Variation in Patient Profiles and Outcomes in US and Non-US Subgroups of the Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) PHOENIX Trial
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Background—: The Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) PHOENIX trial demonstrated superiority of cangrelor in reducing ischemic events at 48 hours in patients undergoing percutaneous coronary intervention compared with clopidogrel. Methods and Results—: We analyzed all patients included in the modified intention-to-treat analysis in US (n=4097; 37.4%) and non-US subgroups (n=6845; 62.6%). The US cohort was older, had a higher burden of cardiovascular risk factors, and had more frequently undergone prior cardiovascular procedures. US patients more frequently underwent percutaneous coronary intervention for stable angina (77.9% versus 46.2%). Almost all US patients (99.1%) received clopidogrel loading doses of 600 mg, whereas 40.5% of non-US patients received 300 mg. Bivalirudin was more frequently used in US patients (56.7% versus 2.9%). At 48 hours, rates of the primary composite end point were comparable in the US and non-US cohorts (5.5% versus 5.2%; P =0.53). Cangrelor reduced rates of the primary composite end point compared with clopidogrel in US (4.5% versus 6.4%; odds ratio 0.70 [95% confidence interval 0.53–0.92]) and in non-US patients (4.8% versus 5.6%; odds ratio 0.85 [95% confidence interval 0.69–1.05]; interaction P =0.26). Similarly, rates of the key secondary end point, stent thrombosis, were reduced by cangrelor in both regions. Rates of Global Use of Strategies to Open Occluded Arteries (GUSTO)–defined severe bleeding were low and not significantly increased by cangrelor in either region. Conclusions—: Despite broad differences in clinical profiles and indications for percutaneous coronary intervention by region in a large global cardiovascular clinical trial, cangrelor consistently reduced rates of ischemic end points compared with clopidogrel without an excess in severe bleeding in both the US and non-US subgroups. Clinical Trial Registration—: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01156571.
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International trials of various pharmacotherapies have sometimes found discordant results in patients enrolled in the United States than seen in overall trial results.
“International trials of various pharmacotherapies have sometimes found discordant results in patients enrolled in the United States than seen in overall trial results.19–32”
From REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States (2020) · cites this paper as [21]
The reasons for discordant US results range from low numbers of patients enrolled in the United States to potential differences in background medical management or in patient risk profiles.
“The reasons range from low numbers of patients enrolled in the United States to potential differences in background medical management or in patient risk profiles.”
From REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States (2020) · cites this paper as [21]
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REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States
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- Authors
- Vaduganathan, M., Harrington, R. A., Stone, G. W., Steg, P. G., Gibson, C. M., Hamm, C. W., Price, M. J., Prats, J., Deliargyris, E. N., Mahaffey, K. W., White, H. D., & Bhatt, D. L.
- Affiliations
- Brigham and Women's Hospital (US)
- From the Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (M.V., D.L.B); Stanford University Medical School, CA (R.A.H., K.W.M.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York City, NY (G.W.S.); FACT (French Alliance for Cardiovascular clinical Trials), DHU FIRE, INSERM Unité 1148, Université Paris-Diderot, and Hôpital Bichat, Assistance-Publique–Hôpitaux de Paris, France, and NHLI, Imperial College, Royal...
- Corresponding author
- Bhatt, Deepak L.
- ORCID
- Venue
- Circulation: Cardiovascular Interventions
- Published
- 2016-06
- Volume
- 9
- Issue
- 6
- ISSN
- 1941-7632 (ISSN-L)
- 1941-7640
- PMC
- PMC4920208
- OpenAlex
- W2430995757
- Cited by
- 12
- References
- 18
- Citations by year
- 2021: 1 · 2019: 3 · 2018: 1 · 2017: 5 · 2016: 2
- FWCI
- 3.03
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- Circulation Cardiovascular Interventions (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion, cc-by)
- Spiral (Imperial College London) (submittedVersion, cc-by)
- Funders
- Medicines Company
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
- Health Sciences › Medicine › Surgery › Coronary Interventions and Diagnostics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Keywords
- cangrelor, clopidogrel, platelet aggregation inhibition, percutaneous coronary intervention, stent thrombosis, bleeding complications, subgroup analysis, cross-national comparison, antiplatelet therapy, ischemic events, bivalirudin, stable angina, clopidogrel loading dose, cardiovascular risk
- MeSH terms
- Clopidogrel, Adenosine Monophosphate, Aged, Brazil, Coronary Thrombosis, Double-Blind Method, Europe, Female, Hemorrhage, Humans, Male, Middle Aged, New Zealand, Platelet Aggregation, Platelet Aggregation Inhibitors, Platelet Function Tests, Prospective Studies, Risk Factors, Thailand, Ticlopidine, Time Factors, United States, Chi-Square Distribution, Logistic Models, Odds Ratio, Treatment Outcome, Kaplan-Meier Estimate, Intention to Treat Analysis, Percutaneous Coronary Intervention
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