替格瑞洛的Champion Phoenix III期临床试验结果.ppt

48-Hour Events PLATFORM OR [95% CI] P value Death/MI/IDR 0.87 (0.71,1.07) 0.17 Death/Q-MI/IDR 0.55 (0.33,0.93) 0.02 Death/Q-MI/ST 0.38 (0.20,0.72) 0.003 PCI Death/MI/IDR 1.05 (0.89,1.24) 0.57 Death/Q-MI/IDR 0.66 (0.42,1.05) 0.08 Death/Q-MI/ST 0.74 (0.43,1.27) 0.27 POOLED Death/MI/IDR 0.97 (0.86,1.11) 0.68 Death/Q-MI/IDR 0.61 (0.43,0.86) 0.005 Death/Q-MI/ST 0.55 (0.36,0.83) 0.004 Cangrelor Better 5.0 2.0 1.0 0.2 0.5 Comparator Better Summary of Clinical Efficacy 1. Bhatt DL, Lincoff AM, Gibson CM, et al. Intravenous platelet blockade with cangrelor during PCI. N Engl J Med 2009;361:2330-41. 2. Harrington RA, Stone GW, McNulty S, et al. Platelet inhibition with cangrelor in patients undergoing PCI. N Engl J Med 2009;361:2318-29. 3. White HD, Chew DP, Dauerman HL, et al. AHJ 2012. CHAMPION PHOENIX Lessons from CHAMPION PCI | PLATFORM Trial Design Implementation Patient population All comers PCI Inclusion of patients with normal cardiac markers at baseline | est. 65% trial population P2Y12 inhibitor na?ve Patients not pre-treated with P2Y12 inhibitor within 7 days prior to angiogram Endpoint definitions MI definition 1 UDMI | Central lab to assure consistency of CKMB mass assay globally | angiographic core lab to consistently assess evidence of ischemia Stent thrombosis definition 2 ARC Definition includes occurrence associated with IDR | Death | MI | also intra-procedural stent thrombosis measured by angiographic core lab 3 1. Thygesen K, Alpert JS, and White HD, on behalf of the Joint ESC/ACCF/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. Eur Heart J. 2007;28:2525-2538. 2. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344-2351. 3. Brener SJ, Cristea E, Kirtane AJ, et al. Intra-Procedural Stent Thrombosis. J Am Coll Cardiol Intv 2013;6:36–43. Universal Definition of MI Thygesen K, Alpert JS,