REVASCAT试验内外的机械取栓术：基于人群的同期卒中登记研究的见解
Mechanical Thrombectomy in and Outside the REVASCAT Trial: Insights From a Concurrent Population-Based Stroke Registry.
作者信息
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
机构信息
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.).
出版信息
Stroke. 2015 Dec;46(12):3437-42. doi: 10.1161/STROKEAHA.115.011050. Epub 2015 Oct 27.
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 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.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01692379.
背景与目的
近期试验表明，在某些近端动脉闭塞的中风患者中，血管内血栓切除术（EVT）优于单纯药物治疗。利用来自“Solitaire FR 装置血管再通与最佳药物治疗对比治疗症状发作 8 小时内急性前循环大血管闭塞性卒中的随机试验（REVASCAT）”的数据以及一个平行的再灌注治疗登记系统，我们试图评估在特定患者群体中 EVT 的应用情况，比较 REVASCAT 试验内和试验外接受治疗患者的结局。
方法
SONIIA [急性卒中在线信息系统]，一个基于人群、政府授权的前瞻性卒中再灌注治疗登记系统，涵盖加泰罗尼亚全体人口，用作数据源。该登记系统记录了 REVASCAT 试验的 5 个关键纳入标准：年龄、卒中严重程度、治疗时间、基线功能状态和闭塞部位。我们比较了试验内和试验外接受治疗患者的手术、安全性和功能结局。
结果
2012 年 11 月至 2014 年 12 月，在加泰罗尼亚 17596 例缺血性卒中患者（人口 750 万）中，2576 例患者接受了再灌注治疗（17/100000 居民 - 年），主要仅为静脉溶栓（2036 例）。在其余 540 例接受 EVT 治疗的患者中，103 例（206 例随机分组中的）在 REVASCAT 试验内接受治疗，437 例在试验外接受治疗。其中，399 例未满足部分研究标准，38 例为试验候选者（8 例在 REVASCAT 中心接受治疗，30 例在 2 个非 REVASCAT 中心接受治疗）。REVASCAT 试验内和试验外接受 EVT 治疗的患者，大多数手术、安全性和功能结局相似。
结论
REVASCAT 纳入了几乎所有符合条件的患者，这些患者占所有接受 EVT 治疗患者的三分之一。REVASCAT 试验内和试验外接受 EVT 治疗的患者结局相似，强化了 EVT 的治疗价值。
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