Venous thromboembolism therapy with rivaroxaban in daily-care patients: Results from the Dresden NOAC registry.

The effectiveness and safety of acute venous thromboembolism (VTE) treatment with rivaroxaban, demonstrated in phase-III trials, needs to be confirmed in daily care. To confirm the positive results of phase-III VTE treatment trials with rivaroxaban in daily care, we used data from the ongoing, prospective, non-interventional Dresden NOAC Registry. For this analysis, only patients with acute VTE who started rivaroxaban within 14days after diagnosis of VTE and who were enrolled within these 14days were evaluated with regard to patient characteristics, treatment persistence and clinical outcomes. Between December 1st 2011 and 30th September 2016, 418 patients with acute VTE and rivaroxaban treatment were enrolled. During rivaroxaban treatment (median rivaroxaban exposure 206d; median follow-up 862d) rates of recurrent VTE and ISTH major bleeding were 1.9% and 3.8%, respectively. At 6months. 58.3% of patients were still taking rivaroxaban, 28.2% had a scheduled end of treatment, 7.2% were switched to other anticoagulants, 1.7% had withdrawn their consent and the remaining 3.6% of patients had unplanned complete discontinuation of anticoagulation. After permanent discontinuation of rivaroxaban, 20 patients experienced a recurrent VTE (7 pulmonary embolism±deep vein thrombosis, 13 deep vein thrombosis) with a mean time between last intake of rivaroxaban and VTE recurrence of 374.3±247.6days (range 28-927d). In daily care patients with acute VTE, rivaroxaban demonstrated high effectiveness with acceptable major bleeding rates. Initial dosing was according to label in over 90% of patients and persistence to rivaroxaban therapy was adequate with low rates of unplanned complete discontinuation.

Effectiveness and safety of rivaroxaban therapy in daily-care patients with atrial fibrillation. Results from the Dresden NOAC Registry.

The effectiveness and safety of rivaroxaban for stroke prevention in atrial fibrillation (SPAF) demonstrated in ROCKET AF needs to be confirmed in daily care. To evaluate effectiveness and safety of rivaroxaban therapy in SPAF patients in daily care, we used data from an ongoing, prospective, non-interventional registry of more than 2700 patients on novel oral anticoagulants in daily care. Between October 1, 2011 and February 28, 2013, a total of 1204 SPAF patients receiving rivaroxaban were enrolled. During a mean follow-up of 796.2 ± 207.3 days, the combined endpoint of stroke/transient ischaemic attack/systemic embolism occurred at a rate of 2.03/100 patient-years in the intention-to-treat analysis (95 % confidence interval [CI] 1.5-2.7) and at 1.7/100 patient-years in the on-treatment analysis (events within 3 days after last intake). On-treatment rates were higher in patients selected for 15 mg rivaroxaban (n=384) once daily [OD] compared with the 820 patients selected for 20 mg OD (2.7 [95 % CI 1.6-4.2] vs 1.25/100 patient-years [95 % CI 0.8-1.9]). On treatment, major bleeding occurred at a rate of 3.0/100 patient-years and significantly more often in patients receiving the 15 mg OD dose compared with the 20 mg OD dose (4.5 vs 2.4/100 patient-years). Rivaroxaban treatment discontinuation occurred in a total of 277 patients during follow-up (12.0/100 patient-years in Kaplan-Meier analysis). Our data contribute to the confirmation of effectiveness and relative safety of rivaroxaban in daily-care patients. Furthermore, rivaroxaban discontinuation rates were considerably lower than those reported for vitamin K antagonists.