Jérémie Abtan1, P Gabriel Steg2, Gregg W Stone3, Kenneth W Mahaffey4, C Michael Gibson5, Christian W Hamm6, Matthew J Price7, Freddy Abnousi7, Jayne Prats8, Efthymios N Deliargyris8, Harvey D White9, Robert A Harrington4, Deepak L Bhatt10. 1. DHU (Département Hospitalo-Universitaire)-FIRE (Fibrosis, Inflammation, REmodelling), Hôpital Bichat, AP-HP (Assistance Publique-Hôpitaux de Paris), Université Paris-Diderot, Sorbonne-Paris Cité, and FACT (French Alliance for Cardiovascular clinical Trials), an F-CRIN network, INSERM U-1148, Paris, France. 2. DHU (Département Hospitalo-Universitaire)-FIRE (Fibrosis, Inflammation, REmodelling), Hôpital Bichat, AP-HP (Assistance Publique-Hôpitaux de Paris), Université Paris-Diderot, Sorbonne-Paris Cité, and FACT (French Alliance for Cardiovascular clinical Trials), an F-CRIN network, INSERM U-1148, Paris, France; NLHI, ICMS, Royal Brompton Hospital, Imperial College, London, United Kingdom. Electronic address: gabriel.steg@bch.aphp.fr. 3. Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York. 4. Stanford Center for Clinical Research (SCCR); Department of Medicine; Stanford School of Medicine, Stanford, California. 5. Beth Israel Deaconess Medical Center, Division of Cardiology, Harvard Medical School, Boston, Massachusetts. 6. Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany. 7. Scripps Clinic and Scripps Translational Science Institute, La Jolla, California. 8. The Medicines Company, Parsippany, New Jersey. 9. University of Auckland, Auckland City Hospital, Auckland, New Zealand. 10. Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts.
Abstract
OBJECTIVES: The purpose of this study was to examine the safety and efficacy of cangrelor in patients with stable angina (SA) or acute coronary syndrome (ACS). BACKGROUND: The CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention) trial demonstrated that cangrelor significantly reduced periprocedural ischemic events in all-comer percutaneous coronary intervention with a modest increase in mild and moderate bleeding. Whether this benefit is consistent across SA and ACS has not been explored fully. METHODS: The CHAMPION PHOENIX trial compared periprocedural administration of cangrelor or clopidogrel, with either a 300- or 600-mg loading dose for the prevention of periprocedural complications in patients undergoing percutaneous coronary intervention. Among the 10,942 patients in the modified intention to treat population, 6,358 patients were classified as having SA, and 4,584 patients had ACS (including unstable angina, non ST-segment elevation myocardial infarction and ST-segment elevation myocardial infarction) at randomization. The primary composite endpoint was death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 h. A key secondary endpoint was stent thrombosis, and the primary safety endpoint was GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries) severe bleeding. RESULTS:Cangrelor consistently reduced the primary endpoint in SA and ACS (odds ratio [OR]: 0.83 [95% confidence interval (CI): 0.67 to 1.01] and OR: 0.71 [95% CI: 0.52 to 0.96], respectively; interaction p = 0.41). Cangrelor also consistently reduced stent thrombosis in SA and ACS (OR: 0.55 [95% CI: 0.30 to 1.01] and OR: 0.67 [95% CI: 0.42 to 1.06], respectively; interaction p = 0.62). The impact of cangrelor on GUSTO severe/moderate bleeding was also similar for SA and ACS (OR: 1.49 [95% CI: 0.67 to 3.33] and OR: 1.79 [95% CI: 0.79 to 4.07], respectively; interaction p = 0.75). CONCLUSIONS: The benefits and risks of cangrelor were consistent in patients with SA and ACS. (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI] [CHAMPION PHOENIX] [CHAMPION]; NCT01156571).
RCT Entities:
OBJECTIVES: The purpose of this study was to examine the safety and efficacy of cangrelor in patients with stable angina (SA) or acute coronary syndrome (ACS). BACKGROUND: The CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention) trial demonstrated that cangrelor significantly reduced periprocedural ischemic events in all-comer percutaneous coronary intervention with a modest increase in mild and moderate bleeding. Whether this benefit is consistent across SA and ACS has not been explored fully. METHODS: The CHAMPION PHOENIX trial compared periprocedural administration of cangrelor or clopidogrel, with either a 300- or 600-mg loading dose for the prevention of periprocedural complications in patients undergoing percutaneous coronary intervention. Among the 10,942 patients in the modified intention to treat population, 6,358 patients were classified as having SA, and 4,584 patients had ACS (including unstable angina, non ST-segment elevation myocardial infarction and ST-segment elevation myocardial infarction) at randomization. The primary composite endpoint was death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 h. A key secondary endpoint was stent thrombosis, and the primary safety endpoint was GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries) severe bleeding. RESULTS:Cangrelor consistently reduced the primary endpoint in SA and ACS (odds ratio [OR]: 0.83 [95% confidence interval (CI): 0.67 to 1.01] and OR: 0.71 [95% CI: 0.52 to 0.96], respectively; interaction p = 0.41). Cangrelor also consistently reduced stent thrombosis in SA and ACS (OR: 0.55 [95% CI: 0.30 to 1.01] and OR: 0.67 [95% CI: 0.42 to 1.06], respectively; interaction p = 0.62). The impact of cangrelor on GUSTO severe/moderate bleeding was also similar for SA and ACS (OR: 1.49 [95% CI: 0.67 to 3.33] and OR: 1.79 [95% CI: 0.79 to 4.07], respectively; interaction p = 0.75). CONCLUSIONS: The benefits and risks of cangrelor were consistent in patients with SA and ACS. (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI] [CHAMPION PHOENIX] [CHAMPION]; NCT01156571).
Authors: Matthew A Cavender; Robert A Harrington; Gregg W Stone; Ph Gabriel Steg; C Michael Gibson; Christian W Hamm; Matthew J Price; Renato D Lopes; Sergio Leonardi; Efthymios N Deliargyris; Jayne Prats; Kenneth W Mahaffey; Harvey D White; Deepak L Bhatt Journal: Circ Cardiovasc Interv Date: 2021-12-17 Impact factor: 7.514
Authors: Akshyaya Pradhan; Aashish Tiwari; Giuseppe Caminiti; Chiara Salimei; Saverio Muscoli; Rishi Sethi; Marco Alfonso Perrone Journal: Int J Environ Res Public Health Date: 2022-07-23 Impact factor: 4.614
Authors: Gregg W Stone; Philippe Généreux; Robert A Harrington; Harvey D White; C Michael Gibson; P Gabriel Steg; Christian W Hamm; Kenneth W Mahaffey; Matthew J Price; Jayne Prats; Efthymios N Deliargyris; Deepak L Bhatt Journal: Eur Heart J Date: 2018-12-07 Impact factor: 29.983