Mechanical Thrombectomy in and Outside the REVASCAT Trial: Insights From a Concurrent Population-Based Stroke Registry

BACKGROUND AND PURPOSE—Recent trials have shown the superiority of endovascular thrombectomy (EVT) over medical therapy alone in certain stroke patients with proximal arterial occlusion. Using data from the Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in...

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Veröffentlicht in:Stroke (1970) 2015-12, Vol.46 (12), p.3437-3442
Hauptverfasser: Urra, Xabier, Abilleira, Sònia, Dorado, Laura, Ribó, Marc, Cardona, Pere, Millán, Mònica, Chamorro, Angel, Molina, Carlos, Cobo, Erik, Dávalos, Antoni, Jovin, Tudor G, Gallofré, Miquel
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container_end_page 3442
container_issue 12
container_start_page 3437
container_title Stroke (1970)
container_volume 46
creator Urra, Xabier
Abilleira, Sònia
Dorado, Laura
Ribó, Marc
Cardona, Pere
Millán, Mònica
Chamorro, Angel
Molina, Carlos
Cobo, Erik
Dávalos, Antoni
Jovin, Tudor G
Gallofré, Miquel
description BACKGROUND AND PURPOSE—Recent trials have shown the superiority of endovascular thrombectomy (EVT) over medical therapy alone in certain stroke patients with proximal arterial occlusion. Using data from the Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke due to Anterior Circulation Large Vessel Occlusion Presenting Within 8-Hours of Symptom Onset (REVASCAT) and a parallel reperfusion treatment registry, we sought to assess the utilization of EVT in a defined patient population, comparing the outcomes of patients treated in and outside the REVASCAT trial. METHODS—SONIIA [Sistema Online d’Informació de l’Ictus Agut], a population-based, government-mandated, prospective registry of reperfusion therapies for stroke encompassing the entire population of Catalonia, was used as data source. The registry documents 5 key inclusion criteria of the REVASCAT trialage, stroke severity, time to treatment, baseline functional status, and occlusion site. We compared procedural, safety, and functional outcomes in patients treated inside and outside the trial. RESULTS—From November 2012 to December 2014, out of 17596 ischemic stroke patients in Catalonia (population 7.5 million), 2576 patients received reperfusion therapies (17/100000 inhabitants-year), mainly intravenous thrombolysis only (2036). From the remaining 540 treated with EVT, 103 patients (out of 206 randomized) were treated within REVASCAT and 437 outside the trial. Of these, 399 did not fulfill some of the study criteria, and 38 were trial candidates (8 treated at REVASCAT centers and 30 at 2 non-REVASCAT centers). The majority of procedural, safety, and functional outcomes were similar in patients treated with EVT within and outside REVASCAT. CONCLUSIONS—REVASCAT enrolled nearly all eligible patients representing one third of all patients treated with EVT. Patients treated with EVT within and outside REVASCAT had similar outcomes, reinforcing the therapeutic value of EVT. CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT01692379.
doi_str_mv 10.1161/STROKEAHA.115.011050
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Using data from the Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke due to Anterior Circulation Large Vessel Occlusion Presenting Within 8-Hours of Symptom Onset (REVASCAT) and a parallel reperfusion treatment registry, we sought to assess the utilization of EVT in a defined patient population, comparing the outcomes of patients treated in and outside the REVASCAT trial. METHODS—SONIIA [Sistema Online d’Informació de l’Ictus Agut], a population-based, government-mandated, prospective registry of reperfusion therapies for stroke encompassing the entire population of Catalonia, was used as data source. The registry documents 5 key inclusion criteria of the REVASCAT trialage, stroke severity, time to treatment, baseline functional status, and occlusion site. We compared procedural, safety, and functional outcomes in patients treated inside and outside the trial. RESULTS—From November 2012 to December 2014, out of 17596 ischemic stroke patients in Catalonia (population 7.5 million), 2576 patients received reperfusion therapies (17/100000 inhabitants-year), mainly intravenous thrombolysis only (2036). From the remaining 540 treated with EVT, 103 patients (out of 206 randomized) were treated within REVASCAT and 437 outside the trial. Of these, 399 did not fulfill some of the study criteria, and 38 were trial candidates (8 treated at REVASCAT centers and 30 at 2 non-REVASCAT centers). The majority of procedural, safety, and functional outcomes were similar in patients treated with EVT within and outside REVASCAT. CONCLUSIONS—REVASCAT enrolled nearly all eligible patients representing one third of all patients treated with EVT. Patients treated with EVT within and outside REVASCAT had similar outcomes, reinforcing the therapeutic value of EVT. CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. 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RESULTS—From November 2012 to December 2014, out of 17596 ischemic stroke patients in Catalonia (population 7.5 million), 2576 patients received reperfusion therapies (17/100000 inhabitants-year), mainly intravenous thrombolysis only (2036). From the remaining 540 treated with EVT, 103 patients (out of 206 randomized) were treated within REVASCAT and 437 outside the trial. Of these, 399 did not fulfill some of the study criteria, and 38 were trial candidates (8 treated at REVASCAT centers and 30 at 2 non-REVASCAT centers). The majority of procedural, safety, and functional outcomes were similar in patients treated with EVT within and outside REVASCAT. CONCLUSIONS—REVASCAT enrolled nearly all eligible patients representing one third of all patients treated with EVT. Patients treated with EVT within and outside REVASCAT had similar outcomes, reinforcing the therapeutic value of EVT. CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. 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source MEDLINE; American Heart Association Journals; Journals@Ovid Complete; Recercat; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection
subjects 92 Biology and other natural sciences
92C Physiological, cellular and medical topics
acute stroke
Aged
Aged, 80 and over
Classificació AMS
clinical trial
Female
Humans
Male
Matemàtica aplicada a les ciències
Matemàtiques i estadística
Mechanical Thrombolysis - methods
Medicina
Middle Aged
Population Surveillance - methods
Processament de dades
Programming (Mathematics)
Prospective Studies
Registries
registry
reperfusion
Retrospective Studies
Stroke - diagnosis
Stroke - epidemiology
Stroke - surgery
thrombectomy
Thrombectomy - methods
Àrees temàtiques de la UPC
title Mechanical Thrombectomy in and Outside the REVASCAT Trial: Insights From a Concurrent Population-Based Stroke Registry
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