Intravenous thrombolysis in patients with ischemic stroke and recent ingestion of direct oral anticoagulants
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Intravenous thrombolysis in patients with ischemic stroke and recent ingestion of direct oral anticoagulants. / Meinel, Thomas R; Wilson, Duncan; Gensicke, Henrik; Scheitz, Jan F; Ringleb, Peter; Goganau, Ioana; Kaesmacher, Johannes; Bae, Hee-Joon; Kim, Do Yeon; Kermer, Pawel; Suzuki, Kentaro; Kimura, Kazumi; Macha, Kosmas; Koga, Masatoshi; Wada, Shinichi; Altersberger, Valerian; Salerno, Alexander; Palanikumar, Logesh; Zini, Andrea; Forlivesi, Stefano; Kellert, Lars; Wischmann, Johannes; Kristoffersen, Espen S; Beharry, James; Barber, P Alan; Hong, Jae Beom; Cereda, Carlo; Schlemm, Eckhard; Yakushiji, Yusuke; Poli, Sven; Leker, Ronen; Romoli, Michele; Zedde, Marialuisa; Curtze, Sami; Ikenberg, Benno; Uphaus, Timo; Giannandrea, David; Portela, Pere Cardona; Veltkamp, Roland; Ranta, Annemarei; Arnold, Marcel; Fischer, Urs; Cha, Jae-Kwan; Wu, Teddy Y; Purrucker, Jan C; Seiffge, David J; DOAC-IVT Writing Group.
in: JAMA NEUROL, Jahrgang 80, Nr. 3, 01.03.2023, S. 233-243.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Intravenous thrombolysis in patients with ischemic stroke and recent ingestion of direct oral anticoagulants
AU - Meinel, Thomas R
AU - Wilson, Duncan
AU - Gensicke, Henrik
AU - Scheitz, Jan F
AU - Ringleb, Peter
AU - Goganau, Ioana
AU - Kaesmacher, Johannes
AU - Bae, Hee-Joon
AU - Kim, Do Yeon
AU - Kermer, Pawel
AU - Suzuki, Kentaro
AU - Kimura, Kazumi
AU - Macha, Kosmas
AU - Koga, Masatoshi
AU - Wada, Shinichi
AU - Altersberger, Valerian
AU - Salerno, Alexander
AU - Palanikumar, Logesh
AU - Zini, Andrea
AU - Forlivesi, Stefano
AU - Kellert, Lars
AU - Wischmann, Johannes
AU - Kristoffersen, Espen S
AU - Beharry, James
AU - Barber, P Alan
AU - Hong, Jae Beom
AU - Cereda, Carlo
AU - Schlemm, Eckhard
AU - Yakushiji, Yusuke
AU - Poli, Sven
AU - Leker, Ronen
AU - Romoli, Michele
AU - Zedde, Marialuisa
AU - Curtze, Sami
AU - Ikenberg, Benno
AU - Uphaus, Timo
AU - Giannandrea, David
AU - Portela, Pere Cardona
AU - Veltkamp, Roland
AU - Ranta, Annemarei
AU - Arnold, Marcel
AU - Fischer, Urs
AU - Cha, Jae-Kwan
AU - Wu, Teddy Y
AU - Purrucker, Jan C
AU - Seiffge, David J
AU - DOAC-IVT Writing Group
AU - Thomalla, Götz
PY - 2023/3/1
Y1 - 2023/3/1
N2 - IMPORTANCE: International guidelines recommend avoiding intravenous thrombolysis (IVT) in patients with ischemic stroke who have a recent intake of a direct oral anticoagulant (DOAC).OBJECTIVE: To determine the risk of symptomatic intracranial hemorrhage (sICH) associated with use of IVT in patients with recent DOAC ingestion.DESIGN, SETTING, AND PARTICIPANTS: This international, multicenter, retrospective cohort study included 64 primary and comprehensive stroke centers across Europe, Asia, Australia, and New Zealand. Consecutive adult patients with ischemic stroke who received IVT (both with and without thrombectomy) were included. Patients whose last known DOAC ingestion was more than 48 hours before stroke onset were excluded. A total of 832 patients with recent DOAC use were compared with 32 375 controls without recent DOAC use. Data were collected from January 2008 to December 2021.EXPOSURES: Prior DOAC therapy (confirmed last ingestion within 48 hours prior to IVT) compared with no prior oral anticoagulation.MAIN OUTCOMES AND MEASURES: The main outcome was sICH within 36 hours after IVT, defined as worsening of at least 4 points on the National Institutes of Health Stroke Scale and attributed to radiologically evident intracranial hemorrhage. Outcomes were compared according to different selection strategies (DOAC-level measurements, DOAC reversal treatment, IVT with neither DOAC-level measurement nor idarucizumab). The association of sICH with DOAC plasma levels and very recent ingestions was explored in sensitivity analyses.RESULTS: Of 33 207 included patients, 14 458 (43.5%) were female, and the median (IQR) age was 73 (62-80) years. The median (IQR) National Institutes of Health Stroke Scale score was 9 (5-16). Of the 832 patients taking DOAC, 252 (30.3%) received DOAC reversal before IVT (all idarucizumab), 225 (27.0%) had DOAC-level measurements, and 355 (42.7%) received IVT without measuring DOAC plasma levels or reversal treatment. The unadjusted rate of sICH was 2.5% (95% CI, 1.6-3.8) in patients taking DOACs compared with 4.1% (95% CI, 3.9-4.4) in control patients using no anticoagulants. Recent DOAC ingestion was associated with lower odds of sICH after IVT compared with no anticoagulation (adjusted odds ratio, 0.57; 95% CI, 0.36-0.92). This finding was consistent among the different selection strategies and in sensitivity analyses of patients with detectable plasma levels or very recent ingestion.CONCLUSIONS AND RELEVANCE: In this study, there was insufficient evidence of excess harm associated with off-label IVT in selected patients after ischemic stroke with recent DOAC ingestion.
AB - IMPORTANCE: International guidelines recommend avoiding intravenous thrombolysis (IVT) in patients with ischemic stroke who have a recent intake of a direct oral anticoagulant (DOAC).OBJECTIVE: To determine the risk of symptomatic intracranial hemorrhage (sICH) associated with use of IVT in patients with recent DOAC ingestion.DESIGN, SETTING, AND PARTICIPANTS: This international, multicenter, retrospective cohort study included 64 primary and comprehensive stroke centers across Europe, Asia, Australia, and New Zealand. Consecutive adult patients with ischemic stroke who received IVT (both with and without thrombectomy) were included. Patients whose last known DOAC ingestion was more than 48 hours before stroke onset were excluded. A total of 832 patients with recent DOAC use were compared with 32 375 controls without recent DOAC use. Data were collected from January 2008 to December 2021.EXPOSURES: Prior DOAC therapy (confirmed last ingestion within 48 hours prior to IVT) compared with no prior oral anticoagulation.MAIN OUTCOMES AND MEASURES: The main outcome was sICH within 36 hours after IVT, defined as worsening of at least 4 points on the National Institutes of Health Stroke Scale and attributed to radiologically evident intracranial hemorrhage. Outcomes were compared according to different selection strategies (DOAC-level measurements, DOAC reversal treatment, IVT with neither DOAC-level measurement nor idarucizumab). The association of sICH with DOAC plasma levels and very recent ingestions was explored in sensitivity analyses.RESULTS: Of 33 207 included patients, 14 458 (43.5%) were female, and the median (IQR) age was 73 (62-80) years. The median (IQR) National Institutes of Health Stroke Scale score was 9 (5-16). Of the 832 patients taking DOAC, 252 (30.3%) received DOAC reversal before IVT (all idarucizumab), 225 (27.0%) had DOAC-level measurements, and 355 (42.7%) received IVT without measuring DOAC plasma levels or reversal treatment. The unadjusted rate of sICH was 2.5% (95% CI, 1.6-3.8) in patients taking DOACs compared with 4.1% (95% CI, 3.9-4.4) in control patients using no anticoagulants. Recent DOAC ingestion was associated with lower odds of sICH after IVT compared with no anticoagulation (adjusted odds ratio, 0.57; 95% CI, 0.36-0.92). This finding was consistent among the different selection strategies and in sensitivity analyses of patients with detectable plasma levels or very recent ingestion.CONCLUSIONS AND RELEVANCE: In this study, there was insufficient evidence of excess harm associated with off-label IVT in selected patients after ischemic stroke with recent DOAC ingestion.
U2 - 10.1001/jamaneurol.2022.4782
DO - 10.1001/jamaneurol.2022.4782
M3 - SCORING: Journal article
C2 - 36807495
VL - 80
SP - 233
EP - 243
JO - JAMA NEUROL
JF - JAMA NEUROL
SN - 2168-6149
IS - 3
ER -