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

J Antonio Gutierrez, Robert A Harrington, James C Blankenship, Gregg W Stone, Ph Gabriel Steg, C Michael Gibson, Christian W Hamm, Matthew J Price, Philippe Généreux, Jayne Prats, Efthymios N Deliargyris, Kenneth W Mahaffey, Harvey D White, Deepak L Bhatt, CHAMPION PHOENIX Investigators, D L Bhatt, G W Stone, K W Mahaffey, C M Gibson, P G Steg, C W Hamm, M J Price, S Leonardi, D Gallup, E Bramucci, P W Radke, P Widimsky, F Tousek, J Tauth, D Spriggs, B T McLaurin, D J Angiolillo, P Genereux, T Liu, J Prats, M Todd, S Skerjanec, H D White, R A Harrington, J Antonio Gutierrez, Robert A Harrington, James C Blankenship, Gregg W Stone, Ph Gabriel Steg, C Michael Gibson, Christian W Hamm, Matthew J Price, Philippe Généreux, Jayne Prats, Efthymios N Deliargyris, Kenneth W Mahaffey, Harvey D White, Deepak L Bhatt, CHAMPION PHOENIX Investigators, D L Bhatt, G W Stone, K W Mahaffey, C M Gibson, P G Steg, C W Hamm, M J Price, S Leonardi, D Gallup, E Bramucci, P W Radke, P Widimsky, F Tousek, J Tauth, D Spriggs, B T McLaurin, D J Angiolillo, P Genereux, T Liu, J Prats, M Todd, S Skerjanec, H D White, R A Harrington

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.

Keywords: Percutaneous coronary intervention; Platelet inhibition; Radial artery.

© The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

Figure 1
Figure 1
Study design. SA, stable angina; NSTE-ACS, non-ST segment elevation acute coronary syndrome; STEMI, ST segment elevation myocardial infarction; PCI, percutaneous coronary intervention.
Figure 2
Figure 2
(A) Kaplan–Meier curves for the primary efficacy endpoint in the subgroup undergoing femoral access (cangrelor vs. clopidogrel). (B) Kaplan–Meier curves for the primary efficacy endpoint in the subgroup undergoing radial access (cangrelor vs. clopidogrel). HR, hazard ratio; CI, confidence interval.
Figure 3
Figure 3
(A) Efficacy of cangrelor vs. clopidogrel in the femoral and radial subgroups. MI, myocardial infarction; IDR, ischaemia-driven revascularization; ST, stent thrombosis; OR, odds ratio; CI, confidence interval. (B) Bleeding with cangrelor vs. clopidogrel in the femoral and radial subgroups. GUSTO, Global Use of Strategies to Open Occluded Arteries; TIMI, Thrombolysis In Myocardial Infarction; ACUITY, Acute Catheterization and Urgent Intervention Triage strategY; OR, odds ratio; CI, confidence interval.

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Source: PubMed

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