Periprocedural bleeding and 1-year outcome after percutaneous coronary interventions: appropriateness of including bleeding as a component of a quadruple end point

J Am Coll Cardiol. 2008 Feb 19;51(7):690-7. doi: 10.1016/j.jacc.2007.10.040.


Objectives: The aim of the study was to investigate the relationship between bleeding within the 30 days after percutaneous coronary interventions (PCI) and 1-year mortality and to assess the appropriateness of inclusion of the periprocedural bleeding in a quadruple composite end point to assess PCI outcome.

Background: Periprocedural bleeding is one of the most frequent complications of PCI.

Methods: This study included 5,384 patients from 4 randomized placebo-controlled trials on the value of abciximab after pre-treatment with 600 mg of clopidogrel: ISAR-REACT, -SWEET, -SMART-2, and -REACT-2. Bleeding--defined according to the Thrombolysis In Myocardial Infarction criteria--included all bleeding events within 30 days after enrollment. The primary end point was 1-year mortality.

Results: In the 4 trials, within the first 30 days there were 42 deaths (0.8%), 314 myocardial infarctions (MIs) (5.8%), 52 urgent revascularizations (1.0%), and 215 bleeding complications (4.0%). Mortality at 1 year was 3.6% (n = 197). A Cox proportional hazards model revealed that the 30-day occurrence of bleeding (hazard ratio [HR] 2.96, 95% confidence interval [CI] 1.96 to 4.48; p < 0.001), MI (HR 2.29, 95% CI 1.52 to 3.46; p < 0.001) and urgent revascularization (HR 2.49, 95% CI 1.16 to 5.35; p = 0.019) independently predicted 1-year mortality. The c statistic was 0.79 for bleeding, 0.78 for MI, and 0.78 for urgent revascularization, demonstrating a comparable discriminatory power of these adverse events for predicting 1-year mortality.

Conclusions: Our study demonstrates a strong relationship between the 30-day frequency of bleeding and 1-year mortality after PCI and supports the inclusion of periprocedural bleeding in a 30-day quadruple end point for the assessment of outcome after PCI.

Publication types

  • Meta-Analysis

MeSH terms

  • Abciximab
  • Aged
  • Angioplasty, Balloon, Coronary / adverse effects*
  • Antibodies, Monoclonal / therapeutic use*
  • Coronary Disease / mortality
  • Coronary Disease / therapy*
  • Female
  • Fibrinolytic Agents / adverse effects
  • Fibrinolytic Agents / therapeutic use*
  • Hemorrhage / epidemiology*
  • Humans
  • Immunoglobulin Fab Fragments / therapeutic use*
  • Male
  • Middle Aged
  • Myocardial Infarction / mortality
  • Outcome Assessment, Health Care
  • Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors*
  • Prognosis
  • Proportional Hazards Models
  • Randomized Controlled Trials as Topic
  • Risk Assessment
  • Sensitivity and Specificity
  • Stents


  • Antibodies, Monoclonal
  • Fibrinolytic Agents
  • Immunoglobulin Fab Fragments
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Abciximab