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Dr. Robert M Califf,
Dr. Roxana Mehran,
Presenter report:Mehran, Roxana (United States of America)Webcast
To determine the impact of major bleeding and/or major adverse cardiac events, a multivariable Cox model was developed with 5 significant baseline predictor variables of mortality within 30 days of presentation with STEMI in patients enrolled in HORIZONS AMI Trial.
The main event endpoints from the trial (including the components of MACE and major bleeding) were then added to the model as time updated covariates. Within 30 days of randomization, there were 93 deaths; 26 following a major bleed (non CABG-related) in 238 patients, 10 deaths following a reinfarction in 65 patients, 9 following 82 ischemic TVRs, and 3 following 22 strokes. In the fully adjusted models, time updated reinfarction (HR [95% CI]= 9.75 [2.72,34.91]) and non-CABG major bleeding (HR [95% CI]= 4.66 [2.84,7.63]) were significantly associated with mortality, yielding 9.0 and 20.3 attributable deaths respectively. Ischemic TVR (HR [95% CI]= 1.11 [0.29,4.21]) and stroke (HR [95% CI]= 2.64 [0.71,9.75]) were not significantly associated with mortality within the first 30 days.
After accounting for baseline predictors, both reinfarction and major bleeding have a significant impact on mortality in the first 30 days after presenting with STEMI. While the hazard ratio for reinfarction is nominally higher, there are more deaths attributable to major bleeding as compared with a reinfarction within the first 30 days in this population. As most drugs which reduce ischemia also increase bleeding, the offsetting impact of adverse ischemic and hemorrhagic events must be carefully examined in future trials.
Discussant: Califf, Robert M (United States of America
Clinical Trial Update I
This congress report accompanies a presentation given at the ESC Congress 2008. Written by the author himself/herself, this report does not necessarily reflect the opinion of the European Society of Cardiology.
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