Author + information
- Received July 31, 2007
- Revision received September 21, 2007
- Accepted October 1, 2007
- Published online February 19, 2008.
- Gjin Ndrepepa, MD⁎,
- Peter B. Berger, MD†,
- Julinda Mehilli, MD⁎,
- Melchior Seyfarth, MD⁎,
- Franz-Josef Neumann, MD‡,
- Albert Schömig, MD⁎,§ and
- Adnan Kastrati, MD⁎,⁎ ()
- ↵⁎Reprint requests and correspondence:
Dr. Adnan Kastrati, Deutsches Herzzentrum, Lazarettstrasse 36, 80636 München, Germany.
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.
- Received July 31, 2007.
- Revision received September 21, 2007.
- Accepted October 1, 2007.
- American College of Cardiology Foundation