San Francisco has been good for CHAMPION PHOENIX. Earlier this year at the American College of Cardiology (ACC) scientific session, investigators reported that cangrelor reduced the rate of ischemic events, including stent thrombosis, during PCI, with no significant increase in severe bleeding. Using that data, they then identified clinical predictors of intraprocedural stent thrombosis Oct. 28 at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.
CHAMPION PHOENIX was a double-blind, placebo-controlled trial that randomized 11,145 patients who underwent urgent or elective PCI and guideline-recommended therapy to receive a bolus and infusion of cangrelor (The Medicine Company) or a loading dose of 600 mg or 300 mg of clopidogrel (Plavix, Bristol Myers-Squibb/Sanofi Aventis). The primary efficacy endpoint was a composite of death, MI, ischemia-driven revascularization or stent thrombosis at 48 hours after randomization. The secondary endpoint was stent thrombosis at 48 hours.
Lead investigator Philippe Genereux, MD, of NewYork-Presbyterian Hospital and Columbia University Medical Center in New York City, shared results from an angiographic analysis of CHAMPION PHOENIX data at a TCT session. Genereux is also director of the Cardiovascular Research Foundation Core Laboratory, which conducted the analyses.
The findings were simultaneously published in the Journal of the American College of Cardiology.
The angiographic study was designed to determine the incidence, predictors and clinical impact of intraprocedural stent thrombosis. In CHAMPION PHOENIX data presented at ACC, stent thrombosis occurred in 0.8 percent of the patients in the cangrelor group and in 1.4 percent in the clopidogrel group.
The angiographic study analyzed data on 10,393 randomized patients frame-by-frame to track the development of intraprocedural stent thrombosis. In a comparison of patients with or without intraprocedural stent thrombosis, they found intraprocedural stent thrombosis was associated with an increase in death and stent thrombosis at 48 hours and 30 days and was a strong predictor of ischemic events.
“The findings underscore the importance of preventing IPST [intraprocedural stent thrombosis], as well as close monitoring and optimal treatments, should IPST occur,” Robert A. Harrington, MD, study co-chair and a professor at Stanford School of Medicine in California, said in a release.
The trial was sponsored by The Medicines Company.