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- Jansen, O, et al.
(author)
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Neurothrombectomy for the treatment of acute ischemic stroke: results from the TREVO study
- 2013
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In: Cerebrovascular diseases (Basel, Switzerland). - : S. Karger AG. - 1421-9786 .- 1015-9770. ; 36:3, s. 218-225
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Journal article (peer-reviewed)abstract
- <b><i>Background:</i></b> Fast recanalization has been shown to be one of the most important factors for good clinical outcome in stroke patients with acute large vessel occlusion. While intravenous thrombolysis has been shown to be of limited effect in patients with large clot burden, intra-arterial neurothrombectomy offers a new and promising possibility to achieve high recanalization rates within a short time. The Trevo device is a stent-like retriever and was primarily designed to remove thrombus in patients experiencing an acute ischemic stroke. We report on the results of the TREVO Study, which was a prospective, multicenter study in acute stroke patients treated with the Trevo device. <b><i>Methods:</i></b> Patients were recruited in seven European centers under the control of an external monitor. Centers were selected because of their long experience with interventional stroke therapy especially with neurothrombectomy. We included adults aged 18-85 years with angiographically confirmed large vessel occlusion strokes and NIHSS scores of 8-30 and treatable within 8 h of symptom onset. The primary endpoint was revascularization, defined as at least TICI (thrombolysis in cerebral infarction) 2a. The revascularization scores were assessed by an independent core lab. Secondary endpoints were clinical outcome at 90 days (mRS 90), any device-related serious adverse events and the rate of symptomatic intracerebral hemorrhages. <b><i>Results:</i></b> 60 patients were enrolled. The overall recanalization rate (≥TICI 2a) was 91.7% and TICI 2b and 3 was achieved in 78.3%. At 90 days, 55% of the patients had a favorable neurological outcome (mRS 0-2) and 20% had died. Patients with successful recanalization (TICI 2a,b/3) had a good 90-day neurological outcome (mRS 0-2) in 60%, whereas no patient without recanalization had a mRS 90 <3. The overall rate of symptomatic intracerebral hemorrhage according to the SITS-MOST criteria was 5% (3/60). <b><i>Conclusions:</i></b> The study suggest that the Trevo Stentriever™ is a safe and effective device, which may offer the possibility of a high reperfusion rate and a high rate of patients with good clinical outcome after acute ischemic stroke due to proximal arterial occlusion. Randomized trials comparing intravenous thrombolysis with neurothrombectomy are now urgently needed to evaluate this new approach of interventional stroke therapy.
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| 2. |
- Kharitonova, T, et al.
(author)
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Hyperdense middle cerebral artery sign on admission CT scan--prognostic significance for ischaemic stroke patients treated with intravenous thrombolysis in the safe implementation of thrombolysis in Stroke International Stroke Thrombolysis Register
- 2009
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In: Cerebrovascular diseases (Basel, Switzerland). - : S. Karger AG. - 1421-9786 .- 1015-9770. ; 27:1, s. 51-59
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Journal article (peer-reviewed)abstract
- <i>Background:</i> Hyperdense middle cerebral artery sign (HMCAS) on CT scan before stroke thrombolysis is associated with increased risk for haemorrhage and unfavourable outcome in several small studies. <i>Methods:</i> We examined baseline characteristics, intracranial haemorrhage and outcomes of intravenous thrombolysis in patients with and without HMCAS using the internet-based Safe Implementation of Thrombolysis in Stroke-International Stroke Thrombolysis Register. Symptomatic intracerebral haemorrhage (SICH) was defined as a National Institute of Health Stroke Scale (NIHSS) score decrease of ≥4 points plus type 2 parenchymal haemorrhage on imaging [Safe Implementation of Thrombolysis in Stroke Monitoring Study (SITS-MOST) definition], or any haemorrhage on follow-up imaging combined with a decrease of at least 1 point on the NIHSS [randomized controlled trial (RCT) definition]. Three-month outcomes were mortality and independence (modified Rankin scale score = 0–2). <i>Results:</i> 1,905 of 10,023 (19.0%) patients had HMCAS. Patients with HMCAS (vs. no HMCAS) were younger (median age 68 vs. 70 years, p < 0.001), had severer stroke (baseline NIHSS score 17 vs. 11, p < 0.05), higher mortality [23% (95% CI 20.0–25.1) vs. 13% (95% CI 12.1–13.7)] and lower independence [31% (95% CI 28.5–33.0) vs. 56% (95% CI 54.8–57.2)]. SICH rates per the SITS-MOST were 1.3% (95% CI 0.8–1.9) versus 1.8% (95% CI 1.5–2.1) and per the RCT definition 10.3% (95% CI 9.0–11.8) versus 6.8% (95% CI 6.2–7.3). In multivariable analysis, HMCAS was not an independent predictor of SICH but of mortality and independence per the SITS-MOST. <i>Conclusions:</i> HMCAS patients had severer stroke and a worse 3-month outcome. The risk for SICH per the SITS-MOST definition was similar compared to non-HMCAS patients, although increased per the RCT definition. There is not sufficient evidence to exclude these patients from intravenous thrombolysis. Combined treatment approaches might be considered in the perspective of the severe outcome and evaluated in RCTs.
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| 5. |
- Wahlgren, N
(author)
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Systemic thrombolysis in clinical practice: what have we learned after the Safe Implementation of Thrombolysis in Stroke Monitoring Study?
- 2009
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In: Cerebrovascular diseases (Basel, Switzerland). - : S. Karger AG. - 1421-9786 .- 1015-9770. ; 2727 Suppl 1, s. 168-176
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Journal article (peer-reviewed)abstract
- The Safe Implementation of Thrombolysis in Stroke Monitoring Study (SITS-MOST) of 6,483 patients treated with intravenous alteplase within 3 h after stroke onset showed that this treatment was as safe and as effective in clinical practice as in randomized controlled trials. SITS-MOST was based on the SITS registry, available over a secure Internet connection. The SITS registry today includes over 22,000 treatment files on intravenous thrombolysis with an inclusion rate of 1,200–1,300 new files every 4 months. SITS now opens for other interventions than intravenous thrombolysis and will soon be available as an optional general stroke register. After SITS-MOST, the registry is generating new information on outcome predictors, treatments in patients in later time windows, patients with hyperdense middle cerebral artery signs, and several publications are in preparation. Important information is currently collected on the effect on door-to-needle time and safety of a broad implementation of thrombolysis in a later time window.
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