Abstract Body: Background and aim: There is lack of information on the association of infarct growth rate (IGR) with clinical outcomes for acute ischemic stroke (AIS) treated with intravenous thrombolysis in the late-time windows. We aimed to explore whether the benefits of tenecteplase would be modified by core growth rates.
Methods: This was a secondary analysis of the Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events–3 (TRACE-3) trial, a phase 3, multicenter, prospective, open-label, randomized, blinded-outcome-assessment trial at 58 centers in China. Patients with large-vessel occlusion (LVO) who had salvageable brain tissue on perfusion imaging and who were unable to access endovascular thrombectomy within 4.5 to 24 hours after the time that the patient was last known to be well were eligible for the trial. Of these, patients with witnessed stroke onset time were included in this analysis. The IGR was categorized according to the median value. The primary outcome was modified Rankin scale (mRS) of 0 or 1 at 90 days. Safety outcomes were symptomatic intracranial hemorrhage (sICH) and deaths.
Results A total of 234 eligible patients were included and the median IGR was 1.24 ml/hour. Based on the median IGR value, 116 patients with IGR≤1.2 ml/hour were assigned to ultraslow IGR group (Tenecteplase, 58; Standard Medical Treatment, 58) and 118 patients with IGR＞1.2ml/hour were in the relatively fast IGR group (Tenecteplase, 58; Standard Medical Treatment, 60). The rate of no disability (mRS≤1) was significantly increased with tenecteplase in relatively fast progressors (39.7% vs 15.0%; adjusted OR 1.25, 95% CI 1.06 to 1.47; P=0.007). The functional status was similar in ultraslow progressors (mRS 0-1: 36.2% vs 34.5%; adjusted OR 1.03, 95% CI 0.86 to 1.24; adjusted P=0.72). The incidence of sICH and mortality did not differ significantly between two treatment regimens in the IGR groups, but numberically, tenecteplase treatment increased deaths in the ultraslow IGR group and decreased deaths in the relatively fast IGR group.
Conclusions Patients with relatively fast IGR benefited from tenecteplase compared with standard medical treatment in AIS-LVO who did not have endovascular thrombectomy in the late time window. For ultraslow progressors, thrombolysis was not recommended for no significant efficacy and numberically increased deaths.