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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

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ABSTRACT

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.

No MeSH data available.


Number of enrolled patients (black bars) and sites (gray bars) per country in the Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) PHOENIX trial.
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Figure 1: Number of enrolled patients (black bars) and sites (gray bars) per country in the Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) PHOENIX trial.

Mentions: From September 30, 2010 to October 3, 2012, CHAMPION PHOENIX randomized 11 145 patients enrolled from 153 global sites from 12 countries (Austria, Brazil, Bulgaria, Czech Republic, Georgia, Germany, Italy, New Zealand, Poland, Russia, Thailand, and the United States). The number of enrolled subjects and sites per country varied (Figure 1). The United States enrolled the highest number of patients (n=4188; 37.6%) from 63 enrolling sites. Of this randomized cohort, 10 942 patients (98.2%) ultimately underwent PCI and received the assigned drug and were included in the intention-to-treat analysis. Follow-up was available at 48 hours and 30 days in 10 939 and 10 919 patients, respectively. The final analytic cohort was based on the intention-to-treat trial population, and the present analysis compared the clinical profiles of patients enrolled from the US (n=4097; 37.4%) versus non-US sites (n=6845; 62.6%).


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
Number of enrolled patients (black bars) and sites (gray bars) per country in the Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) PHOENIX trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4920208&req=5

Figure 1: Number of enrolled patients (black bars) and sites (gray bars) per country in the Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) PHOENIX trial.
Mentions: From September 30, 2010 to October 3, 2012, CHAMPION PHOENIX randomized 11 145 patients enrolled from 153 global sites from 12 countries (Austria, Brazil, Bulgaria, Czech Republic, Georgia, Germany, Italy, New Zealand, Poland, Russia, Thailand, and the United States). The number of enrolled subjects and sites per country varied (Figure 1). The United States enrolled the highest number of patients (n=4188; 37.6%) from 63 enrolling sites. Of this randomized cohort, 10 942 patients (98.2%) ultimately underwent PCI and received the assigned drug and were included in the intention-to-treat analysis. Follow-up was available at 48 hours and 30 days in 10 939 and 10 919 patients, respectively. The final analytic cohort was based on the intention-to-treat trial population, and the present analysis compared the clinical profiles of patients enrolled from the US (n=4097; 37.4%) versus non-US sites (n=6845; 62.6%).

View Article: PubMed Central - PubMed

ABSTRACT

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.

No MeSH data available.