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Vorapaxar reduced hospitalization for limb ischemia, arterial revascularization in PAD patients
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Patients with peripheral artery disease assigned vorapaxar, an investigational platelet blocker, had reduced rates of hospitalization for acute limb ischemia and peripheral arterial revascularization compared with patients assigned to standard care, according to new findings from the TRA-2P TIMI 50 trial.
Hospitalization for acute limb ischemia was 2.3% for patients assigned 2.5 mg vorapaxar daily (Merck) plus standard care vs. 3.9% among patients assigned standard care alone (HR=0.58; 95% CI, 0.39-0.86). The rate of peripheral arterial revascularization was also lower among patients assigned vorapaxar (18.4% vs. 22.2%; HR=0.84; 95% CI, 0.73-0.97).
Marc P. Bonaca, MD, MPH, instructor of medicine at Harvard Medical School and Brigham and Women’s Hospital, and colleagues said the new TRA-2P TIMI 50 substudy data “highlight a novel therapeutic approach to reduce limb ischemia in patients with PAD.”
“We have very few medical therapies that reduce lower limb vascular events and none for acute limb ischemia or limb revascularization,” Bonaca said during a presentation. “So, this is a unique finding in a patient population where we have little to offer.”
However, risk for CV death, MI or stroke was not significantly different between patients assigned vorapaxar and those assigned standard care (11.3% vs. 11.9%; HR=0.94; 95% CI, 0.78-1.14).
Additionally, moderate and severe bleeding was increased with vorapaxar (7.4% vs. 4.5%; HR=1.62; 95% CI, 1.21-2.18), including intracranial hemorrhage (0.9% vs. 0.4%; HR=2.03; 95% CI, 0.82-5.02).
The randomized, double blind, placebo-controlled TRA-2P TIMI 50 trial included 26,449 patients with a history of MI, stroke or PAD who were assigned vorapaxar or standard care. The TRA-2P TIMI 50 trial main results presented earlier this year showed a statistically significant reduction in CV events with vorapaxar, including MI, stroke and CV death. This substudy focused on 3,787 patients with PAD who had a history of symptoms of claudication, an ankle brachial index (ABI) of <0.85 or prior peripheral revascularization for limb ischemia, and no recent MI.
“This is the first outpatient therapy that has been shown to reduce the risk of blood clots and the need for artery-opening revascularization procedures in the legs in patients with PAD,” Bonaca said in a press release. The reduction in both urgent blood clots as well as the need for surgery to treat worsening atherosclerosis suggests that the drug may be working in more than one way.
“For clinicians and researchers, these data show the potential for therapies that can reduce leg problems in patients with PAD rather than just overall CV risk,” he added.
Reference:
- Bonaca MP. Vorapaxar for secondary prevention in patients with peripheral artery disease: Results from the peripheral artery disease cohort of the TRA2P-TIMI 50 trial. Presented at: the American Heart Association/American Stroke Association Emerging Science Series webinar; June 20, 2012.
Disclosures:
- Dr. Bonaca reports research grants from Abbott, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Daiichi Sankyo/Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Pfizer, Roche and Sanofi-Aventis.
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