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Intravenous tissue plasminogen activator (IV-tPA) has been demonstrated by randomized, blinded, controlled clinical trials to provide a statistically significant improvement in clinical outcome in acute ischemic stroke when administered within 4.5 h of onset to carefully selected patients.1–3 Outcomes are still poor in some eligible patients, including those with intracranial large artery thrombotic occlusions and many patients do not meet the stringent eligibility requirements.4 Intra-arterial therapies (IAT) to open large artery occlusions, both with thrombolytic drugs and mechanical devices, have been developed to address these needs. This review summarizes the current evidence for the safety and efficacy of these therapies.
All IAT carry substantial risks of causing neurological worsening. Rates of early symptomatic intracerebral hemorrhage in published studies are consistently 8–11%.5–10 These therapies cannot be considered safe when 1 in 10 patients will be worse off because of the treatment. However, they might still be clinically effective if the overall clinical benefit is sufficient to outweigh these adverse effects.
IAT with thrombolytic drugs has been studied by randomized, controlled clinical trials with clinical endpoints as primary outcome measures. In contrast, published studies of IAT with FDA approved devices for mechanical clot extraction or dissolution have all been single arm studies with no concurrent controls and primary outcome measures based on improving angiographic findings, not clinical outcomes.
Randomized controlled clinical trials of IAT with thrombolytic drugs
There have been five randomized, controlled clinical trials of IAT with thrombolytic drugs for acute ischemic stroke: The Australian Urokinase Stroke Trial, the SYNTHESIS (Local Versus Systemic Thrombolysis for Acute Ischemic Stroke) pilot study, PROACT (Prolyse in Acute Cerebral Thromboembolism Trial) I, PROACT II and MELT (Middle Cerebral Artery Embolism Local Fibrinolytic Intervention Trial). (An additional trial did not have randomized or concealed treatment allocation.11) The Australian Urokinase Stroke Trial was a 1:1 randomized, controlled, open label, blinded follow-up trial …
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