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Anticoagulation with edoxaban in patients with long atrial high-rate episodes ≥24 h 2024 (English)In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 45, no 10, p. 837-849Article in journal (Refereed) Published

Abstract [en]

BACKGROUND AND AIMS: Patients with long atrial high-rate episodes (AHRE) ≥ 24 hours and stroke risk factors are often treated with anticoagulation for stroke prevention. Anticoagulation has never been compared to no anticoagulation in these patients.

METHODS: This secondary prespecified analysis of NOAH-AFNET 6 examined interactions between AHRE duration at baseline and anticoagulation with edoxaban compared to placebo in patients with AHRE and stroke risk factors. The primary efficacy outcome was a composite of stroke, systemic embolism, or cardiovascular death. The safety outcome was a composite of major bleeding and death. Key secondary outcomes were components of these outcomes and ECG-diagnosed atrial fibrillation.

RESULTS: AHRE ≥24 hours were present at baseline in 259/2389 patients enrolled in NOAH-AFNET 6 (11%, 78 ± 7 years old, 28% women, CHA2DS2-VASc score 4). Clinical characteristics were not different from patients with shorter AHRE. During a median follow-up of 1.8 years, the primary outcome occurred in 9/132 patients with AHRE ≥24 hours (4.3%/patient-year, 2 strokes) treated with anticoagulation and in 14/127 patients treated with placebo (6.9%/patient-year, 2 strokes). AHRE duration did not interact with the efficacy (p-interaction = 0.65) or safety (p-interaction = 0.98) of anticoagulation. Analyses including AHRE as a continuous parameter confirmed this. Patients with AHRE ≥24 hours developed more ECG-diagnosed atrial fibrillation (17.0%/patient-year) than patients with shorter AHRE (8.2%/patient-year; p < 0.001).

CONCLUSIONS: This hypothesis-generating analysis does not find an interaction between AHRE duration and anticoagulation therapy in patients with device-detected AHRE and stroke risk factors. Further research is needed to identify patients with long AHRE at high stroke risk.

Place, publisher, year, edition, pages

Oxford University Press, 2024. Vol. 45, no 10, p. 837-849

Keywords [en]

NOAH-AFNET 6, atrial fibrillation, atrial high-rate episodes, stroke

National Category

Cardiology and Cardiovascular Disease

Identifiers

URN: urn:nbn:se:oru:diva-109753DOI: 10.1093/eurheartj/ehad771ISI: 001172582000001PubMedID: 37956458Scopus ID: 2-s2.0-85181170242OAI: oai:DiVA.org:oru-109753DiVA, id: diva2:1813263

Funder

EU, Horizon 2020, 847770

Note

NOAH-AFNET6 was partially funded by BMBF (German Ministry of Education and Research, Berlin, Germany) through the DZHK (German Center for Cardiovascular Research, Berlin, Germany, grant number FKZ 81X2800182) and by Daiichi Sankyo Europe. Further support was provided by European Union CATCH ME (grant agreement no. 633196) to P.K. and U.S. and AFNET; AFFECTEU (grant agreement no. 847770) to P.K.; MAESTRIA (grant agreement 965286) to A.G., P.K., U.S. and AFNET; British Heart Foundation (AA/18/2/34218) to P.K.; German Research Foundation (Ki 509167694) to P.K.; DZHK (grant numbers 81Z0710116 and 81Z0710110) to P.K., Leducq Foundation to P.K., and the Dutch Heart Foundation (EmbRACE, grant number 01–002-2022-0118) to U.S. P.K. was partially supported by European Union AFFECT-EU (grant agreement no. 847770), MAESTRIA (grant agreement no. 965286), and British Heart Foundation (PG/17/30/32961; PG/20/22/35093; AA/18/2/34218); German Center for Cardiovascular Research supported by the German Ministry of Education and Research (DZHK, grant numbers DZHK FKZ 81X2800182, 81Z0710116, and 81Z0710110), German Research Foundation (Ki 509167694), and Leducq Foundation. R.B.S. has received funding from the European Research Council (ERC) under the European Union’s Horizon 2020 research and innovation programme under the grant agreement no. 648131, the European Union’s Horizon 2020 research and innovation programme under the grant agreement no. 847770 (AFFECTEU); German Center for Cardiovascular Research (DZHK e.V.) (81Z1710103 and 81Z0710114); German Ministry of Research and Education (BMBF 01ZX1408A) and ERACoSysMed3 (031L0239); and Wolfgang Seefried project funding German Heart Foundation.

Available from: 2023-11-20 Created: 2023-11-20 Last updated: 2025-02-10Bibliographically approved

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Blomström-Lundqvist, Carina

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