Takeaway
- Patients with worsening acute heart failure with reduced ejection fraction (HFrEF) had 17% lower rate of thromboembolic events with low-dose rivaroxaban (Xarelto; Janssen Pharmaceutica) vs placebo in this post hoc analysis of COMMANDER HF.
- Authors: deaths in COMMANDER HF's primary endpoint “may have masked a favorable association of rivaroxaban and thromboembolic events.”
- Prospective trials needed.
- Commentary discusses risk-benefit ratio, use in dual antiplatelet therapy, whether sudden cardiac death arises from acute thrombosis; concludes ongoing lack of definitive evidence to drive clinical practice.
Why this matters
- ATLAS ACS 2–TIMI 51 and COMPASS found benefit from low-dose rivaroxaban in patients with cardiac disease.
- COMMANDER-HF did not find benefit for composite of all-cause mortality, myocardial infarction, or stroke.
Key results
- Rivaroxaban vs placebo:
- Primary outcome: 13.1% vs 15.5%;
- HR, 0.83 (95% CI, 0.72-0.96; P=.01).
- Primary outcome without sudden/unwitnessed deaths: 6.1% vs 7.6%;
- HR, 0.80 (95% CI, 0.64-0.98; P=.04).
- Primary outcome: 13.1% vs 15.5%;
Study design
- Analysis of multicenter, randomized, double-blind, placebo-controlled COMMANDER HF trial (n=5022).
- Participants with acute-on-chronic HFrEF, coronary artery disease, and sinus rhythm were randomly assigned to low-dose rivaroxaban vs placebo.
- Outcome in this analysis: composite of thromboembolic events.
- Funding: Janssen Research & Development LLC.
Limitations
- Results are hypothesis-generating.
- No external event adjudication.
References
References