Abstract 3342: Adequacy of Inclusion of Post-Procedural Bleeding in a Composite End Point for Assessment of Outcome After Percutaneous Coronary Intervention.
Objective: To assess the adequacy of inclusion of post-procedural bleeding in a quadruple composite end point for the prediction of mortality after percutaneous coronary intervention (PCI).
Methods: This study included 5384 patients from 4 ISAR randomized trials on the value of abciximab: ISAR-REACT, ISAR-SWEET, ISAR-SMART 2 and ISAR-REACT 2. Common inclusion criteria were the presence of native coronary artery disease requiring PCI and pretreatment with 600 mg of clopidogrel at least 2 hours prior to the intervention. Patients were randomized to receive either the standard dose of abciximab plus unfractionated heparin or placebo plus unfractionated heparin. Bleeding was defined according to the Thrombolysis in Myocardial Infarction (TIMI) criteria. Primary end point was one-year mortality.
Results: Within the first 30 days there were 314 myocardial infarctions (5.8%), 52 urgent revascularizations (1.0%) and 215 TIMI major or minor bleeding (4.0%). One-year mortality was 3.6% (n=197). Table⇓ shows one-year mortality among patients with or without 30-day adverse events (myocardial infarction, urgent revascularization or bleeding). Cox proportional hazard model that included all of the 3 adverse events along with baseline characteristics of the patients showed that 30-day myocardial infarction, urgent revascularization or bleeding were all independently associated with one-year mortality with adjusted hazard ratios displayed in the table⇓. The prognostic value of bleeding was not dependent on its classification as major or minor.
Conclusion: Our study supports the inclusion of post-procedural bleeding in a quadruple end point along with death, myocardial infarction and urgent revascularization to assess outcome after percutaneous coronary intervention.