E-SPECT CVT(R) 研究结果公布 -- 这是首项将 NOAC 用于脑静脉血栓的试验

来源: 美通社 / 作者: 美通社 / 时间: 2019-09-06
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德国殷格翰 2019 年 9 月 5 日 / 美通社 / -- 勃林格殷格翰于近日公布了 Re-Spect CVT® 研究的初步分析结果,这是首个探索性、前瞻性、随机对照的 NOAC 研究,研究对象为脑静脉或静脉窦中有血块的患者。该试验旨在研究泰毕全 ®(达比加群酯)和剂量调节后的华法林在 CVT 患者中的安全性和疗效。

此项研究结果为轻中度 CVT 患者的抗凝治疗提供了依据。在研究中,两个治疗组均无复发性静脉血栓栓塞(VTE)事件的发生。1 试验还发现患者的出血率较低,华法林组有两名患者(3.3%)、达比加群组有一名患者(1.7%)出现严重出血。在此次研究中,两个治疗组均未出现死亡事件。[1]

“CVT 全称为脑静脉血栓,主要影响年轻患者和女性,可导致死亡和残疾。CVT 急性期存活的患者可能会出现复发性静脉血栓。为了防止这类情况的发生,通常的临床做法是给患者处方维生素 K 拮抗剂(VKAs,如华法林)。VKAs 在安全性、剂量、可逆性和患者偏好方面均存在局限性。” 葡萄牙里斯本圣玛丽亚医院神经科学和心理健康科主任、RE-SPECT CVT 指导委员会主席 Jose M. Ferro 教授说道。“RE-SPECT CVT 是迄今为止在 CVT 患者中进行的最大规模的试验,涵盖了 120 名患者。试验表明,在使用达比加群抗凝治疗 6 个月后,轻至中度 CVT 患者的 VTE 复发风险较低,且发生严重或临床相关出血事件的概率极低。”

该试验也表明了勃林格殷格翰致力于扩展血栓治疗领域科学知识的决心。此外,试验还帮助我们进一步了解了达比加群的安全性,达比加群的安全性已记录在广泛的 RE-VOLUTION® 试验和登记研究项目中。[2]-[24]

References

[1] Ferro JM. et al. Safety and Efficacy of Dabigatran Etexilate vs Dose-Adjusted Warfarin in Patients With Cerebral Venous Thrombosis: A Randomized Clinical Trial. JAMA Neurol. Published online September 03, 2019. doi:10.1001/jamaneurol.2019.2764[2] Connolly. SJ. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51. [3] Connolly SJ. et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-76.[4] Connolly SJ et al. Additional Events in the RE-LY Trial. N Engl J Med. 2014;371:1464–5[5] Connolly SJ et al. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study. Circulation. 2013;128:237–43[6] Ezekowitz MD et al. Long-term evaluation of dabigatran 150 vs. 110 mg twice a day in patients with non-valvular atrial fibrillation. Europace. 2016;18:973–8[7] Cannon CP et al. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017;377:1513–24[8] Calkins H et al. Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation. N Engl J Med. 2017;376:1627–36[9] Pollack CV et al. Idarucizumab for Dabigatran Reversal - Full Cohort Analysis. N Engl J Med. 2017;377:431–41[10] Pollack CV et al. Idarucizumab for Dabigatran Reversal. N Engl J Med. 2015;373:511–20[11] Eriksson BI et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thomb Haemost. 2007;5:2178–85[12] RE-MOBILIZE Writing Committee et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthroplasty. 2009;24:1–9[13] Eriksson BI et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet 2007;370:949–56[14] Eriksson BI et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II*). A randomised, double-blind, non-inferiority trial. Thromb Haemost. 2011;105:721–9[15] Schulman S et al. Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2009;361:2342–52[16] Schulman S et al. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014;129:764–72[17] Schulman S et al. Extended Use of Dabigatran, Warfarin, or Placebo in Venous Thromboembolism. N Engl J Med. 2013;368:709–18[18] Eikelboom JW et al. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013;369:1206–14[19] Diener HC et al. Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source. N Engl J Med 2019; 380:1906-1917.[20] Ferro JM. et al. Randomized evaluation of the safety and efficacy of dabigatran etexilate versus dose adjusted warfarin in patients with cerebral venous thrombosis (RE-SPECT CVT). Presented on Tuesday 10 May at the 2nd European Stroke Organisation Conference 2016, Barcelona, Spain.[21] Ageno W et al. RE-COVERY DVT/PE: Rationale and design of a prospective observational study of acute venous thromboembolism with a focus on dabigatran etexilate. Thromb Haemost. 2017;117:415–21[22] Huisman MV et al. The Changing Landscape for Stroke Prevention in AF: Findings From the GLORIA-AF Registry Phase 2. J Am Coll Cardiol. 2017;69:777–85[23] Huisman MV et al. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation.Am Heart J.2014;167:329–34[24] Fanikos J et al. RE-VECTO: Idarucizumab drug administration surveillance program results. The Congress on Open Issues in Thrombosis and Hemostasis 2018 jointly with the 9th Russian Conference on Clinical Hemostasiology and Hemorheology. Abstract;68.

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