Aspiration Thrombectomy After Intravenous Alteplase Versus Intravenous Alteplase Alone

被引：230

作者：

Mocco, J. ^{[1
]}

Zaidat, Osama O. ^{[2
]}

von Kummer, Ruediger ^{[3
]}

Yoo, Albert J. ^{[4
]}

Gupta, Rishi ^{[5
]}

Lopes, Demetrius ^{[6
]}

Frei, Don ^{[7
]}

Shownkeen, Harish ^{[8
]}

Budzik, Ron ^{[9
]}

Ajani, Zahra A. ^{[10
]}

Grossman, Aaron ^{[11
]}

Altschul, Dorethea ^{[11
,27
]}

McDougall, Cameron ^{[12
]}

Blake, Lindsey ^{[13
]}

Fitzsimmons, Brian-Fred ^{[14
]}

Yavagal, Dileep ^{[15
]}

Terry, John ^{[16
]}

Farkas, Jeffrey ^{[17
]}

Lee, Seon Kyu ^{[18
]}

Baxter, Blaise ^{[19
]}

Wiesmann, Martin ^{[20
]}

Knauth, Michael ^{[21
]}

Heck, Donald ^{[22
]}

Hussain, Syed ^{[23
]}

Chiu, David ^{[24
]}

Alexander, Michael J. ^{[25
]}

Malisch, Timothy ^{[26
]}

Kirmani, Jawad ^{[28
]}

Miskolczi, Laszlo ^{[29
]}

Khatri, Pooja ^{[30
]}

机构：

[1] Mt Sinai Hlth Syst, New York, NY USA

[2] St Vincent Mercy Med Ctr, Toledo, OH USA

[3] Univ Klinikum Carl Gustav Carus, Dresden, Germany

[4] Texas Stroke Inst, Plano, TX USA

[5] WellStar Hlth Syst, Marietta, GA USA

[6] Rush Univ, Chicago, IL 60612 USA

[7] Swedish Med Ctr, Denver, CO USA

[8] Cent DuPage Hosp, Winfield, IL USA

[9] Riverside Methodist Hosp, Columbus, OH 43214 USA

[10] Kaiser Los Angeles, Los Angeles, CA USA

[11] St Josephs Reg Med Ctr, Paterson, NJ USA

[12] St Josephs BNI, Phoenix, AZ USA

[13] Sunrise Hosp & Med Ctr, Las Vegas, NV USA

[14] Med Coll Wisconsin, Milwaukee, WI 53226 USA

[15] Univ Miami Hlth Syst, Miami, FL USA

[16] Premier Clin Neurosci Inst, Dayton, OH USA

[17] Lutheran Med Ctr, Brooklyn, NY USA

[18] Univ Chicago, Med Ctr, Chicago, IL 60637 USA

[19] Erlanger Hlth Syst, Chattanooga, TN USA

[20] Univ Klinikum Aachen, Aachen, Germany

[21] Univ Med Gottingen, Gottingen, Germany

[22] Forsyth Med Ctr, Winston Salem, NC USA

[23] Sparrow Hosp, Lansing, MI USA

[24] Houston Methodist Hosp, Houston, TX USA

[25] Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA

[26] Alexian Bros, Elk Grove Village, IL USA

[27] Valley Hosp, Ridgewood, NJ USA

[28] JFK Med Ctr, Edison, NJ USA

[29] Holy Cross, Ft Lauderdale, FL USA

[30] Univ Cincinnati, Cincinnati, OH 45221 USA

来源：

STROKE | 2016年 / 47卷 / 09期

关键词：

embolectomy; stent; stroke; thrombectomy; thrombolytic therapy; ACUTE ISCHEMIC-STROKE; 1ST PASS TECHNIQUE; ENDOVASCULAR TREATMENT; T-PA; THROMBOLYSIS; EXPERIENCE; THERAPY; TRIAL; REVASCULARIZATION; RECANALIZATION;

D O I：

10.1161/STROKEAHA.116.013372

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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.

引用

页码：2331 / 2338

页数：8

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