Freddy Abnousi1, Vandana Sundaram2, Celina M Yong1, Jayne Prats3, Efthymios N Deliargyris3, Gregg W Stone4, Christian W Hamm5, Philippe Gabriel Steg6, Charles Michael Gibson7, Harvey D White8, Matthew J Price9, Philippe Généreux4, Manisha Desai2, Lingyao Yang2, Victoria Y Ding2, Robert A Harrington1, Deepak L Bhatt10, Kenneth W Mahaffey11. 1. Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CA. 2. Quantitative Sciences Unit, Department of Medicine, Stanford University School of Medicine, Stanford, CA. 3. The Medicines Company, Parsippany, NJ. 4. Columbia University Medical Center and the Cardiovascular Research Foundation, NY, New York. 5. Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany. 6. DHU (Département Hospitalo-Universitaire)-FIRE (Fibrosis, Inflammation, REmodelling), Hôpital Bichat, AP-HPb (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. 7. Beth Israel Deaconess Medical Center, Division of Cardiology, Harvard Medical School Boston, Boston, MA. 8. University of Auckland, Auckland City Hospital, Auckland, New Zealand. 9. Scripps Clinic and Scripps Translational Science Institute, La Jolla, CA. 10. Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA. 11. Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CA. Electronic address: Kenneth.Mahaffey@stanford.edu.
Abstract
OBJECTIVE: To examine the safety and efficacy of cangrelor in patients with single-vessel disease (SVD) and multi-vessel disease (MVD). BACKGROUND:Cangrelor, an intravenous, rapidly acting P2Y12 inhibitor, is superior to clopidogrel in reducing ischemic events among patients receiving percutaneous coronary intervention (PCI). METHODS: We studied a modified intention to treat population of patients with SVD and MVD from the CHAMPION PHOENIX trial. The primary efficacy outcome was the composite of death, myocardial infarction (MI), ischemia-driven revascularization (IDR), and stent thrombosis (ST) at 48hours. The key safety outcome was non-coronary artery bypass grafting GUSTO severe bleeding at 48hours. RESULTS: Among 10,921 patients, 5,220 (48%) had SVD and 5,701 (52%) had MVD. MVD patients were older and more often had diabetes, hyperlipidemia, hypertension, prior stroke, and prior MI. After adjustment, MVD patients had similar rates of 48-hour death/MI/IDR/ST (6.3% vs 4.2%, adjusted odds ratio [OR] 1.6 [95% CI 0.42-6.06]) and GUSTO severe bleeding (0.1% vs 0.2%, P=.67) compared with SVD patients. Consistent with overall trial findings, cangrelor use reduced ischemic complications in patients with both SVD (3.9% vs 4.5%; OR 0.86, 95% CI 0.65-1.12) and MVD (5.5% vs 7.2%; OR 0.74, 95% CI 0.6-0.92, P-interaction=.43). GUSTO severe bleeding outcomes were not significantly increased with cangrelor or clopidogrel in either SVD or MVD patients. CONCLUSION: In the CHAMPION PHOENIX trial, MVD and SVD patients had similar ischemic outcomes at 48hours and 30days. Cangrelor consistently reduced ischemic complications in both SVD and MVD patients without a significant increase in GUSTO severe bleeding. CLINICAL PERSPECTIVES.
RCT Entities:
OBJECTIVE: To examine the safety and efficacy of cangrelor in patients with single-vessel disease (SVD) and multi-vessel disease (MVD). BACKGROUND:Cangrelor, an intravenous, rapidly acting P2Y12 inhibitor, is superior to clopidogrel in reducing ischemic events among patients receiving percutaneous coronary intervention (PCI). METHODS: We studied a modified intention to treat population of patients with SVD and MVD from the CHAMPION PHOENIX trial. The primary efficacy outcome was the composite of death, myocardial infarction (MI), ischemia-driven revascularization (IDR), and stent thrombosis (ST) at 48hours. The key safety outcome was non-coronary artery bypass grafting GUSTO severe bleeding at 48hours. RESULTS: Among 10,921 patients, 5,220 (48%) had SVD and 5,701 (52%) had MVD. MVD patients were older and more often had diabetes, hyperlipidemia, hypertension, prior stroke, and prior MI. After adjustment, MVD patients had similar rates of 48-hour death/MI/IDR/ST (6.3% vs 4.2%, adjusted odds ratio [OR] 1.6 [95% CI 0.42-6.06]) and GUSTO severe bleeding (0.1% vs 0.2%, P=.67) compared with SVDpatients. Consistent with overall trial findings, cangrelor use reduced ischemic complications in patients with both SVD (3.9% vs 4.5%; OR 0.86, 95% CI 0.65-1.12) and MVD (5.5% vs 7.2%; OR 0.74, 95% CI 0.6-0.92, P-interaction=.43). GUSTO severe bleeding outcomes were not significantly increased with cangrelor or clopidogrel in either SVD or MVD patients. CONCLUSION: In the CHAMPION PHOENIX trial, MVD and SVDpatients had similar ischemic outcomes at 48hours and 30days. Cangrelor consistently reduced ischemic complications in both SVD and MVD patients without a significant increase in GUSTO severe bleeding. CLINICAL PERSPECTIVES.
Authors: Celina M Yong; Vandana Sundaram; Freddy Abnousi; Christoph B Olivier; Jaden Yang; Gregg W Stone; Philippe G Steg; C Michael Gibson; Christian W Hamm; Matthew J Price; Efthymios N Deliargyris; Jayne Prats; Harvey D White; Robert A Harrington; Deepak L Bhatt; Kenneth W Mahaffey Journal: Clin Cardiol Date: 2019-06-29 Impact factor: 2.882