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Clinical Summary

Acute-on-chronic HFrEF: thromboembolic events fall with low-dose rivaroxaban

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).

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


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