The impact of body mass index (BMI) on the benefit and safety profiles of tenecteplase versus alteplase in acute ischemic stroke (AIS) patients remains unclear. This study aimed to evaluate the efficacy and safety of tenecteplase compared to alteplase for AIS patients undergoing intravenous thrombolysis (IVT) across different BMI categories.
This subgroup analysis was derived from the TRACE-2 (Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-2) trial. AIS patients eligible for IVT but ineligible for endovascular thrombectomy were enrolled and randomly assigned to receive either intravenous tenecteplase (0.25 mg/kg) or alteplase (0.9 mg/kg). Patients were classified into underweight (BMI<18.5 kg/m2), normal weight (18.5≤ BMI<23 Kg/m2), overweight (23≤BMI<25 kg/m2), and obese (≥25 kg/m2). The primary efficacy and safety outcome were the proportion of patients achieving a modified Rankin Scale (mRS) score of 0–1 at 90 days and symptomatic intracranial hemorrhage (sICH) within 36 hours, respectively.
Among 1392 patients, 73 (5%) were underweight, 482 (35%) normal weight, 299 (21%) overweight, and 538 (39%) obese. There was no significant difference in the primary efficacy outcome between tenecteplase and alteplase among normal weight, overweight, and obese patients (P=0.15, 0.91, and 0.95, respectively). However, in the underweight group, tenecteplase was associated with a higher proportion of primary efficacy outcome compared to alteplase (25 (65.8%) vs. 10 (30.3%); RR=2.17, 95% CI 1.23 to 3.82, P=0.003). A significant interaction was observed between thrombolytic treatments and BMI categories (P=0.04). No significant difference was noted in the primary safety outcome between tenecteplase and alteplase treatments across all BMI categories.