What does this research mean for the field?

The efficacy and safety of cangrelor compared to clopidogrel during percutaneous coronary intervention are consistent regardless of whether femoral or radial access is used, although absolute bleeding rates are lower with radial access. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

September 23, 2015Open Access

The effect of cangrelor and access site on ischaemic and bleeding events: insights from CHAMPION PHOENIX

Structured PICO

Does cangrelor reduce ischemic events compared to clopidogrel in patients undergoing PCI via femoral or radial access?

Population

11,145 patients undergoing percutaneous coronary intervention (PCI), of which 8,064 (74%) underwent femoral and 2,855 (26%) underwent radial PCI.

Intervention

Cangrelor bolus and 2-h intravenous infusion at the time of PCI

Comparator

Clopidogrel at the time of PCI (matching double-dummy)

Outcome

Composite of death, myocardial infarction, ischaemia-driven revascularization, or stent thrombosis at 48 hcomposite

Cangrelor provides consistent ischemic benefits over clopidogrel during PCI regardless of access site, while radial access is associated with lower absolute bleeding rates.

Abstract

AIMS: To assess whether the use of the femoral or radial approach for percutaneous coronary intervention (PCI) interacted with the efficacy and safety of cangrelor, an intravenous P2Y12 inhibitor, in CHAMPION PHOENIX. METHODS AND RESULTS: A total of 11 145 patients were randomly assigned in a double-dummy, double-blind manner either to a cangrelor bolus and 2-h infusion or to clopidogrel at the time of PCI. The primary endpoint, a composite of death, myocardial infarction, ischaemia-driven revascularization, or stent thrombosis, and the primary safety endpoint, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) defined severe bleeding, were evaluated at 48 h. Of the patients undergoing PCI and receiving study drug treatment, a total of 8064 (74%) and 2855 (26%) patients underwent femoral or radial PCI, respectively. Among the femoral cohort, the primary endpoint rate was 4.8% with cangrelor vs. 6.0% with clopidogrel (odds ratio, OR 95% confidence interval, CI = 0.79 0.65-0.96); among the radial cohort, the primary endpoint was 4.4% with cangrelor vs. 5.7% with clopidogrel (OR 95% CI = 0.76 0.54-1.06), P-interaction 0.83. The rate of GUSTO severe bleeding in the femoral cohort was 0.2% with cangrelor vs. 0.1% with clopidogrel (OR 95% CI = 1.73 0.51-5.93). Among the radial cohort, the rate of GUSTO severe bleeding was 0.1% with cangrelor vs. 0.1% with clopidogrel (OR 95% CI = 1.02 0.14-7.28), P-interaction 0.65. The evaluation of safety endpoints with the more sensitive ACUITY-defined bleeding found major bleeding in the femoral cohort to be 5.2% with cangrelor vs. 3.1% with clopidogrel (OR 95% CI = 1.69 1.35-2.12); among the radial cohort the rate of ACUITY major bleeding was 1.5% with cangrelor vs. 0.7% with clopidogrel (OR 95% CI = 2.17 1.02-4.62, P-interaction 0.54). CONCLUSION: In CHAMPION PHOENIX, cangrelor reduced ischaemic events with no significant increase in GUSTO-defined severe bleeding. The absolute rates of bleeding, regardless of the definition, tended to be lower when PCI was performed via the radial artery. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov identifier: NCT01156571.

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