Outcomes with cangrelor versus clopidogrel on a background of bivalirudin: insights from the CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI])

• Published in: JACC. Cardiovascular interventions Vol. 8; no. 3; p. 424
• Main Authors: White, Harvey D, Bhatt, Deepak L, Gibson, C Michael, Hamm, Christian W, Mahaffey, Kenneth W, Price, Matthew J, Steg, Ph Gabriel, Stone, Gregg W, Cortese, Bernardo, Wilensky, Michael, Deliargyris, Efthymios N, Liu, Tiepu, Prats, Jayne, Harrington, Robert A
• Format: Journal Article
• Language: English
• Published: United States 01.03.2015
• Subjects: Adenosine Monophosphate - adverse effects; Adenosine Monophosphate - analogs & derivatives; Adenosine Monophosphate - therapeutic use; Aged; Anticoagulants - adverse effects; Anticoagulants - therapeutic use; Chi-Square Distribution; Coronary Artery Disease - diagnosis; Coronary Artery Disease - mortality; Coronary Artery Disease - therapy; Coronary Thrombosis - etiology; Coronary Thrombosis - prevention & control; Double-Blind Method; Female; Hemorrhage - chemically induced; Hirudins - adverse effects; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction - etiology; Myocardial Infarction - prevention & control; Odds Ratio; Peptide Fragments - adverse effects; Peptide Fragments - therapeutic use; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - instrumentation; Percutaneous Coronary Intervention - mortality; Platelet Aggregation Inhibitors - adverse effects; Platelet Aggregation Inhibitors - therapeutic use; Recombinant Proteins - adverse effects; Recombinant Proteins - therapeutic use; Risk Factors; Stents; Ticlopidine - adverse effects; Ticlopidine - analogs & derivatives; Ticlopidine - therapeutic use; Time Factors; Treatment Outcome; CHAMPION PHOENIX; cangrelor; bivalirudin; stent thrombosis
• DOI: 10.1016/j.jcin.2014.09.025
• ISSN: 1876-7605

The aim of this study was to examine the efficacy and bleeding outcomes of cangrelor in patients in the CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI]) who underwent percutaneous coronary intervention with bivalirudin. Cangrelor is a potent intravenous P2Y12 inhibitor with rapid onset and offset. In the CHAMPION PHOENIX, cangrelor compared with clopidogrel significantly reduced 48-h ischemic events including stent thrombosis, without increasing major bleeding. Bivalirudin has demonstrated ischemic outcomes similar to those with heparin plus glycoprotein IIb/IIIa inhibition, with reduced bleeding but increased early stent thrombosis. In the modified intent-to-treat population, 2,059 patients (18.8%) received bivalirudin, with 1,014 patients in the cangrelor treatment arm and 1,045 in the clopidogrel treatment arm. At 48 h, the primary endpoint of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis was lower with cangrelor versus clopidogrel (48 [4.7%] vs. 70 [6.7%]; odds ratio [OR]: 0.68, p = 0.047). Death was similar in both arms (2 [0.2%] vs. 2 [0.2%]). Myocardial infarction was reduced by cangrelor (37 [3.6%] vs. 59 [5.6%]; OR: 0.63, p = 0.03), as was death/myocardial infarction (39 [3.8%] vs. 61 [5.8%]; OR: 0.65, p = 0.04). Cangrelor was associated with a nonsignificant trend toward less stent thrombosis (7 [0.7%] vs. 15 [1.4%]; OR: 0.48, p = 0.10), which was evident within 2 h after percutaneous coronary intervention (p = 0.057). GUSTO (Global Use of Strategies to Open Occluded Arteries) severe bleeding was similar in both arms (2 of 1,021 [0.2%] vs. 2 of 1,055 [0.2%]) as were other bleeding definitions and transfusions. Efficacy and safety results were consistent in patients with stable angina, non-ST-segment elevation acute coronary syndrome, and ST-segment elevation myocardial infarction (p for interaction: 0.62 and 0.29). Cangrelor may offer an attractive benefit risk profile when used in combination with bivalirudin.