{"id":22154,"date":"2022-08-19T05:04:00","date_gmt":"2022-08-18T21:04:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=22154"},"modified":"2022-08-19T05:21:52","modified_gmt":"2022-08-18T21:21:52","slug":"22154","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=22154","title":{"rendered":"[Lancet\u53d1\u8868\u8bba\u6587]\uff1a\u5352\u4e2d\u53d1\u75c54.5\u5185\u8840\u7ba1\u5185\u53d6\u6813\u4e0e\u6807\u51c6\u6865\u63a5\u6eb6\u6813\u540e\u8840\u7ba1\u5185\u53d6\u6813"},"content":{"rendered":"\n

Articles<\/p>\n\n\n\n

Endovascular thrombectomy versus standard bridging thrombolytic with endovascular thrombectomy within 4\u00b75 h of stroke onset: an open-label, blinded-endpoint, randomised non-inferiority trial<\/h1>\n\n\n\n

Peter J Mitchell, Bernard Yan, Leonid Churilov, et al<\/h3>\n\n\n\n

Lancet 2022; 400: 116-125<\/h3>\n\n\n\n

https:\/\/doi.org\/10.1016\/S0140-6736(22)00564-5<\/h3>\n\n\n\n

Summary<\/h2>\n\n\n\n

Background<\/h3>\n\n\n\n

The benefit of combined treatment with intravenous thrombolysis<\/a> before endovascular thrombectomy<\/a> in patients with acute ischaemic stroke<\/a> caused by large vessel occlusion remains unclear. We hypothesised that the clinical outcomes of patients with stroke with large vessel occlusion treated with direct endovascular thrombectomy<\/a> within 4\u00b75 h would be non-inferior compared with the outcomes of those treated with standard bridging therapy (intravenous thrombolysis before endovascular thrombectomy).<\/p>\n\n\n\n

Methods<\/h3>\n\n\n\n

DIRECT-SAFE was an international, multicentre, prospective, randomised, open-label, blinded-endpoint trial. Adult patients with stroke and large vessel occlusion in the intracranial internal carotid artery<\/a>, middle cerebral artery<\/a> (M1 or M2), or basilar artery<\/a>, confirmed by non-contrast CT and vascular imaging, and who presented within 4\u00b75 h of stroke onset were recruited from 25 acute-care hospitals in Australia, New Zealand, China, and Vietnam. Eligible patients were randomly assigned (1:1) via a web-based, computer-generated randomisation procedure stratified by site of baseline arterial occlusion<\/a> and by geographic region to direct endovascular thrombectomy or bridging therapy. Patients assigned to bridging therapy received intravenous thrombolytic<\/a> (alteplase or tenecteplase) as per standard care at each site; endovascular thrombectomy was also per standard of care, using the Trevo device (Stryker Neurovascular, Fremont, CA, USA) as first-line intervention. Personnel assessing outcomes were masked to group allocation; patients and treating physicians were not. The primary efficacy endpoint was functional independence defined as modified Rankin Scale<\/a> score 0\u20132 or return to baseline at 90 days, with a non-inferiority margin of \u20130\u00b71, analysed by intention to treat<\/a> (including all randomly assigned and consenting patients) and per protocol. The intention-to-treat population was included in the safety analyses. The trial is registered with ClinicalTrials.gov, NCT03494920, and is closed to new participants.<\/p>\n\n\n\n

Findings<\/h3>\n\n\n\n

Between June 2, 2018, and July 8, 2021, 295 patients were randomly assigned to direct endovascular thrombectomy (n=148) or bridging therapy (n=147). Functional independence occurred in 80 (55%) of 146 patients in the direct thrombectomy group and 89 (61%) of 147 patients in the bridging therapy group (intention-to-treat risk difference \u20130\u00b7051, two-sided 95% CI \u20130\u00b7160 to 0\u00b7059; per-protocol risk difference \u20130\u00b7062, two-sided 95% CI \u20130\u00b7173 to 0\u00b7049). Safety outcomes were similar between groups, with symptomatic intracerebral haemorrhage<\/a> occurring in two (1%) of 146 patients in the direct group and one (1%) of 147 patients in the bridging group (adjusted odds ratio 1\u00b770, 95% CI 0\u00b722\u201313\u00b704) and death in 22 (15%) of 146 patients in the direct group and 24 (16%) of 147 patients in the bridging group (adjusted odds ratio 0\u00b792, 95% CI 0\u00b746\u20131\u00b784).<\/p>\n\n\n\n

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Interpretation<\/h3>\n\n\n\n

We did not show non-inferiority of direct endovascular thrombectomy compared with bridging therapy. The additional information from our study should inform guidelines to recommend bridging therapy as standard treatment.<\/p>\n\n\n\n

Funding<\/h3>\n\n\n\n

Australian National Health and Medical Research Council and Stryker USA.<\/p>\n","protected":false},"excerpt":{"rendered":"

Articles Endovascular thrombectomy versus standard brid […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/22154"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=22154"}],"version-history":[{"count":2,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/22154\/revisions"}],"predecessor-version":[{"id":22157,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/22154\/revisions\/22157"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=22154"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=22154"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=22154"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}