Abstract WP310: Outcomes after Intracranial Hemorrhage in Patients with Atherosclerotic Vascular Disease: Observations from the TRA 2°P-TIMI 50 Trial
Intracranial hemorrhage (ICH) is a serious complication of antithrombotic therapy and is associated with high mortality (>50% at 30 days). The frequency of ICH subtypes and their outcomes in the era of contemporary oral antiplatelet therapy have not been well described.
Methods: TRA 2°P-TIMI 50 was a randomized trial of 26449 pts with history of atherothrombosis randomized to vorapaxar or placebo plus standard antiplatelet therapy. Patients qualified with myocardial infarction (MI), peripheral artery disease (PAD) (N=21,492 combined), or recent ischemic stroke (CVD, 2 wks to 12 mo. N=4860). ICH was adjudicated by an independent CEC and analyzed in the safety cohort (N=26,352)
Results: A total of 155 ICH events occurred. Traumatic/Provoked ICH was most frequent (Figure A). ICH occurred more frequently in patients qualified with CVD compared to those qualified with MI/PAD (1.4% vs 0.4%, p<0.001). In CVD patients spontaneous intracerebral/subarachnoid (44%) occurred most frequently followed by traumatic/provoked (30%), ischemic stroke with conversion (24%), and non-traumatic subdural/epidural hematoma (1.6%) (Figure A). In MI/PAD patients, traumatic/provoked ICH occurred most frequently (Figure A). Overall ICH was associated with a 32.9% mortality. Mortality varied by subtype with the highest after spontaneous intracerebral/subarachnoid (Figure B). ICH was more frequent with vorapaxar compared to placebo (HR 1.94, p<0.001). There was no difference in mortality (p=NS) after any ICH or in Rankin Score >= 4 (p=NS) after stroke associated ICH in patients receiving vorapaxar compared with placebo.
Conclusions: The frequency and subtypes of ICH vary based on patient history. Case-fatality rates vary based on subtype. These findings suggest that events traditionally categorized broadly as ICH are heterogeneous in specific types and outcomes. These subtypes should be considered discretely both clinically and in research.
- © 2012 by American Heart Association, Inc.