Sònia Abilleira Castells, neurologist. Plan for Cerebral Vascular Disease
A clinical trial conducted entirely in Catalonia with the participation of four tertiary stroke hospitals and the support of the master plan for cerebral vascular disease, showed that treatment with catheters in the acute phases of severe ischemic stroke is crucial for good clinical outcomes.
Ischemic stroke causes around 8,500 annual hospitalizations in Catalonia. An estimated 70% of patients are either dead or are in a situation of dependency within 5-years of the stroke. Until now, the only treatment available to us was a drug administered intravenously in the first 4.5 hours of the stroke achieving lysis or a rupture of the thrombus which for a percentage of the patients increased the likelihood of survival without significant neurological sequels. This treatment, known as intravenous thrombolysis has a very low efficiency when the thrombus is located on a main artery of the brain which happens in 25% of cases, translating clinically into more severe strokes.
Besides clinical reasons, time also plays a key role in determining both the appropriateness and effectiveness of intravenous thrombolytic therapy and, as in other time dependent pathologies, the organization of the different care levels integrated in the health system is key to ensuring that the patient arrives early at a suitable hospital with necessary technology and skilled professionals. Thus, in May 2006 the master plan of cerebral vascular disease launched an organized territorial model based on a stroke code system in order to improve patients’ access to intravenous thrombolysis, the only scientific evidence-based treatment, from a wide territorial perspective. The outcome of this care model in Catalonia between 2006 and 2014 has seen a very important increase both in the number of acute patients cared for via activation of the stroke code, as well as in the number of patients receiving reperfusion treatment. Since 2011, all this therapeutic activity is collected prospectively in the register of population reperfusion “Online Acute Stroke Information System “.
Conducting this randomized REVASCAT clinical trial (clinicalTrials.gov, NCT01692379) has been undertaken in this well organized territorial context at a time when, although many believed that stroke treatment with catheters was the most efficient, the certainty was that the effect had not been proven in any of the clinical trials. REVASCAT randomized the first patient on November 24, 2012 and in a record time of only two years and with only 4 involved hospitals it has managed to recruit 206 patients. The main objectives of REVASCAT were: (1) to determine the efficacy and safety of mechanical thrombectomy with Solitaire performed within 8 hours of stroke compared with the best medical treatment and (2) establishing the proportion of eligible patients treated outside the clinical trial. REVASCAT has proven that patients treated with mechanical thrombectomy quadruple the chances of having more autonomy in their daily lives; increased by 70% the options of recovering their functional capacity; reduced to more than half the size of the final cerebral infarct caused by stroke, and have a perception of significantly improved post-stroke life quality. Finally, the unique and distinctive aspect of REVASCAT is that the coexistence of the reperfusion register of Catalonia allowed detection of only 8 trial drop outs. This fact is crucial as it ensures that the results are generally applicable to the target population.
The REVASCAT results were presented for the first time in the congress of the European Stroke Organisation (17-19/04/2015, Glasgow) coinciding with the publication in the New England Journal of Medicine.