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A study with ACS patients scheduled for PCI on CHAMPION–PCI and CHAMPION–PLATFORM
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CHAMPION (CHAMPION–PCI and
CHAMPION–PLATFORM)
CHAMPION (CHAMPION–PCI and CHAMPION–PLATFORM)
• Population:
ACS patients scheduled for PCI
• Treatments:
CHAMPION–PCI: 8716 patients randomized to cangrelor infusion (within 30
minutes before PCI and continued for two hours) followed by clopidogrel 600 mg, or
clopidogrel 600 mg (within 30 minutes before PCI) followed by placebo tablets
CHAMPION–PLATFORM: 5362 patients randomized to cangrelor infusion (within
30 minutes before PCI and continued for two hours) followed by clopidogrel 600 mg
at the end of the infusion, or placebo infusion followed by clopidogrel 600 mg given
after PCI
• Primary outcome:
All-cause death/MI/ischemia-driven revascularization at 48 hours
D Bhatt (Brigham and Women’s Hospital, Boston, MA) American Heart Association 2009 Scientific Sessions
Outcome
Cangrelor
(n=3889), %
Clopidogrel
(n=3865), %
Odds ratio
(95% CI)
p
Death/MI/ischemia-driven revascularization
(primary end point)
7.5 7.1 1.05 (0.88–1.24) 0.59
Major bleeding, ACUITY criteria 3.6 2.9 1.26 (0.99–1.60) 0.06
Major bleeding, TIMI criteria 0.4 0.3 1.36 (0.68–2.17) 0.39
Severe or life-threatening bleeding, GUSTO criteria 0.2 0.3 0.91 (0.39–2.14) 0.82
Major results at 48 hours
• Cangrelor was not superior to clopidogrel with respect to the primary end point
CHAMPION–PCI: Results
Outcome
Cangrelor
(n=2654), %
Placebo
(n=2641), %
Odds ratio
(95% CI)
p
Death/MI/ischemia-driven revascularization
(primary end point)
7.0 8.0 0.87 (0.71–1.07) 0.17
Death 0.2 0.7 0.33 (0.13–0.83) 0.02
Stent thrombosis 0.2 0.6 0.31 (0.11–0.85) 0.02
Major bleeding, ACUITY criteria 5.5 3.5 1.61 (1.23–2.10) <0.001
Major bleeding, TIMI criteria 0.2 0.3 0.44 (0.14–1.44) 0.17
Severe or life-threatening bleeding, GUSTO criteria 0.3 0.2 1.50 (0.53–4.21) 0.45
Major results at 48 hours
• No significant difference in the primary end point between cangrelor and placebo
groups
• Stent thrombosis and death (two prespecified end points) significantly reduced
in the cangrelor group
CHAMPION–PLATFORM: Results
CHAMPION: Commentary*
*All comments from Cangrelor in CHAMPION: What went wrong?
(http://www.theheart.org/article/1023633.do)
"We used a relatively liberal definition for periprocedural MI of three times upper
limit of normal for CKMB rises . . . In hindsight, it would probably have been better
to use a stricter definition like five times the upper limit of normal or even eight
times."
- Dr Robert Harrington
(lead investigator , CHAMPION–PCI)
"The CHAMPION investigators have overestimated the relevance of some of their
observations . . . The most likely explanation for these findings is the play of
chance."
- Dr Sanjay Kaul
"There is a great interest in cangrelor, as it is the first IV P2Y12 antagonist, which
we would welcome for acute use in the cath lab."
- Dr David Faxon
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