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J Am Heart Assoc. 2018 Dec 18;7(24):e009609. doi: 10.1161/JAHA.118.009609.

Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes: Insights From the TRACER Trial.

Author information

1
1 Department of Cardiology University of California Irvine Medical Center Orange CA.
2
2 Department of Medicine Duke Clinical Research Institute Durham NC.
3
3 Division of Cardiovascular Medicine Stanford University School of Medicine Stanford CA.
4
4 Division of Cardiology University of Alberta Edmonton Canada.
5
5 South Australian Health and Medical Research Institute Flinders University and Medical Centre Adelaide Australia.
6
6 Uppsala Clinical Research Center Uppsala University Uppsala Sweden.
7
7 Division of Cardiovascular Medicine Gill Heart Institute University of Kentucky Lexington KY.
8
8 Johnson & Johnson New Brunswick NJ.
9
9 Department of Cardiovascular Sciences University Hospitals Leuven Leuven Belgium.
10
10 Green Lane Cardiovascular Service Auckland City Hospital Auckland New Zealand.
11
11 Department of Medicine Stanford University School of Medicine Stanford CA.

Abstract

Background Vorapaxar, a protease-activated receptor-1 antagonist, is approved for secondary prevention of cardiovascular events but is associated with increased intracranial hemorrhage. Methods and Results TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) was a trial of vorapaxar versus placebo among patients with acute coronary syndrome. Strokes were adjudicated by a central events committee. Of 12 944 patients, 199 (1.5%) had ≥1 stroke during the study period (median follow-up, 477 days). Four patients had a single stroke of unknown type; 195 patients had ≥1 stroke classified as hemorrhagic or nonhemorrhagic (165 nonhemorrhagic, 28 hemorrhagic, and 2 both). Strokes occurred in 96 of 6473 patients (1.5%) assigned vorapaxar and 103 of 6471 patients (1.6%) assigned placebo. Kaplan-Meier incidence of stroke for vorapaxar versus placebo was higher for hemorrhagic stroke (0.45% versus 0.14% [hazard ratio, 2.74; 95% confidence interval, 1.22-6.15]), lower but not significantly different for nonhemorrhagic stroke (1.53% versus 1.98% at 2 years [hazard ratio, 0.79; 95% confidence interval, 0.58-1.07]), and similar for stroke overall (1.93% versus 2.13% at 2 years [hazard ratio, 0.94; 95% confidence interval, 0.71-1.24]). Conclusions Stroke occurred in <2% of patients. Vorapaxar-assigned patients had increased hemorrhagic stroke but a nonsignificant trend toward lower nonhemorrhagic stroke. Overall stroke frequency was similar with vorapaxar versus placebo.

KEYWORDS:

acute coronary syndrome; stroke; vorapaxar

PMID:
30526198
DOI:
10.1161/JAHA.118.009609
Free PMC Article

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