ATLAS ACS 2-TIMI 51 Trial

Trial Details

Acronym: Anti-Xa Therapy to Lower cardiovascular events in Addition to Standard therapy in subjects with Acute Coronary Syndromes - Thrombolysis In Myocardial Infarction 51

Purpose: Evaluated twice-daily rivaroxaban at two doses in patients who recently experienced an ACS.

Format: Double-blind, placebo-controlled, randomized

Treatment Group 1: twice-daily rivaroxaban (2.5 mg)

Treatment Group 2: twice-daily rivaroxaban (5.0 mg)

Control Group: placebo

Number of Patients: 15,526

Centers: 766

Countries: 44

Inclusion Criteria:

• Presented with symptoms suggestive of an acute coronary syndrome
• AND either STEMI, non-STEMI or unstable angina

Exclusion Criteria:

• Platelet count of less than 90,000 per cubic millimeter
• A hemoglobin level of less than 10 g per deciliter
• Or a creatinine clearance of less than 30 ml per minute
• Clinically significant gastrointestinal bleeding within 12 months before randomization
• Previous intracranial hemorrhage
• Previous ischemic stroke or transient ischemic attack in patients who were taking both aspirin and a thienopyridine

Primary Endpoint: composite of death from cardiovascular causes, myocardial infarction, or stroke

Secondary Endpoints:

• death from any cause, myocardial infarction, or stroke
• TIMI major bleeding not related to coronary-artery bypass grafting

Follow-up: maximum, 31 months

Summary:

The ATLAS ACS 2 – TIMI 51 trial found rivaroxaban reduced the risk for the composite endpoint of death from cardiovascular causes, MI or stroke vs. placebo (8.9% vs. 10.7%, respectively; HR = 0.84; 95% CI, 0.74-0.96). Improvements were seen with both 2.5 mg (9.1% vs. 10.7%, P = .02) and 5 mg (8.8% vs. 10.7%, P = .03). Rivaroxaban increased the rates for non-fatal major bleeding (2.1% vs. 0.6%, P < .001) and intracranial hemorrhage (0.6% vs. 0.2%, P = .009) but not for fatal bleeding (0.3% vs. 0.2%, P = .66).

Original Publication:

Mega JL, et al. N Engl J Med. 2012;doi:10.1056/NEJMoa1112277.

Healio/Cardiology News Coverage:

ATLAS ACS: Adding rivaroxaban to antiplatelet therapy reduced death rates in ACS