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Early Versus Late Initiation of Direct Oral Anticoagulants After Ischemic Stroke in People With Atrial Fibrillation and Hemorrhagic Transformation: Prespecified Subanalysis of the Randomized-controlled ELAN Trial

Standard

Early Versus Late Initiation of Direct Oral Anticoagulants After Ischemic Stroke in People With Atrial Fibrillation and Hemorrhagic Transformation: Prespecified Subanalysis of the Randomized-controlled ELAN Trial. / Rohner, Roman; Kneihsl, Markus; Goeldlin, Martina B; Hakim, Arsany; Branca, Mattia; Abend, Stefanie; Valenzuela Pinilla, Waldo; Fenzl, Sabine; Rezny-Kasprzak, Beata; Strbian, Daniel; Trelle, Sven; Paciaroni, Maurizio; Thomalla, Götz; Michel, Patrik; Nedeltchev, Krassen; Gattringer, Thomas; Sandset, Else C; Bonati, Leo; Aguiar de Sousa, Diana; Sylaja, P N; Ntaios, George; Koga, Masatoshi; Gdovinova, Zuzana; Lemmens, Robin; Bornstein, Natan M; Kelly, Peter; Katan, Mira; Horvath, Thomas; Dawson, Jesse; Fischer, Urs; ELAN Investigators.

In: CIRCULATION, Vol. 150, No. 1, 02.07.2024, p. 19-29.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Rohner, R, Kneihsl, M, Goeldlin, MB, Hakim, A, Branca, M, Abend, S, Valenzuela Pinilla, W, Fenzl, S, Rezny-Kasprzak, B, Strbian, D, Trelle, S, Paciaroni, M, Thomalla, G, Michel, P, Nedeltchev, K, Gattringer, T, Sandset, EC, Bonati, L, Aguiar de Sousa, D, Sylaja, PN, Ntaios, G, Koga, M, Gdovinova, Z, Lemmens, R, Bornstein, NM, Kelly, P, Katan, M, Horvath, T, Dawson, J, Fischer, U & ELAN Investigators 2024, 'Early Versus Late Initiation of Direct Oral Anticoagulants After Ischemic Stroke in People With Atrial Fibrillation and Hemorrhagic Transformation: Prespecified Subanalysis of the Randomized-controlled ELAN Trial', CIRCULATION, vol. 150, no. 1, pp. 19-29. https://doi.org/10.1161/CIRCULATIONAHA.124.069324

APA

Rohner, R., Kneihsl, M., Goeldlin, M. B., Hakim, A., Branca, M., Abend, S., Valenzuela Pinilla, W., Fenzl, S., Rezny-Kasprzak, B., Strbian, D., Trelle, S., Paciaroni, M., Thomalla, G., Michel, P., Nedeltchev, K., Gattringer, T., Sandset, E. C., Bonati, L., Aguiar de Sousa, D., ... ELAN Investigators (2024). Early Versus Late Initiation of Direct Oral Anticoagulants After Ischemic Stroke in People With Atrial Fibrillation and Hemorrhagic Transformation: Prespecified Subanalysis of the Randomized-controlled ELAN Trial. CIRCULATION, 150(1), 19-29. https://doi.org/10.1161/CIRCULATIONAHA.124.069324

Vancouver

Rohner R, Kneihsl M, Goeldlin MB, Hakim A, Branca M, Abend S et al. Early Versus Late Initiation of Direct Oral Anticoagulants After Ischemic Stroke in People With Atrial Fibrillation and Hemorrhagic Transformation: Prespecified Subanalysis of the Randomized-controlled ELAN Trial. CIRCULATION. 2024 Jul 2;150(1):19-29. https://doi.org/10.1161/CIRCULATIONAHA.124.069324

Bibtex

@article{d5c6410377b6456ebf356216b7eb26c0,
title = "Early Versus Late Initiation of Direct Oral Anticoagulants After Ischemic Stroke in People With Atrial Fibrillation and Hemorrhagic Transformation: Prespecified Subanalysis of the Randomized-controlled ELAN Trial",
abstract = "BACKGROUND: Whether hemorrhagic transformation (HT) modifies the treatment effect of early compared with late initiation of direct oral anticoagulation in people with ischemic stroke and atrial fibrillation is unknown.METHODS: This is a post hoc analysis of the ELAN trial (Early Versus Late Initiation of Direct Oral Anticoagulants in Post-Ischaemic Stroke Patients With Atrial Fibrillation). The primary outcome was a composite of recurrent ischemic stroke, symptomatic intracranial hemorrhage, major extracranial bleeding, systemic embolism, or vascular death within 30 days. Secondary outcomes were the individual components, 30- and 90-day functional outcome. We estimated outcomes based on HT, subclassified as hemorrhagic infarction (HI) or parenchymal hemorrhage (PH) on prerandomization imaging (core laboratory rating) using adjusted risk differences between treatment arms.RESULTS: Overall, 247 of 1970 participants (12.5%) had HT (114 HI 1, 77 HI 2, 34 PH 1, 22 PH 2). For the primary outcome, the estimated adjusted risk difference (early versus late) was -2.2% (95% CI, -7.8% to 3.5%) in people with HT (HI: -4.7% [95% CI, -10.8% to 1.4%]; PH: 6.1% [95% CI, -8.5% to 20.6%]) and -0.9% (95% CI, -2.6% to 0.8%) in people without HT. Numbers of symptomatic intracranial hemorrhage were identical in people with and without HT. With early treatment, the estimated adjusted risk difference for poor 90-day functional outcome (modified Rankin Scale score, 3-6) was 11.5% (95% CI, -0.8% to 23.8%) in participants with HT (HI: 7.4% [95% CI, -6.4% to 21.2%]; PH: 25.1% [95% CI, 0.2% to 50.0%]) and -2.6% (95% CI, -7.1% to 1.8%) in people without HT.CONCLUSIONS: We found no evidence of major treatment effect heterogeneity or safety concerns with early compared with late direct oral anticoagulation initiation in people with and without HT. However, early direct oral anticoagulation initiation may worsen functional outcomes in people with PH.REGISTRATION: URL: http://www.clinicaltrials.gov; Unique identifier: NCT03148457.",
author = "Roman Rohner and Markus Kneihsl and Goeldlin, {Martina B} and Arsany Hakim and Mattia Branca and Stefanie Abend and {Valenzuela Pinilla}, Waldo and Sabine Fenzl and Beata Rezny-Kasprzak and Daniel Strbian and Sven Trelle and Maurizio Paciaroni and G{\"o}tz Thomalla and Patrik Michel and Krassen Nedeltchev and Thomas Gattringer and Sandset, {Else C} and Leo Bonati and {Aguiar de Sousa}, Diana and Sylaja, {P N} and George Ntaios and Masatoshi Koga and Zuzana Gdovinova and Robin Lemmens and Bornstein, {Natan M} and Peter Kelly and Mira Katan and Thomas Horvath and Jesse Dawson and Urs Fischer and {ELAN Investigators}",
year = "2024",
month = jul,
day = "2",
doi = "10.1161/CIRCULATIONAHA.124.069324",
language = "English",
volume = "150",
pages = "19--29",
journal = "CIRCULATION",
issn = "0009-7322",
publisher = "Lippincott Williams and Wilkins",
number = "1",

}

RIS

TY - JOUR

T1 - Early Versus Late Initiation of Direct Oral Anticoagulants After Ischemic Stroke in People With Atrial Fibrillation and Hemorrhagic Transformation: Prespecified Subanalysis of the Randomized-controlled ELAN Trial

AU - Rohner, Roman

AU - Kneihsl, Markus

AU - Goeldlin, Martina B

AU - Hakim, Arsany

AU - Branca, Mattia

AU - Abend, Stefanie

AU - Valenzuela Pinilla, Waldo

AU - Fenzl, Sabine

AU - Rezny-Kasprzak, Beata

AU - Strbian, Daniel

AU - Trelle, Sven

AU - Paciaroni, Maurizio

AU - Thomalla, Götz

AU - Michel, Patrik

AU - Nedeltchev, Krassen

AU - Gattringer, Thomas

AU - Sandset, Else C

AU - Bonati, Leo

AU - Aguiar de Sousa, Diana

AU - Sylaja, P N

AU - Ntaios, George

AU - Koga, Masatoshi

AU - Gdovinova, Zuzana

AU - Lemmens, Robin

AU - Bornstein, Natan M

AU - Kelly, Peter

AU - Katan, Mira

AU - Horvath, Thomas

AU - Dawson, Jesse

AU - Fischer, Urs

AU - ELAN Investigators

PY - 2024/7/2

Y1 - 2024/7/2

N2 - BACKGROUND: Whether hemorrhagic transformation (HT) modifies the treatment effect of early compared with late initiation of direct oral anticoagulation in people with ischemic stroke and atrial fibrillation is unknown.METHODS: This is a post hoc analysis of the ELAN trial (Early Versus Late Initiation of Direct Oral Anticoagulants in Post-Ischaemic Stroke Patients With Atrial Fibrillation). The primary outcome was a composite of recurrent ischemic stroke, symptomatic intracranial hemorrhage, major extracranial bleeding, systemic embolism, or vascular death within 30 days. Secondary outcomes were the individual components, 30- and 90-day functional outcome. We estimated outcomes based on HT, subclassified as hemorrhagic infarction (HI) or parenchymal hemorrhage (PH) on prerandomization imaging (core laboratory rating) using adjusted risk differences between treatment arms.RESULTS: Overall, 247 of 1970 participants (12.5%) had HT (114 HI 1, 77 HI 2, 34 PH 1, 22 PH 2). For the primary outcome, the estimated adjusted risk difference (early versus late) was -2.2% (95% CI, -7.8% to 3.5%) in people with HT (HI: -4.7% [95% CI, -10.8% to 1.4%]; PH: 6.1% [95% CI, -8.5% to 20.6%]) and -0.9% (95% CI, -2.6% to 0.8%) in people without HT. Numbers of symptomatic intracranial hemorrhage were identical in people with and without HT. With early treatment, the estimated adjusted risk difference for poor 90-day functional outcome (modified Rankin Scale score, 3-6) was 11.5% (95% CI, -0.8% to 23.8%) in participants with HT (HI: 7.4% [95% CI, -6.4% to 21.2%]; PH: 25.1% [95% CI, 0.2% to 50.0%]) and -2.6% (95% CI, -7.1% to 1.8%) in people without HT.CONCLUSIONS: We found no evidence of major treatment effect heterogeneity or safety concerns with early compared with late direct oral anticoagulation initiation in people with and without HT. However, early direct oral anticoagulation initiation may worsen functional outcomes in people with PH.REGISTRATION: URL: http://www.clinicaltrials.gov; Unique identifier: NCT03148457.

AB - BACKGROUND: Whether hemorrhagic transformation (HT) modifies the treatment effect of early compared with late initiation of direct oral anticoagulation in people with ischemic stroke and atrial fibrillation is unknown.METHODS: This is a post hoc analysis of the ELAN trial (Early Versus Late Initiation of Direct Oral Anticoagulants in Post-Ischaemic Stroke Patients With Atrial Fibrillation). The primary outcome was a composite of recurrent ischemic stroke, symptomatic intracranial hemorrhage, major extracranial bleeding, systemic embolism, or vascular death within 30 days. Secondary outcomes were the individual components, 30- and 90-day functional outcome. We estimated outcomes based on HT, subclassified as hemorrhagic infarction (HI) or parenchymal hemorrhage (PH) on prerandomization imaging (core laboratory rating) using adjusted risk differences between treatment arms.RESULTS: Overall, 247 of 1970 participants (12.5%) had HT (114 HI 1, 77 HI 2, 34 PH 1, 22 PH 2). For the primary outcome, the estimated adjusted risk difference (early versus late) was -2.2% (95% CI, -7.8% to 3.5%) in people with HT (HI: -4.7% [95% CI, -10.8% to 1.4%]; PH: 6.1% [95% CI, -8.5% to 20.6%]) and -0.9% (95% CI, -2.6% to 0.8%) in people without HT. Numbers of symptomatic intracranial hemorrhage were identical in people with and without HT. With early treatment, the estimated adjusted risk difference for poor 90-day functional outcome (modified Rankin Scale score, 3-6) was 11.5% (95% CI, -0.8% to 23.8%) in participants with HT (HI: 7.4% [95% CI, -6.4% to 21.2%]; PH: 25.1% [95% CI, 0.2% to 50.0%]) and -2.6% (95% CI, -7.1% to 1.8%) in people without HT.CONCLUSIONS: We found no evidence of major treatment effect heterogeneity or safety concerns with early compared with late direct oral anticoagulation initiation in people with and without HT. However, early direct oral anticoagulation initiation may worsen functional outcomes in people with PH.REGISTRATION: URL: http://www.clinicaltrials.gov; Unique identifier: NCT03148457.

U2 - 10.1161/CIRCULATIONAHA.124.069324

DO - 10.1161/CIRCULATIONAHA.124.069324

M3 - SCORING: Journal article

C2 - 38753452

VL - 150

SP - 19

EP - 29

JO - CIRCULATION

JF - CIRCULATION

SN - 0009-7322

IS - 1

ER -