TRITON-TIMI 38 (Trial to AssessImprovement in Therapeutic Outcomes byOptimizing Platelet Inhibition withPrasugrel-Thrombolysis In MyocardialInfarction)
TRITON-TIMI 38 (Trial to Assess Improvement in TherapeuticOutcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis In Myocardial Infarction)S Wiviott (Brigham and Womens Hospital, Boston, MA)American Heart Association 2007 Scientific Sessions• Population and treatment: 13 608 moderate- to high-risk ACS patients scheduled for PCI Randomized to prasugrel (60-mg loading dose and then 10-mg daily maintenance dose) or clopidogrel (300-mg/75-mg) for six to 15 months• Outcomes: Primary efficacy end point: CV death/MI/stroke Key safety end point: TIMI major bleeding not related to CABG
TRITON-TIMI 38: Results (efficacy)• Prasugrel significantly reduced the primary efficacy end point, as well as some key secondary end points (MI, TVR, and stent thrombosis) vs clopidogrelMajor efficacy results at 15 monthsEnd point Prasugrel Clopidogrel Hazard ratio p (n=6813), % (n=6795), % (95% CI)CV death/MI/stroke 9.9 12.1 0.81 (0.73–0.90) <0.001CV death 2.1 2.4 0.89 (0.70–1.12) 0.31Nonfatal MI 7.3 9.5 0.76 (0.67–0.85) <0.001Nonfatal stroke 1.0 1.0 1.02 (0.71–1.45) 0.93Death from any cause 3.0 3.2 0.95 (0.78–1.16) 0.64Urgent TVR 2.5 3.7 0.66 (0.54–0.81) <0.001Stent thrombosis 1.1 2.4 0.48 (0.36–0.64) <0.001TVR=target vessel revascularization
TRITON-TIMI 38: Results (safety)• There were significant increases in major bleeding, life-threatening bleeding, and fatal bleeding with prasugrel vs clopidogrelMajor bleeding results at 15 monthsEnd point Prasugrel Clopidogrel Hazard ratio p (n=6813), % (n=6795), % (95% CI)Non–CABG-related TIMI major bleed 2.4 1.8 1.32 (1.03–1.68) 0.03Life-threatening bleed 1.4 0.9 1.52 (1.08–2.13) 0.01Fatal bleed 0.4 0.1 4.19 (1.58–11.11) 0.002Major or minor TIMI bleeding 5.0 3.8 1.31 (1.11–1.56) 0.002Bleed requiring transfusion 4.0 3.0 1.34 (1.11–1.63) <0.001CABG-related TIMI major bleeda 13.4 3.2 4.73 (1.90–11.82) <0.001a. Relates to the number of patients who underwent CABG (179 in the prasugrel group and 189 in theclopidogrel group)
TRITON-TIMI 38: Commentary*"Prasugrel appears to be particularly potent, with the danger of serious bleeding inpatients who undergo CABG or who have cerebrovascular disease. It will also beinteresting to see how well this drug is tolerated in the real treatment world." - Dr Eric Topol"The holy grail of antithrombotic drug development is balancing improvedefficacy against the risk of increased bleeding. It appears that prasugrel has fallenshort in this regard." - Dr Sanjay Kaul*All comments from TRITON-TIMI 38: Prasugrel lowers events but ups bleeding vs clopidogrel(http://www.theheart.org/article/823247.do)
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