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J Am Coll Cardiol. 2014 Feb 25;63(7):619-29. doi: 10.1016/j.jacc.2013.10.022. Epub 2013 Oct 30.

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).

Author information

  • 1Columbia 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.
  • 2Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York.
  • 3Stanford University, Stanford, California.
  • 4Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
  • 5Institut 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.
  • 6Cardiovascular Research Foundation, New York, New York; New York Methodist Hospital, Brooklyn, New York.
  • 7University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.
  • 8Scripps Clinic and Scripps Translational Science Institute, La Jolla, California.
  • 9The Medicines Company, Parsippany, New Jersey.
  • 10Cardiovascular Research Foundation, New York, New York.
  • 11University of Giessen and Kerckhoff Heart Center, Bad Nauheim, Germany.
  • 12Auckland City Hospital, Auckland, New Zealand.
  • 13Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts. Electronic address: DLBHATTMD@post.harvard.edu.

Abstract

OBJECTIVES:

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).

Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

KEYWORDS:

IPST; PCI; cangrelor; stent thrombosis

PMID:
24184169
[PubMed - indexed for MEDLINE]
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