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CHAMPION PCI: Cangrelor not superior to clopidogrel in patients undergoing PCI

Cangrelor was noninferior and preserved at least 50% of the effect of a 600-mg dose of clopidogrel.

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American Heart Association Scientific Sessions 2009

Cangrelor did not reduce a composite endpoint of death, MI or ischemia-driven revascularization vs. clopidogrel, according to results from the CHAMPION PCI study.

Researchers for the phase-3 study had planned to enroll approximately 9,000 patients, but the trial was prematurely halted by an interim review panel after it concluded that the study would be unlikely to reach its primary endpoint. At study termination, 8,820 patients had been enrolled. Patients were randomly assigned to receive either cangrelor 30 mcg per kilogram of body weight (n=3,897) or a 600-mg dose of clopidogrel (n=3,871). The primary study endpoint was a composite of death, MI and ischemia-driven revascularization at 48 hours following percutaneous coronary intervention.

According to the study results, there was no difference between cangrelor and clopidogrel for the combined endpoint at 48 hours (7.5% vs. 7.1%, P=.59). Patients receiving cangrelor had increased minor bleeding as measured by criteria of both the ACUITY trial (17.6% vs. 15.2%; OR=1.19; 95% CI, 1.06-1,33) and the GUSTO trial (19.6% vs. 16.9%; OR=1.20; 95% CI, 1.07-1.34) vs. clopidogrel, and had a trend toward major bleeding as assessed by the ACUITY criteria (3.6% vs. 2.9%; OR=1.26; 95% CI, 0.99-1.60). There were no differences between study groups in the risk for blood transfusions, however (1.1% vs. 1.0%; OR=1.09; 95% CI, 0.72-1.67).

“Cangrelor was not superior to 600 mg of clopidogrel in these moderate-risk to high-risk patients,” Robert A. Harrington, MD, director of the Duke Clinical Research Institute in Durham, N.C., said in his presentation. “Platelet function testing did reveal that cangrelor provides very rapid ADP blockade and did not interfere with post-PCI clopidogrel. There was an increase in ACUITY minor and GUSTO mild bleeding, although no increase in more important measures of bleeding.”

For more information:

• Harrington R. LBCT 01 #93. Presented at: American Heart Association Scientific Sessions 2009; Nov. 14-18; Orlando, Fla.

One does not, in the setting of CHAMPION, have to hypothesize interference or any kind of rebound effect. This effect may just simply be that that with cangrelor cessation, one expects full platelet function recovery within one hour. With clopidogrel 600 mg, one expects a full effect on platelet function at two hours. This window of one hour may be very important, as this is the period immediately post-PCI when the patient is most at risk for platelet activation. This may have had a role in the CHAMPION results.

– Alan Michelson, MD
Director, Center for Platelet Research Studies, Children’s Hospital Boston

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