Academic Journal
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'
| العنوان: | 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' |
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| المؤلفون: | Huijboom, M., Maarse, M., Aarnink, E., Dijk, V. van, Swaans, M., Heijden, J. van der, Ijsselmuiden, S., Folkeringa, R., Blaauw, Y., Elvan, A., Stevenhagen, J., Vlachojannis, G., Voort, P. van der, Westra, S.W., Chaldoupi, M., Khan, M., Groot, J., Kley, F. van der, Mieghem, N. van, Dijk, E.J. van, Dijkgraaf, M., Tijssen, J., Boersma, L. |
| المصدر: | American Heart Journal, 250, pp. 45-56 |
| سنة النشر: | 2022 |
| المجموعة: | Radboud University: DSpace |
| مصطلحات موضوعية: | Radboudumc 16: Vascular damage RIHS: Radboud Institute for Health Sciences, Radboudumc 3: Disorders of movement DCMN: Donders Center for Medical Neuroscience |
| الوصف: | Contains fulltext : 252137.pdf (Publisher’s version ) (Open Access) ; 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | unknown |
| Relation: | https://repository.ubn.ru.nl//bitstream/handle/2066/252137/252137.pdf; https://repository.ubn.ru.nl/handle/2066/252137; https://doi.org/10.1016/j.ahj.2022.05.001 |
| DOI: | 10.1016/j.ahj.2022.05.001 |
| الاتاحة: | https://repository.ubn.ru.nl//bitstream/handle/2066/252137/252137.pdf https://repository.ubn.ru.nl/handle/2066/252137 https://doi.org/10.1016/j.ahj.2022.05.001 |
| رقم الانضمام: | edsbas.7EA1E86E |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.ahj.2022.05.001 |
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