Thrombectomy in patients ineligible for iv tPA (THRILL)

被引：13

作者：

Bendszus, Martin ^{[1
]}

Thomalla, Goetz ^{[2
]}

Knauth, Michael ^{[3
]}

Hacke, Werner ^{[4
]}

Bonekamp, Susanne ^{[1
]}

Fiehler, Jens ^{[5
]}

机构：

[1] Heidelberg Univ, Neuroradiol, D-69120 Heidelberg, Germany

[2] Univ Med Ctr Hamburg Eppendorf UKE, Dept Neurol, Hamburg, Germany

[3] Univ Med Goettingen, Neuroradiol, Gottingen, Germany

[4] Heidelberg Univ, Neurol, D-69120 Heidelberg, Germany

[5] Univ Med Ctr Hamburg Eppendorf, Neurol, Hamburg, Germany

来源：

INTERNATIONAL JOURNAL OF STROKE | 2015年 / 10卷 / 06期

关键词：

acute stroke therapy; clinical trial; intervention; ischemic stroke; treatment; tPA; ACUTE ISCHEMIC-STROKE; REVASCULARIZATION; THROMBOLYSIS;

D O I：

10.1111/ijs.12527

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

RationaleA relevant proportion of patients with acute ischemic stroke are ineligible for intravenous thrombolysis with recombinant tissue plasminogen activator. Mechanical thrombectomy offers a treatment alternative for these patients; however, only few data are available on its safety and efficacy. Aims and/or hypothesisThe aim of this study was to compare safety and efficacy of stent retrievers as device class with best medical care alone in acute stroke patients with large intracranial vessel occlusion in the anterior circulation who are not eligible for intravenous thrombolysis with recombinant tissue plasminogen activator up to eight-hours of symptom onset. DesignThrombectomy in patients ineligible for iv tPA' is a prospective, open-label, blinded end-point, binational (Germany and Austria), two-arm, randomized, controlled, post-market study. Study outcome(s)Primary end-point is the modified Rankin Score shift analysis 90 days (14) after stroke. Secondary end-points are excellent neurological outcomes (modified Rankin Score1), good neurological outcomes (modified Rankin Score2 or National Institutes of Health Stroke Scale improvement10), difference between predicted infarct volume and actual core infarct volume (computed tomography or magnetic resonance imaging) at 30 (+/- 6)h post-ictus, successful recanalization (thrombolysis in cerebral infarction score 2b or 3), functional health status 90 (+/- 14) days after stroke (European Quality of Life-5 Dimensions) as well as common safety end-points (adverse event, serious adverse event, symptomatic intracranial haemorrhage at 30 (+/- 6)h, death, or dependency). DiscussionWhether mechanical thrombectomy in patients with acute ischemic stroke who are not eligible for intravenous thrombolysis with recombinant tissue plasminogen activator improves clinical outcomes is unclear. Thrombectomy in patients ineligible for iv tPA' may change clinical practice by providing evidence of an effective and safe treatment for such patients.

引用

页码：950 / 955

页数：6

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