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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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| 4. |
- Behrendt, Christian-Alexander, et al.
(författare)
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Editor's Choice - Recommendations for Registry Data Collection for Revascularisations of Acute Limb Ischaemia : A Delphi Consensus from the International Consortium of Vascular Registries
- 2019
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 57:6, s. 816-821
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To develop a minimum core data set for evaluation of acute limb ischaemia (ALI) revascularisation treatment and outcomes that would enable collaboration among international registries. Methods: A modified Delphi approach was used to achieve consensus among international multidisciplinary vascular specialists and registry members of the International Consortium of Vascular Registries (ICVR). Variables identified in the literature or suggested by the expert panel, and variables, including definitions, currently used in 15 countries in the ICVR, were assessed to define both a minimum core and an optimum data set to register ALI treatment. Clinical relevance and practicability were both assessed, and consensus was defined as >= 80% agreement among participants. Results: Of 40 invited experts, 37 completed a preliminary survey and 31 completed the two subsequent Delphi rounds via internet exchange and face to face discussions. In total, 117 different items were generated from the various registry data forms, an extensive review of the literature, and additional suggestions from the experts, for potential inclusion in the data set. Ultimately, 35 items were recommended for inclusion in the minimum core data set, including 23 core items important for all registries, and an additional 12 more specific items for registries capable of capturing more detail. These 35 items supplement previous data elements recommended for registering chronic peripheral arterial occlusive disease treatment. Conclusion: A modified Delphi study allowed 37 international vascular registry experts to achieve a consensus recommendation for a minimum core and an optimum data set for registries covering patients who undergo ALI revascularisation. Continued global harmonisation of registry infrastructure and definition of items allows international comparisons and global quality improvement. Furthermore, it can help to define and monitor standards of care and enable international research collaboration.
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- De La Motte, L., et al.
(författare)
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Is EVAR a durable solution? Indications for reinterventions
- 2018
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Ingår i: Journal of Cardiovascular Surgery. - 0021-9509. ; 59:2, s. 201-212
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCION: Indications for reinterventions after endovascular aneurysm repair (EVAR), as well as their occurrence in number and time, are important to establish in order to optimize patient selection, postprocedure surveillance and also to guide improvements in endograft designs. The aim of this report was to present an overview of current data on reinterventions after elective EVAR. EVIDENCE ACQUISITION: Qualitative review of studies reporting on reinterventions after elective EVAR, identified by a systematic literature search in MEDLINE, EMBASEand the Cochrane Library for publications from 2010 to 13th of November 2017. EVIDENCESYNTHESIS: Twenty-Three studies reporting on 83,307 patients met the inclusion criteria. Index procedures were performed between 1996-2014. There was wide heterogeneity in reporting standards. Type Iendoleaks were reported in 0.6%-13% and type IIIendoleaks in 0.9-2.1% with a significant improvement for newer devices. Migration rates varied between 0-4%. Endoleak type II was the most common indication for re-intervention ranging from 14-25.3% although the majority resolved without intervention. Rupture rates ranged from 0-5.4% and carried a high mortality (60-67%). Ruptures occurred at any time after the index procedure. Limb ischemia rates were reported at 0.4-11.9% with re-intervention rates between 0.06-11.9%. Wound related complications and related re-interventions were the indication in 0.5-14% and 0.3-6.5%, respectively. Endograft infection carried a high risk of mortality and was described in 0.3-3.6%, often related to graft-enteric fistula and the majority had an open explantation of the endograft. CONCLUSIONS: This review showed that the rates of complications and techniques for reintervention developed over time with a tendency towards better outcomes considering the aneurysm related indications. Significant factors that led to subsequent secondary interventions were migration, rupture, infections and type Iand IIendoleaks. Patients treated with earlier generation endografts are still alive and need continued surveillance to detect these severe complications before they lead to rupture. © 2018 Edizioni Minerva Medica.
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