INVICTUS: Rivaroxaban vs. VKA Therapy For Patients With Rheumatic Heart Disease-Associated AFib
Compared with rivaroxaban therapy, vitamin K antagonist (VKA) therapy in patients with rheumatic heart disease-associated atrial fibrillation (AFib) was associated with a lower rate of cardiovascular events or death and no higher rate of bleeding, according to findings from the INVICTUS trial presented Aug. 28 during ESC Congress 2022 in Barcelona, and simultaneously published in the New England Journal of Medicine.
Stuart J. Connolly, MD, et al., randomly assigned 4,531 patients from Africa, Asia and Latin America (mean age 50.5 years; 72.3% women) to receive standard doses of rivaroxaban or dose-adjusted VKA therapy. All patients had AFib and echocardiographically-documented rheumatic heart disease and at least one of the following: CHA2DS2VASc score of at least 2, a mitral-valve area of no more than 2 cm2, left atrial spontaneous echo contrast, or left atrial thrombus. The primary outcome was a composite of stroke, systemic embolism, myocardial infarction, or death from vascular or unknown causes. The primary safety outcome was major bleeding.
Results found that 560 patients in the rivaroxaban group and 446 in the VKA group had a primary-outcome event. The restricted mean survival time was 1,599 days in the rivaroxaban group and 1,675 days in the VKA group. Researchers noted that permanent discontinuation of trial medication was more common with patients in the rivaroxaban group compared with those in the VKA group. Additionally, a higher incidence of death occurred in the rivaroxaban group. There was no significant difference in the rate of major bleeding between the two groups.
In a related editorial comment, Gregory Y.H. Lip, MD, FACC, says the trial findings are “highly relevant” to countries with a high prevalence of rheumatic heart disease-associated AFib and “suggest that VKA therapy may be the preferred oral anticoagulation strategy over rivaroxaban” in this patient group, given its ties to lower mortality and lower risk of stroke. However, he also cautions that “to have a major effect on clinical outcomes, holistic treatment of [these] patients … is needed in integrated care-management pathways that look beyond anticoagulation alone.”
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias
Keywords: ESC Congress, ESC22, ACC International, Rivaroxaban, Atrial Fibrillation, Vitamin K, Factor Xa Inhibitors
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