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• W3191589232 abstract "The precise incidence of superficial vein thrombosis (SVT) is unknown. It is likely more prevalent than deep vein thrombosis (DVT), which is approximately 1 in 1 000 cases.1 An annual incidence of 0·64% [95% confidence interval (CI) 0·55–0·74%] was reported in a community-based study of 265, 687 participants in France.2 Historically, SVT was considered a self-limiting condition, however, a significant risk of progression to DVT or pulmonary embolism (PE) is now accepted.3, 4 Specifically, 6–14% of SVT cases have associated DVT, 20–33% have asymptomatic PE, and 2–13% have symptomatic PE.1 Risk factors for developing lower-limb SVT are similar to those for DVT; these include varicose veins, thrombophilia, reduced mobility, pregnancy, active cancer, and a personal or family history of venous thromboembolism (VTE).5 The American College of Chest Physicians guidelines recommend SVT treatment with prophylactic fondaparinux or low-molecular-weight heparin (LMWH) over no anti-coagulation (Grade 2B evidence), and fondaparinux over LMWH (Grade 2C evidence).6 Rivaroxaban has since been reported as non-inferior to fondaparinux in the SURPRISE study.7 In 2019 we amended our protocol to recommend rivaroxaban 10 mg daily for six weeks for SVT > 5cm in length, and one of: above-knee involvement, severe symptoms, involvement of long saphenous vein, history of DVT or SVT or recent surgery in non-cancer patients, in line with the rivaroxaban treatment arm of the SURPRISE study. SVT within 3 cm of the saphenofemoral junction is managed as DVT with full-dose anti-coagulation. Additionally, patients with SVT < 5 cm or SVT > 5cm with no risk factors are treated conservatively with non-steroidal anti-inflammatory medications. At our centre, patients are reviewed at one week to assess symptomatic improvement and ensure tolerance to rivaroxaban, and again before the end of treatment, if required. The efficacy and safety of rivaroxaban for the treatment of SVT in real-world clinical practice has not yet been described. We conducted a retrospective case note review to assess adherence to local guidance and the efficacy and safety of rivaroxaban for patients with SVT attending the anti-coagulation clinics at King’s College Hospital and Princess Royal University Hospital, London. Patients with an objective diagnosis of SVT were identified between June 2019 and December 2020. All patients had an isolated SVT confirmed by compression ultrasonography.8 The primary efficacy outcome was SVT, DVT, or PE within 90 days of diagnosis. Primary safety outcomes were treatment-emergent major or clinically relevant non-major bleeding (CRNMB). Bleeding was defined using the International Society on Thrombosis and Haemostasis criteria.9 Baseline characteristics and outcome data were extracted from the local hospital electronic patient record (EPR; Allscripts Sunrise™, Chicago, IL, USA), and anti-coagulation clinic database (DAWN xs) for each patient. In total, 125 patients were diagnosed with an isolated SVT; 71 cases were excluded (Fig 1). Fifty-four patients were treated with rivaroxaban for isolated SVT. Patient characteristics are summarised in Table I. 52/54 cases (96·3%) were lower limb. The majority involved the LSV (n = 39, 72·2%). The most frequently reported risk factors were varicose veins (75·9%), body weight >100 kg (30·2%) and previous VTE (29·6%). Patients with active cancer received prophylactic enoxaparin; however, one patient was diagnosed with lymphoma after rivaroxaban had commenced. There was one extension from the short saphenous vein to a distal DVT in a patient who re-presented with worsening pain and swelling in the calf. No additional thromboembolic events occurred during or within 90 days after completing treatment. There was one episode (1·9%) of CRNMB in a patient with an ulcerated sigmoid colon who developed black stools (but no fall in haemoglobin) within 24 h of commencing rivaroxaban. Treatment was discontinued. No extension was found on compression ultrasonography seven days later. With the exception of one patient who discontinued rivaroxaban due to bleeding, all patients completed six weeks of treatment. 40/54 cases (74·1%) were reviewed within one week of diagnosis. 41/46 (89·1%) had a second review. Two patients were invited but did not attend their follow-up appointment. In our real-world experience, rivaroxaban was effective and safe for the treatment of SVT. Our results compare favourably with existing data. The SURPRISE study was a randomised, non-inferiority phase 3b study to assess whether rivaroxaban was non-inferior to fondaparinux for treatment of isolated SVT. The primary outcome was a composite of symptomatic DVT or PE, progression or recurrence of SVT and all-cause mortality. 3% (7/211, 95% CI: 1·6–6·7) in the rivaroxaban arm reported the primary efficacy outcome compared with 2% (4/224; 95% CI: 0·7–4·5) at 45 days in the fondaparinux arm.7 There were no major bleeds in either arm; however, 3% (6/236; 95% CI: 1·2–5·4) and <1% (1/235; 95% CI: 0·1–2·4) reported CRNMB in the rivaroxaban and fondaparinux arms respectively at 45 days. The rivaroxaban arm contained a high proportion of participants at higher VTE recurrence risk, including: prior VTE (117/236, 50%), age >65 (89/236, 38%) and cancer (20/236, 9%), providing reassurance for the use of rivaroxaban in this population. We chose to exclude cancer patients from our protocol due to the limited evidence, the potential need for diagnostic procedures and potential interactions with chemotherapy. More recently, Kearon and colleagues reported efficacy and safety data for rivaroxaban 10 mg once daily compared with placebo for isolated SVT in a phase 3, multi-centre, randomised study of 85 patients. This study closed early due to recruitment difficulties. Thrombotic complications were reported in 1/43 (2·3%) receiving rivaroxaban compared with 5/42 (11·9%) receiving placebo (absolute risk reduction = 9·0%; 95% CI: −22 to 5·9%). No major bleeds were observed. Data concerning CRNMB were not reported.10 There are a number of advantages to using an oral agent. Discomfort with injections may result in non-compliance.11 Administration of parenteral anti-coagulation can require community nurse support, which is both costly and time-consuming. Rivaroxaban represents a reasonable oral alternative with a reduced burden on healthcare resources. The findings of this study should be reviewed in the context of its limitations: a retrospective study with a small sample size. A larger population is needed to demonstrate the efficacy and safety of rivaroxaban for this indication. Patients are not routinely followed up at three months and patients presenting elsewhere would not be captured; potentially underestimating the recurrence rates. Our results suggest that rivaroxaban is a reasonable oral alternative to LMWH or fondaparinux for the treatment of isolated SVT. REC collected and analysed the data and wrote the manuscript. VS analysed the data and wrote the manuscript. LNR designed, supervised the study and critically reviewed the manuscript. AG, SG collected data. JCz, RKP, CR, BV and RA critically reviewed the manuscript. All authors approved the final version. The author(s) received no financial support for the research, authorship, and/or publication of this article. REC, VS, AG, SG, BV have no competing interests. JCz has received a travel grant from Mitsubishi pharma and honoraria/speaker fees from Bayer and Sanofi. RKP has received speaker fees from Bayer. CR has received grants from Sanofi, Baxter, Biomarin, research support from Volition and is a medical adviser to Hemab and Alnylam. RA reports grants from Bayer, personal fees from Bayer, Cardinal Health and Sanofi and non-financial support from Bayer and Sanofi. LNR has received speaker fees and a travel grant from Bayer, and an investigator-initiated research grant and a travel grant from Sanofi." @default.
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• W3191589232 date "2021-08-05" @default.
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• W3191589232 title "Rivaroxaban for the treatment of superficial vein thrombosis, experience at King’s College Hospital" @default.
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