Explore the vast range of titles available.

In this trial involving asymptomatic patients with severe carotid stenosis, stenting was noninferior to endarterectomy with regard to the primary composite end point of death, stroke, or myocardial infarction within 30 days or ipsilateral stroke within 1 year after the procedure. Stroke is the fifth leading cause of death and the leading cause of disability among U.S. adults. It affects nearly 800,000 people in the United States annually, resulting in more than 170,000 deaths and causing major disability among the survivors, at a cost estimated to exceed $41 billion annually. 1 Extracranial carotid-artery disease is responsible for up to 20% of these strokes. The Asymptomatic Carotid Atherosclerosis Stenosis (ACAS) and Asymptomatic Carotid Surgery (ACST) trials showed that among asymptomatic patients with carotid-artery stenosis of greater than 60% of the diameter of the artery, the risk of stroke or death was lower when . . .

In this long-term follow-up of a randomized trial comparing endarterectomy with stenting for carotid-artery stenosis, the risks of periprocedural stroke, myocardial infarction, or death and subsequent ipsilateral stroke did not differ between groups over a 10-year period. We previously reported the outcomes up to 4 years in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST). 1 No significant difference was shown between patients assigned to stenting and those assigned to endarterectomy with respect to the composite primary end point of periprocedural stroke, myocardial infarction, or death and subsequent ipsilateral stroke. At baseline, the mean age of the patients was 69 years, and at that age the average life expectancy is 15 years for men and 17 years for women. 2 As such, long-term treatment differences should be central to treatment decisions. We now report whether the outcomes after stenting . . .

Stenting is an alternative to endarterectomy for treatment of carotid artery stenosis, but long-term efficacy is uncertain. We report long-term data from the randomised International Carotid Stenting Study comparison of these treatments. Patients with symptomatic carotid stenosis were randomly assigned 1:1 to open treatment with stenting or endarterectomy at 50 centres worldwide. Randomisation was computer generated centrally and allocated by telephone call or fax. Major outcomes were assessed by an independent endpoint committee unaware of treatment assignment. The primary endpoint was fatal or disabling stroke in any territory after randomisation to the end of follow-up. Analysis was by intention to treat ([ITT] all patients) and per protocol from 31 days after treatment (all patients in whom assigned treatment was completed). Functional ability was rated with the modified Rankin scale. This study is registered, number ISRCTN25337470. 1713 patients were assigned to stenting (n=855) or endarterectomy (n=858) and followed up for a median of 4·2 years (IQR 3·0–5·2, maximum 10·0). Three patients withdrew immediately and, therefore, the ITT population comprised 1710 patients. The number of fatal or disabling strokes (52 vs 49) and cumulative 5-year risk did not differ significantly between the stenting and endarterectomy groups (6·4% vs 6·5%; hazard ratio [HR] 1·06, 95% CI 0·72–1·57, p=0·77). Any stroke was more frequent in the stenting group than in the endarterectomy group (119 vs 72 events; ITT population, 5-year cumulative risk 15·2% vs 9·4%, HR 1·71, 95% CI 1·28–2·30, p<0·001; per-protocol population, 5-year cumulative risk 8·9% vs 5·8%, 1·53, 1·02–2·31, p=0·04), but were mainly non-disabling strokes. The distribution of modified Rankin scale scores at 1 year, 5 years, or final follow-up did not differ significantly between treatment groups. Long-term functional outcome and risk of fatal or disabling stroke are similar for stenting and endarterectomy for symptomatic carotid stenosis. Medical Research Council, Stroke Association, Sanofi-Synthélabo, European Union.

In this randomized comparison of stenting and endarterectomy as treatment for carotid-artery stenosis, there was no significant difference in the rate of the composite primary end point of stroke, myocardial infarction, or death (7.2% and 6.8%, respectively; P=0.51). Stroke was more common with carotid-artery stenting than carotid endarterectomy; myocardial infarction was more common with carotid endarterectomy. The 4-year rate of stroke or death was 6.4% for carotid-artery stenting and 4.7% for carotid endarterectomy (P=0.03). In this randomized comparison of stenting and endarterectomy as treatment for carotid-artery stenosis, there was no significant difference in the rate of the composite primary end point of stroke, myocardial infarction, or death (7.2% and 6.8%, respectively). Carotid-artery atherosclerosis is an important cause of ischemic stroke. 1 Carotid endarterectomy has been established as effective treatment for both symptomatic patients and asymptomatic patients. 2 – 4 Carotid-artery stenting is another option for treatment. The results of randomized trials comparing carotid-artery stenting and carotid endarterectomy for use in symptomatic patients are conflicting. 5 – 7 The primary aim of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) was to compare the outcomes of carotid-artery stenting with those of carotid endarterectomy among patients with symptomatic or asymptomatic extracranial carotid stenosis. Methods Study Design CREST is a randomized, controlled trial with blinded end-point adjudication. Ethics review . . .

If carotid artery narrowing remains asymptomatic (ie, has caused no recent stroke or other neurological symptoms), successful carotid endarterectomy (CEA) reduces stroke incidence for some years. We assessed the long-term effects of successful CEA. Between 1993 and 2003, 3120 asymptomatic patients from 126 centres in 30 countries were allocated equally, by blinded minimised randomisation, to immediate CEA (median delay 1 month, IQR 0·3–2·5) or to indefinite deferral of any carotid procedure, and were followed up until death or for a median among survivors of 9 years (IQR 6–11). The primary outcomes were perioperative mortality and morbidity (death or stroke within 30 days) and non-perioperative stroke. Kaplan-Meier percentages and logrank p values are from intention-to-treat analyses. This study is registered, number ISRCTN26156392. 1560 patients were allocated immediate CEA versus 1560 allocated deferral of any carotid procedure. The proportions operated on while still asymptomatic were 89·7% versus 4·8% at 1 year (and 92·1% vs 16·5% at 5 years). Perioperative risk of stroke or death within 30 days was 3·0% (95% CI 2·4–3·9; 26 non-disabling strokes plus 34 disabling or fatal perioperative events in 1979 CEAs). Excluding perioperative events and non-stroke mortality, stroke risks (immediate vs deferred CEA) were 4·1% versus 10·0% at 5 years (gain 5·9%, 95% CI 4·0–7·8) and 10·8% versus 16·9% at 10 years (gain 6·1%, 2·7–9·4); ratio of stroke incidence rates 0·54, 95% CI 0·43–0·68, p<0·0001. 62 versus 104 had a disabling or fatal stroke, and 37 versus 84 others had a non-disabling stroke. Combining perioperative events and strokes, net risks were 6·9% versus 10·9% at 5 years (gain 4·1%, 2·0–6·2) and 13·4% versus 17·9% at 10 years (gain 4·6%, 1·2–7·9). Medication was similar in both groups; throughout the study, most were on antithrombotic and antihypertensive therapy. Net benefits were significant both for those on lipid-lowering therapy and for those not, and both for men and for women up to 75 years of age at entry (although not for older patients). Successful CEA for asymptomatic patients younger than 75 years of age reduces 10-year stroke risks. Half this reduction is in disabling or fatal strokes. Net benefit in future patients will depend on their risks from unoperated carotid lesions (which will be reduced by medication), on future surgical risks (which might differ from those in trials), and on whether life expectancy exceeds 10 years. UK Medical Research Council, BUPA Foundation, Stroke Association.

The International Carotid Stenting Study (ICSS) of stenting and endarterectomy for symptomatic carotid stenosis found a higher incidence of stroke within 30 days of stenting compared with endarterectomy. We aimed to compare the rate of ischaemic brain injury detectable on MRI between the two groups. Patients with recently symptomatic carotid artery stenosis enrolled in ICSS were randomly assigned in a 1:1 ratio to receive carotid artery stenting or endarterectomy. Of 50 centres in ICSS, seven took part in the MRI substudy. The protocol specified that MRI was done 1–7 days before treatment, 1–3 days after treatment (post-treatment scan), and 27–33 days after treatment. Scans were analysed by two or three investigators who were masked to treatment. The primary endpoint was the presence of at least one new ischaemic brain lesion on diffusion-weighted imaging (DWI) on the post-treatment scan. Analysis was per protocol. This is a substudy of a registered trial, ISRCTN 25337470. 231 patients (124 in the stenting group and 107 in the endarterectomy group) had MRI before and after treatment. 62 (50%) of 124 patients in the stenting group and 18 (17%) of 107 patients in the endarterectomy group had at least one new DWI lesion detected on post-treatment scans done a median of 1 day after treatment (adjusted odds ratio [OR] 5·21, 95% CI 2·78–9·79; p<0·0001). At 1 month, there were changes on fluid-attenuated inversion recovery sequences in 28 (33%) of 86 patients in the stenting group and six (8%) of 75 in the endarterectomy group (adjusted OR 5·93, 95% CI 2·25–15·62; p=0·0003). In patients treated at a centre with a policy of using cerebral protection devices, 37 (73%) of 51 in the stenting group and eight (17%) of 46 in the endarterectomy group had at least one new DWI lesion on post-treatment scans (adjusted OR 12·20, 95% CI 4·53–32·84), whereas in those treated at a centre with a policy of unprotected stenting, 25 (34%) of 73 patients in the stenting group and ten (16%) of 61 in the endarterectomy group had new lesions on DWI (adjusted OR 2·70, 1·16–6·24; interaction p=0·019). About three times more patients in the stenting group than in the endarterectomy group had new ischaemic lesions on DWI on post-treatment scans. The difference in clinical stroke risk in ICSS is therefore unlikely to have been caused by ascertainment bias. Protection devices did not seem to be effective in preventing cerebral ischaemia during stenting. DWI might serve as a surrogate outcome measure in future trials of carotid interventions. UK Medical Research Council, the Stroke Association, Sanofi-Synthélabo, European Union, Netherlands Heart Foundation, and Mach-Gaensslen Foundation.

In this randomized trial of patients with symptomatic carotid stenosis of 60% or more, patients who underwent endarterectomy had lower rates of death or stroke at 1 month and 6 months than patients who underwent stenting. In this randomized trial of patients with symptomatic carotid stenosis of 60% or more, patients who underwent endarterectomy had lower rates of death or stroke at 1 month and 6 months than patients who underwent stenting. Findings from two large randomized, clinical trials 1 – 3 have established endarterectomy as the standard treatment for severe symptomatic carotid-artery stenosis. As compared with endarterectomy, stenting avoids the need for general anesthesia and an incision in the neck that could lead to nerve injury and wound complications. The costs may be less than those of surgery, mainly because the hospital stay is shorter. However, stenting also carries a risk of stroke and local complications, and the long-term efficacy of this technique is not well known. A systematic review 4 of five randomized trials comparing stenting with endarterectomy 5 – 10 concluded that the current . . .

Carotid stenting is a potential alternative to carotid endarterectomy but whether this technique is as safe as surgery and whether the long-term protection against stroke is similar to that of surgery are unclear. We previously reported that in patients in the Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial, the rate of any stroke or death within 30 days after the procedure was higher with stenting than with endarterectomy. We now report the results up to 4 years. In this follow-up study of a multicentre, randomised, open, assessor-blinded, non-inferiority trial, we compared outcome after stenting with outcome after endarterectomy in 527 patients who had carotid stenosis of at least 60% that had recently become symptomatic. The primary endpoint of the EVA-3S trial was the rate of any periprocedural stroke or death (ie, within 30 days after the procedure). The prespecified main secondary endpoint was a composite of any periprocedural stroke or death and any non-procedural ipsilateral stroke during up to 4 years of follow-up. Other trial outcomes were any stroke or periprocedural death, any stroke or death, and the above endpoints restricted to disabling or fatal strokes. This trial is registered with ClinicalTrials.gov, number NCT00190398. 262 patients were randomly assigned to endarterectomy and 265 to stenting. The cumulative probability of periprocedural stroke or death and non-procedural ipsilateral stroke after 4 years of follow-up was higher with stenting than with endarterectomy (11·1% vs 6·2%, hazard ratio [HR] 1·97, 95% CI 1·06–3·67; p=0·03). The HR for periprocedural disabling stroke or death and non-procedural fatal or disabling ipsilateral stroke was 2·00 (0·75–5·33; p=0·17). A hazard function analysis showed the 4-year differences in the cumulative probabilities of outcomes between stenting and endarterectomy were largely accounted for by the higher periprocedural (within 30 days of the procedure) risk of stenting compared with endarterectomy. After the periprocedural period, the risk of ipsilateral stroke was low and similar in both treatment groups. For any stroke or periprocedural death, the HR was 1·77 (1·03–3·02; p=0·04). For any stroke or death, the HR was 1·39 (0·96–2·00; p=0·08). The results of this study suggest that carotid stenting is as effective as carotid endarterectomy for middle-term prevention of ipsilateral stroke, but the safety of carotid stenting needs to be improved before it can be used as an alternative to carotid endarterectomy in patients with symptomatic carotid stenosis. French Ministry of Health.

In the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial of 334 patients with carotid-artery disease, carotid-artery stenting was not inferior to endarterectomy at 30 days or at 1 year. Most patients were followed for an additional 2 years. There was no significant difference between the two groups in the composite end point of death, stroke, or myocardial infarction within 30 days or death or ipsilateral stroke between 31 days and 3 years. In the SAPPHIRE trial of patients with carotid-artery disease, carotid-artery stenting was not inferior to endarterectomy at 30 days or at 1 year. In this follow-up study, there was no significant difference between the two groups in the composite end point of death, stroke, or myocardial infarction within 30 days or death or ipsilateral stroke between 31 days and 3 years. There is a direct relationship between the degree of carotid artery stenosis and the risk of ipsilateral stroke. 1 , 2 Carotid revascularization by means of carotid endarterectomy has proved highly successful in reducing the incidence of stroke among patients with moderate-to-severe symptomatic carotid stenosis 1 as well as among those with severe asymptomatic carotid stenosis. 3 Although carotid endarterectomy has been considered the gold standard for the treatment of carotid stenosis for decades, carotid artery stenting has emerged as an alternative type of treatment for this common disorder. 4 , 5 The Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) . . .

Patients with severe carotid-artery stenosis, who are at high risk for stroke, usually undergo endarterectomy. This clinical trial compared endarterectomy and carotid stenting with the use of a stent with an emboli-protection device in patients with severe carotid-artery stenosis. Stenting was found to be not inferior to endarterectomy with respect to clinical outcome. Therefore, the less invasive approach may be an acceptable alternative among patients with high-risk carotid-artery stenosis. The less invasive approach may be an acceptable alternative among patients with high-risk carotid-artery stenosis. Several trials have shown carotid endarterectomy to be superior to medical management for the prevention of stroke in patients with symptomatic or asymptomatic carotid-artery stenosis. 1 – 3 The patients in the North American Symptomatic Carotid Endarterectomy Trial (NASCET) and those in the Asymptomatic Carotid Atherosclerosis Study (ACAS) were carefully selected and had low rates of surgical complications. 1 , 3 Many patients for whom surgery poses a high risk, however, routinely undergo carotid endarterectomy in clinical practice and were excluded from these trials, and such patients have outcomes that are substantially worse than those reported in these trials. 4 During the past decade, carotid . . .