Abstract:
BACKGROUND: patients with atrial fibrillation (AF) under treatment with chronic oral anticoagulation (OAC) often require coronary angiography with or without percutaneous coronary intervention (PCI). Deciding the management of OAC during this periprocedural period requires balancing the risks of hemorrhage and thrombotic complications. Guidelines recommend an uninterrupted strategy in patients receiving Vitamin-K Antagonists (VKA). However, for patients undergoing coronary angiography or PCI while on direct oral anticoagulants (DOACs), withdrawal 12-24 h prior to the procedure is still recommended. This is based on expert opinions given the lack of evidence. Therefore, whether DOAC discontinuation prior to trans-radial coronary procedures should be the strategy of choice is a matter of debate and solid evidence is needed to guide clinical decision making.
METHODS: The DOAC-NOSTOP study is a prospective, single-arm, open-label study evaluating the safety of DOACs continuation in 200 patients undergoing transradial percutaneous coronary procedures. DOAC treatment will not be interrupted throughout the periprocedural period. Primary outcome will be Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 events, assessed at a 30-day follow-up.
CONCLUSIONS: The DOAC-NOSTOP is the first study prospectively assessing the risk of bleeding with uninterrupted DOAC in patients undergoing trans-radial percutaneous coronary procedures.
摘要:
背景:接受慢性口服抗凝治疗(OAC)的房颤(AF)患者通常需要进行冠状动脉造影,有或没有经皮冠状动脉介入治疗(PCI)。决定围手术期OAC的管理需要平衡出血和血栓并发症的风险。指南建议接受维生素K拮抗剂(VKA)的患者采用不间断的策略。然而,对于接受冠状动脉造影或PCI同时使用直接口服抗凝药(DOAC)的患者,仍建议在手术前12-24小时退出。这是基于缺乏证据的专家意见。因此,是否应在经桡动脉冠状动脉手术前停用DOAC作为选择策略尚有争议,需要有确凿的证据来指导临床决策.
方法:DOAC-NOSTOP研究是一项前瞻性研究,单臂,开放标签研究评估了200例接受经桡动脉经皮冠状动脉手术的患者继续DOACs的安全性.DOAC治疗在整个围手术期不会中断。主要结果将是出血学术研究联盟(BARC)类型2,3或5事件,在30天的随访中评估。
结论:DOAC-NOSTOP是第一项前瞻性评估经桡动脉途径经皮冠状动脉手术患者DOAC不间断出血风险的研究。