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SAN FRANCISCO — Cangrelor, a potent intravenous adenosine diphosphate-receptor antagonist, significantly reduced the rate of ischemic events, including stent thrombosis, during PCI without increasing severe bleeding when compared with clopidogrel, according to a late-breaking trial presented here.
“Intravenous cangrelor may be an attractive option across the full spectrum of PCI, including stable angina, non-STEMI and STEMI,” Deepak L. Bhatt, MD, MPH, trialinvestigator with the VA Boston Healthcare System, said during a presentation.
Deepak L. Bhatt
Two earlier large phase 3 trials, CHAMPION PCI and CHAMPION PLATFORM, tested cangrelor in PCI, but neither trial met the primary endpoint, according to Bhatt, who is Chief Medical Editor for Cardiology Today’s Intervention.
The double blind, placebo-controlled CHAMPION PHOENIX trial included 11,145 patients who were undergoing either urgent or elective PCI and receiving guideline-recommended therapy. Bhattand fellow trial researchers randomly assigned patients to bolus and infusion of cangrelor (The Medicines Company), which acts rapidly and has quickly reversible effects, or a loading of 600 mg or 300 mg of clopidogrel (Plavix, Sanofi-Aventis). They defined the primary efficacy endpoint as a composite of death, MI, ischemia-driven revascularization or stent thrombosis 48 hours after randomization.
Compared with clopidogrel, the primary efficacy endpoint was significantly lower in the cangrelor group (4.7% vs. 5.9%; adjusted OR=0.78; P=.005), while the rate of severe bleeding, the study’s primary safety endpoint, was similar (cangrelor, 0.16% vs. clopidogrel, 0.11%; OR=1.5; P=.44). Further analysis revealed that the number needed to treat with cangrelor to prevent one primary endpoint event was 84 (95% CI, 49-285).
Researchers also reported a lower rate of stent thrombosis in the cangrelor group (0.8% vs. 1.4%; OR=0.62; P=.01).
At 30 day follow-up, the benefit in the composite efficacy endpoint in the cangrelor arm was sustained (6% vs. 7%; OR=0.85; P=.01).
Trial limitations of note, Bhatt said, include the potential for the observed benefits of cangrelor to be attenuated with a longer duration of pretreatment and the use of ticagrelor or prasugrel, and a loading dose of 600 mg has become more common than 300 mg, although the results are still significant in the three-quarters of patients who received 600 mg as the loading dose.
Results of the CHAMPION PHOENIX trial were published simultaneously in TheNew England Journal of Medicine. – by Brian Ellis
Bhatt DL. N Engl J Med. 2013;doi:10.1056/NEJMoa1300815.
Disclosure: Bhatt reports receiving research grants from Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Medtronic, Sanofi Aventis and The Medicines Company and reports involvement in unfunded research for FlowCo, PLx Pharma and Takeda.The trial was funded by The Medicines Company.
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