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The effect of rivaroxaban on myocardial infarction in the ATLAS ACS 2 - TIMI 51 trial
Matthew A Cavender1, C Michael Gibson1, Eugene Braunwald1
1TIMI Study Group, Heart & Vascular Center, Brigham and Women's Hospital and Harvard Medical School, USA.
Insights
Rivaroxaban significantly reduced spontaneous myocardial infarctions (MI) in patients after acute coronary syndrome (ACS). The drug also decreased MIs with extensive biomarker release and ST-segment elevation, improving outcomes.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Acute coronary syndrome (ACS) is a critical condition requiring effective secondary prevention strategies.
- Rivaroxaban has demonstrated efficacy in reducing major adverse cardiovascular events post-ACS.
- Understanding the specific impact of rivaroxaban on different types and sizes of myocardial infarction (MI) is crucial for optimizing treatment.
Purpose of the Study:
- To investigate the effect of rivaroxaban on the incidence of spontaneous (Type 1) myocardial infarctions (MI) in patients following ACS.
- To characterize the impact of rivaroxaban on MI size, specifically focusing on events with large biomarker elevations (troponin or CK-MB).
- To evaluate the effect of rivaroxaban on ST-segment elevation myocardial infarction (STEMI) events.
Main Methods:
- The ATLAS ACS 2-TIMI 51 study randomized 15,526 patients with recent ACS to rivaroxaban (2.5 mg or 5 mg BID) or placebo.
- Myocardial infarctions (MI) occurring post-randomization were adjudicated by an independent clinical events committee and classified by type.
- Two-year Kaplan-Meier event rates, hazard ratios (HR), and 95% confidence intervals (CI) were used for analysis.
Main Results:
- Rivaroxaban significantly reduced the incidence of spontaneous (Type 1) MI compared to placebo (4.4% vs 5.7%, HR 0.80, p=0.01).
- Both rivaroxaban doses showed a trend towards reducing spontaneous MI, with the 5 mg BID dose reaching statistical significance (4.1% vs 5.7%, HR 0.77, p=0.01).
- Rivaroxaban significantly decreased MI events characterized by large troponin or CK-MB elevations (1.8% vs 2.4%, HR 0.73, p=0.03) and STEMI events (1.7% vs 2.5%, HR 0.74, p=0.04).
Conclusions:
- In post-ACS patients, the majority of subsequent MIs are spontaneous, and rivaroxaban effectively reduces their incidence.
- Rivaroxaban demonstrated a significant reduction in MIs associated with substantial biomarker release.
- The findings highlight rivaroxaban's benefit in reducing both spontaneous and more severe forms of MI following ACS.
Aims:
Rivaroxaban reduces cardiovascular death, myocardial infarction (MI), or stroke in patients following acute coronary syndrome (ACS). We aimed to characterize the specific effects of rivaroxaban on the size and type of MI.
Methods:
The Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis in Myocardial Infarction 51 (ATLAS ACS 2-TIMI 51) study randomized 15,526 patients with a recent ACS to rivaroxaban 2.5 mg BID, rivaroxaban 5 mg BID, or placebo. An independent clinical events committee adjudicated each MI that occurred during the study and further classified them based on type. Data are presented as two-year Kaplan-Meier event rates and hazard ratios (HRs) and 95% confidence intervals (CI).
Results:
In total, 665 patients experienced a post-randomization MI. The majority (n=535, 80.5%) were spontaneous (Type 1) events. Rivaroxaban reduced spontaneous MI when compared with placebo (4.4% vs 5.7%, HR 0.80, 95% 0.67-0.95, p=0.01), and there were directionally consistent reductions with both the 2.5 mg BID (4.7% vs 5.7%, HR 0.84, 95% 0.68-1.02, p=0.08) and 5 mg BID doses (4.1% vs 5.7%, HR 0.77, 95% 0.62-0.94, p=0.01) as compared with placebo. Rivaroxaban reduced MI with large elevations in troponin or creatine kinase-MB (CK-MB) fraction (1.8% vs 2.4%, HR 0.73, 95% CI 0.56-0.96, p=0.03) and STEMI events (1.7% vs 2.5%, HR 0.74, 95% CI 0.56-0.99, p=0.04).
Conclusions:
In patients stabilized and followed after ACS, the majority of MIs that occur are spontaneous and rivaroxaban significantly reduced the incidence of these events. Notably, rivaroxaban reduced MIs with extensive biomarker release and ST-segment elevation.
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