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Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes: Insights From the TRACER Trial
Univ Calif Irvine, Dept Cardiol, Med Ctr, Orange, CA 92668 USA.
Duke Clin Res Inst, Dept Med, Durham, NC 27710 USA.
Stanford Univ, Div Cardiovasc Med, Sch Med, Stanford, CA USA.
Duke Clin Res Inst, Dept Med, Durham, NC 27710 USA.
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2018 (English)In: Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, ISSN 2047-9980, E-ISSN 2047-9980, Vol. 7, no 24, article id e009609Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2018. Vol. 7, no 24, article id e009609
Keywords [en]
acute coronary syndrome, stroke, vorapaxar
National Category
Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:uu:diva-375901DOI: 10.1161/JAHA.118.009609ISI: 000455184800006PubMedID: 30526198OAI: oai:DiVA.org:uu-375901DiVA, id: diva2:1285352
Available from: 2019-02-04 Created: 2019-02-04 Last updated: 2019-02-04Bibliographically approved

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