CHAMPION (CHAMPION–PCI and CHAMPION–PLATFORM)D Bhatt (Brigham and Women’s Hospital, Boston, MA)American Heart Association 2009 Scientific Sessions• 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
CHAMPION–PCI: Results• Cangrelor was not superior to clopidogrel with respect to the primary end pointMajor results at 48 hoursOutcome Cangrelor Clopidogrel Odds ratio p (n=3889), % (n=3865), % (95% CI)Death/MI/ischemia-driven revascularization 7.5 7.1 1.05 (0.88–1.24) 0.59(primary end point)Major bleeding, ACUITY criteria 3.6 2.9 1.26 (0.99–1.60) 0.06Major bleeding, TIMI criteria 0.4 0.3 1.36 (0.68–2.17) 0.39Severe or life-threatening bleeding, GUSTO criteria 0.2 0.3 0.91 (0.39–2.14) 0.82
CHAMPION–PLATFORM: Results• 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 groupMajor results at 48 hoursOutcome Cangrelor Placebo Odds ratio p (n=2654), % (n=2641), % (95% CI)Death/MI/ischemia-driven revascularization 7.0 8.0 0.87 (0.71–1.07) 0.17(primary end point)Death 0.2 0.7 0.33 (0.13–0.83) 0.02Stent thrombosis 0.2 0.6 0.31 (0.11–0.85) 0.02Major bleeding, ACUITY criteria 5.5 3.5 1.61 (1.23–2.10) <0.001Major bleeding, TIMI criteria 0.2 0.3 0.44 (0.14–1.44) 0.17Severe or life-threatening bleeding, GUSTO criteria 0.3 0.2 1.50 (0.53–4.21) 0.45
CHAMPION: Commentary*"We used a relatively liberal definition for periprocedural MI of three times upperlimit of normal for CKMB rises . . . In hindsight, it would probably have been betterto use a stricter definition like five times the upper limit of normal or even eighttimes." - Dr Robert Harrington (lead investigator , CHAMPION–PCI)"The CHAMPION investigators have overestimated the relevance of some of theirobservations . . . The most likely explanation for these findings is the play ofchance." - Dr Sanjay Kaul"There is a great interest in cangrelor, as it is the first IV P2Y12 antagonist, whichwe would welcome for acute use in the cath lab." - Dr David Faxon*All comments from Cangrelor in CHAMPION: What went wrong?(http://www.theheart.org/article/1023633.do)
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