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Dr. Jessica Mega
Presenter: Jessica Mega | see Discussant report
BackgroundPatients remain at risk of recurrent cardiovascular events despite medical therapies and interventional strategies following a ST-segment elevation myocardial infarction (STEMI). In the ATLAS ACS 2-TIMI 51 trial, the factor Xa inhibitor rivaroxaban reduced cardiovascular events in ACS patients. The present analysis reports the results of rivaroxaban versus placebo in the pre-specified subgroup of patients following a STEMI.
MethodsATLAS ACS 2-TIMI 51 was a randomized, placebo-controlled study involving 44 countries and 15,526 patients. The present analysis includes 7,817 patients following a STEMI who underwent randomization to twice daily dosing of either rivaroxaban 2.5 mg, rivaroxaban 5 mg, or placebo. Data are presented as 2 year Kaplan–Meier event rates, and testing was based on the log-rank test, stratified by the intention to use a thienopyridine.
ResultsRivaroxaban was associated with a reduction in the composite primary efficacy endpoint of cardiovascular death, myocardial infarction, or stroke, as compared with placebo (8.4% vs. 10.6%, HR 0.81, 95% CI 0.67-0.97, P=0.019). Rivaroxaban 2.5 mg twice daily (8.7% vs. 10.6%, P=0.047) and 5 mg twice daily (8.2% vs. 10.6%, P=0.051) as compared with placebo exhibited directionally consistent reductions in the primary efficacy endpoint. Rivaroxaban 2.5 mg twice daily reduced cardiovascular death (2.5% vs. 4.2%, P=0.006) and all-cause death (3.0% vs. 4.7%, P=0.008); this survival benefit was not seen with 5 mg twice daily dose. Rivaroxaban, as compared with placebo, increased the rates of TIMI major bleeding not related to CABG (2.2% vs. 0.6%, P<0.001) and intracranial hemorrhage (0.6% vs. 0.1%, P=0.015), without a significant increase in fatal bleeding (0.2% vs. 0.1%, P=0.51). Rivaroxaban 2.5 mg twice daily resulted in less fatal bleeding than rivaroxaban 5 mg twice daily (1 event vs. 8 events, P=0.018).
SummaryIn patients with a recent STEMI, rivaroxaban reduced the risk of the composite endpoint of cardiovascular death, myocardial infarction, or stroke, and the 2.5 mg twice daily dose demonstrated a mortality benefit. Rivaroxaban as compared with placebo increased the risk of major bleeding and intracranial hemorrhage, but there was no increase in fatal bleeding.
ConclusionsTreatment with very low dose rivaroxaban (2.5 mg BID) offers an effective strategy to reduce thrombotic events in patients following a STEMI.
Discussant: Andreas Michael | see Presenter abstract
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Clinical Trial & Registry Update II: Updates on Heart Failure and Coronary Artery Disease
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