Journal of Neuroradiology (2015) 42, 65—66

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EDITORIAL

The long way to positive trials for mechanical thrombectomy in acute ischemic stroke The proposal for using endovascular treatment (EVT) in the management of acute ischemic stroke (AIS) started more than 30 years ago with the first publication of Zeumer et al. [1]. Clinical validation of EVT in this indication was a very long process with successive technical developments and alternating positive and negative trials [2]. Year 2013 was the ‘‘annus horribilis’’ for EVT in AIS with the simultaneous publication of 3 randomized controlled trials (RCT) showing no superiority of EVT versus medical management (including IV thrombolysis) [3—5]. However, it soon became obvious that these 3 trials had a number of limitations, including the fact that for some of them demonstration of a large vessel occlusion (LVO) was not a criterion for patient’s selection (IMS III and SYNTHESIS) and that multiple EV techniques that were used were already obsolete at the time of publications [6,7]. Year 2015 will finally be the year of the success for EVT with 5 trials showing mechanical thrombectomy to be superior to medical treatment in the management of patients with AIS (Table 1). MR CLEAN was published at the very beginning of 2015 and showed an increased rate of functional independence in the EVT group (32.6%) compared to the usual care group (19.1%) with an absolute difference of 13.5% [8]. In contrast to the IMS 3, MR RESCUE, and SYNTHESIS trials, 190 out the 196 (96.9%) patients who effectively received EVT were treated with stent-retrievers. Subgroup analysis showed the benefit of mechanical thrombectomy in elderly patients and in patients with associated extracranial internal carotid artery occlusion and the very limited benefit of EVT in patients with low ASPECT score. MR CLEAN positive results prompted intermediate analysis in several RCTs (ESCAPE, EXTEND-IA, SWIFT PRIME) dealing with mechanical thrombectomy that showed again positive results for this technique [9,10]. A total of 316 patients underwent randomization in ESCAPE before the trial was stopped: 165 in the thrombectomy group and 150 http://dx.doi.org/10.1016/j.neurad.2015.03.001 0150-9861/© 2015 Published by Elsevier Masson SAS.

in the control group. Stent-retrievers were used in 86.1% of patients in the thrombectomy group. The adjusted risk ratio for a mRS shift with thrombectomy at 90 days was 3.1. A mRS of 0—2 at 90 days was observed in 53.0% in thrombectomy vs. 29.3% in controls (P < 0.001). Mortality was significantly lower in intervention group (10.4%) compared to 19.0% in control group. All subgroups of patients had similar benefit, including the elderly. EXTEND-IA trial was prematurely stopped because of a positive interim analysis of the first 70 randomized patients (35 in the intervention group and 35 in the control group). All patients in the intervention group were treated with Solitaire. Early reperfusion of the ischemic tissue at 24 h hours was 100% in intervention group vs. 37% in the control group (P < 0.001). Early neurologic improvement (NIHSS reduction ≥ 8 points or NIHSS 0-1 at 3 days) was 80% in intervention group vs 37% in the control group (P < 0.001). mRS 0—2 at 90 days was 71% in thrombectomy patients and 40% in controls (P < 0.01). There was a trend towards reduction of mortality in intervention group (9% versus 20% in control group; P = 0.18). SWIFT PRIME results are still unpublished. Finally, THRACE intermediate analysis performed after the announcement at International Stroke Conference 2015 in Nashville of the positive results of the above-mentioned trials also showed positive results for mechanical thrombectomy as announced just few days ago to the participating centers. After the positive results of MR CLEAN, ESCAPE, EXTENDIA, and SWIFT PRIME, recommendations were rapidly published on line by ESO/ESMINT/ESNR, including the following: • mechanical thrombectomy, in addition to intravenous thrombolysis within 4.5 hours when eligible, is recommended to treat acute stroke patients with large artery occlusions in the anterior circulation up to 6 hours after symptom onset (Grade A, Level 1a, KSU Grade A);

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Editorial

Table 1

Summary of the results of MR CLEAN, ESCAPE, EXTEND-IA, and SWIFT PRIME.

Patients NIHSS Control EVT Stent-retriever mRs 0—2 Control EVT Death Control EVT NTTa a

MR CLEAN

ESCAPE

EXTEND-IA

SWIFT PRIME

502

316

70

196

18 17 97.4%

17 16 86.1%

13 17 100.0%

17 17 100.0%

19.1% 32.6%

29.3% 53.0%

40.0% 71.4%

35.5% 60.2%

18.4% 18.9% 7.4

19.0% 10.4% 4

20.0% 8.6% 3.2

12.4% 9.2% 4

Number needed to treat.

• mechanical thrombectomy should be performed as soon as possible after its indication (Grade A, Level 1a, KSU Grade A); • for mechanical thrombectomy, stent-retrievers approved by local health authorities should be considered (Grade A, Level 1a, KSU Grade A). The positive trials as well as the new recommendations will have a tremendous impact on the management of patients with AIS and also on the organization of stroke care system, as it will be necessary to offer this demanding treatment by well-trained interventional neuroradiologists to all patients without delay [11]. Further trials will be necessary to analyze with precision the technical refinements that can improve the results of medical thrombectomy with stent-retrievers (general anesthesia/conscious sedation, Use of balloon guiding catheter, type of aspiration to be used. . .) and also to precisely define arterial occlusion type, brain pathology, and finally the time window in which EVT is indicated for patients with anterior or posterior circulation stroke as well as the management of patients with wake-up stroke [12]. In conclusion, year 2015 is an important milestone for the management of patients with AIS and in the field of INR, but we are just at the beginning of the story and the full involvement of the INR community will be necessary to implement this technique in the daily management of the patients and to improve it.

References [1] Zeumer H, Hacke W, Kolmann HL, et al. Local fibrinolysis in basilar artery thrombosis. Dtsch Med Wochenschr 1982;107:728—31. [2] Pierot L, Soize S, Benaissa A, et al. Evolution of the techniques for the endovascular treatment of acute ischemic stroke: from intra-arterial thrombolytics to stent-retrievers. Stroke 2015. [3] Broderick JP, Palesch YY, Demchuk AM, et al. Endovascular treatment after intravenous t-PA versus t-PA alone for stroke. N Engl J Med 2013;368:893—903.

[4] Ciccone A, Valvassori L, Nichelatti M, et al. Endovascular treatment for acute ischemic stroke. N Engl J Med 2013;368:904—13. [5] Kidwell CS, Jahan R, Gornbein J, et al. A trial of imaging selection and endovascular treatment for ischemic stroke. N Engl J Med 2013;368:914—23. [6] Pierot L, Gralla J, Cognard C, et al. Mechanical thrombectomy after IMS III, synthesis, and MR-RESCUE. AJNR Am J Neuroradiol 2013;34:1671—3. [7] Pierot L, Söderman M, Bendszus M, et al. Statement of ESMINT and ESNR regarding recent trials evaluating the endovascular treatment at the acute stage of ischemic stroke. Neuroradiology 2013;55:1313—8. [8] Berkhemer OA, Fransen PSS, Beumer D, et al. A randomized trial for intraarterial treatment for acute ischemic stroke. N Engl J Med 2015;372:11—20. [9] Goyal M, Demchuk AM, Menon BK, et al. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med 2015. [10] Campbell BC, Mitchell PJ, Kleinig TJ, et al. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med 2015. [11] Flodmark O, Grisold W, Richling B, et al. Training of future interventional neuroradiologists: the European approach. Stroke 2012;43:2810—3. [12] Soize S, Kadziolka K, Estrade L, et al. Mechanical thrombectomy in acute stroke: prospective pilot trial of the Solitaire FR device while under conscious sedation. AJNR Am J Neuroradiol 2013;34:360—5.

Laurent Pierot ∗ Department of Neuroradiology, Hôpital Maison Blanche, CHU Reims, University Reims-Champagne-Ardenne, 45, rue Cognacq-Jay, 51092 Reims cedex, France Christophe Cognard Department of Neuroradiology, University Hospital of Toulouse, Toulouse, France Serge Bracard Department of Neuroradiology, University Hospital of Nancy, Nancy, France ∗

Corresponding author. Tel.: +33 3 26 78 87 64; fax: +33 3 26 78 75 94. E-mail address: [email protected] (L. Pierot)

The long way to positive trials for mechanical thrombectomy in acute ischemic stroke.

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