CHAMPION PHOENIX
Trial question
What is the effect of cangrelor in patients who were undergoing either urgent or elective PCI?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 10942
10942 patients (3051 female, 7891 male).
Inclusion criteria: patients who were undergoing either urgent or elective PCI and were receiving guideline-recommended therapy.
Key exclusion criteria: pregnancy, age < 18 years, receipt of a P2Y12 inhibitor or abciximab at any time in the 7 days before randomization and receipt of eptifibatide or tirofiban or fibrinolytic therapy in the 12 hours before randomization.
Interventions
N=5472 cangrelor (a bolus of 30 mcg/kg body weight followed by an infusion of 4 mcg/kg/minute).
N=5470 clopidogrel (600 mg or 300 mg loading dose).
Primary outcome
Death, MI, ischemia-driven revascularization, or stent thrombosis at 48 hours after randomization
4.7%
5.9%
5.9 %
4.4 %
3.0 %
1.5 %
0.0 %
Cangrelor
Clopidogrel
Significant
increase ▲
NNH = 83
Significant increase in death, MI, ischemia-driven revascularization, or stent thrombosis at 48 hours after randomization (4.7% vs. 5.9%).
Secondary outcomes
Significant decrease in stent thrombosis at 48 hours (0.8% vs. 1.4%; OR 0.62, 95% CI 0.43 to 0.9).
Significant decrease in intraprocedural stent thrombosis (0.6% vs. 1%; OR 0.65, 95% CI 0.42 to 0.99).
Significant decrease in use of rescue therapy with a glycoprotein IIb/IIIa inhibitor (2.3% vs. 3.5%; OR 0.65, 95% CI 0.52 to 0.82).
Safety outcomes
No significant differences in GUSTO-defined severe bleeding, adverse events.
Significant differences in procedural complications (3.4% vs. 4.5%), transient dyspnea (1.2% vs. 0.3%).
Conclusion
In patients who were undergoing either urgent or elective PCI and were receiving guideline-recommended therapy, cangrelor was superior to clopidogrel with respect to death, MI, ischemia-driven revascularization, or stent thrombosis at 48 hours after randomization.
Reference
Bhatt DL, Stone GW, Mahaffey KW et al. Effect of platelet inhibition with cangrelor during PCI on ischemic events. N Engl J Med. 2013 Apr 4;368(14):1303-13.
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