Standalone Thoracoscopic Left Atrial Appendage Closure Versus Medical Therapy in Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Region Skane
- 入组人数
- 936
- 试验地点
- 1
- 主要终点
- Number of participants strokes, major bleedings, other arterial thromboembolic events and cardiovascular or unknown death measured per 100 patient years.
研究概览
简要总结
Surgical left atrial appendage closure (LAAC) has been associated with reduced rates of stroke in patients with atrial fibrillation (AF) who have undergone cardiac surgery. In recent time, procedures with catheter-based devices for LAAC have failed to achieve results that would make them considered a safe alternative to oral anticoagulation. Several concerns regarding catheter-based devices have been raised due to their contact with circulating blood, device migration and periprocedural complications. LAAC using an externally placed clip via thoracoscopy would elude some of these concerns and may therefore be a feasible alternative to oral anticoagulation in patients with AF.
This study aims to assess whether thoracoscopic left atrial appendage closure (TLAAC) is noninferior to medical treatment in patients with AF and an elevated bleeding risk using or being planned to initiate OAC and in those patients with clinical contraindications to oral anticoagulants.
详细描述
Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide and is associated with a markedly increased risk of ischemic stroke, heart failure, cognitive decline, systemic embolism, hospitalization, and mortality. AF-related strokes are often severe, disabling, and recurrent. Based on extrapolation of published regional Swedish data, 350-400 000 individuals in Sweden have atrial fibrillation, of whom 81% are treated with OAC:s. Despite major advances in anticoagulation, AF continues to represent one of the most important cardiovascular contributors to long-term disability and healthcare expenditure.
For decades, oral anticoagulation with vitamin K antagonists represented the cornerstone of stroke prevention. The introduction of direct anticoagulant (DOAC) treatment fundamentally altered the therapeutic landscape. Trials including RE-LY, ROCKET-AF and ARISTOTLE demonstrated that DOAC therapy provides excellent protection against stroke/systemic embolism while reducing intracranial hemorrhage compared with warfarin. Consequently, DOACs became the standard of care for most patients with nonvalvular AF and are supported as first line treatment for most patients with nonvalvular AF.
However, anticoagulation is not without its downsides. Despite modern OACs, treatment poses a significant bleeding risk and a lifelong treatment burden. Clinical decision making is complicated by patient frailty, renal dysfunction, liver disease and by patients with previous history of intracranial or gastrointestinal bleeding. Furthermore, long-term adherence is imperfect in real-world practice. In above mentioned trials, the annual bleeding risk ranged from 2.1-3.6% in patients treated with OAC, corresponding to 8400-14400 Swedish patients having major bleeding events from AF-related OAC treatment each year.
Long-term anticoagulation may be associated with treatment burden, fear of bleeding, reduced treatment satisfaction, and impaired quality of life in some patients. Thus, the concept of a nonpharmacological strategy to prevent stroke remains highly attractive.
Left atrial appendage closure While initial trials showed promising results of catheter based endocardial LAAC in the Warfarin era, the CLOSURE-AF trial recently showed that that endocardial devices, including the WATCHMAN™ and the Amplatzer™ Amulet™, do not achieve results making them a feasible replacement for modern OAC therapy in AF patients with elevated bleeding risk. The limitations of endocardial LAAC have several explanations. Implantation of a foreign body within the left atrium creates a potential substrate for thrombus formation. Device-related thrombi have been associated with increased risk of ischemic stroke and remain a recognized complication of endocardial LAAC. Incomplete sealing may allow persistent blood flow into the appendage, potentially preserving thromboembolic risk. In addition, many patients require OAC or dual antiplatelet therapy during the endothelialisation period. Procedure related risks include vascular complications, procedure-related stroke, device embolization and pericardial tamponade .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and any of criteria 2-3
- •AF with a CHA2DS2-VA score ≥2 and a HAS-BLED score ≥3 or other clinically significant bleeding condition and ongoing OAC treatment
- •AF with a CHA2DS2-VA score ≥2 but deemed unfit for OAC by responsible physician due to clinical contraindications (e.g. amyloid angiopathy, previous intracranial haemorrhage or severe gastrointestinal bleeding).
排除标准
- •Clinical frailty score ≥5
- •Indication for OAC other than AF
- •Indication for dual antiplatelet therapy, if OAC is discontinued
- •Previous open-heart surgery
- •Present indication for cardiac surgery
- •Present indication for ablation for atrial fibrillation
- •Previous radiation therapy of the chest, due to malignancy
- •Previous pericarditis or myocarditis
- •Previous surgery including access to the left pleural space
- •Documented FEV1<70% or other significant pulmonary disease (including but not restricted to fibrosis, pulmonary post-covid syndrome, cystic fibrosis)
- •Ongoing treatment with corticosteroids or previous treatment for more than 3 consecutive months.
- •Allergy to contrast media
- •Patient already included in another interventional clinical trial
- •Patient listed abroad, which would render them to be lost to follow-up after discharge
- •Patient does not understand study information given in the local language or, for other reasons, is deemed unfit to participate according to the investigators
结局指标
主要结局
Number of participants strokes, major bleedings, other arterial thromboembolic events and cardiovascular or unknown death measured per 100 patient years.
时间窗: Mean follow up of 3 years
Intention to treat analysis of the primary outcome is the composite endpoint of stroke, major bleeding defined as a BARC III bleeding, other arterial thromboembolic events and cardiovascular or unknown death measured per 100 patient years.
次要结局
- Analysis of risk ratio for primary endpoint(Mean follow up of 3 years)
- Proportion of patients receiving OAC treatment(Mean follow up of 3 years)
- Quality of life survey; 36-Item Short Form Survey Instrument (SF-36)(Baseline, 2 months after inclusion and 1 and 2 years after inclusion)
- Number of patients with need for catheter ablation(Mean follow up of 3 years)
- Proportion of patients with need for new class I or III antiarrhythmic drugs for AF symptom reduction(Mean follow up of 3 years)
- Procedural success(Day 60 postoperatively)