| 1. |
- Ederle, Joerg, et al.
(författare)
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Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial
- 2010
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Ingår i: The Lancet. - 1474-547X. ; 375:9719, s. 985-997
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Tidskriftsartikel (refereegranskat)abstract
- Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470. Findings The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4.0%) events of disabling stroke or death in the stenting group compared with 27 (3.2%) events in the endarterectomy group (hazard ratio [HR] 1.28, 95% CI 0.77-2.11). The incidence of stroke, death, or procedural myocardial infarction was 8.5% in the stenting group compared with 5.2% in the endarterectomy group (72 vs 44 events; HR 1.69, 1.16-2.45, p=0.006), Risks of any stroke (65 vs 35 events; HR 1.92, 1.27-2.89) and all-cause death (19 vs seven events; HR 2.76, 1.16-6.56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0.0197). Interpretation Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.
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| 2. |
- Mattle, HP, et al.
(författare)
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Analysis of revascularisation in ischaemic stroke with EmboTrap (ARISE I study) and meta-analysis of thrombectomy
- 2019
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Ingår i: Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences. - : SAGE Publications. - 2385-2011. ; 25:3, s. 261-270
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Tidskriftsartikel (refereegranskat)abstract
- The goal of the analysis of revascularisation in ischaemic stroke with EmboTrap study (ARISE I) was to demonstrate the effectiveness of EmboTrap. Methods ARISE I was an open label, single arm, multicentre, prospective study for the treatment of acute stroke due to large vessel occlusion. The primary outcome was revascularisation of the target vessel as measured by the modified thrombolysis in cerebrovascular infarction (mTICI) score of at least 2b following thrombectomy with EmboTrap. For comparison of the ARISE I results a meta-analysis of eight randomised controlled trials was performed. Results ARISE I enrolled 40 patients. Their baseline characteristics that are predictors of stroke outcome and procedure timings in ARISE I were similar to those reported in recent randomised controlled trials. The primary outcome, good revascularisation rates (mTICI 2b/3 scores) after three or fewer passes with EmboTrap were 75% (95% confidence interval (CI) 62–88%), which is the same as 74% found in randomised controlled trials (difference of 0.8%, P = 0.95). After additional EmboTrap passes or the use of another device mTICI 2b/3 scores rose to 85% (95% CI 74–96%), which was also similar to the randomised controlled trials (difference 11%, P = 0.38). The high revascularisation rates in ARISE I converted into 64% good clinical outcomes (modified Rankin scale ≤2) compared to 50% in randomised controlled trials (difference 14%; 95% CI –13.7–41.7%; P = 0.32). Conclusions ARISE I demonstrates that thrombectomy using the EmboTrap stent retriever yields similar results to devices that were used in recent randomised controlled trials for the treatment of stroke due to large vessel occlusions. ClinicalTrials.gov identifier NCT02190552
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| 3. |
- Fernández-de-las-Peñas, César, et al.
(författare)
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Serological Biomarkers at Hospital Admission and Hospitalization Treatments Are Not Related to Sensitization-Associated Symptoms in Patients with Post-COVID Pain
- 2023
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Ingår i: Pathogens. - 2076-0817. ; 12:10
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Tidskriftsartikel (refereegranskat)abstract
- Current evidence suggests that a group of patients who had survived coronavirus disease, 2019 (COVID-19) and developed post-COVID pain can exhibit altered nociceptive processing. The role of serological biomarkers and hospitalization treatments in post-COVID pain is unclear. This study aimed to investigate the association of serological biomarkers and treatments received during hospitalization with sensitization-associated symptoms in COVID-19 survivors with post-COVID pain. One hundred and eighty-three (n = 183) patients who had been hospitalized due to COVID-19 in one urban hospital of Madrid (Spain) during the first wave of the pandemic were assessed in a face-to-face interview 9.4 (SD 3.4) months after hospitalization. Levels of 19 serological biomarkers, hospitalization data, and treatments during hospitalization were obtained from hospital records. Sensitization-associated symptoms (Central Sensitization Inventory, CSI), sleep quality (Pittsburgh Sleep Quality Index, PSQI), pain catastrophism (Pain Catastrophizing Scale), and anxiety/depressive level (Hospital Anxiety and Depression Scale, HADS) were assessed. The prevalence of post-COVID pain was 40.9% (n = 75). Twenty-nine (38.6%) patients had sensitization-associated symptoms. Overall, no differences in hospitalization data and serological biomarkers were identified according to the presence of sensitization-associated symptoms. The analysis revealed that patients with sensitization-associated symptoms exhibited higher lymphocyte count and lower urea levels than those without sensitization-associated symptoms, but differences were small. Pain catastrophism and depressive levels, but not fatigue, dyspnea, brain fog, anxiety levels, or poor sleep, were higher in individuals with sensitization-associated symptoms. In conclusion, this study revealed that sensitization-associated post-COVID pain symptoms are not associated with serological biomarkers at hospital admission and hospitalization treatments received.
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| 4. |
- Garcia-Loro, F., et al.
(författare)
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PILAR : A Federation of VISIR Remote Laboratory Systems for Educational Open Activities
- 2018
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Ingår i: Proceedings of 2018 IEEE International Conference on Teaching, Assessment, and Learning for Engineering, TALE 2018. - : Institute of Electrical and Electronics Engineers Inc.. - 9781538665220 ; , s. 134-141
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Konferensbidrag (refereegranskat)abstract
- Social demands have promoted an educational approach based on an 'anywhere and anytime' premise. Remote laboratories have emerged as the answer to the demands of technical educational areas for adapting themselves to this scenario. The result has not only benefit distance learning students but has provided new learning scenarios both for teachers and students as well as allowing a flexible approach to experimental topics. However, as any other solution for providing practical scenarios (hands-on labs, virtual labs or simulators), remote labs face several constraints inherited from the subsystems of its deployment - hardware (real instruments, equipment and scenario) and software (analog/digital conversions, communications, workbenches, etc.}. This paper describes the Erasmus+ project Platform Integration of Laboratories based on the Architecture of visiR (PILAR) which deals with several units of the federation installed in different educational institutions and devoted to analog electronics and electrical circuits. Based on the limitations of remote labs, the need for the federation will be justified and its benefits will be described by taking advantage of its strengths. The challenges that have come up during the different stages and the different approaches to design are also going to be described and analyzed. © 2018 IEEE.
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| 5. |
- Jansen, O, et al.
(författare)
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Neurothrombectomy for the treatment of acute ischemic stroke: results from the TREVO study
- 2013
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Ingår i: Cerebrovascular diseases (Basel, Switzerland). - : S. Karger AG. - 1421-9786 .- 1015-9770. ; 36:3, s. 218-225
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Tidskriftsartikel (refereegranskat)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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