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Stroke risk lowered with vorapaxar in patients with prior MI, PAD
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Vorapaxar reduced the risk for ischemic stroke in patients with a history of MI or peripheral arterial disease, according to new data from the TRA 2P-TIMI 50 trial.
Researchers also found no significant increase in risk for hemorrhagic conversion or death among patients who had an ischemic stroke while taking vorapaxar (Zontivity, Merck), an antiplatelet agent approved by the FDA in May.
Previous research demonstrated an increased risk for intracranial hemorrhage associated with vorapaxar, and the drug is contraindicated in patients with a history of stroke. Marc P. Bonaca, MD, MPH, and colleagues investigated the incidence of new ischemic stroke and subsequent death or intracerebral hemorrhage in the 20,170 patients (mean age, 60 years; 22% women) with prior MI or PAD but no cerebrovascular disease enrolled in the TRA 2P–TIMI 50 pivotal trial.
Patients were randomly assigned vorapaxar 2.5 mg/day or placebo. Most patients were being treated with aspirin, and some with thienopyridine therapy, ACE inhibitor and/or angiotensin receptor blocker. Median follow-up was 31 months.
Compared with placebo, vorapaxar reduced the risk for first ischemic stroke (HR=0.57; 95% CI, 0.43-0.75), Bonaca, from the TIMI Study Group, cardiovascular division, department of medicine, Brigham and Women’s Hospital and Harvard Medical School, and colleagues reported.
In patients who had a new ischemic stroke during the study period (n=204), the researchers found no association between treatment with vorapaxar and risk for hemorrhagic conversion (HR=1.19; 95% CI, 0.49-2.91) or death (HR=1.09; 95% CI, 0.57-2.07).
Bonaca and colleagues found an increase in hemorrhagic stroke (HR=2.79; 95% CI, 1-7.73), but a reduction in overall stroke (HR=0.67; 95% CI, 0.52-0.87) associated with vorapaxar.
The benefit was on the background of aspirin therapy and was observed whether or not a patient was also taking a thienopyridine, the researchers wrote.
Disclosure: The study was supported by a grant from Merck & Co. See the full study for a list of the researchers’ relevant financial disclosures.
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