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

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.