Department of Emergency Medicine, Clinic of Internal Medicine, Østfold Hospital Trust, Grålum, Norway.
Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Blood Adv. 2020 Jun 9;4(11):2468-2476. doi: 10.1182/bloodadvances.2020001556.
Guidelines suggest using empiric low-molecular-weight heparin if the diagnostic workup of deep vein thrombosis (DVT) is expected to be delayed. The role of direct oral anticoagulants for deferred compression ultrasound imaging (CUS) in patients with suspected DVT remains unexplored. The main objective of the study was to assess the safety of deferring CUS with therapeutic doses of rivaroxaban. We prospectively included consecutive outpatients referred to the Emergency Department at Østfold Hospital, Norway, with suspected first or recurrent lower-extremity DVT between February 2015 and November 2018. Patients were discharged with rivaroxaban 15 mg twice daily while awaiting CUS within 24 hours if D-dimer level was ≥0.5 mg/L fibrinogen-equivalent units. The primary outcome was the rate of major bleeding incidents from study inclusion until DVT was confirmed and anticoagulation therapy continued, or otherwise up to 48 hours following administration of the last tablet of rivaroxaban. The secondary outcome was the rate of progressive DVT symptoms or symptoms or signs of pulmonary embolism between hospital discharge until venous thromboembolism was diagnosed. Six hundred twenty-four of 1653 patients referred with suspected DVT were included (37.7%; 95% confidence interval [CI], 35.4-40.1). DVT was diagnosed in 119 patients (19.1%; 95% CI, 16.1-22.3). There were no major bleeding incidents, yielding an observed major bleeding rate of 0% (1-sided 95% CI <0.4). No patients experienced major complications in the interval that CUS was deferred (0%; 95% CI, 0.0-0.6). Deferring CUS for up to 24 hours in patients with suspected DVT with therapeutic doses of rivaroxaban is a safe strategy. This trial was registered at www.clinicaltrials.gov as #NCT02486445.
指南建议，如果深静脉血栓形成（DVT）的诊断检查预计会延迟，则使用经验性低分子肝素。直接口服抗凝剂在疑似 DVT 患者中延迟行压缩超声成像（CUS）的作用尚未得到探索。该研究的主要目的是评估在接受治疗剂量利伐沙班的患者中延迟 CUS 的安全性。我们前瞻性地纳入了 2015 年 2 月至 2018 年 11 月期间连续就诊于挪威 Østfold 医院急诊科的疑似首次或复发性下肢 DVT 的门诊患者。如果 D-二聚体水平≥0.5 毫克/升纤维蛋白原等价单位，则在 24 小时内进行 CUS，并在等待期间给予利伐沙班 15 毫克，每日两次。主要结局是从研究纳入到 DVT 得到证实且抗凝治疗继续进行，或否则在给予利伐沙班最后一片药物后的 48 小时内的大出血事件发生率。次要结局是从出院到静脉血栓栓塞症诊断期间，进展性 DVT 症状或肺栓塞的症状或体征发生率。1653 例疑似 DVT 患者中，624 例（37.7%；95%置信区间[CI]，35.4-40.1）被纳入。119 例患者诊断为 DVT（19.1%；95% CI，16.1-22.3）。无大出血事件，实际大出血发生率为 0%（单侧 95% CI<0.4）。在延迟 CUS 的期间，无患者发生重大并发症（0%；95% CI，0.0-0.6）。在接受治疗剂量利伐沙班的疑似 DVT 患者中，延迟 24 小时内进行 CUS 是一种安全策略。该试验在 www.clinicaltrials.gov 注册，编号为 NCT02486445。
