March 6, 2015 — Merck announced results from two post-hoc analyses of the TRA 2°P TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) trial of Zontivity (vorapaxar), one of the largest secondary prevention studies of an antiplatelet medicine. These data on additional endpoints in subgroups of patients with peripheral arterial disease (PAD) are being presented at the 2015 American College of Cardiology (ACC) Scientific Sessions, March 14-16, 2015, in San Diego.
Zontivity is indicated for the reduction of thrombotic cardiovascular (CV) events in patients with a history of myocardial infarction (MI) or in patients with PAD. The May 2014 United States approval of Zontivity was based on the pivotal TRA 2°P TIMI 50 study, in which Zontivity was shown to reduce the rate of a combined endpoint of CV death, MI, stroke and urgent coronary revascularization (UCR) when added to aspirin and/or clopidogrel.
“As treating physicians, we are always concerned about our patients with PAD because of their risk for both systemic cardiovascular events as well as limb vascular events including acute limb ischemia and disease progression leading to peripheral revascularizations,” said Marc P. Bonaca, M.D., MPH, investigator, TIMI Study Group and associate physician at Brigham and Women’s Hospital and Harvard Medical School in Boston, Mass. “Because there are limited options available to reduce the risk of limb vascular events, these exploratory subgroup analyses raise important hypotheses regarding the role of Zontivity (vorapaxar) in the management of PAD.”
TRA 2°P TIMI 50 was a 26,449-patient, randomized, double-blind, placebo-controlled trial in which participants had a history of spontaneous MI within the prior two weeks to twelve months, ischemic stroke or documented (symptomatic) PAD. Patients were followed for up to four years, with a median follow-up of 2.5 years. Zontivity, when used daily with standard of care that included aspirin and/or a thienopyridine (principally clopidogrel), was superior to standard of care alone in reducing the incidence of both the primary combined endpoint of CV death, MI, stroke, and UCR and a key secondary composite endpoint of CV death, MI and stroke.
Data being presented at ACC include two post-hoc subgroup analyses that explored the use of Zontivity in certain patients with established PAD. PAD is generally defined as obstruction of arteries supplying the lower extremities, most commonly due to atherosclerosis. People with PAD are at increased risk for heart attack, stroke, and CV death. People with PAD are also at risk for complications from ischemia involving the lower extremities, and this was the focus of the two subgroup analyses being presented.
More specifically, these exploratory analyses looked at rates of:
1. Acute limb ischemia (ALI), a serious condition caused by an abrupt interruption of blood flow to a limb due to embolic or thrombotic vascular occlusion, which can result in limb loss.
2. Peripheral artery revascularization (PR), either a percutaneous (generally with stenting) or surgical procedure that restores blood flow to a limb that is supplied by blocked arteries.
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