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Background <p>Despite current guidelines recommending against intravenous thrombolysis (IVT) in acute ischemic stroke (AIS) patients with direct oral anticoagulants (DOAC) within prior 48&#xa0;h, latest real-world data indicate no increased bleeding risk. However, these observations are based mainly on alteplase (rt-PA), whereas data for tenecteplase (TNK) are scarce.</p> Methods <p>We retrospectively compared data from our stroke registry of AIS-patients with DOAC (intake within the last 48&#xa0;h), who received IVT either with rt-PA or TNK without prior antagonization. The primary outcome was the rate of symptomatic intracranial hemorrhage (sICH) per SITS-Most criteria. Secondary outcomes included the rate of any ICH or major bleeding, rate of mortality, neurological and functional outcome at discharge.</p> Results <p>82 AIS-patients were included, with 42 patients receiving TNK und 40 patients receiving rt-PA. Median age was 83 y for TNK patients and 82 y for rt-PA patients. Median NIHSS score at admission for TNK was 9 points for both groups (<i>p</i> = 0.61). Median drug-specific DOAC plasma level was 49 ng/mL for TNK <i>versus</i> 24 ng/mL for rt-PA (<i>p</i> = 0.04). We found no statistically significant increased risk for neither sICH (TNK 2.4% vs. rt-PA 2.5%; <i>p</i> = 1), nor for other safety outcomes for TNK-treated patients compared with rt-PA. The rate of excellent functional outcome (TNK 61.9% vs. rt-PA 52.5%) was similar among both groups. High drug-specific DOAC plasma levels were not related to an increased rate of hemorrhagic complications in our cohort.</p> Conclusion <p>We report no increased rate of (s)ICH for TNK based IVT compared with rt-PA in AIS-patients with DOAC, indicating a similar safety profile. Moderate to high drug-specific DOAC levels were no surrogates for hemorrhagic complications, supporting the implementation of specific Standard Operating Procedures for IVT in DOAC-treated patients. Contrary to previous studies, we did not observe an increased rate of early recanalization of LVO in TNK-treated patients in this small single-center cohort.</p> Trial registration <p>n/A.</p>

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Safety of tenecteplase versus alteplase for intravenous thrombolysis in acute ischemic stroke patients with direct oral anticoagulation: experience from a German stroke center

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  • 发表日期：

    2025年11月14日

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  • Lena Mers,
  • Anna Bogdanova,
  • Alexander Sekita,
  • Ludwig Singer,
  • Manuel Schmidt,
  • Bernd Kallmuenzer,
  • Stefan Schwab,
  • Stefan T. Gerner

摘要

Background

Despite current guidelines recommending against intravenous thrombolysis (IVT) in acute ischemic stroke (AIS) patients with direct oral anticoagulants (DOAC) within prior 48 h, latest real-world data indicate no increased bleeding risk. However, these observations are based mainly on alteplase (rt-PA), whereas data for tenecteplase (TNK) are scarce.

Methods

We retrospectively compared data from our stroke registry of AIS-patients with DOAC (intake within the last 48 h), who received IVT either with rt-PA or TNK without prior antagonization. The primary outcome was the rate of symptomatic intracranial hemorrhage (sICH) per SITS-Most criteria. Secondary outcomes included the rate of any ICH or major bleeding, rate of mortality, neurological and functional outcome at discharge.

Results

82 AIS-patients were included, with 42 patients receiving TNK und 40 patients receiving rt-PA. Median age was 83 y for TNK patients and 82 y for rt-PA patients. Median NIHSS score at admission for TNK was 9 points for both groups (p = 0.61). Median drug-specific DOAC plasma level was 49 ng/mL for TNK versus 24 ng/mL for rt-PA (p = 0.04). We found no statistically significant increased risk for neither sICH (TNK 2.4% vs. rt-PA 2.5%; p = 1), nor for other safety outcomes for TNK-treated patients compared with rt-PA. The rate of excellent functional outcome (TNK 61.9% vs. rt-PA 52.5%) was similar among both groups. High drug-specific DOAC plasma levels were not related to an increased rate of hemorrhagic complications in our cohort.

Conclusion

We report no increased rate of (s)ICH for TNK based IVT compared with rt-PA in AIS-patients with DOAC, indicating a similar safety profile. Moderate to high drug-specific DOAC levels were no surrogates for hemorrhagic complications, supporting the implementation of specific Standard Operating Procedures for IVT in DOAC-treated patients. Contrary to previous studies, we did not observe an increased rate of early recanalization of LVO in TNK-treated patients in this small single-center cohort.

Trial registration

n/A.