Rachel P Rosovsky, Stavros V Konstantinides, John M Moriarty, Suhail Y Dohad, Ido Weinberg, Sahil A Parikh, Richard Channick, Robert A Lookstein
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引用次数: 0
摘要
背景：治疗性抗凝疗法（AC）是肺栓塞（PE）的标准疗法。机械性血栓切除术（MT）是治疗肺栓塞的常用血管内治疗方法，并在单臂试验中得到了充分研究。与单纯 AC 相比，MT 的随机疗效仍有待研究：STORM-PE（ClinicalTrials.gov Identifier：NCT05684796）是与肺栓塞反应团队联盟（The Pulmonary Embolism Response Team ConsortiumTM）合作开展的一项上市后国际开放标签试验。多达 100 名确诊急性中高危 PE 患者将按 1:1 随机分配，接受单纯 AC 或 AC 加使用 Indigo 抽吸系统（Penumbra 公司）的计算机辅助真空血栓清除术 (CAVT)。主要结果是 48 小时后 RV/LV 比值的平均变化，由计算机断层扫描肺血管造影 (CTPA) 评估，并由盲法独立成像核心实验室裁定。其他终点包括综合主要不良事件、功能结果（6 分钟步行测试、纽约心脏协会分级、静脉血栓栓塞后功能状态量表、改良医学研究委员会呼吸困难量表、博格量表）、生活质量（肺栓塞生活质量问卷和 EQ-5D-5L）、死亡率和 90 天内无症状 PE 复发。临床事件委员会将对不良事件的因果关系和归因进行裁定，独立的数据安全监测委员会将对研究进行监督。STORM-PE由Penumbra公司资助：STORM-PE试验将有助于为急性中高危PE患者使用CAVT机械血栓切除术进行一线治疗提供参考，并为未来的相关指南和护理标准提供依据：STORM-PE，NCT05684796，注册于 https://clinicaltrials.gov/study/NCT05684796。
A prospective, multicenter, randomized controlled trial evaluating anticoagulation alone vs anticoagulation plus computer assisted vacuum thrombectomy for the treatment of intermediate-high-risk acute pulmonary embolism: Rationale and design of the STORM-PE study.
Background: Therapeutic anticoagulation (AC) is standard care for pulmonary embolism (PE). Endovascular therapy with mechanical thrombectomy (MT) is commonly performed for PE and well-studied in single-arm trials. The efficacy benefit of MT over AC alone in a randomized fashion remains unstudied.
Methods and results: STORM-PE (ClinicalTrials.gov Identifier: NCT05684796) is a post-market, international, open-label trial conducted in partnership with The Pulmonary Embolism Response Team ConsortiumTM. Up to 100 patients with confirmed acute intermediate-high-risk PE demonstrated by right ventricular (RV) dysfunction with a right-to-left ventricular (RV/LV) ratio ≥1.0 and elevated cardiac biomarkers will be randomized 1:1 to receive AC alone or AC plus Computer Assisted Vacuum Thrombectomy (CAVT) with the Indigo Aspiration System (Penumbra Inc.). The primary outcome is a mean change in RV/LV ratio at 48 hours, assessed by computed tomographic pulmonary angiography (CTPA) and adjudicated by a blinded, independent imaging Core Lab. Additional endpoints are composite major adverse events, functional outcomes (6-minute walk test, New York Heart Association classification, post-venous thromboembolism functional status scale, modified Medical Research Council Dyspnea Scale, Borg Scale), quality of life (Pulmonary Embolism Quality of Life Questionnaire and EQ-5D-5L), mortality, and symptomatic PE recurrence through 90 days. A Clinical Events Committee will adjudicate adverse events for causality and attribution and an independent Data Safety Monitoring Board will oversee the study. STORM-PE is funded by Penumbra Inc.
Conclusions: The STORM-PE trial will help inform future guidelines and standards of care related to frontline treatment using mechanical thrombectomy with CAVT for patients with acute intermediate-high-risk PE.
Trial registration: STORM-PE, NCT05684796, is registered at https://clinicaltrials.gov/study/NCT05684796.
期刊介绍：
The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
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