Abstract TP058: Leech and Earthworm Extract Injection Improves Functional Outcomes in Diabetic Stroke Patients Post-thrombolysis: A Multicenter Registry Study

Background: Prior studies indicated that diabetic acute ischemic stroke (AIS) patients undergoing intravenous thrombolysis (IVT) experienced worse functional outcomes. The leech and earthworm extract injection (Shuxuetong, SXT) has demonstrated its effectiveness and safety following IVT by improving inadequate reperfusion and attenuating ischemia-reperfusion injury. However, its benefits and risks in diabetic patients remain unclear. This study aims to investigate functional outcomes in diabetic AIS patients post-IVT. Methods: We analyzed prospectively collected data from the ENSURE registry across 79 centers in China between October 2023 and August 2025. Consecutive patients treated with alteplase or tenecteplase within 4.5 hours of symptom onset and with diabetes mellitus (DM) or hypoglycemic agent use were included, while those treated with endovascular therapy were excluded. Exposure was defined as SXT administration (6 ml daily) following thrombolysis. The primary effectiveness outcome was excellent functional outcome (modified Rankin Scale 0-1) at 90 days. Safety outcomes included symptomatic intracranial hemorrhage (sICH) and death. Propensity score matching (PSM) was performed to balance baseline characteristics, with a caliper of 0.2. The study was registered on ClinicalTrials.gov (NCT 06018181). Results: Of 1,910 consecutive IVT-treated AIS patients, 459 were eligible for analysis (SXT: n = 225, non-SXT: n = 234). Before PSM, the SXT group exhibited a lower prevalence of atrial fibrillation (3.6% vs 9.4%, P = 0.019), lower diastolic blood pressure (84 mmHg vs 88 mmHg, P = 0.048), and less severe neurological deficits on admission (NIHSS: 3 vs 4, P = 0.012) compared with non-SXT group. After PSM, 400 matched patients (SXT: n = 200, non-SXT: n = 200) were analyzed, with baseline characteristics well balanced (Table 1). The SXT group showed a significantly higher rate of excellent functional outcomes (84.0% vs 71.5%; OR 2.09, 95% CI 1.29–3.41; P = 0.004) (Figure 1). sICH was observed in 1 vs 3, and death in 2 vs 9 for the SXT and non-SXT group respectively. Conclusions: SXT significantly improved functional outcomes in diabetic AIS patients following thrombolysis. The effects of SXT in diabetic AIS patients undergoing IVT warrant further investigation.