Article

O-007 Natural History of Acute Ischaemic Stroke from Large Vessel Occlusion Demonstrates Efficacy of Mechanical Thrombectomy: Preliminary Results of the Penumbra FIRST Study

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Abstract

Introduction/Purpose Current literature has only limited information on the natural history of the stroke cohort eligible for mechanical thrombectomy. This has contributed to the uncertainties over the benefits of mechanical thrombectomy devices since they were approved either by single arm trials or with another device as active control. The aim of FIRST is to gather real world control data to reference results from mechanical thrombectomy trials in the proper context. Materials and Methods The FIRST Trial is a prospective, multicentre, single arm natural history study of a stroke cohort eligible for but untreated by endovascular therapy presenting within 8 hours of symptom onset from a large vessel occlusion and a NIHSS score ≥10. Patients should be ineligible or refractory to lytic therapy. The primary endpoint is 90-day functional outcome as defined by a mRS 0–2. Results For this interim analysis, 61 enrolled patients met study criteria. The mean age was 67.7 ± 15.7 years; median NIHSS score was 18 (IQR14–22). Target vessel occlusions were located in the ICA (28%), MCA (67%), and other (5%). At admission, the TIMI 0–1 rate was 98% (59/60), and the TICI 0–1 rate was 98% (58/59). Of these, only 10% (4/41) and 12% (5/41) showed spontaneous recanalisation (TIMI 2–3 or TICI 2a-3). Twelve of 54 (22%) patients achieved a good 90-day outcome, and 25 of 61 (41%) died. The serious adverse event rate within 24 hours of stroke onset was 54% (33/61), including cerebral oedema (8 cases) and respiratory failure (4 cases). Eleven (18%) patients suffered intracerebral haemorrhage. 33 (56%) were refractory to IV rtPA. Compared with PROACT II placebo patients, the stroke cohort eligible for mechanical thrombectomy who were untreated have different baseline characteristics, a lower recanalisation rate, and worse outcome. The graph shows a comparison of 90-day good outcome in the FIRST vs Penumbra System Trials, trichotomised by pre-ASPECTS scores. Conclusion Large vessel acute ischaemic stroke is a malignant disease wherein 78% of patients will either die or suffer long-term disabilities if untreated. When compared to the same stroke cohort without treatment, IA intervention with the Penumbra System consistently showed treatment effects. There are substantial differences in entry criteria and clinical outcomes between the FIRST and PROACT 2 patient populations. These results suggest it is not appropriate to use the PROACT placebo patients as historical controls for mechanical thrombectomy trials. FIRST data may serve as a benchmark for future trials. Disclosures V. Janardhan: None. L. Carlson: None. R. Gianatasio: None. S. Chen: None. P. Bhuva: None. M. Murray: None. M. Vijayappa: None. P. Hansen: None. R. Cheung: None. T. Leung: None. I. Grunwald: 6; C; Penumbra, Inc. H. Hernandez: 5; C; Penumbra, Inc. L. Barraza: 5; C; Penumbra, Inc. H. Buell: 5; C; Penumbra, Inc. S. Kuo: 5; C; Penumbra, Inc. A. Bose: 4; C; Penumbra, Inc. 5; C; Penumbra, Inc. S. Sit: 4; C; Penumbra, Inc. 5; C; Penumbra, Inc.

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... IV TPA is the fastest way to initiate therapy in hyperacute ischaemic stroke, but its efficacy in patients with lVo is questionable: it is well documented that IV TPA has limited efficacy in recanalising lVo [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32] (see Table 2) and recanalisation is a strong predictor of good outcome 7,9,10,11,[22][23][24]34 . The larger clot volume en-ing endovascular therapy 6 . The 61 enrolled patients with national Institute of Health Stroke Scale (nIHSS)>10, median nIHSS 18 and occlusion sites of the terminal internal carotid artery (TICA) in 28% and MCA in 67% achieved a favourable 90-day outcome (mrS 0-2) in 22% and 41% died. ...
... The recent trial evidence is critically appraised and a multitude of observational studies describing the use of stent-retriever technology are presented. ographic evidence of proximal anterior circulation occlusions 6 . In the SToPstroke study, 35% of patients with nIHSS>10 treated with IV TPA achieved favourable outcome versus 17% of controls. ...
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This is a literature review on to the use of endovascular therapy in hyperacute ischaemic stroke secondary to large vessel occlusion (LVO). The prognosis for LVO is generally poor and the efficacy of intravenous tissue plasminogen activator (IV TPA) in the treatment of this subtype of stroke is questionable. It is well documented that recanalisation is associated with improved outcomes but IV TPA has limited efficacy in LVO recanalisation and the complication rates are higher for IV TPA in this stroke subset. Improved recanalisation rates have been demonstrated with intra-arterial TPA and first and second generation mechanical techniques but the rate of favourable outcome has not overtly mirrored this improvement. Several controversial trials using these early techniques have recently been published but fail to reflect modern practice which centres on the use of stent-retriever technology. This has been proven to be superior to older techniques. Not only are recanalisation rates higher, but the speed of recanalisation is greater and clinical results are improved. Multiple observational studies demonstrate consistently high rates of LVO recanalisation; TICI 2b/3 in the order of 65–95% and, rates of favourable outcome (mRS 0–2) in the order of 55% (42.5–77%) in clinically moderate to severe stroke with complicating symptomatic haemorrhage in the order of 1.5–15%. A major factor determining outcome is time to treatment but success has been demonstrated using these devices with bridging therapy, after IV TPA failure or as a stand-alone treatment.
... [1][2][3][4][5][6][7][8][9][10][11][12] As well as intracranial access failure, thrombus extraction failure is responsible in approximately 40% of unsuccessful procedures. 16 The natural history of non-recanalized ELVO stroke is poor, 35 and equally, those patients suffering procedural failure commonly fair poorly also. In the Solitaire With the Intention For Thrombectomy as Primary Endovascular Treatment (SWIFT PRIME) trial, 15 with 29% in those with lesser degrees of patency (mAOL 0-2). ...
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Background: The crucial role of thrombectomy in the management of emergent large vessel occlusive stroke is not disputed but there is a technical failure rate in a significant minority of patients whose outcomes are often poor. Our objective was to perform a systematic review and meta-analysis to assess the safety and efficacy of permanent self-expandable stent deployment as a bailout procedure in cases of failed anterior circulation thrombectomy. Methods: Two independent reviewers searched the Pubmed (Medline) database for studies reporting outcomes following failed endovascular thrombectomy with subsequent rescue therapy employing self-expandable stents. Results: Eight studies (one prospective, seven retrospective) originating from Europe, Asia, and America comprising 160 patients met the inclusion criteria. Estimated baseline National Institutes of Health Stroke Scale score was 17.1 (95% CI 15.7 to 18.4). Following failed thrombetcomy and stent deployment, the rate of favorable outcome (modified Rankin Scale score 0–2) was 43% (95% CI 34% to 53%). Pooled mortality was 21% (95% CI 13% to 33%). Successful recanalization (Thrombolysis in Cerebral Infarction (TICI) 2b–3 or Thrombolysis in Myocardial Infarction (TIMI) 2–3) was 71% (95% CI 63% to 77%). Symptomatic intracerebral hemorrhage was seen in 12% (95% CI 7% to 18%). The Solitaire stent (Medtronic) was the most commonly deployed stent following failed thrombectomy attempts (66%; 95% CI 31% to 89%). Pre- or post-stent angioplasty was performed in 39%of patients (95% CI 29% to 48%). Glycoprotein IIb/IIIa inhibitors were used in 89% (95% CI 71% to 97%). 95% of patients received postprocedural antiplatelet therapy. Conclusion: A rescue stent procedure seems reasonable as a last resort following failed thrombectomy but currently the level of evidence is limited. Prospective registries may aid in guiding future recommendations.
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