Improving neurological outcome for acute basilar artery occlusion with sufficient recanalization after thrombectomy by intraarterial tenecteplase (INSIST-IT): Rationale and design

Abstract

Background: The potential benefit of intraarterial tenecteplase in acute basilar artery occlusion (BAO) patients with successful reperfusion following endovascular treatment (EVT) has not been studied. Aims: To explore the efficacy and safety of intraarterial tenecteplase in acute BAO patients with successful reperfusion after EVT. Sample size estimates: A maximum of 228 patients are required to test the superiority hypothesis with 80% power according to a two-side 0.05 level of significance, stratified by center. Design: We will conduct a prospective, randomized, adaptive-enrichment, open-label, blinded-end point, multicenter trial. Eligible BAO patients with successful recanalization after EVT [modified Thrombolysis in Cerebral Infarction (mTICI) 2b-3] will be randomly assigned into the experimental and control group with a 1:1 ratio. Patients in the experimental group will receive intraarterial tenecteplase (0.2–0.3 mg/min for 20–30 min), while patients in the control group will receive routine treatment according to the usual practice of each center. Patients in both groups will receive standard guideline-based medical treatment. Outcome: The primary efficacy endpoint is a favorable functional outcome, defined as the modified Rankin Scale 0–3 at 90 days after randomization. The primary safety endpoint is symptomatic intracerebral hemorrhage, defined as National Institutes of Health Stroke Scale score increase ⩾4 caused by intracranial hemorrhage within 48 h after randomization. Subgroup analysis of the primary outcome will be performed by age, gender, baseline NIHSS score, baseline pc-ASPECTS, intravenous thrombolysis, time from estimated symptom onset to treatment, mTICI, blood glucose, and stroke etiology. Conclusions: The results of this study will provide evidence of whether adjunct use of intraarterial tenecteplase after successful reperfusion with EVT is associated with better outcomes for acute BAO patients.

Endovascular Thrombectomy for Anterior Circulation Large Vessel Occlusion Stroke: An Evolution of Trials

“…The trial was stopped early due to lack of placebo supply. If confirmed with other studies, 62 this may have implications for stroke management aimed at restoring functional independence, although potential hemorrhagic risks need also to be weighed.…”

Benefit of endovascular treatment for primary versus secondary medium vessel occlusion: A multi‐center experience

“…34 It is noteworthy that secondary MeVO had poorer outcomes compared with LVO, 13 suggesting the need for more effective EVT methods to achieve complete recanalization, such as intra-arterial thrombolysis during EVT. 35,36 The presence of LMC varied by the location of arterial occlusion and was associated with good outcomes. [37][38][39] In this study, the proportion of LMC in patients with primary MeVO was significantly lower than that in patients with secondary MeVO (23% vs. 45%).…”

“… 34 It is noteworthy that secondary MeVO had poorer outcomes compared with LVO, 13 suggesting the need for more effective EVT methods to achieve complete recanalization, such as intra‐arterial thrombolysis during EVT. 35 , 36 …”

Endovascular Therapy for Acute Stroke: New Evidence and Indications

“…We must also search for optimizing firstpass effect [83][84][85] and adjunctive therapies to help maximize the benefit of EVT. 47,[86][87][88][89][90][91][92] EVT has changed the stroke treatment landscape and the stroke literature is now flourishing with new studies. We provide a summary of select studies representing the newest evidence that may inform decisions outside of the typical indications for EVT in an AIS.…”