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Background: There are limited data on the long-term risk of venous thromboembolism (VTE) after high-risk isolated superficial vein thrombosis (iSVT) treated with anticoagulants., Objectives: To determine the short- and long-term risk of VTE and iSVT recurrence after cessation of anticoagulant treatment and to calculate 45-day cumulative bleeding incidence in patients with iSVT., Methods: Between January 2014 and December 2021, 229 patients with high-risk iSVT (ie, thrombus length ≥5cm), without active cancer, with no history of VTE or iSVT, and who had received anticoagulant treatment for the iSVT were identified through the Venous Thrombosis Registry in Østfold Hospital (TROLL registry), Norway. Cumulative incidences of VTE and iSVT recurrence, as well as cumulative incidences of major and clinically relevant nonmajor bleeding events, were assessed., Results: Median age was 60 years (IQR, 48-71), and 125 (55%) were women. Most patients were treated with direct oral anticoagulants (74%), and of these, 79% received a dose of rivaroxaban 10 mg daily. Low-molecular-weight heparin was given to 26% of the patients. The 1- and 5-year cumulative incidences of VTE after iSVT were 4.6% (95% CI, 2.5-8.3) and 15.9% (95% CI, 10.8-22.9), respectively. Further, the 1- and 5-year cumulative incidences of iSVT recurrence were 6.5% (95% CI, 3.9-10.7) and 15.9% (95% CI, 10.8-23.1), respectively. The overall 45-day cumulative incidence of major and clinically relevant nonmajor bleeding events was 0.4% (95% CI, 0.06-3.06) and 1.8% (95% CI, 0.7-4.6), respectively. No major bleeding events were observed in patients treated with direct oral anticoagulants., Conclusion: Despite anticoagulant treatment, the risk of VTE after high-risk iSVT was substantial, while bleeding complications were low., Competing Interests: Declaration of competing interests C.T.J. reports lecture honoraria from Bayer. W.G. reports fees for participation on advisory boards from Amgen, Novartis, Pfizer, Principia Biopharma Inc (a Sanofi Company), Sanofi, SOBI, Griffols, UCB, and Argenx; lecture honoraria from Bayer, Amgen, Novartis, Pfizer, Bristol Myers Squibb, SOBI, Griffols, and Sanofi; and research grants from Bayer and BMS/Pfizer. E.T. reports fees from Novartis, SOBI, Alexion, Janssen, BiGene, AbbVie, Grifols, Jazz, Takeda, and Incyte. H.H.P. reports fees from Novartis and Sanofi. M.T., E.F., and S.K.B. have no competing interests to disclose., (Copyright © 2023 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved.)

Background: Isolated distal deep vein thrombosis (IDDVT) is a common presentation of deep vein thrombosis. There are limited data on the long-term risk of recurrence after IDDVT., Objectives: We aimed to determine the short- and long-term incidence of venous thrombosis (VTE) recurrence after cessation of anticoagulation and the 3-month incidence of bleeding during anticoagulant treatment in patients with IDDVT., Methods: Between January 2005 and May 2020, 475 patients with IDDVT and without active cancer were identified from the Venous Thrombosis Registry in Østfold Hospital, which is an ongoing registry of consecutive patients with VTE at Østfold Hospital, Norway. Major and clinically relevant, nonmajor bleeding as well as recurrent VTE were registered, and the cumulative incidences of these events were assessed., Results: The median age of the patients was 59 years (IQR, 48-72 years), 243 (51%) patients were women, and 175 events (36.8%) were classified as unprovoked. The 1-, 5-, and 10-year cumulative incidences of recurrent VTE were 5.6% (95% CI, 3.7-8.4), 14.7% (95% CI, 11.1-19.4), and 27.2% (95% CI, 21.1-34.5), respectively. The recurrence rates were higher for unprovoked IDDVT than for provoked IDDVT. Among the recurrent events, 18 (29%) were pulmonary embolisms and 21 (33%) were proximal deep vein thromboses. The 3-month cumulative incidence of major bleeding was 1.5% (95% CI, 0.7-3.1) overall and 0.8% (95% CI, 0.2-3.1) when restricted to patients treated with direct oral anticoagulants., Conclusion: Despite initial treatment, the long-term risk of VTE recurrence after first-time IDDVT is high. The bleeding rates during anticoagulation, particularly with direct oral anticoagulants, were acceptably low., Competing Interests: Declaration Of Competing Interests C.T.J. reports lecture honoraria from Bayer. W.G. reports fees for participation in the advisory board of Amgen, Novartis, Pfizer, Principia Biopharma Inc (a Sanofi company), Sanofi, SOBI, Griffols, UCB, Argenx, and Cellphire and lecture honoraria from Bayer, Amgen, Novartis, Pfizer, Bristol Myers Squibb, SOBI, Griffols, and Sanofi. E.T. reports lecture honoraria from BMS, Pfizer, Bayer, Alexion, Novartis, AOP, Incyte, Grifols, SOBI, Takeda, and Janssen. H.H.P. reports fees from Novartis and Sanofi. M.T., E.F., and S.K.B. disclose no conflict of interest., (Copyright © 2023 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved.)

Purpose: The incidence of venous thromboembolism (VTE) is expected to increase over the next decades, further increasing its substantial impact on patients and health care resources. Registries have the benefit of reporting real-world data without excluding clinically important subgroups. Our aim was to describe a Norwegian VTE registry and to provide descriptive data on the population and management., Registry Population: The Venous Thrombosis Registry in Østfold Hospital (TROLL) is an ongoing registry of consecutive patients diagnosed with, treated, and/or followed up for VTE at Østfold Hospital, Norway, since 2005. Baseline and follow-up data, including demographics, clinical features, risk factors, diagnostic procedures, classification of VTE, and treatment were collected during hospitalization, and at scheduled outpatient visits., Findings to Date: From January 2005 to June 2021, 5037 patients were eligible for research in TROLL. Median age was 67 years (interquartile range, 55-77), and 2622 (52.1%) were male. Of these, 2736 (54.3%) had pulmonary embolism (PE), 2034 (40.4%) had deep vein thrombosis (DVT), and 265 (5.3%) had upper-extremity DVT or splanchnic or cerebral sinus vein thrombosis. In total, 2330 (46.3%) were classified as unprovoked VTE, and 1131 (22.5%) had cancer. Direct oral anticoagulants were the most frequent therapeutic agents (39.3%) followed by low-molecular-weight heparins (30.4%) and vitamin K antagonists (30.3%). Outpatient treatment for PE increased from 4% in 2005 to 23% in 2019., Future Plans: TROLL is a population-based ongoing registry that represents a valuable source of real-world data that will be used for future research on the management and outcomes of VTE., (© 2022 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis (ISTH).)

Background: Rivaroxaban was the first new oral anticoagulant approved for treatment of venous thromboembolism (VTE). Clinical trials have shown that rivaroxaban is noninferior to conventional anticoagulation for VTE in efficacy and safety. Increased fatigue after the initiation of rivaroxaban has been observed in clinical practice, but data on this potential side effect are lacking., Objective: The study aimed to evaluate development of fatigue in patients treated for VTE, comparing rivaroxaban to other anticoagulants., Methods: Patients were prospectively recruited after a diagnosis of VTE. The Fatigue Questionnaire was used to determine the level of fatigue at baseline, at 3 weeks of treatment, and either at 1 month after the discontinuation of treatment if the treatment was discontinued after 3 months or at 6 months if treatment was continued beyond this time. Data was analyzed by a linear mixed model., Results: A total of 126 patients were included. Mean age was 59 years; 77 (61%) were males. Fifty-seven patients (45%) were diagnosed with deep vein thrombosis, 48 (38%) with pulmonary embolism, and 21 (17%) with both. Predicted changes in fatigue scores from baseline to the last measurement were -0.007 and -2.49 for the rivaroxaban and the other-anticoagulants groups, respectively, neither of which were statistically significant. No difference was detected between rivaroxaban and the other-anticoagulants group at any time point, including subgroup analysis comparing over and under 6 months of treatment duration., Conclusion: In this small study, our results suggest no increase in the level of fatigue after the initiation of treatment with rivaroxaban for VTE., (© 2020 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals, Inc on behalf of International Society on Thrombosis and Haemostasis.)