated only modest ability to discriminate 30-day and one-year mortality (adjusted C-statistics range: 0.49 to 0.67).

Conclusions: Commonly employed clinical definitions variably identify rates of bleeding after PCI. Severe or major, but not mild or minor, bleeding is independently associated with increased 30-day and one-year mortality. These data may aid in selection of appropriate bleeding metrics in future clinical trials.

Trial registration: ClinicalTrials.gov NCT00305162 NCT00385138 NCT01156571.

MeSH terms

  • Aged
  • Blood Loss, Surgical / mortality*
  • Blood Loss, Surgical / prevention & control
  • Blood Transfusion / mortality
  • Clinical Trials, Phase III as Topic
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / surgery*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / mortality*
  • Platelet Aggregation Inhibitors / administration & dosage
  • Postoperative Hemorrhage / chemically induced
  • Postoperative Hemorrhage / mortality*
  • Postoperative Hemorrhage / therapy
  • Randomized Controlled Trials as Topic
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome

Substances

  • Platelet Aggregation Inhibitors

Associated data

  • ClinicalTrials.gov/NCT00305162
  • ClinicalTrials.gov/NCT00385138
  • ClinicalTrials.gov/NCT01156571