In the INVICTUS trial, vitamin K antagonist therapy produced better cardiovascular and mortality without additional bleeding than rivaroxaban in patients with rheumatic heart disease–associated atrial fibrillation, researchers report. The study included 4,531 participants with atrial fibrillation and echocardiographically documented rheumatic heart disease who were randomized to the factor Xa inhibitor rivaroxaban or dose-adjusted vitamin K antagonist therapy.
A total of 560 patients receiving rivaroxaban and 446 patients on vitamin K antagonist therapy had a composite efficacy outcome of stroke, systemic embolism, myocardial infarction, or death from vascular (cardiac or noncardiac) or unknown causes. “The restricted mean survival time was 1599 days in the rivaroxaban group and 1675 days in the vitamin K antagonist group (difference, −76 days; 95% confidence interval [CI], −121 to −31; P <0.001),” the authors write. “A higher incidence of death occurred in the rivaroxaban group than in the vitamin K antagonist group (restricted mean survival time, 1608 days vs. 1680 days; difference, −72 days; 95% CI, −117 to −28).”
Throughout the 4-year trial, permanent discontinuation of trial medication was more common with rivaroxaban than with vitamin K antagonist therapy. The rate of bleeding was not significantly different between the treatments.
Editorial: “The INVICTUS trial is an important trial that is highly relevant to countries with a high prevalence of rheumatic heart disease–associated atrial fibrillation,” editorialists write. “The results of this trial suggest that vitamin K antagonist therapy may be the preferred oral anticoagulation strategy over rivaroxaban in patients with atrial fibrillation associated with rheumatic heart disease; its use is associated with lower mortality and a lower risk of stroke. Nonetheless, to have a major effect on clinical outcomes, holistic treatment of patients with rheumatic heart disease–associated atrial fibrillation is needed in integrated care-management pathways that look beyond anticoagulation alone.”
Source: New England Journal of Medicine