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Intra-arterial alteplase after thrombectomy improves three-month functional recovery in large vessel stroke
1. Adding a thrombolytic agent delivered through the arterial catheter immediately following mechanical clot extraction increased near-complete functional recovery at three months.
2. Rates of symptomatic brain bleeding did not differ meaningfully between groups, but three-month mortality was significantly higher in the combination arm.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Even when endovascular thrombectomy achieves successful recanalization of a large vessel occlusion, a substantial proportion of patients develop lasting disability. This may be due to persistent obstruction of distal arterial branches. This multicenter trial evaluated whether infusing alteplase through the arterial catheter immediately after angiographically successful thrombectomy could resolve residual perfusion deficits and improve clinical outcomes. The researchers demonstrated that a significantly larger proportion of treated patients achieved minimal or no disability at three months, and follow-up CT perfusion imaging confirmed markedly lower rates of residual cerebral hypoperfusion. Symptomatic intracranial hemorrhage remained infrequent and comparable between arms. However, 90-day all-cause mortality was significantly higher in the alteplase group. Despite this, the investigators noted that the causes of death were diverse, with only one death classified as treatment-related. Strengths of the trial included its randomized, multicenter design with blinded outcome adjudication. Limitations included a baseline age imbalance between the experimental and control groups and a narrow scope of patient enrollment confined to predominantly Spanish stroke centers, the latter possibly impacting generalizability. Overall, findings from this trial positioned intra-arterial thrombolysis as a promising adjunct to thrombectomy, but the mortality signal necessitates validation in larger, placebo-controlled, multinational studies before adoption into routine clinical practice.
Click to read the study in JAMA
In-Depth [randomized controlled trial]: This phase 3, randomized, open-label clinical trial was conducted across 14 comprehensive stroke centers in Spain from December 2023 through November 2025. Eligible patients were adults with anterior circulation large vessel occlusion who underwent thrombectomy within 24 hours of symptom onset and achieved substantial angiographic reperfusion. The intervention arm (n = 214) received alteplase at 0.225 mg/kg infused over 15 minutes via microcatheter positioned in the ipsilateral internal carotid artery. The control arm (n = 219) received thrombectomy alone. The primary endpoint was a 90-day modified Rankin scale (mRS) of 0-1, indicating excellent functional recovery. This was achieved by 57.5% (123/214) of the alteplase group compared to 42.5% (93/219) of controls (adjusted risk difference, 15.0%; 95% CI 5.7% to 24.3%; P = .002), with directional consistency across all prespecified subgroups. Among secondary endpoints, residual cerebral hypoperfusion on follow-up CT perfusion was present in 28.6% (55/192) of the alteplase arm versus 50.5% (96/190) of controls (adjusted risk difference, -22.0%; 95% CI -31.5 to -12.4%; P < .001). Health-related quality of life at 90 days was significantly higher in the alteplase group than in controls (adjusted risk difference, 0.07%; 95% CI 0.01 to 0.12; P = .02). Additionally, rates of symptomatic intracranial hemorrhage were comparable between groups (1.4% vs. 0.5%, adjusted OR, 3.10; 95% CI 0.32 to 30.0; P = .33). However, 90-day all-cause mortality was significantly higher in the alteplase group compared to the control group (12.1% vs. 6.4%, adjusted risk difference, 5.9%; 95% CI 0.5% to 11.3%; P = .03). Findings from this study suggested improved functional outcomes in patients treated with intra-arterial thrombolysis after thrombectomy, but the mortality signal in the alteplase group underscored the need for further large-scale, placebo-controlled, multinational investigation before this strategy can be incorporated into standard stroke care.
Image: PD
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