Relation of periprocedural bleeding complications and long-term outcome in patients undergoing percutaneous coronary revascularization (from the Evaluation of Oral Xemilofiban in Controlling Thrombotic Events [EXCITE] Trial)

Am J Cardiol. 2009 Apr 1;103(7):917-22. doi: 10.1016/j.amjcard.2008.12.017. Epub 2009 Feb 7.

Abstract

Several clinical trials have shown that antagonists of the glycoprotein IIb/IIIa receptor decreased the incidence of death, nonfatal myocardial infarction, and the need for urgent revascularization when administered immediately before or during the 24- to 48-hour period after percutaneous coronary intervention (PCI). However, these agents increased the risk of thrombocytopenia and periprocedural bleeding complications. Therefore, the relation between periprocedural bleeding complications during PCI and long-term outcome was assessed in 6,995 patients in the EXCITE trial. Periprocedural bleeding was classified as none, mild, moderate, and severe. Measured outcomes included the incidence of all-cause mortality or the composite end point (cardiovascular disease) of death, myocardial infarction, or stroke. Subjects were followed up for a median of 210 days (7 months). Mean patient age was 59.1 years, and 21.8% were women. Periprocedural bleeding complications occurred in 1,869 patients (26.7%), and blood transfusion was administered to 189 patients (2.7%). In multivariate analysis, periprocedural bleeding complications were significantly associated with increased risk of the composite outcome for mild (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.64 to 0.97), moderate (HR 2.38, 95% CI 1.78 to 3.20), and severe bleeding complications (HR 3.55, 95% CI 2.20 to 5.73) during follow-up. Also, the necessity of blood transfusion was an important predictor of the composite end point (HR 2.61, 95% CI 1.96 to 3.60). Patients in the United States were more likely to be administered a blood transfusion than non-US patients independently of cardiovascular risk factors. In conclusion, moderate and severe periprocedural bleeding complications increased the risk of mortality and incident cardiovascular events after PCI.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Angioplasty, Balloon, Coronary / methods*
  • Benzamidines / administration & dosage*
  • Benzamidines / adverse effects
  • Coronary Angiography
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / therapy*
  • Coronary Thrombosis / epidemiology
  • Coronary Thrombosis / prevention & control*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Electrocardiography
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Platelet Aggregation Inhibitors / administration & dosage
  • Platelet Aggregation Inhibitors / adverse effects
  • Postoperative Hemorrhage / blood
  • Postoperative Hemorrhage / epidemiology
  • Postoperative Hemorrhage / etiology*
  • Preoperative Care / adverse effects*
  • Risk Factors
  • Survival Rate / trends
  • Thrombocytopenia / blood
  • Thrombocytopenia / chemically induced*
  • Thrombocytopenia / complications
  • Time Factors
  • Treatment Outcome
  • United States / epidemiology

Substances

  • Benzamidines
  • Platelet Aggregation Inhibitors
  • xemilofiban