Department of Medicine, McMaster University, TAARI, Hamilton, ON, Canada.
Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.
J Thromb Haemost. 2016 Jun;14(6):1206-10. doi: 10.1111/jth.13330. Epub 2016 May 10.
Essentials Heparin-induced thrombocytopenia (HIT) is a thrombogenic condition that is difficult to treat. We evaluated rivaroxaban as a treatment option in patients with suspected or confirmed HIT. One patient had recurrent thrombosis and 9/10 patients with thrombocytopenia had platelet recovery. Rivaroxaban may be an effective and safe treatment option for HIT.
Background Rivaroxaban is a direct oral anti-Xa inhibitor that has the potential to greatly simplify treatment of heparin-induced thrombocytopenia (HIT). Objectives To evaluate the efficacy and safety of rivaroxaban in this patient population, we conducted a multicenter, single-arm, prospective cohort study of patients with suspected or confirmed HIT. Patients/Methods Twenty-two consecutive adults with suspected or confirmed HIT received rivaroxaban 15 mg bid until a local HIT assay result was available. Participants with a positive local assay result continued rivaroxaban 15 mg bid until platelet recovery (or until day 21 if they had acute thrombosis at study entry), then stepped down to rivaroxaban 20 mg daily until day 30. Results and Conclusions The primary outcome measure, incidence of new symptomatic, objectively-confirmed venous and arterial thromboembolism at 30 days, occurred in one HIT-positive participant (4.5%; 95% confidence interval [CI], 0-23.5%) and one HIT-positive participant required limb amputation despite platelet recovery. Platelet recovery was achieved in nine out of 10 HIT-positive patients with thrombocytopenia. Rivaroxaban appears to be effective for treating patients with confirmed HIT, although the small number of patients enrolled limits precision.
为了评估利伐沙班在该患者人群中的疗效和安全性,我们进行了一项多中心、单臂、前瞻性队列研究,纳入了疑似或确诊 HIT 的患者。
22 例连续的疑似或确诊 HIT 成人患者接受利伐沙班 15 mg,bid,直至获得当地 HIT 检测结果。当地检测结果阳性的患者继续利伐沙班 15 mg,bid,直至血小板恢复(如果在研究入组时存在急性血栓形成,则直至第 21 天),然后降至利伐沙班 20 mg,qd,直至第 30 天。
主要终点为 30 天内新发有症状的、经客观证实的静脉和动脉血栓栓塞事件的发生率,1 例 HIT 阳性患者(4.5%;95%置信区间[CI],0-23.5%)和 1 例 HIT 阳性患者发生新的血栓栓塞事件,尽管血小板恢复,但仍需截肢。10 例血小板减少的 HIT 阳性患者中有 9 例血小板恢复。
利伐沙班似乎对治疗确诊的 HIT 患者有效,尽管入组患者数量较少,限制了精确度。