38 research outputs found

    Status Update and Interim Results from the Asymptomatic Carotid Surgery Trial-2 (ACST-2)

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    Objectives: ACST-2 is currently the largest trial ever conducted to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in patients with severe asymptomatic carotid stenosis requiring revascularization. Methods: Patients are entered into ACST-2 when revascularization is felt to be clearly indicated, when CEA and CAS are both possible, but where there is substantial uncertainty as to which is most appropriate. Trial surgeons and interventionalists are expected to use their usual techniques and CE-approved devices. We report baseline characteristics and blinded combined interim results for 30-day mortality and major morbidity for 986 patients in the ongoing trial up to September 2012. Results: A total of 986 patients (687 men, 299 women), mean age 68.7 years (SD ± 8.1) were randomized equally to CEA or CAS. Most (96%) had ipsilateral stenosis of 70-99% (median 80%) with contralateral stenoses of 50-99% in 30% and contralateral occlusion in 8%. Patients were on appropriate medical treatment. For 691 patients undergoing intervention with at least 1-month follow-up and Rankin scoring at 6 months for any stroke, the overall serious cardiovascular event rate of periprocedural (within 30 days) disabling stroke, fatal myocardial infarction, and death at 30 days was 1.0%. Conclusions: Early ACST-2 results suggest contemporary carotid intervention for asymptomatic stenosis has a low risk of serious morbidity and mortality, on par with other recent trials. The trial continues to recruit, to monitor periprocedural events and all types of stroke, aiming to randomize up to 5,000 patients to determine any differential outcomes between interventions. Clinical trial: ISRCTN21144362. © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved

    Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy

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    Background: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods: ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings: Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation: Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding: UK Medical Research Council and Health Technology Assessment Programme

    Caratterizzazione di varietà di riso italiano

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    E' stato effettuato uno studio per la caratterizzazione di varietà di riso italiano con particolare riferimento al riso del Delta del Po

    A multicentric experience with open surgical repair and endovascular exclusion of popliteal artery aneurysms

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    Introduction: The aim of this study was to analyse early and follow-up results of the treatment of popliteal artery aneurysms (PAAs) performed with open surgical repair or with endovascular exclusion with endografts in a multicentric retrospective registry involving seven Italian vascular centres. Materials and methods: We retrospectively collected data concerning 178 open surgical interventions (OR group) and 134 endovascular exclusions (ER group) for PAAs performed between January 2000 and December 2011. Early and follow-up results were analysed in terms of mortality, graft patency, reintervention and limb preservation. Results: OR patients were more frequently symptomatic (64%, 115 cases) than patients in the ER group (34%, 51 cases; p < 0.001), had more frequently acute limb ischaemia (23% and 6.5%, respectively; p < 0.001) and had more frequently a run-off score <2 (39% and 26%, respectively, p = 0.03). In the OR group there were no perioperative deaths; six thromboses (3.3%) and one amputation occurred. In the ER group mortality was 1.5%; 13 thromboses (9.7%) and one amputation (0.5%) occurred. Mean duration of follow-up was 30.6 ± 27.5 months. In the OR group primary and secondary patency, freedom from reintervention and limb preservation rates at 48 months were 63.5% (standard error (SE) 0.05), 76.5% (SE 0.05), 72.5% (SE 0.06) and 89.7% (SE 0.05), respectively. The corresponding figures in the ER group were 73.4% (SE 0.04), 85% (SE 0.04), 75% (SE 0.04) and 97% (SE 0.04), respectively. Conclusions: In this large multicentric retrospective registry, open and endovascular treatment of PAAs are used in different patients with regard to clinical and anatomical characteristics. Both treatments are feasible and safe, providing satisfactory early and long-term results. © 2012 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved

    A multicentric experience with open surgical repair and endovascular exclusion of popliteal artery aneurysms.

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    INTRODUCTION: The aim of this study was to analyse early and follow-up results of the treatment of popliteal artery aneurysms (PAAs) performed with open surgical repair or with endovascular exclusion with endografts in a multicentric retrospective registry involving seven Italian vascular centres. MATERIALS AND METHODS: We retrospectively collected data concerning 178 open surgical interventions (OR group) and 134 endovascular exclusions (ER group) for PAAs performed between January 2000 and December 2011. Early and follow-up results were analysed in terms of mortality, graft patency, reintervention and limb preservation. RESULTS: OR patients were more frequently symptomatic (64%, 115 cases) than patients in the ER group (34%, 51 cases; p < 0.001), had more frequently acute limb ischaemia (23% and 6.5%, respectively; p < 0.001) and had more frequently a run-off score <2 (39% and 26%, respectively, p = 0.03). In the OR group there were no perioperative deaths; six thromboses (3.3%) and one amputation occurred. In the ER group mortality was 1.5%; 13 thromboses (9.7%) and one amputation (0.5%) occurred. Mean duration of follow-up was 30.6 \ub1 27.5 months. In the OR group primary and secondary patency, freedom from reintervention and limb preservation rates at 48 months were 63.5% (standard error (SE) 0.05), 76.5% (SE 0.05), 72.5% (SE 0.06) and 89.7% (SE 0.05), respectively. The corresponding figures in the ER group were 73.4% (SE 0.04), 85% (SE 0.04), 75% (SE 0.04) and 97% (SE 0.04), respectively. CONCLUSIONS: In this large multicentric retrospective registry, open and endovascular treatment of PAAs are used in different patients with regard to clinical and anatomical characteristics. Both treatments are feasible and safe, providing satisfactory early and long-term results
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