Thromb Haemost 2017; 117(06): 1093-1100
DOI: 10.1160/TH16-12-0958
Cellular Haemostasis and Platelets
Schattauer GmbH

Characteristics of dyspnoea and associated clinical outcomes in the CHAMPION PHOENIX study

William A. Parker
1  University of Sheffield, Sheffield, UK
,
Deepak L. Bhatt
2  Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts, USA
,
Jayne Prats
3  The Medicines Company, Parsippany, New Jersey, USA
,
Jonathan R. S. Day
4  AstraZeneca, Luton, UK
,
Philippe Gabriel Steg
5  FACT (French Alliance for Cardiovascular clinical Trials), DHU FIRE, INSERM Unité 1148, Université Paris-Diderot, and Hôpital Bichat, Assistance-Publique–Hôpitaux de Paris, Paris, France
6  NHLI, Imperial College, Royal Brompton Hospital, London, UK
,
Gregg W. Stone
7  Columbia University Medical Center and the Cardio -vascular Research Foundation, New York City, New York, USA
,
Christian W. Hamm
8  Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany
,
Kenneth W. Mahaffey
9  Stanford Center for Clinical Research (SCCR), Department of Medicine, Stanford University School of Medicine, Stanford, California, USA
,
Matthew J. Price
10  Scripps Clinic and Scripps Translational Science Institute, La Jolla, California, USA
,
C. Michael Gibson
11  Beth Israel Deaconess Medical Center, Division of Cardiology, Boston, Massachusetts, USA
,
Harvey D. White
12  Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
,
Robert F. Storey
1  University of Sheffield, Sheffield, UK
,
the CHAMPION PHOENIX Investigators› Author Affiliations
Financial support: The CHAMPION program was supported by The Medicines Company.
Further Information

Publication History

Received: 22 December 2016

Accepted after major revision: 23 February 2017

Publication Date:
28 November 2017 (online)

Summary

Dyspnoea may be induced by some reversibly-binding P2Y12 inhibitors, including cangrelor and ticagrelor. Dyspnoea was not associated with any compromise to the efficacy of ticagrelor in the PLATO study. The CHAMPION PHOENIX study (NCT01156571) compared initial treatment with cangrelor versus initial treatment with clopidogrel in patients undergoing PCI. We investigated the incidence, characteristics, and associated clinical outcomes in patients with dyspnoea in CHAMPION PHOENIX. Adverse events (AEs) of dyspnoea to 48 hours were recorded in patients randomised to cangrelor or clopidogrel in CHAMPION PHOENIX. The composite primary endpoint of death, myocardial infarction, ischaemia-driven revascularisation, or stent thrombosis as well its individual components were assessed in patients who did or did not report dyspnoea. A total of 68 (1.2 %) cangrelor-treated patients and 18 (0.3 %) clopidogrel-treated patients reported dyspnoea (p<0.001). Most dyspnoea events in cangrelor-treated patients were considered mild (71 %) or moderate (28 %) and only one event was considered severe and led to discontinuation of cangrelor. The dyspnoea events in the clopidogrel-treated patients were mild (78 %) or moderate (22 %). Characteristics of dyspnoea were consistent with those seen in the CHAMPION programme as a whole. In the modified intention-to-treat population, rates of the composite primary outcome and its individual components were not affected by the presence of dyspnoea in cangrelor-treated patients. Cangrelor-related dyspnoea is transient, usually mild or moderate, and unlikely to lead to discontinuation of therapy. The occurrence of dyspnoea does not seem to be associated with any reduction in the efficacy of cangrelor compared with clopidogrel as initial therapy in PCI patients.

Supplementary Material to this article is available online at www.thrombosis-online.com.

* A full list of the investigators can be found in Bhatt DL et al. N Engl J Med 2013; 368: 1303–1313.