title: Impact of intraprocedural stent thrombosis during percutaneous coronary intervention: insights from the CHAMPION PHOENIX Trial (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention).
abstract: OBJECTIVE
  This study sought to evaluate the clinical impact of intraprocedural stent thrombosis (IPST), a relatively new endpoint.
  
  
  BACKGROUND
  In the prospective, double-blind, active-controlled CHAMPION PHOENIX (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention) trial, cangrelor significantly reduced periprocedural and 30-day ischemic events in patients undergoing percutaneous coronary intervention (PCI), including IPST.
  
  
  METHODS
  An independent core laboratory blinded to treatment assignment performed a frame-by-frame angiographic analysis in 10,939 patients for the development of IPST, defined as new or worsening thrombus related to stent deployment at any time during the procedure. Adverse events were adjudicated by an independent, blinded clinical events committee.
  
  
  RESULTS
  IPST developed in 89 patients (0.8%), including 35 of 5,470 (0.6%) and 54 of 5,469 (1.0%) patients in the cangrelor and clopidogrel arms, respectively (odds ratio: 0.65; 95% confidence interval: 0.42 to 0.99; p = 0.04). Compared to patients without IPST, IPST was associated with a marked increase in composite ischemia (death, myocardial infarction [MI], ischemia-driven revascularization, or new-onset out-of-laboratory stent thrombosis [Academic Research Consortium]) at 48 h and at 30 days (29.2% vs. 4.5% and 31.5% vs. 5.7%, respectively; p < 0.0001 for both). After controlling for potential confounders, IPST remained a strong predictor of all adverse ischemic events at both time points.
  
  
  CONCLUSIONS
  In the large-scale CHAMPION PHOENIX trial, the occurrence of IPST was strongly predictive of subsequent adverse cardiovascular events. The potent intravenous adenosine diphosphate antagonist cangrelor substantially reduced IPST, contributing to its beneficial effects at 48 h and 30 days. (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI] [CHAMPION PHOENIX]; NCT01156571).
authors.affiliation: Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York; Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Quebec, Canada.
authors.forename: Philippe
authors.initials: P
authors.lastname: Généreux
authors.affiliation: Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.affiliation: Stanford University, Stanford, California.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
authors.affiliation: Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.affiliation: Institut National de la Santé et de la Recherche Médicale-Unité 698, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, and Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France, and Royal Brompton Hospital, London, United Kingdom.
authors.forename: Ph Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: Cardiovascular Research Foundation, New York, New York; New York Methodist Hospital, Brooklyn, New York.
authors.forename: Sorin J
authors.initials: SJ
authors.lastname: Brener
authors.affiliation: University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.
authors.forename: Dominick J
authors.initials: DJ
authors.lastname: Angiolillo
authors.affiliation: Scripps Clinic and Scripps Translational Science Institute, La Jolla, California.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Price
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: Jayne
authors.initials: J
authors.lastname: Prats
authors.affiliation: Cardiovascular Research Foundation, New York, New York.
authors.forename: Laura
authors.initials: L
authors.lastname: LaSalle
authors.affiliation: Scripps Clinic and Scripps Translational Science Institute, La Jolla, California.
authors.forename: Tiepu
authors.initials: T
authors.lastname: Liu
authors.affiliation: Scripps Clinic and Scripps Translational Science Institute, La Jolla, California.
authors.forename: Meredith
authors.initials: M
authors.lastname: Todd
authors.affiliation: Scripps Clinic and Scripps Translational Science Institute, La Jolla, California.
authors.forename: Simona
authors.initials: S
authors.lastname: Skerjanec
authors.affiliation: University of Giessen and Kerckhoff Heart Center, Bad Nauheim, Germany.
authors.forename: Christian W
authors.initials: CW
authors.lastname: Hamm
authors.affiliation: Stanford University, Stanford, California.
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Mahaffey
authors.affiliation: Auckland City Hospital, Auckland, New Zealand.
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.affiliation: Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts. Electronic address: DLBHATTMD@post.harvard.edu.
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
mesh_terms: D000249:Adenosine Monophosphate / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000368:Aged; D000077144:Clopidogrel; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007431:Intraoperative Complications / Q000175:diagnosis* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods / Q000592:standards*; D011446:Prospective Studies; D059039:Standard of Care / Q000592:standards*; D015607:Stents / Q000009:adverse effects; D013927:Thrombosis / Q000175:diagnosis* / Q000453:epidemiology; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D000249:Adenosine Monophosphate; C117446:cangrelor; D000077144:Clopidogrel; D013988:Ticlopidine
keywords: IPST; PCI; cangrelor; stent thrombosis