Long-term VTE treatment with rivaroxaban: Results from the DRESDEN NOAC REGISTRY.

Data on long-term effectiveness and safety of venous thromboembolism (VTE) treatment with rivaroxaban are scarce and not available from randomized clinical trials. To supplement the positive results of phase III VTE treatment trials with rivaroxaban, we used data from the ongoing, prospective, non-interventional DRESDEN NOAC REGISTRY to evaluate long-term management patterns and clinical outcomes. Between December 1st 2011 and September 30th 2020, 812 patients with acute VTE (575 DVT; 237 PE) and rivaroxaban treatment were prospectively followed. During treatment (median rivaroxaban exposure 1.1 years IQR 0.3-5.0 years; median follow-up 6.1 years IQR 4.7-7.8 years) rates of recurrent VTE and ISTH major bleeding were 0.7/100 pt. years (95% CI 0.4-1.1) and 2.1/100 pt. years; 95% CI 1.5-2.8, respectively. Of the 427 patients still taking rivaroxaban at 12 months, 276 and 202 were still taking rivaroxaban at 3 and 5 years, respectively. "Scheduled end of treatment" was the leading discontinuation reason also beyond 12 months. When exposure days were divided by the number of major clinical outcomes (recurrent VTE + other major cardiovascular + ISTH major bleeding), continued rivaroxaban treatment had the longest "exposure per event" period (6398 days/event) compared to patients switching to alternative treatments (4658 days/event) or stopping anticoagulation completely (4337 days/event). Our results confirm low thrombotic and major bleeding rates for long-term VTE treatment with rivaroxaban. Beyond 12 months, scheduled treatment discontinuations still occur. Although 3-5% of patients planned for indefinite rivaroxaban therapy switched to other anticoagulants each year, the overall persistence to rivaroxaban was high.

5-year outcomes from rivaroxaban therapy in atrial fibrillation: Results from the Dresden NOAC Registry.

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.