{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T15:43:52Z","timestamp":1792683832484,"version":"4.5.0"},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T00:00:00Z","timestamp":1765843200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T00:00:00Z","timestamp":1765843200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100010763","name":"Zorginstituut Nederland","doi-asserted-by":"publisher","award":["2020006340"],"award-info":[{"award-number":["2020006340"]}],"id":[{"id":"10.13039\/501100010763","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Neth Heart J"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The left atrial appendage is the dominant source of cardioembolic stroke in patients with atrial fibrillation (AF). Contemporary guidelines recommend considering left atrial appendage occlusion (LAAO) in AF patients contraindicated to oral anticoagulation therapy (OAC), but randomized controlled trial (RCT) data for this subpopulation are lacking.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>COMPARE LAAO was designed as an event-driven, multicenter, prospective, randomized, open, blinded endpoint (PROBE) trial that randomized AF patients with an increased thromboembolic risk and a\u00a0contraindication to OAC 2:1 to LAAO or standard-of-care (SOC). The co-primary endpoints comprised\u00a01) time to first occurrence of ischemic\/hemorrhagic\/undetermined stroke and\u00a02) time to first occurrence of all-cause stroke\/TIA\/SE. The trial aimed to enroll 609 patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>After randomization of 69\u00a0patients, the trial was terminated prematurely by the sponsor due to a\u00a0slow inclusion rate. Results are discussed briefly without formal statistical testing. All-cause stroke occurred in 7\/48 and 2\/21\u00a0patients randomized to LAAO and SOC, respectively. According to the as-treated principle, all-cause stroke occurred in 5\/41 and 4\/28\u00a0patients treated with LAAO and SOC. The composite of all-cause stroke\/TIA\/SE occurred in 10\/48 and 4\/21\u00a0patients randomized to and 8\/41 and 6\/28\u00a0patients treated with LAAO and SOC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Insufficient statistical power of COMPARE LAAO impedes drawing any conclusions. Among other factors, the loss of perceived clinical equipoise among physicians proved problematic for successful trial completion. Conducting an RCT on LAAO vs SOC in OAC-ineligible patients appears infeasible globally, which threatens to preclude reimbursement in the Netherlands for these patients that have no proven alternative.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s12471-025-02005-7","type":"journal-article","created":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T07:57:39Z","timestamp":1765871859000},"page":"18-26","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Left atrial appendage occlusion vs standard of care in high stroke risk atrial fibrillation patients ineligible for anticoagulation: COMPARE-LAAO"],"prefix":"10.1007","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0189-8647","authenticated-orcid":false,"given":"Errol W.","family":"Aarnink","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marina F. 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Y.\u00a0Blaauw reports a\u00a0research grant and consulting fee from Boston Scientific. Fees go to the Cardiology department. N.M.\u00a0van Mieghem reports grants from Abbott, Boston Scientific, Edwards Liefesciences, Medtronic, Meril, Pie Medical, PulseCath BV and Teleflex, and consulting fees from Abbott, Abiomed, Alleviant, Medical Inc., AncorValve, Anteris, Approxima Srl, Bolt Medical, Boston Scientific, Daiichi Sankyo, LUMA Vision, Materialise, Medtronic, Pie Medical, Polares, PulseCath BV and Siemens. M.J.\u00a0Swaans reports consulting fees from Abbott Vascular, Bioventrix Inc., Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, GE Healthcare, Medtronic, Philips Healthcare and Siemens Healthcare. J.R.\u00a0de Groot , M.G.\u00a0Dijkgraaf and L.V.A.\u00a0Boersma are Editors of the Netherlands Heart Journal. M.G.\u00a0Dijkgraaf has no other possible conflicts of interest to declare. L.V.A.\u00a0Boersma reports consulting fees and honoraria from Boston Scientific. All fees go to the department. E.W.\u00a0Aarnink, M.F.M.\u00a0Huijboom, F.\u00a0van der Kley, R.\u00a0Folkeringa, P.H.\u00a0van der Voort, J.\u00a0Stevenhagen, G.J.\u00a0Vlachojannis, M.\u00a0Chaldoupi, V.F.\u00a0van Dijk, E.J.\u00a0van Dijk and J.G.P.\u00a0Tijssen have no conflicts of interest related to this manuscript.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}}]}}