- Karthikeyan G, et al. INVICTUS - Rivaroxaban versus VKA for rheumatic atrial fibrillation. Hot Line Session 5, ESC Congress 2022, Barcelona, Spain, 26–29 August.
- Connolly SJ, et al. N Engl J Med. Aug 28 2022; DOI: 10.1056/NEJMoa2209051.
Prof. Ganesan Karthikeyan (All India Institute of Medical Sciences, New Delhi, India) presented the findings of the INVICTUS (NCT02832544) trial, which compared cardiovascular outcomes in patients with rheumatic heart disease-associated AF randomised to either receive treatment with factor Xa inhibitor rivaroxaban or with a standard vitamin K antagonist. The primary efficacy endpoint was a composite of stroke, systemic embolism, myocardial infarction, or death from vascular (cardiac or non-cardiac) or unknown causes. The primary safety endpoint was major bleeding according to the ISTH (International Society on Thrombosis and Haemostasis).
Of the 4,531 patients included in the final analysis, with average follow-up of 3.1 years (mean age 50.5 years, 72.3% women), the primary endpoint analysis favoured treatment with vitamin K antagonist over rivaroxaban (HR 1.25; 95% CI 1.10–1.41), and as such, the proportional hazards assumption was not met. The restricted mean survival time was reduced by 76 days in the rivaroxaban group versus the vitamin K antagonist arm (95% CI -121 to -31; P<0.001). Furthermore, a higher incidence of death was reported in the rivaroxaban arm than in the vitamin K antagonist arm (difference -72 days; 95% CI -117 to -28). The rate of major bleeding was similar in both arms.