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

Eur Heart J. 2016 Apr 7;37(14):1122-30. doi: 10.1093/eurheartj/ehv498. Epub 2015 Sep 23.

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenosine Monophosphate / administration & dosage
  • Adenosine Monophosphate / adverse effects
  • Adenosine Monophosphate / analogs & derivatives*
  • Aged
  • Clopidogrel
  • Coronary Thrombosis / etiology
  • Double-Blind Method
  • Female
  • Femoral Artery
  • Graft Occlusion, Vascular / etiology
  • Hemorrhage / chemically induced*
  • Humans
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Myocardial Infarction / etiology
  • Myocardial Ischemia / therapy*
  • Myocardial Revascularization / statistics & numerical data
  • Percutaneous Coronary Intervention / adverse effects*
  • Percutaneous Coronary Intervention / methods
  • Platelet Aggregation Inhibitors / administration & dosage
  • Purinergic P2Y Receptor Antagonists / administration & dosage*
  • Purinergic P2Y Receptor Antagonists / adverse effects
  • Radial Artery
  • Stents
  • Ticlopidine / administration & dosage
  • Ticlopidine / analogs & derivatives
  • Treatment Outcome

Substances

  • Platelet Aggregation Inhibitors
  • Purinergic P2Y Receptor Antagonists
  • Adenosine Monophosphate
  • cangrelor
  • Clopidogrel
  • Ticlopidine

Associated data

  • ClinicalTrials.gov/NCT01156571