Thromb Res. 2021 Mar 8;202:24-30. doi: 10.1016/j.thromres.2021.03.004. Online ahead of print.
INTRODUCTION: Following successful phase-III trials, direct oral anticoagulants such as rivaroxaban have largely replaced warfarin for stroke prevention in atrial fibrillation (SPAF). However, data from randomized trials should be confirmed in unselected cohorts.
MATERIALS AND METHODS: Prospective registries can provide such data but often limit follow-up to short periods only. Extending our previously reported follow-up of 2.2 years in 1204 SPAF patients receiving rivaroxaban in the non-interventional DRESDEN NOAC REGISTRY, we now provide prospectively collected 5 years data (mean follow-up 5.5 ± 2.3 years) for this cohort.
RESULTS: Between 1 October 2011 and 31 December 2019, the combined endpoint of stroke/transient ischemic attack/systemic embolism occurred at a rate of 2.3/100 patient-years in the intention-to-treat analysis (95% confidence interval [CI] 1.9-2.7) and at 1.6/100 patient-years in the on-treatment analysis (events within 3 days after last drug intake). On-treatment rates for major or clinically relevant non-major bleeding were 3.1 and 19.6/100 patient-years, respectively. Rivaroxaban treatment discontinuation occurred in a total of 574 patients during follow-up (11.0/100 patient-years in Kaplan-Meier analysis) and 426 patient died (all-cause mortality 6.3/100 pt. years; mean time from enrolment 3.6 ± 2.1 years), of which the causes of death were reported as arterial or venous embolism for 32 patients (21 occurring after treatment discontinuation and 11 during active treatment) and as bleeding for 24 patients.
CONCLUSIONS: Our data provide reassuring long-term outcome data for an elderly, co-morbid SPAF population, especially with regard to the low rate of fatal thromboembolic and bleeding complications.