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Background <p>The impact of direct oral anticoagulants (DOAC) on haematoma size after intracerebral haemorrhage (ICH) compared to no-anticoagulation is controversial and prospective data are lacking.</p> Methods <p>The investigator-initiated, multicentre, prospective RASUNOA-prime study enrolled patients with non-traumatic ICH and atrial fibrillation while on a DOAC, vitamin K antagonist (VKA) or no anticoagulation (non-OAC). Neuroimaging was reviewed centrally blinded to group allocation. Primary endpoint was haematoma expansion (≥ 6.5&#xa0;ml or ≥ 33%, any new intraventricular blood or an increase in modified Graeb score by ≥ 2 points) between baseline and follow-up scan within 72&#xa0;h after symptom onset.</p> Results <p>Of 1,440 patients screened, 951 patients with ICH symptom onset less than 24&#xa0;h before admission were enrolled. Baseline scans were performed at a median of 2&#xa0;h (IQR 1–6) after symptom onset. Neurological deficit and median baseline haematoma volumes (11&#xa0;ml; IQR 4–39) did not differ among 577 DOAC, 251 VKA and 123 non-OAC patients. Haematoma expansion was observed in DOAC patients in 142/356 (39.9, 95%-CI 34.8–45.0%), VKA in 47/155 (30.3, 95-CI 23.1%–37.6%), versus non-OAC in 22/74 (29.7, 19.3–40.1%). Unspecific reversal agents in DOAC-ICH (212/356, 59.6%) did not affect the haematoma expansion rate compared to no-antagonization.</p> Conclusion <p>Baseline haematoma volume and risk of haematoma expansion did not differ statistically significantly in patients with and without DOAC.</p>

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Association of oral anticoagulants with risk of brain haemorrhage expansion compared to no-anticoagulation

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  • 发表日期：

    2025年2月12日

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  • Roland Veltkamp,
  • Kirsten Haas,
  • Viktoria Rücker,
  • Uwe Malzahn,
  • Adrian Heeger,
  • David Kinzler,
  • Patrick Müller,
  • Pascal Rappard,
  • Timolaos Rizos,
  • Johannes Schiefer,
  • Christian Opherk,
  • Waltraud Pfeilschifter,
  • Katharina Althaus,
  • Peter Schellinger,
  • Bernadette Gaida,
  • Maria Magdalena Gabriel,
  • Georg Royl,
  • Darius G. Nabavi,
  • Karl Georg Haeusler,
  • Christian H. Nolte,
  • Marc E. Wolf,
  • Sven Poli,
  • Marilen Sieber,
  • Pascal Mosimann,
  • Peter U. Heuschmann,
  • Jan C. Purrucker,
  • Solveig Horstmann,
  • Alexandra Krauß,
  • Caroline Renninger,
  • Peter Ringleb,
  • Arno Reich,
  • Eve Kohler,
  • Erendira Boss,
  • Jan Hendrik Schaefer,
  • Marc Pflug,
  • Bettina von Sarnowski,
  • Gerrit Maximilian Große,
  • Johanna Ernst,
  • Karin Weißenborn,
  • Ramona Schupper,
  • Hans Worthmann,
  • Susanne Riebau,
  • Olaf Crome,
  • Boris Dimitrijeski,
  • Jens Offermann,
  • Ida Rangus,
  • Elisabeth Schmid,
  • Khouloud Poli,
  • Johannes Tünnerhoff,
  • Dominik Michalski,
  • Johann O. Pelz,
  • Martin Juenemann,
  • Tobias BraunTobias J. Müller,
  • Katja Wartenberg,
  • Andreas Binder,
  • Johannes Meyne,
  • Benno Ikenberg,
  • Johanna Härtl,
  • Michael Ohms,
  • Sebasitan Edelbusch,
  • Marc Fatar,
  • Angelika Alonso,
  • Martin Nückel,
  • Frank Erbguth,
  • Alexandra Grau,
  • Udo Selig,
  • Rainer Dziewas,
  • Jens Minnerup,
  • Kristian Barlinn,
  • Kathrin Haase,
  • Götz Thomalla,
  • Milani Deb-Chatterji,
  • Mathias Mäurer,
  • Mathias Pfau,
  • Peter Michels,
  • Zoran Vukovic,
  • Timo Uphaus,
  • Klaus Gröschel,
  • Sonja Gröschel,
  • Marianne Hahn,
  • Joannes Mühler,
  • Klaus Dötter,
  • Michaela Wagner-Heck,
  • Frank Arne Wollenweber,
  • Sebastian Jander,
  • John-Ih Lee,
  • Wolf-Rüdiger Schäbitz,
  • Inken Piehl,
  • Michael Frattner,
  • Dimitre Staykov,
  • Christian Urbanek,
  • Sabine Schröder,
  • Sylke Düllberg-Boden,
  • Pawel Kermer,
  • Matthias Kaste,
  • Lars Marquardt,
  • Haiko Kazarians,
  • Christoph Kleinschnitz,
  • Peter Kraft,
  • Frank Hoffmann,
  • Andrea Kraft,
  • Jürgen Hartmut Faiss,
  • Gernot Reimann,
  • Michael Schwarz,
  • Thorsten Steiner,
  • Albrecht Günther,
  • Uta Meyding Lamadé,
  • Matthias W. Lorenz

摘要

Background

The impact of direct oral anticoagulants (DOAC) on haematoma size after intracerebral haemorrhage (ICH) compared to no-anticoagulation is controversial and prospective data are lacking.

Methods

The investigator-initiated, multicentre, prospective RASUNOA-prime study enrolled patients with non-traumatic ICH and atrial fibrillation while on a DOAC, vitamin K antagonist (VKA) or no anticoagulation (non-OAC). Neuroimaging was reviewed centrally blinded to group allocation. Primary endpoint was haematoma expansion (≥ 6.5 ml or ≥ 33%, any new intraventricular blood or an increase in modified Graeb score by ≥ 2 points) between baseline and follow-up scan within 72 h after symptom onset.

Results

Of 1,440 patients screened, 951 patients with ICH symptom onset less than 24 h before admission were enrolled. Baseline scans were performed at a median of 2 h (IQR 1–6) after symptom onset. Neurological deficit and median baseline haematoma volumes (11 ml; IQR 4–39) did not differ among 577 DOAC, 251 VKA and 123 non-OAC patients. Haematoma expansion was observed in DOAC patients in 142/356 (39.9, 95%-CI 34.8–45.0%), VKA in 47/155 (30.3, 95-CI 23.1%–37.6%), versus non-OAC in 22/74 (29.7, 19.3–40.1%). Unspecific reversal agents in DOAC-ICH (212/356, 59.6%) did not affect the haematoma expansion rate compared to no-antagonization.

Conclusion

Baseline haematoma volume and risk of haematoma expansion did not differ statistically significantly in patients with and without DOAC.