Intra-arterial tenecteplase for acute basilar artery occlusion with sufficient recanalization after thrombectomy: the INSIST-IT randomized clinical trial

The clinical effect of adjunctive intra-arterial tenecteplase after successful recanalization in acute basilar artery occlusion (BAO) remains uncertain. In this prospective, randomized, adaptive-enrichment, open label, blinded-end point, multi-center trial, patients with BAO within 24 h of estimated symptom onset who achieved successful reperfusion after endovascular treatment (EVT) were randomized (1:1) to intra-arterial tenecteplase (n = 75) or control (only received standard medical therapy, n = 69). The primary efficacy outcome was independent ambulation (modified Rankin Scale 0–3) at 90 days; the primary safety outcome was symptomatic intracranial hemorrhage (sICH). The trial was stopped early due to safety concerns and lack of efficacy per Data Safety and Monitoring Committee recommendation. Among 144 randomized patients, 143 (99.3%) completed follow-up. At 90 days, independent ambulation was achieved in 40.0% of the tenecteplase group versus 50.0% in the control group (OR 0.67; 95% CI 0.34–1.29; P = 0.23). sICH occurred in 6.2% versus 4.8% (OR 1.31; 95% CI 0.28–6.89; P = 0.73). All-cause mortality at 90 days was 41.3% versus 26.5% (OR 1.96; 95% CI 0.97–4.03; P = 0.063). In this prematurely terminated trial, adjunctive intra-arterial tenecteplase did not improve functional outcomes in patients with BAO. Acute basilar artery occlusion (BAO) is a life-threatening cause of stroke, and whether intra-arterial tenecteplase after successful recanalization leads to improved outcomes is unclear. This randomized trial by Chen and colleagues was stopped early for safety concerns and shows that adjunctive intra-arterial tenecteplase does not improve functional outcomes in acute BAO.