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CHAMPION PLATFORM: Cangrelor not superior to placebo for reduction of combined study endpoint
Patients receiving cangrelor demonstrated improvement in all-cause mortality and stent thrombosis, however.
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American Heart Association Scientific Sessions 2009
Cangrelor failed to meet its primary endpoint of reduced MI, all-cause mortality and ischemia-driven revascularization within 48 hours of treatment.
Researchers for the phase-III CHAMPION PLATFORM trial enrolled 5,362 patients who had received angioplasty plus stenting in the study and randomly assigned them to receive either cangrelor (n=2,654) or placebo (n=2,641). The trial was prematurely terminated by an interim review board after it was determined that the study would not meet its primary endpoint.
The researchers reported no difference between cangrelor and placebo on the primary study endpoint (7.0% vs. 8.0%, P=.1746). Despite failing to meet the endpoint, patients receiving cangrelor had a 67% reduction in all-cause mortality (0.2% vs. 0.7%, P=.0189) and had lower rates of stent thrombosis at 48 hours vs. (0.2% vs. 0.6%, P=.0223). Results 30-day time-to-event analysis of stent thrombosis in the population suggested that patients taking cangrelor had lower stent thrombosis vs. placebo (P=.0442). Landmark analysis of 48-hour/30-day mortality suggested that cangrelor was associated with reduced mortality at 48-hours (0.2% vs. 0.7%, P=.0137), but that the benefit faded out to 30 days (1.1% vs. 1.1%, P=.9654).
“The differences in the primary endpoint were not statistically significant, but there were lower rates of stent thrombosis and mortality that are biologically plausible given the mode of action of cangrelor,” Deepak L. Bhatt, MD, chief of cardiology at the VA Boston Healthcare System, and member of Cardiology Today’s Editorial Board, said in his presentation. “The effect on harder endpoints, but not periprocedural MI, is intriguing and calls into question the definition and ascertainment of periprocedural MI used in this trial. Further study of cangrelor is warranted given these results.”
For more information:
- Bhatt D. LBCT 01 #93. Presented at: American Heart Association Scientific Sessions 2009; Nov. 14-18; Orlando, Fla.
The CHAMPION PLATFORM trial supports the need for potent platelet inhibition prior to PCI. Cangrelor, while not meeting its primary endpoint, significantly reduced death and stent thrombosis. Cangrelor has promise as a rapid, potent intravenous antiplatelet agent during PCI. Future trials should be considered with upfront use, longer duration of infusion and bridging of patients to surgery.
– David P. Faxon, MD
Professor of Medicine, Brigham and Women’s Hospital, Boston
Cardiology Today Editorial Board member
