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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

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...

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Autores principales: Vaduganathan, Muthiah, Harrington, Robert A., Stone, Gregg W., Steg, Ph. Gabriel, Gibson, C. Michael, Hamm, Christian W., Price, Matthew J., Prats, Jayne, Deliargyris, Efthymios N., Mahaffey, Kenneth W., White, Harvey D., Bhatt, Deepak L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4920208/
https://www.ncbi.nlm.nih.gov/pubmed/27313282
http://dx.doi.org/10.1161/CIRCINTERVENTIONS.116.003612
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author Vaduganathan, Muthiah
Harrington, Robert A.
Stone, Gregg W.
Steg, Ph. Gabriel
Gibson, C. Michael
Hamm, Christian W.
Price, Matthew J.
Prats, Jayne
Deliargyris, Efthymios N.
Mahaffey, Kenneth W.
White, Harvey D.
Bhatt, Deepak L.
author_facet Vaduganathan, Muthiah
Harrington, Robert A.
Stone, Gregg W.
Steg, Ph. Gabriel
Gibson, C. Michael
Hamm, Christian W.
Price, Matthew J.
Prats, Jayne
Deliargyris, Efthymios N.
Mahaffey, Kenneth W.
White, Harvey D.
Bhatt, Deepak L.
author_sort Vaduganathan, Muthiah
collection PubMed
description 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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spelling pubmed-49202082016-07-12 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 Vaduganathan, Muthiah Harrington, Robert A. Stone, Gregg W. Steg, Ph. Gabriel Gibson, C. Michael Hamm, Christian W. Price, Matthew J. Prats, Jayne Deliargyris, Efthymios N. Mahaffey, Kenneth W. White, Harvey D. Bhatt, Deepak L. Circ Cardiovasc Interv Original Articles 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. Lippincott Williams & Wilkins 2016-06 2016-06-21 /pmc/articles/PMC4920208/ /pubmed/27313282 http://dx.doi.org/10.1161/CIRCINTERVENTIONS.116.003612 Text en © 2016 The Authors. Circulation: Cardiovascular Interventions is published on behalf of the American Heart Association, Inc., by Wolters Kluwer. This is an open access article under the terms of the Creative Commons Attribution (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited.
spellingShingle Original Articles
Vaduganathan, Muthiah
Harrington, Robert A.
Stone, Gregg W.
Steg, Ph. Gabriel
Gibson, C. Michael
Hamm, Christian W.
Price, Matthew J.
Prats, Jayne
Deliargyris, Efthymios N.
Mahaffey, Kenneth W.
White, Harvey D.
Bhatt, Deepak L.
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4920208/
https://www.ncbi.nlm.nih.gov/pubmed/27313282
http://dx.doi.org/10.1161/CIRCINTERVENTIONS.116.003612
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