The Baim Institute and Harvard Medical School, Boston, MA.
Baylor Scott & White Health, Baylor Scott & White Research Institute, Dallas, TX.
Am Heart J. 2022 Mar;245:19-28. doi: 10.1016/j.ahj.2021.10.188. Epub 2021 Nov 1.
Ticagrelor is often administered to patients with acute coronary syndromes. However, when these patients require urgent or emergent cardiothoracic (CT) surgery the presence of ticagrelor significantly increases surgical bleeding. The goal of the current trial is to evaluate the effectiveness and safety of the DrugSorb-ATR hemoadsorption device for the intraoperative removal of ticagrelor to reduce postoperative bleeding in the above patient population. The Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T) Trial is a multi-center, double-blind, randomized, controlled trial enrolling patients who require cardiothoracic surgery on cardiopulmonary bypass (CPB) within 48 hours of last ticagrelor dose.
Subjects will be randomized 1:1 to receive either the DrugSorb-ATR device or an identical sham device during CPB. The study will enroll up to 120 subjects at 20 U.S centers, and the primary outcome is the composite of fatal perioperative bleeding, moderate/severe/massive bleeding according to the Universal Definition of Perioperative Bleeding in Cardiac Surgery (UDPB), and 24 hours chest tube drainage. The components of the composite are hierarchically ranked according to clinical significance and the primary analysis will utilize the Win Ratio method. Percent change in ticagrelor levels before and after CPB (drug removal) will be the key secondary endpoint. An independent Clinical Events Committee will adjudicate all clinical endpoints including safety endpoints relating to postoperative thrombotic events. Subjects will be followed through 30 days after the index operation.
The results from STAR-T, if positive, will potentially support FDA market approval for DrugSorb-ATR, and provide a solution to an important unmet clinical need.
替格瑞洛常用于治疗急性冠脉综合征患者。然而，当这些患者需要紧急或即刻进行心胸（CT）手术时，替格瑞洛的存在会显著增加手术出血风险。本试验旨在评估 DrugSorb-ATR 血液吸附装置在术中清除替格瑞洛以减少上述患者人群术后出血的有效性和安全性。Safe and Timely Antithrombotic Removal - Ticagrelor（STAR-T）试验是一项多中心、双盲、随机、对照试验，招募在最后一剂替格瑞洛后 48 小时内需要体外循环（CPB）下心胸手术的患者。
受试者将以 1:1 的比例随机接受 CPB 期间使用 DrugSorb-ATR 装置或相同的假装置。该研究将在美国 20 个中心招募最多 120 名受试者，主要结局是围手术期致命性出血、根据心胸外科围手术期出血的通用定义（UDPB）定义的中度/重度/大量出血以及 24 小时胸腔引流管引流量的复合终点。复合终点的组成部分根据临床意义进行分层排名，主要分析将利用 Win 比值法。CPB 前后（药物清除）替格瑞洛水平的百分比变化将是关键次要终点。所有临床终点（包括与术后血栓形成事件相关的安全性终点）都将由独立的临床事件委员会进行裁决。受试者将在指数手术后 30 天内进行随访。
如果 STAR-T 结果为阳性，将有可能支持 FDA 批准 DrugSorb-ATR 上市，并为重要的未满足的临床需求提供解决方案。
