Rivaroxaban in acute venous thromboembolism: UK prescribing experience

Abstract

Background Rivaroxaban was reported as effective as traditional therapies for the acute treatment of venous thromboembolism (VTE) with fewer major bleeding complications in the seminal Einstein program and is now a recommended option for the treatment of VTE around the world. Objective To report the safety and efficacy of rivaroxaban in daily care for the management of acute VTE in the United Kingdom. Patients/Method The FIRST registry is a UK‐only, multicenter, noninterventional, observational VTE study (NCT 02248610). Consecutive patients diagnosed with acute VTE, managed with rivaroxaban, were recruited and followed for up to 5 years. The primary outcomes were treatment‐emergent symptomatic objectively diagnosed recurrent VTE, major and clinically relevant nonmajor bleeding (CRNMB), and all‐cause mortality. Results A total of 1262 participants were recruited between 2014 and 2018. Participants were heterogeneous, with age range 18 to 95 years, weight 35 to 234 kg, and maximum body mass index 64.4 kg/m 2 . The median duration of treatment exposure was 135 days (interquartile range [IQR], 84‐307) and overall follow‐up 497 days (IQR, 175‐991). There were seven episodes of symptomatic VTE recurrence, 0.6%, (0.74/100 patient‐years; 95% confidence interval [CI], 0.19‐1.28). There were 79 of 1239 (6.4%), 8.66 of 100 patient‐years (95% CI, 6.90‐10.73) first episodes of major or CRNMB, which were most frequently reported by women aged <50 years as abnormal vaginal bleeding. Conclusions Rivaroxaban is an effective and safe single drug modality for the treatment of VTE in daily practice in the United Kingdom. Data to determine the optimal anticoagulation therapy for women of childbearing age are needed.

Adherence to rivaroxaban for the treatment of venous thromboembolism–Results from the FIRST registry

“…The study methodology has previously been reported. 49 The study population for this analysis was the safety population, which included any participant who had received ≥1 dose of rivaroxaban.…”

“…Findings from the FIRST registry demonstrated that rivaroxaban was effective for the majority of patients in daily care. 49 However, 7/1262 (0.6%) reported an episode of VTE recurrence. Five out of those seven cases were as a result of nonadherence to anticoagulation therapy.…”

Pooled Analysis of Rivaroxaban therapy for acute venous thromboembolism in FIRST registry, SWIVTER and DRESDEN NOAC registry

“…However, these observational studies differ considerably in design, patient selection, duration of follow‐up, and outcome definitions, limiting generalizability of conclusions. We therefore set out to investigate the methodological and clinical differences across three prospective regional noninterventional registries: the Follow‐up in Rivaroxaban Patients in Setting of Thromboembolism (FIRST) registry in the United Kingdom, 16 , 17 the Register for New Oral Anticoagulants (DRESDEN NOAC) registry in Germany 12 , 18 and the Swiss Venous Thromboembolism Registry (SWIVTER) in Switzerland. 13 We assessed the overall effectiveness and safety of acute VTE treatment with rivaroxaban.…”