Cost-effectiveness analyses and LOng Term follow-up in patients randomised in a Multicenter Randomized CLinical trial of Endovascular treatment for Acute ischemic stroke in The Netherlands

The current study describes a cost-effectiveness analysis on top of a large clinical trial investigating the effect of
endovascular treatment on overall functional outcome after acute ischemic stroke. This so-called MR CLEAN trial is funded by the Netherlands Heart Foundation and is including patients since 2010. It will generate data on
efficacy, safety and effectiveness of cerebral endovascular treatment, and will provide important information on logistics and implementation of endovascular treatment in the Netherlands. However, it is also mandatory to study the cost effectiveness of this new and expensive treatment modality and assess its health care budget impact before large scale implementation eventually starts. The MR CLEAN trial is an ideal setting for measuring the societal costs related to endovascular treatment after strok. The current study will measure all direct and indirect medical as well as direct non-medical costs of treating stroke patients in the trial, thereby enabling a full economic evaluation of cerebral endovascular treatment (against standard care) from a societal perspective with the costs per patient with poor outcome and the costs per quality-adjusted life year as the outcome parameters. The time horizon will be two years. Long-term consequences of endovascular treatment in patients with cerebral infarction beyond two years until the end of life will be addressed in a model-based analysis assuming different scenarios of natural courses of stroke. In addition, a budget impact analysis is proposed by combining the health care cost data with national incidence and prevalence estimates of stroke. The MR CLEAN trial itself will answer the question whether higher recanalization rates improve functional outcome and quality of life. The current proposal will investigate whether the treatment can be considered to be cost-effective and what the Dutch Health Care budget impact will be.

3 months, 6 months, 1 year, 1,5 years and 2 years

endovascular treatment consist of arterial catheterization with a microcatheter to the level of occlusion and delivery of a thrombolytic agent and/ or mechanical thrombectomy.
Both alteplase and urokinase for intra-arterial thrombolysis is allowed into the trial, a dose of 1 mg alteplase is considered to be equivalent to 10.000-15.000 U urokinase.44
Mechanical treatment may consist of mechanical thrombectomy, aspiration, or stenting. Specific recommendations with regards to procedures and devices will be issued regularly by the trial steering committee.