Intravenous thrombolysis in patients with recent intake of direct oral anticoagulants: A target trial analysis after the liberalization of institutional guidelines.

Bücke, Philipp; Jung, Simon; Kaesmacher, Johannes; Goeldlin, Martina B; Horvath, Thomas; Prange, Ulrike; Beyeler, Morin; Fischer, Urs; Arnold, Marcel; Seiffge, David J; Meinel, Thomas R (2024). Intravenous thrombolysis in patients with recent intake of direct oral anticoagulants: A target trial analysis after the liberalization of institutional guidelines. (In Press). European stroke journal, p. 23969873241252751. Sage 10.1177/23969873241252751

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INTRODUCTION

This study aimed to report the safety and efficacy of off-label intravenous thrombolysis (IVT) with alteplase after sequentially liberalizing our institutional guidelines allowing IVT for patients under direct oral anticoagulants (DOACs) regardless of plasma levels, time of last intake, and without prior anticoagulation reversal therapy.

PATIENTS AND METHODS

We utilized the target-trial methodology to emulate hypothetical criteria of a randomized controlled trial in our prospective stroke registry. Consecutive DOAC patients (06/2021-11/2023) otherwise qualifying for IVT were included. Safety and efficacy outcomes (symptomatic intracranial hemorrhage [ICH], any radiological ICH, major bleeding, 90-day mortality, 90-day good functional outcome [mRS 0-2 or return to baseline]) were assessed using inverse-probability-weighted regression-adjustment comparing patients with versus without IVT.

RESULTS

Ninety eight patients fulfilled the target-trial criteria. IVT was given in 49/98 (50%) patients at a median of 178 (interquartile range 134-285) min after symptom onset with median DOAC plasma level of 77 ng/ml (15 patients had plasma levels > 100 ng/ml; 25/49 [51%] were treated within 12 h after last DOAC ingestion). Endovascular therapy was more frequent in patients without IVT (73% vs 33%). Symptomatic ICH occurred in 0/49 patients receiving IVT and 2/49 patients without IVT (adjusted difference -2.5%; 95% CI -5.9 to 0.8). The rates of any radiological ICH were comparable. Patients receiving IVT were more likely to have good functional outcomes.

DISCUSSION AND CONCLUSION

After liberalizing our approach for IVT regardless of recent DOAC intake, we did not experience any safety concerns. The association of IVT with better functional outcomes warrants prospective randomized controlled trials.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology
04 Faculty of Medicine > Department of Radiology, Neuroradiology and Nuclear Medicine (DRNN) > Institute of Diagnostic and Interventional Neuroradiology

UniBE Contributor:

Bücke, Philipp Jonas, Jung, Simon, Kaesmacher, Johannes, Göldlin, Martina Béatrice, Horvath, Thomas Nikolaus, Prange, Ulrike, Beyeler, Morin, Fischer, Urs Martin, Arnold, Marcel, Seiffge, David Julian, Meinel, Thomas Raphael

Subjects:

600 Technology > 610 Medicine & health

ISSN:

2396-9873

Publisher:

Sage

Language:

English

Submitter:

Pubmed Import

Date Deposited:

14 May 2024 09:03

Last Modified:

15 May 2024 06:28

Publisher DOI:

10.1177/23969873241252751

PubMed ID:

38738861

Uncontrolled Keywords:

anticoagulants atrial fibrillation stroke therapeutic thrombolysis

BORIS DOI:

10.48350/196746

URI:

https://boris.unibe.ch/id/eprint/196746

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