Efficacy and safety of cangrelor in patients with peripheral artery disease undergoing percutaneous coronary intervention - Insights from the CHAMPION program.

Background: Peripheral artery disease (PAD) is associated with an increased risk of ischemic events following percutaneous coronary intervention (PCI). More aggressive antiplatelet therapy may mitigate this risk. The present study evaluates the efficacy of cangrelor in patients with PAD undergoing PCI.
Methods and Results: This is a pooled analysis from the CHAMPION PCI, CHAMPION PLATFORM, AND CHAMPION PHOENIX trials, evaluating cangrelor versus either clopidogrel or placebo in PCI patients. The occurrence of the primary endpoint of death, myocardial infarction, or ischemia-driven revascularization (IDR) was assessed in patients with and without PAD. GUSTO severe bleeding at 48 h was also evaluated. There were 1720 (7%) patients with PAD and 22,802 (93%) without PAD. After adjustment for differences in baseline variables, PAD patients, compared with those without PAD, experienced increased odds of the primary endpoint (OR [95% CI] = 1.27 [0.91, 1.77], P = 0.16) and GUSTO severe bleeding (OR [95% CI] = 3.24 [1.28, 8.21], P = 0.01). In PAD patients, the primary endpoint was 4.7% with cangrelor vs. 7.2% with clopidogrel (OR [95% CI] = 0.64 [0.42,0.96]); in patients without PAD the primary endpoint was 3.5% with cangrelor vs. 4.2% with clopidogrel (OR [95% CI] = 0.83 [0.72,0.95]), P-interaction 0.23. Among patients with or without PAD, there was no significant difference in the rate of GUSTO severe bleeding with cangrelor compared with control, P-interaction 0.86.
Conclusions: In a pooled analysis of the CHAMPION studies, PAD was associated with increased rates of ischemic and bleeding complications. Cangrelor reduced the odds of ischemic events, without increasing GUSTO severe bleeding.
Clinical Trial Registration: clinicaltrials.gov identifiers: CHAMPION PCI (NCT00305162), CHAMPION PLATFORM(NCT00385138), CHAMPION PHOENIX (NCT01156571).
Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. J. Antonio Gutierrez discloses the following – personal fees from Janssen Pharmaceuticals. Dr. Robert A. Harrington discloses the following relationships – personal fees from Amgen Inc., Daiichi-Lilly, GILEAD Sciences, Gilead Sciences Inc., Janssen R and D, Medtronic, Merk, Novartis Corporation, The Medicines Company, Vida Health, Vox Media, and WebMD; Grants from AstraZeneca, BMS, CSL Behring, GSK, Merk, Portola, Sanofi-aventis, and The Medicines Company; ownership in Element Science and Myokardia; Advisory role in Evidint and Scandu. Dr. Gregg W. Stone discloses personal fees from Boston Scientific, InspireMD, Atrium, Daiichi-Lilly, and Astra Zeneca. Dr. Ph Gabriel Steg discloses the following relationships – Institutional research grant from Merck, Sanofi, and Servier; speaking or consulting fees from Amarin, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers-Squibb, CSL-Behring, Daiichi-Sankyo, GlaxoSmithKline, Janssen, Lilly, Merck Novartis, Pfizer, Regeneron, Sanofi, Servier, and The Medicines Company. Dr. Charles Michael Gibson discloses personal fees from The Medicines Company. Dr. Christian W. Hamm discloses the following relationships – Advisory board and speaking fees from AstraZeneca, Boehringer Ingelheim; speaking fees from Bayer, Daiichi Sankyo, Lilly, and Sanofi Aventis. Dr. Matthew J. Price reports personal fees from The Medicines Company, during the conduct of the study, AstraZeneca, Merck & Co., Accriva Diagnostics, Boston Scientific, Medtronic, and Terumo. Dr. Renato D. Lopes discloses the following relationships - Institutional research grant and consulting fees from Bristol-Myers Squibb; institutional research grant from GlaxoSmithKline; consulting fees from Bayer, Boehringer Ingleheim, Pfizer, Merck, Portola. Dr. Sergio Leonardi discloses the following relationships - Advisory Board: The Medicine Company, AstraZeneca, and Eli Lilly. Dr. Jayne Prats discloses the following relationships — was an employee of the Medicines Company at the time of the study and is a consultant for Chiesi USA. Dr. Efthymios N. Deliagyris discloses the following relationships — was an employee of the Medicines Company. Dr. Mahaffey discloses personal fees from American College of Cardiology, grants from Amgen, personal fees from AstraZeneca, personal fees from Bayer, personal fees from Boehringer Ingelheim, personal fees from Bristol Myers Squibb, personal fees from Cubist, grants from Daiichi, personal fees from Eli Lilly, personal fees from Epson, personal fees from Forest, personal fees from Glaxo Smith Kline, grants and personal fees from Johnson & Johnson, grants and personal fees from Medtronic, personal fees from Merck, personal fees from Mt. Sinai, personal fees from Myokardia, personal fees from Omthera, personal fees from Portola, personal fees from Purdue Pharma, personal fees from Spring Publishing, grants from St. Jude, grants from Tenax, personal fees from Vindico, personal fees from WebMD, outside the submitted work. Dr. White discloses grants from Sanofi-Aventis, grants from Eli Lilly, grants from National Institute of Health, grants from GSK, grants from Merck Sharpe & Dohme, grants and personal fees from AstraZeneca, outside. Dr. Deepak L. Bhatt discloses the following relationships - Advisory Board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Cleveland Clinic, Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine, Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Chiesi (including for serving as co-Chair and co-PI of the CHAMPION trials), Eisai, Ethicon, Forest Laboratories, Ironwood, Ischemix, Lilly, Medtronic, Pfizer, Roche, Sanofi Aventis, The Medicines Company (including for serving as co-Chair and co-PI of the CHAMPION trials); Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease); Site Co-Investigator: Biotronik, Boston Scientific, St. Jude Medical (now Abbott); Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, PLx Pharma, Takeda.
(© 2021 The Authors.)