General Hospital Roberto Santos, Salvador, Bahia, Brazil.
Federal University of Bahia, Medical School-UFBA/FAMEB, XV de novembro Square, s/n-Largo do Terreiro de Jesus, Salvador, BA, 40025-010, Brazil.
Drugs R D. 2018 Dec;18(4):303-308. doi: 10.1007/s40268-018-0249-5.
Mechanical heart valves (MHV) are extremely durable, but they require permanent use of anticoagulation to prevent thromboembolic events. The only approved therapeutic options are vitamin K antagonists (VKAs), such as warfarin. As a drug class, clinical management is difficult, therefore new alternatives need to be evaluated.
RIWA is a phase II/III, prospective, open-label, randomized, pilot study designed to investigate oral rivaroxaban 15 mg twice daily compared with dose-adjusted warfarin for the prevention of stroke (ischemic or hemorrhagic) and systemic embolism in patients with MHV, from August 2018 to December 2019. Patients will undergo transesophageal echocardiography at the beginning and the end of the study (follow-up time 90 days). On an explanatory basis, all events will be analyzed, including stroke, peripheral systemic embolism, valve thrombosis, significant bleeding and death.
Warfarin and similar VKAs are standard therapy for patients with an MHV. Even with the appropriate use of therapy, the incidence of thromboembolic events is high at 1-4% per year. Furthermore, bleeding risk is significant, ranging from 2 to 9% per year. The new frontier to be overcome in relation to use of the new oral anticoagulants is undoubtedly in patients with MHV. A significant portion of people with MHV worldwide will benefit if noninferiority of these new agents is confirmed.
ClinicalTrials.gov identifier: NCT03566303. Recruitment Status: Recruiting. First Posted: 25 June 2018. Last Update Posted: 25 June 2018.
机械心脏瓣膜（MHV）极其耐用，但为了预防血栓栓塞事件，它们需要持续使用抗凝剂。唯一批准的治疗选择是维生素 K 拮抗剂（VKA），如华法林。作为一类药物，临床管理较为困难，因此需要评估新的替代药物。
RIWA 是一项 II/III 期、前瞻性、开放标签、随机、试点研究，旨在研究每日两次口服利伐沙班 15mg 与调整剂量的华法林预防 MHV 患者中风（缺血性或出血性）和全身性栓塞的疗效，研究时间为 2018 年 8 月至 2019 年 12 月。患者将在研究开始和结束时（随访时间 90 天）进行经食管超声心动图检查。基于解释性，将分析所有事件，包括中风、外周系统性栓塞、瓣膜血栓形成、严重出血和死亡。
华法林和类似的 VKA 是 MHV 患者的标准治疗方法。即使采用适当的治疗方法，血栓栓塞事件的发生率仍很高，每年为 1-4%。此外，出血风险显著，每年为 2-9%。使用新型口服抗凝剂需要克服的新前沿无疑是在 MHV 患者中。如果这些新药物的非劣效性得到证实，全球范围内很大一部分 MHV 患者将受益。
ClinicalTrials.gov 标识符：NCT03566303。招募状态：招募中。首次发布：2018 年 6 月 25 日。最新更新发布：2018 年 6 月 25 日。
