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Study Summary

In the PLATO study, ticagrelor significantly reduced the rate of death from vascular causes, myocardial infarction or stroke, compared with clopidogrel, among acute coronary syndrome patients. However, very few patients presenting with ST-segment elevation myocardial infarction (STEMI) undergoing pharmacologic reperfusion with fibrinolytics were included in this landmark trial. Accordingly, the TREAT investigators conducted a randomized, international, open-label trial with blinded outcome assessment that evaluated ticagrelor compared with clopidogrel in 3,799 patients who received fibrinolytic therapy for STEMI. Patients, of whom 90% had been pretreated with clopidogrel, were randomized to delayed ticagrelor versus clopidogrel at a median of 11 hours after fibrinolysis. The primary safety outcome of TIMI major bleeding had occurred in 0.73% of the ticagrelor group vs. 0.69% of the clopidogrel group (p<0.001 for noninferiority) at 30 days. Secondary efficacy outcomes of major adverse cardiovascular events were 4.0% with ticagrelor and 4.3% with clopidogrel (p = 0.57) (see accompanying Hurst’s Central Illustration).

Commentary

Study Strengths: The main strength of this study is that it revisits an issue that is not as applicable to the PCI-capable world but continues to be the mainstay of therapy in certain parts of the world. In this context, this study suggests that ticagrelor is safe as a delayed therapy following fibrinolysis, however there are several caveats to note.

Study Limitations: Patients in this study were generally young, predominantly male, with few comorbid risk factors, precluding generalizability to an older and/or higher-bleeding risk cohort. Although the primary endpoint of non-inferiority was met, this result should be interpreted with caution given that the non-inferiority margin was wide and the event rate was much lower than expected. In regards to efficacy, the study was underpowered to formulate any definitive inference on the comparative efficacy with respect to ischemic events.

Next Steps/Clinical Perspective: Notwithstanding its limitations, findings from this study provide important insights on the comparative safety and efficacy of ticagrelor versus clopidogrel in a STEMI population that has not been adequately studied to date. This trial suggests that ticagrelor is non-inferior to clopidogrel following reperfusion with fibrinolytics with respect to 30-day bleeding.

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