Abstract

Background: Patients with peripheral artery disease (PAD) are high risk for adverse cardiovascular and bleeding events. In CHAMPION-PHOENIX, cangrelor, an intravenous P2Y12 inhibitor, reduced rates of ischemic events in patients undergoing PCI. Hypothesis: We hypothesize that cangrelor will safely reduce ischemic events in patients with PAD undergoing PCI. Methods: A total of 11,145 patients were randomly assigned in a double-dummy, double-blind manner to either cangrelor followed by clopidogrel 600 mg or to clopidogrel loading at PCI. The primary endpoint was a composite of death, MI, ischemia-driven revascularization (IDR), or stent thrombosis (ST) at 48 hours. Results: 837 (8%) patients with PAD and 9,994 (90%) patients with no prior history of PAD underwent PCI. Among the PAD cohort the primary endpoint occurred in 20 (4.5%) cangrelor vs. 44 (11.4%) clopidogrel patients (OR [95% CI] = 0.36 [0.21, 0.63]), and 235 (4.7%) cangrelor vs. 276 (5.5%) clopidogrel patients (OR [95%CI] = 0.86 [0.72, 1.03]) without PAD (p for interaction = 0.003). Among the PAD cohort the rate of GUSTO severe/life-threatening bleeding was 0.4% cangrelor vs. 0% clopidogrel (p = 0.19), and 0.1% cangrelor vs. 0.1% clopidogrel patients (OR [95%CI] = 1.78 [0.52, 6.07], p = 0.35) without PAD (p for interaction = 0.34). The rate of blood transfusion in the PAD cohort was 0.9% cangrelor vs. 0% clopidogrel (p = 0.06), and 0.4% cangrelor vs. 0.3% clopidogrel patients (OR [95%CI] = 1.42 [0.73, 2.76], p = 0.30) without PAD (p for interaction = 0.13). Conclusion: In CHAMPION-PHOENIX, cangrelor significantly reduced ischemic events with no significant increase in severe bleeding or transfusions in patients with PAD.

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