静脉注射阿替普酶后进行抽吸血栓切除术与单纯静脉注射阿替普酶的比较。
Aspiration Thrombectomy After Intravenous Alteplase Versus Intravenous Alteplase Alone.
作者信息
Mocco J, Zaidat Osama O, von Kummer Rüdiger, Yoo Albert J, Gupta Rishi, Lopes Demetrius, Frei Don, Shownkeen Harish, Budzik Ron, Ajani Zahra A, Grossman Aaron, Altschul Dorethea, McDougall Cameron, Blake Lindsey, Fitzsimmons Brian-Fred, Yavagal Dileep, Terry John, Farkas Jeffrey, Lee Seon Kyu, Baxter Blaise, Wiesmann Martin, Knauth Michael, Heck Donald, Hussain Syed, Chiu David, Alexander Michael J, Malisch Timothy, Kirmani Jawad, Miskolczi Laszlo, Khatri Pooja
机构信息
From the Mount Sinai Health System, New York, NY (J.M.); St. Vincent Mercy Medical Center, Toledo, OH (O.O.Z.); Universitätsklinikum Carl Gustav Carus, Dresden, Germany (R.v.K.); Texas Stroke Institute, Plano (A.J.Y.); WellStar Health System, Marietta, GA (R.G.); Rush University, Chicago, IL (D.L.); Swedish Medical Center, Denver, CO (D.F.); Central DuPage Hospital, Winfield, IL (H.S.); Riverside Methodist Hospital, Columbus, OH (R.B.); Kaiser Los Angeles, CA (Z.A.A.); St. Joseph's Regional Medical Center, Paterson, NJ (A.G., D.A.); St. Joseph's BNI, Phoenix, AZ (C.M.); Sunrise Hospital and Medical Center, Las Vegas, NV (L.B.); Medical College of Wisconsin, Milwaukee (B.-F.F.); University of Miami Health System, FL (D.Y.); Premier Clinical Neuroscience Institute, Dayton, OH (J.T.); Lutheran Medical Center, Brooklyn, NY (J.F.); University of Chicago Medical Center, IL (S.K.L.); Erlanger Health System, Chattanooga, TN (B.B.); Universitätsklinikum Aachen, Germany (M.W.); Universitätsmedizin Göttingen, Germany (M.K.); Forsyth Medical Center, Winston-Salem, NC (D.H.); Sparrow Hospital, Lansing, MI (S.H.); Houston Methodist Hospital, TX (D.C.); Cedars-Sinai Medical Center, Los Angeles, CA (M.J.A.); Alexian Brothers, Elk Grove, IL (T.M.); The Valley Hospital, Ridgewood, NJ (D.A.); JFK Medical Center, Edison, NJ (J.K.); Holy Cross, Fort Lauderdale, FL (L.M.); and University of Cincinnati, OH (P.K.).
出版信息
Stroke. 2016 Sep;47(9):2331-8. doi: 10.1161/STROKEAHA.116.013372. Epub 2016 Aug 2.
BACKGROUND AND PURPOSE
Thrombectomy, primarily with stent retrievers with or without adjunctive aspiration, provided clinical benefit across multiple prospective randomized trials. Whether this benefit is exclusive to stent retrievers is unclear.
METHODS
THERAPY (The Randomized, Concurrent Controlled Trial to Assess the Penumbra System's Safety and Effectiveness in the Treatment of Acute Stroke; NCT01429350) was an international, multicenter, prospective, randomized (1:1), open label, blinded end point evaluation, concurrent controlled clinical trial of aspiration thrombectomy after intravenous alteplase (IAT) administration compared with intravenous-alteplase alone in patients with large vessel ischemic stroke because of a thrombus length of ≥8 mm. The primary efficacy end point was the percent of patients achieving independence at 90 days (modified Rankin Scale score, 0-2; intention-to-treat analysis). The primary safety end point was the rate of severe adverse events (SAEs) by 90 days (as treated analysis). Patients were randomized 1:1 across 36 centers in 2 countries (United States and Germany).
RESULTS
Enrollment was halted after 108 (55 IAT and 53 intravenous) patients (of 692 planned) because of external evidence of the added benefit of endovascular therapy to intravenous-alteplase alone. Functional independence was achieved in 38% IAT and 30% intravenous intention-to-treat groups (P=0.52). Intention-to-treat ordinal modified Rankin Scale odds ratio was 1.76 (95% confidence interval, 0.86-3.59; P=0.12) in favor of IAT. Secondary efficacy analyses all demonstrated a consistent direction of effect toward benefit of IAT. No differences in symptomatic intracranial hemorrhage rates (9.3% IAT versus 9.7% intravenous, P=1.0) or 90-day mortality (IAT: 12% versus intravenous: 23.9%, P=0.18) were observed.
CONCLUSIONS
THERAPY did not achieve its primary end point in this underpowered sample. Directions of effect for all prespecified outcomes were both internally and externally consistent toward benefit. It is possible that an alternate method of thrombectomy, primary aspiration, will benefit selected patients harboring large vessel occlusions. Further study on this topic is indicated.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01429350.
背景与目的
血栓切除术，主要是使用或不使用辅助抽吸的支架取栓器，在多项前瞻性随机试验中均显示出临床获益。尚不清楚这种获益是否仅局限于支架取栓器。
方法
THERAPY（评估Penumbra系统治疗急性卒中安全性和有效性的随机、同期对照试验；NCT01429350）是一项国际多中心前瞻性随机（1:1）开放标签、盲终点评估的同期对照临床试验，比较了静脉注射阿替普酶（IAT）后进行抽吸血栓切除术与单纯静脉注射阿替普酶在血栓长度≥8mm的大血管缺血性卒中患者中的疗效。主要疗效终点是90天时达到独立的患者百分比（改良Rankin量表评分，0 - 2；意向性分析）。主要安全性终点是90天时严重不良事件（SAE）发生率（实际治疗分析）。患者在2个国家（美国和德国）的36个中心按1:1随机分组。
结果
在纳入了108例（计划纳入692例中的）患者（55例IAT组和53例静脉注射组）后，由于有外部证据表明血管内治疗相对于单纯静脉注射阿替普酶有额外获益，试验提前终止。意向性分析中，IAT组和静脉注射组分别有38%和30%的患者实现功能独立（P = 0.52）。意向性分析的序贯改良Rankin量表优势比为1.76（95%置信区间，0.86 - 3.59；P = 0.12），倾向于IAT组。次要疗效分析均显示出IAT组有获益的一致效应方向。在症状性颅内出血发生率（IAT组为9.3%，静脉注射组为9.7%，P = 1.0）或90天死亡率（IAT组：12%，静脉注射组：23.9%，P = 0.18）方面未观察到差异。
结论
THERAPY在这个样本量不足的试验中未达到其主要终点。所有预先设定结局的效应方向在内部和外部均一致显示为有获益。一种替代的血栓切除方法，即单纯抽吸，可能会使部分患有大血管闭塞的患者获益。对此主题有必要进行进一步研究。
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