To characterize the clinical and therapeutic profile of patients treated off-label with tenecteplase (TNK) for acute ischemic stroke (AIS) at a single center in Bogotá, Colombia.

Although recombinant tissue plasminogen activator (r-tPA) is the only FDA-approved thrombolytic agent for treating AIS, several studies suggest that TNK may offer significant advantages (longer half-life, easier administration, and greater fibrin affinity). The intermittent shortage of r-tPA in middle-income countries has obligated the off-label use of TNK for AIS treatment.

Retrospective, cross-sectional study that retrieves descriptive data on the clinical and therapeutic profiles of patients receiving TNK for AIS between 2023 and 2024. Outcomes were assessed using the modified Rankin Scale (mRS). Favorable functional outcome was defined as mRS≤2.

Thrombolysis with TNK was performed on 64 patients with AIS, with a mean age of 66 years. Most patients were females (57.8%). The most common etiology of stroke was cryptogenic (51.5%), followed by cardioembolic (26.5%). The main reason for using TNK was the shortage of r-tPA (34.37%). Mechanical thrombectomy (MT) was indicated in 31.25% (n=20) of patients with large vessel occlusion (LVO); however, it was not performed in 35% (n=7) of these cases. Among patients without LVO, 69.7% achieved a favorable functional outcome at discharge. In patients with LVO, only 15% had a favorable outcome. Parenchymatous hemorrhage occurred in 12.5% of cases (n=8). Overall mortality rate was 23.43% (n=15).

In this study, TNK offered access to thrombolytic therapy in situations where r-tPA is scarce, with favorable outcomes in more than half of the patients. High mortality and poor outcomes associated with LVO may be linked to limited access to MT. These findings support the use of TNK as an alternative in resource-limited settings.