Intra-arterial tenecteplase for acute basilar artery occlusion with sufficient recanalization after thrombectomy: the INSIST-IT randomized clinical trial.
Liang Liu, Wei Li, Jing Qiu et al.
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In 30 seconds
The INSIST-IT multicentre, prospective, randomised trial assessed adjunctive intra-arterial tenecteplase after successful endovascular reperfusion in patients with acute basilar artery occlusion treated within 24 hours of estimated symptom onset. The trial was stopped early following safety concerns and lack of efficacy. At 90 days, independent ambulation (modified Rankin Scale 0–3) occurred in 40.0% of patients assigned tenecteplase and 50.0% assigned standard medical therapy alone (OR 0.67; 95% CI 0.34-1.29; P = 0.23). The investigators concluded that tenecteplase did not improve functional outcomes.
Key findings
- Independent ambulation at 90 days occurred in 40.0% with tenecteplase versus 50.0% with control (OR 0.67; 95% CI 0.34-1.29; P = 0.23).
- Symptomatic intracranial hemorrhage occurred in 6.2% versus 4.8% (OR 1.31; 95% CI 0.28-6.89; P = 0.73).
- 90-day all-cause mortality was 41.3% with tenecteplase versus 26.5% with control (OR 1.96; 95% CI 0.97-4.03; P = 0.063).
- The trial was terminated early on the Data Safety and Monitoring Committee's recommendation because of safety concerns and lack of efficacy.
Why it matters
Basilar artery occlusion is a serious condition, and this trial directly tested whether adding intra-arterial thrombolysis after successful thrombectomy improves recovery. The results did not show better functional outcomes, while mortality was numerically higher in the tenecteplase group. These findings inform assessment of adjunctive treatment, but early termination and imprecise estimates limit certainty.
What to keep in mind
The trial was stopped early, limiting the strength and precision of its efficacy and safety estimates.