COMPARE LAAO：随机对照试验“比较左心耳封堵术与高卒中风险且不适合使用口服抗凝治疗的房颤患者标准治疗的有效性和安全性”的原理与设计
COMPARE LAAO: Rationale and design of the randomized controlled trial "COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy".
作者信息
Huijboom Marina, Maarse Moniek, Aarnink Errol, van Dijk Vincent, Swaans Martin, van der Heijden Jeroen, IJsselmuiden Sander, Folkeringa Richard, Blaauw Yuri, Elvan Arif, Stevenhagen Jeroen, Vlachojannis George, van der Voort Pepijn, Westra Sjoerd, Chaldoupi Marisevi, Khan Muchtiar, de Groot Joris, van der Kley Frank, van Mieghem Nicolas, van Dijk Ewoud, Dijkgraaf Marcel, Tijssen Jan, Boersma Lucas
机构信息
Cardiology Department, St. Antonius Hospital, Nieuwegein, The Netherlands; Amsterdam University Medical Center, location AMC, Cardiology Department, Amsterdam, The Netherlands.
Cardiology Department, St. Antonius Hospital, Nieuwegein, The Netherlands; Amsterdam University Medical Center, location AMC, Cardiology Department, Amsterdam, The Netherlands.
出版信息
Am Heart J. 2022 Aug;250:45-56. doi: 10.1016/j.ahj.2022.05.001. Epub 2022 May 7.
BACKGROUND
Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking.
STUDY OBJECTIVES
To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications.
STUDY DESIGN
This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands.
SUMMARY
The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use.
NCT TRIAL NUMBER
NCT04676880.
背景
左心耳封堵术（LAAO）为心房颤动（AF）患者预防中风提供了一种替代口服抗凝药（OAC）的方法。对于有OAC长期或永久性禁忌证的患者，缺乏随机对照试验（RCT）数据。
研究目的
评估LAAO在不符合使用OAC条件的AF患者中的疗效和安全性。共同主要疗效终点为：（1）首次发生中风（缺血性、出血性或不明原因）的时间；（2）首次发生中风、短暂性脑缺血发作（TIA）和系统性栓塞（SE）复合事件的时间。主要安全终点为围手术期并发症的30天发生率。
研究设计
这是一项多中心、研究者发起、开放标签、盲终点（PROBE）、优效性驱动的RCT。CHA₂DS₂-VASc评分男性≥2分、女性≥3分且有OAC长期或永久性禁忌证的AF患者将按2:1的比例随机分为器械组或对照组。器械组患者将接受经皮LAAO，并将根据方案接受术后双联抗血小板治疗（DAPT），而对照组患者将继续其目前的治疗，包括不进行抗血栓治疗或由主要负责医生酌情进行（D）APT。在这个终点驱动的试验设计中，假设LAAO与保守治疗相比中风风险降低50%，将对609例患者进行至少1年、最多5年的随访。将进行成本效益和预算影响分析，以便就荷兰目标人群LAAO的报销问题做出决策。
总结
COMPARE LAAO试验将研究LAAO在具有高血栓栓塞风险且有OAC使用禁忌证的AF患者中预防血栓栓塞事件的临床优效性和成本效益。
NCT试验编号：NCT04676880。
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