Harvey D White1, Deepak L Bhatt2, C Michael Gibson3, Christian W Hamm4, Kenneth W Mahaffey5, Matthew J Price6, Ph Gabriel Steg7, Gregg W Stone8, Bernardo Cortese9, Michael Wilensky10, Efthymios N Deliargyris11, Tiepu Liu11, Jayne Prats11, Robert A Harrington5. 1. Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. Electronic address: HarveyW@adhb.govt.nz. 2. Brigham and Women's Hospital, Heart & Vascular Center, and Harvard Medical School, Boston, Massachusetts. 3. Beth Israel Hospital, Boston, Massachusetts. 4. University of Giessen and Kerckhoff Heart Center, Bad Nauheim, Germany. 5. Department of Medicine, Stanford University School of Medicine, Stanford, California. 6. Scripps Clinic and Scripps Translational Science Institute, La Jolla, California. 7. Institut National de la Santé et de la Recherche Médicale-Unité 114, Paris, France; Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris, France; Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France; Royal Brompton Hospital, London, United Kingdom. 8. Columbia University Medical Center and The Cardiovascular Research Foundation, New York, New York. 9. Interventional Cardiology, A.O. Fatebenefratelli, Bastioni di Porta Nuova, Milan, Italy. 10. Cardiology PC, Birmingham, Alabama. 11. The Medicines Company, Parsippany, New Jersey.
Abstract
OBJECTIVES: 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 withbivalirudin. BACKGROUND: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. METHODS: 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. RESULTS: 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). CONCLUSIONS:Cangrelor may offer an attractive benefit risk profile when used in combination with bivalirudin.
RCT Entities:
OBJECTIVES: 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. BACKGROUND: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. METHODS: 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. RESULTS: 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). CONCLUSIONS:Cangrelor may offer an attractive benefit risk profile when used in combination with bivalirudin.
Authors: Heerajnarain Bulluck; Mervyn H H Chan; Jennifer A Bryant; Ping Chai; Ashish Chawla; Terrance S Chua; Yiu-Cho Chung; Gao Fei; Hee H Ho; Andrew F W Ho; Andrew J Hoe; Syed S Imran; Chi-Hang Lee; Swee H Lim; Boon W Liew; Patrick L Z Yun; Marcus O E Hock; Valeria Paradies; Matthew T Roe; Lynette Teo; Aaron S Wong; Evelyn Wong; Philip E Wong; Timothy Watson; Mark Y Chan; Jack W Tan; Derek J Hausenloy Journal: Clin Cardiol Date: 2018-12-17 Impact factor: 2.882
Authors: Kurt Huber; Gregory Ducrocq; Christian W Hamm; Arnoud van 't Hof; Frédéric Lapostolle; Pierre Coste; Giovanni Gordini; Jacob Steinmetz; Freek W A Verheugt; Jennifer Adgey; Lutz Nibbe; Vojko Kaniĉ; Peter Clemmensen; Uwe Zeymer; Debra Bernstein; Jayne Prats; Efthymios N Deliargyris; Ph Gabriel Steg Journal: Open Heart Date: 2017-11-28