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- 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. |
- Wiedmann, Silke, et al.
(författare)
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Variations in Quality Indicators of Acute Stroke Care in 6 European Countries The European Implementation Score (EIS) Collaboration
- 2012
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Ingår i: Stroke. - Philadelphia : Lippincott Williams & Wilkins. - 0039-2499 .- 1524-4628. ; 43:2, s. 458-463
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Tidskriftsartikel (refereegranskat)abstract
- Background and Purpose-Quality indicators serve as standards of care by which performance of individual hospitals is measured. Although several audits for monitoring quality of stroke care have been established in Europe, there is currently no consensus on quality indicators for acute stroke care or for methodology for collecting information on these measures. Methods-An up-to-date inventory on European stroke audits in place in 2006 was performed in the course of a project funded by the European Union (European Implementation Score Collaboration [EIS]). Two regional (Flanders, Belgium; Catalonia, Spain) and 4 national (Germany, Scotland, Sweden, England/Wales/Northern Ireland) stroke audits took part. Between November 2009 and July 2010, 2 standardized surveys and a series of interviews were performed to determine characteristics, methods, and content of these quality initiatives. For quality purposes, all summarized information was validated by representatives of the respective audits. Results-Overall, 123 quality indicators (91 process, 24 outcome, and 8 structural indicators) were identified. Anticoagulants in patients with atrial fibrillation and brain imaging were the only quality indicators used in all, whereas another 13 indicators were used in at least 2 of the quality initiatives. Substantial variations were found across the audits in terms of the development process of quality indicators, inclusion criteria, participation, population coverage, data documentation, follow-ups, benchmarking, and feedback of results to participants. Conclusions-There is a huge variety in measuring performance of acute stroke care in Europe, hampering valid comparisons of acute stroke care. Common standards for defining quality indicators and collecting information required for these measures should be defined in Europe. (Stroke. 2012;43:458-463.)
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