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在THERAPY试验中,血栓长度对动脉内抽吸血栓切除术预后的影响。

Impact of Thrombus Length on Outcomes After Intra-Arterial Aspiration Thrombectomy in the THERAPY Trial.

作者信息

Yoo Albert J, Khatri Pooja, Mocco J, Zaidat Osama O, Gupta Rishi, Frei Donald, Lopes Demetrius, Shownkeen Harish, Berkhemer Olvert A, Meyer Denise, Hak Susana S, Kuo Sophia S, Buell Hope, Bose Arani, Sit Siu Po, von Kummer Rüdiger

机构信息

From the Texas Stroke Institute, Dallas, (A.J.Y.); University of Cincinnati, OH (P.K.); Mount Sinai Health System, New York (J.M.); St. Vincent Mercy Medical Center, Toledo, OH (O.O.Z.); WellStar Health System, Marietta, GA (R.G.); Swedish Medical Center, Englewood, CO (D.F.); Rush University, Chicago, IL (D.L.); Central DuPage Hospital, Winfield, IL (H.S.); Amsterdam Medical Center, the Netherlands (O.A.B.); Academic Medical Center Amsterdam, Erasmus MC University Medical Center Rotterdam, the Netherlands (O.A.B.); Maastricht University Medical Center, the Netherlands (O.A.B.); Penumbra, Inc, Alameda, CA (D.M., S.S.H., S.S.K., H.B., A.B., S.P.S.); and Universitätsklinikum Carl Gustav Carus, Dresden, Germany (R.v.K.).

出版信息

Stroke. 2017 Jul;48(7):1895-1900. doi: 10.1161/STROKEAHA.116.016253. Epub 2017 Jun 8.

DOI:10.1161/STROKEAHA.116.016253
PMID:28596447
Abstract

BACKGROUND AND PURPOSE

Increasing thrombus length (TL) impedes recanalization after intravenous (IV) thrombolysis. We sought to determine whether the clinical benefit of aspiration thrombectomy relative to IV r-tPA (recombinant tissue-type plasminogen activator) may be greater at longer TL.

METHODS

THERAPY was a randomized trial of aspiration thrombectomy plus IV r-tPA versus IV r-tPA alone in large-vessel stroke patients with prospective TL measurement ≥8 mm. In this post hoc study, we evaluated the association of TL with trial end points and potential endovascular treatment effect, using univariate, multivariable, and multiplicative interaction analyses.

RESULTS

TL data were available for all 108 patients (28% internal carotid artery, 62% M1, and 10% M2). Median TL was 14.0 mm (interquartile range, 9.7-19.5 mm). Longer TL was associated with worse outcome (90-day modified Rankin Scale score: odds ratio, 1.24 per 5-mm TL increment; 95% confidence interval, 1.04-1.52; =0.02), even after adjusting for key outcome predictors (adjusted =0.004). Longer TL was also associated with more serious adverse events (adjusted =0.01), more symptomatic hemorrhages (adjusted =0.03), and increased mortality (adjusted =0.01). No significant relationship was observed between TL and angiographic reperfusion (modified thrombolysis in cerebral ischemia 2b-3), but greater TL was associated with longer endovascular procedural times (ρ=0.36; =0.045). Increasing TL was associated with greater aspiration thrombectomy treatment effect (interaction term =0.03). This might be related to a potentially stronger adverse effect of increasing TL on 90-day modified Rankin Scale for patients treated with IV r-tPA (ρ=0.39; =0.01) compared with intra-arterial therapy (ρ=0.20; =0.165).

CONCLUSIONS

Ischemic stroke patients with longer symptomatic thrombi have worse 90-day clinical outcomes but may have a greater relative benefit of aspiration thrombectomy over IV r-tPA alone.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT01429350.

摘要

背景与目的

静脉溶栓后血栓长度(TL)增加会阻碍血管再通。我们试图确定在血栓长度较长时,相对于静脉注射重组组织型纤溶酶原激活剂(r-tPA),取栓术的临床获益是否更大。

方法

THERAPY是一项针对大血管卒中患者的随机试验,比较单独静脉注射r-tPA与取栓术联合静脉注射r-tPA的疗效,这些患者的前瞻性血栓长度测量值≥8mm。在这项事后分析研究中,我们使用单变量、多变量和乘法交互分析评估血栓长度与试验终点及潜在血管内治疗效果之间的关联。

结果

108例患者均有血栓长度数据(28%为颈内动脉,62%为M1段,10%为M2段)。中位血栓长度为14.0mm(四分位间距为9.7 - 19.5mm)。即使在对关键预后预测因素进行校正后,血栓长度越长,预后越差(90天改良Rankin量表评分:每增加5mm血栓长度,比值比为1.24;95%置信区间为1.04 - 1.52;P = 0.02)(校正后P = 0.004)。血栓长度越长,严重不良事件也越多(校正后P = 0.01),有症状性出血更多(校正后P = 0.03),死亡率增加(校正后P = 0.01)。未观察到血栓长度与血管造影再通(改良脑缺血溶栓分级2b - 3级)之间存在显著关系,但血栓长度越长,血管内手术时间越长(Spearman相关系数ρ = 0.36;P = 0.045)。血栓长度增加与取栓术治疗效果增强相关(交互项P = 0.03)。这可能与血栓长度增加对静脉注射r-tPA治疗患者90天改良Rankin量表评分的潜在不良影响更强有关(Spearman相关系数ρ = 0.39;P = 0.01),而与动脉内治疗相比影响较弱(Spearman相关系数ρ = 0.20;P = 0.165)。

结论

有症状血栓较长的缺血性卒中患者90天临床预后较差,但相对于单独静脉注射r-tPA,取栓术可能具有更大的相对获益。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT01429350。

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