Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes: Insights From the TRACER Trial
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)...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2018-12-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.118.009609 |
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| author | Leo Ungar Robert M. Clare Fatima Rodriguez Bradley J. Kolls Paul W. Armstrong Philip Aylward Claes Held David J. Moliterno John Strony Frans Van de Werf Lars Wallentin Harvey D. White Pierluigi Tricoci Robert A. Harrington Kenneth W. Mahaffey Chiara Melloni |
| author_facet | Leo Ungar Robert M. Clare Fatima Rodriguez Bradley J. Kolls Paul W. Armstrong Philip Aylward Claes Held David J. Moliterno John Strony Frans Van de Werf Lars Wallentin Harvey D. White Pierluigi Tricoci Robert A. Harrington Kenneth W. Mahaffey Chiara Melloni |
| author_sort | Leo Ungar |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-13T01:51:31Z |
| format | Article |
| id | doaj.art-ddd00c1d3d304d07b3f96b5f6ed6633f |
| institution | Directory Open Access Journal |
| issn | 2047-9980 |
| language | English |
| last_indexed | 2024-12-13T01:51:31Z |
| publishDate | 2018-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj.art-ddd00c1d3d304d07b3f96b5f6ed6633f2022-12-22T00:03:31ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802018-12-0172410.1161/JAHA.118.009609Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes: Insights From the TRACER TrialLeo Ungar0Robert M. Clare1Fatima Rodriguez2Bradley J. Kolls3Paul W. Armstrong4Philip Aylward5Claes Held6David J. Moliterno7John Strony8Frans Van de Werf9Lars Wallentin10Harvey D. White11Pierluigi Tricoci12Robert A. Harrington13Kenneth W. Mahaffey14Chiara Melloni15Department of Cardiology University of California Irvine Medical Center Orange CADepartment of Medicine Duke Clinical Research Institute Durham NCDivision of Cardiovascular Medicine Stanford University School of Medicine Stanford CADepartment of Medicine Duke Clinical Research Institute Durham NCDivision of Cardiology University of Alberta Edmonton CanadaSouth Australian Health and Medical Research Institute Flinders University and Medical Centre Adelaide AustraliaUppsala Clinical Research Center Uppsala University Uppsala SwedenDivision of Cardiovascular Medicine Gill Heart Institute University of Kentucky Lexington KYJohnson & Johnson New Brunswick NJDepartment of Cardiovascular Sciences University Hospitals Leuven Leuven BelgiumUppsala Clinical Research Center Uppsala University Uppsala SwedenGreen Lane Cardiovascular Service Auckland City Hospital Auckland New ZealandDepartment of Medicine Duke Clinical Research Institute Durham NCDepartment of Medicine Stanford University School of Medicine Stanford CADepartment of Medicine Stanford University School of Medicine Stanford CADepartment of Medicine Duke Clinical Research Institute Durham NCBackground 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.https://www.ahajournals.org/doi/10.1161/JAHA.118.009609acute coronary syndromestrokevorapaxar |
| spellingShingle | Leo Ungar Robert M. Clare Fatima Rodriguez Bradley J. Kolls Paul W. Armstrong Philip Aylward Claes Held David J. Moliterno John Strony Frans Van de Werf Lars Wallentin Harvey D. White Pierluigi Tricoci Robert A. Harrington Kenneth W. Mahaffey Chiara Melloni Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes: Insights From the TRACER Trial Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease acute coronary syndrome stroke vorapaxar |
| title | Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes: Insights From the TRACER Trial |
| title_full | Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes: Insights From the TRACER Trial |
| title_fullStr | Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes: Insights From the TRACER Trial |
| title_full_unstemmed | Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes: Insights From the TRACER Trial |
| title_short | Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes: Insights From the TRACER Trial |
| title_sort | stroke outcomes with vorapaxar versus placebo in patients with acute coronary syndromes insights from the tracer trial |
| topic | acute coronary syndrome stroke vorapaxar |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.118.009609 |
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