phology. One of the remaining concerns is uncertainty about the long-term effect of persistent blood flow within the aneurysm sac after endovascular grafting, an occurrence known as endoleak. 1 In fact, endoleak development constitutes one of the prime reasons to perform postoperative surveillance by regularly performed image studies, usually computed tomography (CT) scanning. [2][3][4] The main purpose of EAR is to prevent death from rupture of the aneurysm, and early identification of endoleaks is intended to help obtain this goal. Protocols for when and how to manage endoleaks have been suggested, despite conflicting opinions on the natural history of endoleaks. 5 Several investigators consider the presence of perigraft flow to be evidence of failed treatment because it may predict aneurysmal enlargement and eventual rupture. 6-8 A contrasting opinion was presented in a recent study in which no relation between early endoleaks and late rupture, conversion to open surgery, and death could be demonstrated. 9 From this latter report, it might be concluded that the observation of perigraft flow had little consequence for the ultimate fate of the patient.Clinical management of endoleak may differ between types of endoleak. A generally accepted classification dis-Although the durability of endovascular repair of abdominal aortic aneurysms (AAAs) (EAR) is not definitively established, this treatment method is increasing in popularity among patients and doctors. Physicians from different vascular-oriented disciplines have engaged in workshops and training sessions to learn how to perform the technique in patients with suitable aneurysm mor-461 Objective: The purpose of this study was to assess the incidence, risk factors, and consequences of endoleaks after endovascular repair of abdominal aortic aneurysm. Methods: Data on 2463 patients were collected from 87 European centers and recorded in a central database. Preoperative data were compared for patients with collateral retrograde perfusion (type II) endoleak (group A), patients with devicerelated (type I and III) endoleaks (group B), and patients in whom no endoleak was detected (group C). Only endoleaks observed after the first postoperative month of follow-up were taken into consideration. Regression analysis was performed to investigate statistical relationships between the occurrence and type of endoleak and preoperative patient and morphologic characteristics, operative details, type of device, and experience of the operating team. In addition, postoperative changes in aneurysmal morphology, the need for secondary interventions, conversions to open repair, aneurysmal rupture, and mortality during follow-up were compared between these study groups. Results: Patients in group A had a higher prevalence of a patent inferior mesenteric artery compared with patients without endoleak. Patients in group B were treated more frequently than patients in group C by an operating team with experience of less than 30 procedures. The mean follow-up period was 15.4 months. Seco...

SummaryBackgroundStents 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.MethodsThe 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.FindingsThe 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).InterpretationCompletion 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.FundingMedical Research Council, the Stroke Association, Sanofi-Synthélabo, European Union.

This study evaluated the efficacy and safety of intramuscular administration of NV1FGF, a plasmid-based angiogenic gene delivery system for local expression of fibroblast growth factor 1 (FGF-1), versus placebo, in patients with critical limb ischemia (CLI). In a double-blind, randomized, placebo-controlled, European, multinational study, 125 patients in whom revascularization was not considered to be a suitable option, presenting with nonhealing ulcer(s), were randomized to receive eight intramuscular injections of placebo or 2.5 ml of NV1FGF at 0.2 mg/ml on days 1, 15, 30, and 45 (total 16 mg: 4 x 4 mg). The primary end point was occurrence of complete healing of at least one ulcer in the treated limb at week 25. Secondary end points included ankle brachial index (ABI), amputation, and death. There were 107 patients eligible for evaluation. Improvements in ulcer healing were similar for use of NV1FGF (19.6%) and placebo (14.3%; P = 0.514). However, the use of NV1FGF significantly reduced (by twofold) the risk of all amputations [hazard ratio (HR) 0.498; P = 0.015] and major amputations (HR 0.371; P = 0.015). Furthermore, there was a trend for reduced risk of death with the use of NV1FGF (HR 0.460; P = 0.105). The adverse event incidence was high, and similar between the groups. In patients with CLI, plasmid-based NV1FGF gene transfer was well tolerated, and resulted in a significantly reduced risk of major amputation when compared with placebo.

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.

Reconstructive surgery should be viewed from the following, more realistic, perspective. For patients with rest pain (and/or ankle pressure > 40 mmHg), 100% cumulative patency is equivalent to 64% resolution of symptoms at 1 year, as the rest may have improved without treatment. For high risk patients (tissue loss and/or ankle pressure < 40 mmHg), 100% cumulative patency is equivalent to 93% limb salvage at 1 year. Future reports should identify these two groups separately, as the dominant difference between outcome studies is the proportion of subcritical patients in the study rather than better surgical or radiological techniques. This stratification also has an important bearing on pharmacotherapy trials.