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  • Erica S. Zado
    Correspondence
    Address reprint requests and correspondence: Ms Erica S. Zado, Section of Cardiac Electrophysiology, Cardiovascular Division, Hospital of the University of Pennsylvania, Founders 9, 3400 Spruce St, Philadelphia, PA 19104.
    Affiliations
    Section of Cardiac Electrophysiology, Cardiovascular Division, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
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Published:September 07, 2022DOI:https://doi.org/10.1016/j.hrthm.2022.09.006
      In this randomized controlled trial, Connolly et al (N Engl J Med 2022;387:978, PMID 36036525) sought to assess the safety and efficacy of rivaroxaban vs vitamin K antagonists (VKAs) in patients with rheumatic heart disease (RHD) and atrial fibrillation (AF). Patients with RHD were routinely excluded from the pivotal trials comparing rivaroxaban and other non-VKA oral anticoagulants (NOACs) with the VKA warfarin. The INVICTUS trial (Investigation of Rheumatic AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies) was conducted in 138 sites in 34 countries in Africa, Latin America, and Asia. Patients with AF and echocardiographically proven RHD were randomized in a 1:1 fashion to rivaroxaban or VKA (warfarin or acenocoumarol depending on which is available locally). In addition to RHD on the echocardiogram and AF, each patient had to have either a CHA2DS2-VASc score of ≥2, moderate to severe mitral stenosis (MS; mitral valve area < 2 cm2), or left atrial spontaneous contrast or left atrial thrombus on the echocardiogram. Exclusion criteria included patients with mechanical valves and patients with creatinine clearance < 15 mL/min. The original study design was a noninferiority study with a primary efficacy outcome that was a composite of stroke and systemic embolism, and a primary safety outcome of major bleeding. However, after blinded analysis of events during the course of the trial, the rate of stroke and systemic embolism was lower than anticipated. Therefore, the primary end point was adjusted to a composite of stroke, systemic embolism, myocardial infarction, and death from vascular (cardiac or noncardiac) causes or death from unknown causes.
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