RUBY-1: a randomized, double-blind, placebo-controlled trial of the safety and tolerability of the novel oral factor Xa inhibitor darexaban (YM150) following acute coronary syndrome
Key result
Darexaban added to dual antiplatelet therapy after ACS increased major or clinically relevant non-major bleeding compared to placebo (pooled HR 2.275; 95% CI 1.13-4.60; P=0.022).
Why the study?
Does darexaban added to dual antiplatelet therapy increase bleeding or improve efficacy outcomes in patients with recent high-risk ACS?
Population
1279 patients with recent high-risk non-ST-segment or ST-segment elevation ACS
Comparison
Darexaban added to dual antiplatelet treatment vs Placebo added to dual antiplatelet treatment
Design
RCT, randomized, parallel-group, double-blind
Follow-up
26 weeks
Authors
Discussion
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Implication
Dose-dependent bleeding rise without efficacy signal in phase 2 RCT cautions against darexaban post-ACS; challenges additive oral anticoagulation on DAPT.
Study Design
Type
RCT (n=1,279)
Blinding
double-blind
Randomization
randomized
Multicenter
Yes
Structured PICO
Does darexaban added to dual antiplatelet therapy increase bleeding or improve efficacy outcomes in patients with recent high-risk ACS?
P
Population
1,279 patients with recent high-risk non-ST-segment or ST-segment elevation ACS followed for 26 weeks.
I
Intervention
Darexaban (5 mg b.i.d., 10 mg o.d., 15 mg b.i.d., 30 mg o.d., 30 mg b.i.d., or 60 mg o.d.) added to dual antiplatelet treatment
C
Comparator
Placebo added to dual antiplatelet treatment
O
Outcome
Incidence of major or clinically relevant non-major bleeding eventssafety
Main Result
Hazard Ratio: 2.275 (95% CI 1.13–4.6)
p-value: p=0.022
Darexaban added to dual antiplatelet therapy after ACS significantly increases bleeding risk without an apparent efficacy benefit, though the study was underpowered for efficacy.
Limitations
- underpowered for efficacy
Cite This Study
Steg et al. (2011) conducted an RCT in acute coronary syndrome (ACS) (n=1,279). darexaban (YM150) vs. placebo was evaluated on incidence of major or clinically relevant non-major bleeding events (HR 2.275, 95% CI 1.13-4.60, p=0.022). Darexaban added to dual antiplatelet therapy after ACS increased major or clinically relevant non-major bleeding compared to placebo (pooled HR 2.275; 95% CI 1.13-4.60; P=0.022).