Mechanical Thrombectomy in and Outside the REVASCAT Trial: Insights From a Concurrent Population-Based Stroke Registry.
OBJECTIVE
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 trial: age, 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.


BACKGROUND
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01692379.
From the Stroke Unit, Hospital Clínic, Barcelona, Spain (X.U., A.C.); August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain (X.U., A.C.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain (S.A., M.G.); Department of Neuroscience. Hospital Germans Trias, Badalona, Spain (L.D., M.M., A.D.); Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R., C.M.); Stroke Unit, Hospital de Bellvitge, L'Hospitalet de Llobregat, Spain (P.C.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); and Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.). xurra@clinic.cat.
Xabier
X
Urra
From the Stroke Unit, Hospital Clínic, Barcelona, Spain (X.U., A.C.); August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain (X.U., A.C.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain (S.A., M.G.); Department of Neuroscience. Hospital Germans Trias, Badalona, Spain (L.D., M.M., A.D.); Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R., C.M.); Stroke Unit, Hospital de Bellvitge, L'Hospitalet de Llobregat, Spain (P.C.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); and Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.).
Sònia
S
Abilleira
From the Stroke Unit, Hospital Clínic, Barcelona, Spain (X.U., A.C.); August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain (X.U., A.C.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain (S.A., M.G.); Department of Neuroscience. Hospital Germans Trias, Badalona, Spain (L.D., M.M., A.D.); Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R., C.M.); Stroke Unit, Hospital de Bellvitge, L'Hospitalet de Llobregat, Spain (P.C.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); and Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.).
Laura
L
Dorado
From the Stroke Unit, Hospital Clínic, Barcelona, Spain (X.U., A.C.); August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain (X.U., A.C.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain (S.A., M.G.); Department of Neuroscience. Hospital Germans Trias, Badalona, Spain (L.D., M.M., A.D.); Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R., C.M.); Stroke Unit, Hospital de Bellvitge, L'Hospitalet de Llobregat, Spain (P.C.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); and Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.).
Marc
M
Ribó
From the Stroke Unit, Hospital Clínic, Barcelona, Spain (X.U., A.C.); August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain (X.U., A.C.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain (S.A., M.G.); Department of Neuroscience. Hospital Germans Trias, Badalona, Spain (L.D., M.M., A.D.); Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R., C.M.); Stroke Unit, Hospital de Bellvitge, L'Hospitalet de Llobregat, Spain (P.C.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); and Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.).
Pere
P
Cardona
From the Stroke Unit, Hospital Clínic, Barcelona, Spain (X.U., A.C.); August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain (X.U., A.C.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain (S.A., M.G.); Department of Neuroscience. Hospital Germans Trias, Badalona, Spain (L.D., M.M., A.D.); Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R., C.M.); Stroke Unit, Hospital de Bellvitge, L'Hospitalet de Llobregat, Spain (P.C.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); and Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.).
Mònica
M
Millán
From the Stroke Unit, Hospital Clínic, Barcelona, Spain (X.U., A.C.); August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain (X.U., A.C.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain (S.A., M.G.); Department of Neuroscience. Hospital Germans Trias, Badalona, Spain (L.D., M.M., A.D.); Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R., C.M.); Stroke Unit, Hospital de Bellvitge, L'Hospitalet de Llobregat, Spain (P.C.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); and Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.).
Angel
A
Chamorro
From the Stroke Unit, Hospital Clínic, Barcelona, Spain (X.U., A.C.); August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain (X.U., A.C.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain (S.A., M.G.); Department of Neuroscience. Hospital Germans Trias, Badalona, Spain (L.D., M.M., A.D.); Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R., C.M.); Stroke Unit, Hospital de Bellvitge, L'Hospitalet de Llobregat, Spain (P.C.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); and Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.).
Carlos
C
Molina
From the Stroke Unit, Hospital Clínic, Barcelona, Spain (X.U., A.C.); August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain (X.U., A.C.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain (S.A., M.G.); Department of Neuroscience. Hospital Germans Trias, Badalona, Spain (L.D., M.M., A.D.); Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R., C.M.); Stroke Unit, Hospital de Bellvitge, L'Hospitalet de Llobregat, Spain (P.C.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); and Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.).
Erik
E
Cobo
From the Stroke Unit, Hospital Clínic, Barcelona, Spain (X.U., A.C.); August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain (X.U., A.C.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain (S.A., M.G.); Department of Neuroscience. Hospital Germans Trias, Badalona, Spain (L.D., M.M., A.D.); Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R., C.M.); Stroke Unit, Hospital de Bellvitge, L'Hospitalet de Llobregat, Spain (P.C.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); and Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.).
Antoni
A
Dávalos
From the Stroke Unit, Hospital Clínic, Barcelona, Spain (X.U., A.C.); August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain (X.U., A.C.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain (S.A., M.G.); Department of Neuroscience. Hospital Germans Trias, Badalona, Spain (L.D., M.M., A.D.); Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R., C.M.); Stroke Unit, Hospital de Bellvitge, L'Hospitalet de Llobregat, Spain (P.C.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); and Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.).
Tudor G
TG
Jovin
From the Stroke Unit, Hospital Clínic, Barcelona, Spain (X.U., A.C.); August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain (X.U., A.C.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain (S.A., M.G.); Department of Neuroscience. Hospital Germans Trias, Badalona, Spain (L.D., M.M., A.D.); Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R., C.M.); Stroke Unit, Hospital de Bellvitge, L'Hospitalet de Llobregat, Spain (P.C.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); and Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.).
Miquel
M
Gallofré
D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D061185:Mechanical Thrombolysis / Q000379:methods*; D008875:Middle Aged; D011159:Population Surveillance / Q000379:methods; D011446:Prospective Studies; D012042:Registries; D012189:Retrospective Studies; D020521:Stroke / Q000175:diagnosis* / Q000453:epidemiology / Q000601:surgery*; D017131:Thrombectomy / Q000379:methods
acute stroke; clinical trial; registry; reperfusion; thrombectomy