Treatment of Femoropopliteal Lesions With the BioMimics 3D Vascular Stent System: Two-Year Results From the MIMICS-2 Trial.

PURPOSE: To report the safety and effectiveness outcomes through 2 years of the BioMimics 3D Vascular Stent System in the treatment of symptomatic patients with atherosclerotic femoropopliteal disease. MATERIALS AND METHODS: The tubular, nitinol BioMimics 3D stent, which was designed to impart a helical shape to the arterial segment, was implanted in 271 patients (mean age 68.4±9.5 years; 180 men) with de novo femoropopliteal lesions enrolled at 43 investigational sites [31 US (n=162), 6 German (n=78), and 6 Japanese (n=31)] in the prospective, single-arm MIMICS-2 investigational device exemption trial (ClinicalTrials.gov identifier NCT02400905) between June 2015 and October 2016. Mean lesion length was 81.2±38.4 mm, 30.0% of patients had total occlusions, and 45.9% had moderate to severe calcification. Primary safety and effectiveness endpoints were compared at 1 year with prespecified objective performance goals (OPGs) set by the VIVA Physicians organization. Outcomes through 2 years are reported. RESULTS: The primary effectiveness endpoint of 12-month primary stent patency was met by 182 of 249 patients (73.1%, 95% CI 67.3% to 78.2%), exceeding the OPG of 66%. The primary safety endpoint of 30-day freedom from major adverse events (MAEs) was met in 268 of 269 patients (99.6%, 95% CI 97.7% to 100%), exceeding the OPG of 88%. Kaplan-Meier estimates of freedom from loss of primary patency were 83.1% at 12 months and 70.2% at 24 months, freedom from MAEs estimates were 86.9% at 12 months and 79.2% at 24 months, and freedom from clinically-driven target lesion revascularization estimates were 88.0% at 12 months and 83.0% at 24 months. At 24 months, 88.2% of patients showed improvement of ≥1 Rutherford category; the ankle-brachial index was >0.9 for 64.4% vs 11.3% at baseline. There were no cases of stent fracture. CONCLUSION: Through 24 months, the BioMimics 3D Vascular Stent System provided safe and effective treatment for femoropopliteal lesions in patients with symptomatic peripheral artery disease.

Sentry Bioconvertible Inferior Vena Cava Filter: Study of Stages of Incorporation in an Experimental Ovine Model.

The Sentry inferior vena cava (IVC) filter is designed to provide temporary protection from pulmonary embolism (PE) and then bioconvert to become incorporated in the vessel wall, leaving a patent IVC lumen. Objective. To evaluate the performance and stages of incorporation of the Sentry IVC filter in an ovine model. Methods. Twenty-four bioconvertible devices and 1 control retrievable filter were implanted in the infrarenal IVC of 25 sheep, with extensive daily monitoring and intensive imaging. Vessels and devices were analyzed at early (≤98 days, n = 10) and late (180 ± 30 days, n = 14 study devices, 1 control) termination and necropsy time-points. Results. Deployment success was 100% with all devices confirmed in filtering configuration, there were no filter-related complications, and bioconversion was 100% at termination with vessels widely patent. By 98 days for all early-incorporation analysis animals, the stabilizing cylindrical part of the Sentry frame was incorporated in the vessel wall, and the filter arms were retracted. By 180 days for all late-incorporation analysis animals, the filter arms as well as frames were stably incorporated. Conclusions. Through 180 days, there were no filter-related complications, and the study devices were all bioconverted and stably incorporated, leaving all IVCs patent.

Helical Centerline Stent Improves Patency: Two-Year Results From the Randomized Mimics Trial.

BACKGROUND: Reintervention in the femoropopliteal artery is frequent and a major driver of cost-effectiveness. High wall shear generated by swirling blood flow is associated with reduced occurrence of atherosclerosis and restenosis. This trial investigated the clinical and hemodynamic outcomes of the BioMimics 3D self-expanding tubular nitinol stent with helical centerline geometry compared with a straight stent in the femoropopliteal artery. METHODS AND RESULTS: In a prospective, multicenter, randomized controlled trial, 76 patients with symptomatic peripheral arterial disease were randomized 2:1 to receive a helical or a straight stent. An independent core laboratory adjudicated angiographic and ultrasound parameters. The primary safety end point was freedom from a composite of all death, target limb amputation, and target lesion revascularization at 30 days. The primary effectiveness end point was freedom from clinically driven target lesion revascularization at 6 months. Patency was a secondary end point. Subjects were followed up for 2 years from intervention. The primary safety (1-sided P<0.01) and efficacy (1-sided P<0.001) end points for the helical stent were met. The proportion of patients treated with the helical stent who maintained patency at 12 and 24 months was 80% and 72%, respectively, compared with 71% and 55% for the control group. The difference was significant through 24 months (P=0.05). Freedom from clinically driven target lesion revascularization for the helical compared with straight stent was 91% versus 92% at 12 months and 91% versus 76% at 24 months. CONCLUSIONS: Both groups had similar safety outcomes and clinically driven target lesion revascularization to 2 years. However, after placement of a BioMimics 3D helical stent, there was improved patency to 2 years. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02163863.

Evaluation of a noise reduction imaging technology in iliac digital subtraction angiography: noninferior clinical image quality with lower patient and scatter dose.

PURPOSE: To determine whether equivalent-quality images can be obtained from digital subtraction angiography (DSA) of the iliac artery after implementation of a novel imaging technology that reduces patient and scatter x-ray dose. MATERIALS AND METHODS: Imaging using two randomly ordered DSA runs was performed in 51 adults scheduled for iliac artery angiography or intervention or both. One DSA run used standard acquisition chain and image processing algorithms (referred to as " reference DSA"), and the other DSA run used dose-reduction and real-time advanced image noise reduction technology (referred to as "study DSA"). The quality of each pair of runs, consecutively performed without changes in working projection or injection parameters, was independently rated by five radiologists blinded to the imaging technology used. Patient radiation dose was evaluated using air kerma and dose area product, and scatter dose was evaluated using three dosimeters (DoseAware, Philips Healthcare, Best, The Netherlands), located at fixed positions. RESULTS: Comparable image pairs were available in 48 patients. There were 44 patients undergoing treatment involving the common (n = 33) or external (n = 29) iliac arteries. Study DSA images were rated as equal to or better than reference DSA images for 96% of comparisons, with an average overall agreement among raters of 0.93 (95% confidence interval, 0.65-0.96). Mean patient radiation dose (n = 48) and scatter dose rate for the three dosimeters (n = 50) was 83% ± 5 and 69% ± 10 lower, respectively, using the study technology (P < .001). CONCLUSIONS: Iliac artery DSA performed using a dose-reduction and real-time advanced image noise reduction technology results in image quality that is noninferior to conventional DSA but with significantly lower patient and scatter radiation exposure (P < .001).

Ischemic brain lesions after carotid artery stenting increase future cerebrovascular risk.

BACKGROUND: Brain lesions on diffusion-weighted imaging (DWI) are frequently found after carotid artery stenting (CAS), but their clinical relevance remains unclear. OBJECTIVES: This study sought to investigate whether periprocedural ischemic DWI lesions after CAS or carotid endarterectomy (CEA) are associated with an increased risk of recurrent cerebrovascular events. METHODS: In the magnetic resonance imaging (MRI) substudy of ICSS (International Carotid Stenting Study), 231 patients with symptomatic carotid stenosis were randomized to undergo CAS (n=124) or CEA (n=107). MRIs were performed 1 to 7 days before and 1 to 3 days after treatment. The primary outcome event was stroke or transient ischemic attack in any territory occurring between the post-treatment MRI and the end of follow-up. Time to occurrence of the primary outcome event was compared between patients with (DWI+) and without (DWI-) new DWI lesions on the post-treatment scan in the CAS and CEA groups separately. RESULTS: Median time of follow-up was 4.1 years (interquartile range: 3.0 to 5.2). In the CAS group, recurrent stroke or transient ischemic attack occurred more often among DWI+ patients (12 of 62) than among DWI- patients (6 of 62), with a cumulative 5-year incidence of 22.8% (standard error [SE]: 7.1%) and 8.8% (SE: 3.8%), respectively (unadjusted hazard ratio: 2.85; 95% confidence interval: 1.05 to 7.72; p=0.04). In DWI+ and DWI- patients, 8 and 2 events, respectively, occurred within 6 months after treatment. In the CEA group, there was no difference in recurrent cerebrovascular events between DWI+ and DWI- patients. CONCLUSIONS: Ischemic brain lesions discovered on DWI after CAS seem to be a marker of increased risk for recurrent cerebrovascular events. Patients with periprocedural DWI lesions might benefit from more aggressive and prolonged antiplatelet therapy after CAS. (A Randomised Comparison of the Risks, Benefits and Cost Effectiveness of Primary Carotid Stenting With Carotid Endarterectomy: International Carotid Stenting Study; ISRCTN25337470).

Length of carotid stenosis predicts peri-procedural stroke or death and restenosis in patients randomized to endovascular treatment or endarterectomy.

BACKGROUND: The anatomy of carotid stenosis may influence the outcome of endovascular treatment or carotid endarterectomy. Whether anatomy favors one treatment over the other in terms of safety or efficacy has not been investigated in randomized trials. METHODS: In 414 patients with mostly symptomatic carotid stenosis randomized to endovascular treatment (angioplasty or stenting; n = 213) or carotid endarterectomy (n = 211) in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS), the degree and length of stenosis and plaque surface irregularity were assessed on baseline intraarterial angiography. Outcome measures were stroke or death occurring between randomization and 30 days after treatment, and ipsilateral stroke and restenosis ≥50% during follow-up. RESULTS: Carotid stenosis longer than 0.65 times the common carotid artery diameter was associated with increased risk of peri-procedural stroke or death after both endovascular treatment [odds ratio 2.79 (1.17-6.65), P = 0.02] and carotid endarterectomy [2.43 (1.03-5.73), P = 0.04], and with increased long-term risk of restenosis in endovascular treatment [hazard ratio 1.68 (1.12-2.53), P = 0.01]. The excess in restenosis after endovascular treatment compared with carotid endarterectomy was significantly greater in patients with long stenosis than with short stenosis at baseline (interaction P = 0.003). Results remained significant after multivariate adjustment. No associations were found for degree of stenosis and plaque surface. CONCLUSIONS: Increasing stenosis length is an independent risk factor for peri-procedural stroke or death in endovascular treatment and carotid endarterectomy, without favoring one treatment over the other. However, the excess restenosis rate after endovascular treatment compared with carotid endarterectomy increases with longer stenosis at baseline. Stenosis length merits further investigation in carotid revascularisation trials.

Absent right common carotid artery with stenting of symptomatic internal carotid artery stenosis.

Absent common carotid artery with independent origin of internal and external carotid arteries from the subclavian artery is a rare but recognized phenomenon. We describe one such case with an associated symptomatic proximal high-grade stenosis of the right internal carotid artery. The abnormal carotid anatomy was not initially well appreciated, resulting in a failed surgical exploration and subsequent successful endovascular carotid stenting. To our knowledge, this is the first reported case of carotid stent in a right internal carotid artery originating from the subclavian artery.

Assessment of reverse flow as a means of cerebral protection during carotid artery stent placement with diffusion-weighted and transcranial Doppler imaging.

PURPOSE: To assess the effectiveness of flow reversal as an alternative means of cerebral protection by using transcranial Doppler recordings and diffusion-weighted imaging (DWI) as surrogate markers of brain injury. MATERIALS AND METHODS: Eighteen patients with symptomatic carotid artery disease were recruited. Magnetic resonance imaging was performed before the intervention and at 3 and 24 hours and 30 days after the intervention to detect new ischemic lesions with DWI. Transcranial Doppler recordings were made during the procedure to assess for microembolic signals (MESs). Data were compared against data from a historical control cohort of patients who underwent CAS placement with or without filter protection (n = 15 each) under the same protocol in a different study. RESULTS: There were fewer periprocedural new lesions on DWI in the reverse-flow cohort compared with the historical control cohort with filter protection (P = .084). Reverse flow revealed significantly fewer MESs during the whole procedure compared with the filter-protected group (P = .01) but not the unprotected group (P = .55). There was a marked decrease in MES counts for reverse flow protection during the embologenic stages of the procedure (P = .004). CONCLUSIONS: Use of the reverse flow device was associated with fewer overall lesions on DWI and proportionately fewer positive scans compared with the use of filter-type devices (P = .08, not significant). Transcranial Doppler recordings demonstrated a significant reduction in embolization to the brain during carotid artery stent placement with the use of reverse-flow cerebral protection.

Characteristics of ischemic brain lesions after stenting or endarterectomy for symptomatic carotid artery stenosis: results from the international carotid stenting study-magnetic resonance imaging substudy.

BACKGROUND AND PURPOSE: In a substudy of the International Carotid Stenting Study (ICSS), more patients had new ischemic brain lesions on diffusion-weighted magnetic resonance imaging (MRI) after stenting (CAS) than after endarterectomy (CEA). In the present analysis, we compared characteristics of diffusion-weighted MRI lesions. METHODS: Number, individual and total volumes, and location of new diffusion-weighted MRI lesions were compared in patients with symptomatic carotid stenosis randomized to CAS (n=124) or CEA (n=107) in the ICSS-MRI substudy. RESULTS: CAS patients had higher lesion numbers than CEA patients (1 lesion, 15% vs 8%; 2-5 lesions, 19% vs 5%; >5 lesions, 16% vs 4%). The overall risk ratio for the expected lesion count with CAS versus CEA was 8.8 (95% confidence interval, 4.4-17.5; P<0.0001) and significantly increased among patients with lower blood pressure at randomization, diabetes mellitus, stroke as the qualifying event, left-side stenosis, and if patients were treated at centers routinely using filter-type protection devices during CAS. Individual lesions were smaller in the CAS group than in the CEA group (P<0.0001). Total lesion volume per patient did not differ significantly. Lesions in the CAS group were more likely to occur in cortical areas and subjacent white matter supplied by leptomeningeal arteries than lesions in the CEA group (odds ratio, 4.2; 95% confidence interval, 1.7-10.2; P=0.002). CONCLUSIONS: Compared with patients undergoing CEA, patients treated with CAS had higher numbers of periprocedural ischemic brain lesions, and lesions were smaller and more likely to occur in cortical areas and subjacent white matter. These findings may reflect differences in underlying mechanisms of cerebral ischemia.

A contemporary review of cystic adventitial disease.

Cystic adventitial disease (CAD) is a rare vascular disorder, predominantly seen in young healthy men with minimal cardiovascular risk factors. Cystic adventitial disease can affect both arteries and veins. Patients with arterial CAD present with sudden onset or rapidly progressing claudication symptoms, and those with venous CAD present with limb swelling or very rarely deep vein thrombosis. Diagnosis is confirmed with the aid of imaging techniques such as ultrasonography, computed tomography, or magnetic resonance scan. Surgical resection or evacuation of the lesion is usually the preferred approach, with only mixed results reported for percutaneous endovascular techniques.

New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS).

BACKGROUND: 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. METHODS: 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. FINDINGS: 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). INTERPRETATION: 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. FUNDING: UK Medical Research Council, the Stroke Association, Sanofi-Synthélabo, European Union, Netherlands Heart Foundation, and Mach-Gaensslen Foundation.

Long-term results of carotid artery stents to manage symptomatic carotid artery stenosis and factors that affect outcome.

BACKGROUND: Limited data are available about the long-term outcomes of the use of carotid artery stents in symptomatic patients and the impact of patient variables on the durability of endovascular carotid procedures. Outcome data previously reported from registry series mix symptomatic and asymptomatic patients. We present analysis of long-term follow-up, with independent neurological assessment, for patients with symptomatic high-grade carotid lesions undergoing stenting to identify patients at risk of recurrence. METHODS AND RESULTS: Prospectively collected data on 563 carotid stenting procedures in a single center were analyzed. Univariate and multivariate techniques were used to identify risk groups and beneficial technical adaptations. Ipsilateral stroke rates for all patients were 4.8%, 7.0%, and 9.5% at 30 days, 1 year, and 4 years, respectively. The rates improved to 2.7%, 4.1%, and 4.5% when patients were treated with optimal therapy. Retinal events had a lower risk of long-term recurrent ipsilateral stroke (hazard ratio=0.228, CI=0.082 to 0.632, P=0.004) than cerebral events. A recurrent or residual stenosis of >50% had a statistically significant effect on long-term stroke recurrence in multivariate analysis (hazard ratio=2.187, CI=1.173 to 4.078, P=0.014). CONCLUSIONS: Patients with retinal presentations are a lower risk group to treat. Residual stenosis or restenosis >50% has a statistically significant trend to an increased risk of recurrence for ipsilateral stroke in the long term in this population. In our patients, a combination of procedural modifications and pharmacological changes seems to improve outcomes.

Filter-protected versus unprotected carotid artery stenting: a randomised trial.

BACKGROUND: Our aim was to determine whether filter protection reduces embolisation to the brain during carotid artery stenting (CAS). METHODS: Thirty patients with symptomatic carotid artery stenosis > or =70% (North American Symptomatic Carotid Endarterectomy Trial) were randomly assigned to filter-protected or unprotected CAS. Diffusion-weighted magnetic resonance imaging (DWI) of the brain was performed before and at 3 time points after CAS. In a subset of patients, high-intensity transient signals on transcranial Doppler (TCD) were recorded with categorisation of emboli. Data were independently reviewed off-site. RESULTS: There were no significant differences in mean age, proportion of octogenarians or presenting symptoms between the groups. On procedural DWI (1-3 and 24 h after stenting), there were 7/24 (29%) and 4/22 (18%) new lesions in protected and unprotected patients respectively (p = 0.38). At 30 days there were 9/33 (26%) and 4/33 (12%) lesions in protected and unprotected patients, respectively (p = 0.1). On TCD there were significantly more signals in total as well as particulate emboli during filter-protected CAS (426.5 and 251.3) than during unprotected CAS (165.2 and 92) - p = 0.01 and 0.03, respectively. CONCLUSIONS: Filter-protected CAS is associated with an increase in new lesions on DWI and significantly higher rates of total and particulate microembolisation on TCD than unprotected CAS. The clinical significance of these findings requires further study.

Endovascular treatment with angioplasty or stenting versus endarterectomy in patients with carotid artery stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial.

BACKGROUND: Endovascular treatment (angioplasty with or without stenting) is an alternative to carotid endarterectomy for carotid artery stenosis but there are scarce long-term efficacy data showing that it prevents stroke. We therefore report the long-term results of the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS). METHODS: Between March, 1992, and July, 1997, patients who presented at a participating centre with a confirmed stenosis of the internal carotid artery that was deemed equally suitable for either carotid endarterectomy or endovascular treatment were randomly assigned to either treatment in equal proportions by telephone or fax from the randomisation service at the Oxford Clinical Trials Unit, UK. Patients were seen by an independent neurologist at 1 and 6 months after treatment and then every year after randomisation for as long as possible, up to a maximum of 11 years. Major outcome events were transient ischaemic attack, non-disabling, disabling, and fatal stroke, myocardial infarction, and death from any other cause. Outcomes were adjudicated on by investigators who were masked to treatment. Analysis was by intention to treat. This study is registered, number ISRCTN 01425573. FINDINGS: 504 patients with stenosis of the carotid artery (90% symptomatic) were randomly assigned to endovascular treatment (n=251) or surgery (n=253). Within 30 days of treatment, there were more minor strokes that lasted less than 7 days in the endovascular group (8 vs 1) but the number of other strokes in any territory or death was the same (25 vs 25). There were more cranial nerve palsies (22 vs 0) in the endarterectomy group than in the endovascular group. Median length of follow up in both groups was 5 years (IQR 2-6). By comparing endovascular treatment with endarterectomy after the 30-day post-treatment period, the 8-year incidence and hazard ratio (HR) at the end of follow-up for ipsilateral non-perioperative stroke was 11.3% versus 8.6% (HR 1.22, 95% CI 0.59-2.54); for ipsilateral non-perioperative stroke or TIA was 19.3% versus 17.2% (1.29, 0.78-2.14); and for any non-perioperative stroke was 21.1% versus 15.4% (1.66, 0.99-2.80). INTERPRETATION: More patients had stroke during follow-up in the endovascular group than in the surgical group, but the rate of ipsilateral non-perioperative stroke was low in both groups and none of the differences in the stroke outcome measures was significant. However, the study was underpowered and the confidence intervals were wide. More long-term data are needed from the on going stenting versus endarterectomy trials. FUNDING: British Heart Foundation; UK National Health Service Management Executive; UK Stroke Association.

Long-term risk of carotid restenosis in patients randomly assigned to endovascular treatment or endarterectomy in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial.

BACKGROUND: In the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS), early recurrent carotid stenosis was more common in patients assigned to endovascular treatment than it was in patients assigned to endarterectomy (CEA), raising concerns about the long-term effectiveness of endovascular treatment. We aimed to investigate the long-term risks of restenosis in patients included in CAVATAS. METHODS: 413 patients who were randomly assigned in CAVATAS and completed treatment for carotid stenosis (200 patients had endovascular treatment and 213 patients had endarterectomy) had prospective clinical follow-up at a median of 5 years and carotid duplex ultrasound at a median of 4 years. We investigated the cumulative long-term incidence of carotid restenosis after endovascular treatment and endarterectomy, the effect of the use of stents on restenosis after endovascular treatment, risk factors for the development of restenosis, and the effect of carotid restenosis on the risk of recurrent cerebrovascular events. Analysis was by intention to treat. This study is registered, number ISRCTN01425573. FINDINGS: Severe carotid restenosis (>or=70%) or occlusion occurred significantly more often in patients in the endovascular arm than in patients in the endarterectomy arm (adjusted hazard ratio [HR] 3.17, 95% CI 1.89-5.32; p<0.0001). The estimated 5-year incidence of restenosis was 30.7% in the endovascular arm and 10.5% in the endarterectomy arm. Patients in the endovascular arm who were treated with a stent (n=50) had a significantly lower risk of developing restenosis of 70% or greater compared with those treated with balloon angioplasty alone (n=145; HR 0.43, 0.19-0.97; p=0.04). Current smoking or a history of smoking was a predictor of restenosis of 70% or more (2.32, 1.19-4.54; p=0.01) and the early finding of moderate stenosis (50-69%) up to 60 days after treatment was associated with the risk of progression to restenosis of 70% or more (3.76, 1.88-7.52; p=0.0002). The composite endpoint of ipsilateral non-perioperative stroke or transient ischaemic attack occurred more often in patients in whom restenosis of 70% or more was diagnosed in the first year after treatment compared with patients without restenosis of 70% or more (5-year incidence 23%vs 11%; HR 2.18, 1.04-4.54; p=0.04), but the increase in ipsilateral stroke alone was not significant (10%vs 5%; 1.67, 0.54-5.11). INTERPRETATION: Restenosis is about three times more common after endovascular treatment than after endarterectomy and is associated with recurrent ipsilateral cerebrovascular symptoms; however, the risk of recurrent ipsilateral stroke is low. Further data are required from on-going trials of stenting versus endarterectomy to ascertain whether long-term ultrasound follow-up is necessary after carotid revascularisation. FUNDING: British Heart Foundation; UK National Health Service Management Executive; UK Stroke Association.

Lessons from EVA-3S and SPACE.

Carotid endarterectomy (CEA) was established as the gold standard for treatment of carotid occlusive disease by several landmark papers published in the 1990s. With the continued trend toward less invasive therapies, carotid artery stenting (CAS) has challenged CEA for treatment of significant carotid artery disease. Several trials have now compared CEA and CAS and a subsequent Cochrane review indicated that the 30-day complication rates were equivalent. Unfortunately, comparative long-term data are still lacking. Two new trials comparing CAS with CAE in patients with symptomatic internal carotid artery disease have recently been published, but to what extent have they usefully added to the available data?

Stent implantation for acute iliac artery occlusions: initial experience.

PURPOSE: Treatment options for acute occlusion of the iliac arteries include surgical thrombectomy, surgical bypass, and endovascular interventions such as thrombolysis and mechanical thrombectomy with or without adjunctive angioplasty or stent implantation. Acute lesions are not usually treated by stent implantation for fear of distal embolism. The purpose of this study was to retrospectively review a single-center experience of primary iliac stent implantation for acute ischemia secondary to acute thrombosis. MATERIALS AND METHODS: Between April 2004 and August 2005, seven patients (five men and two women; mean age, 69.9 y; range, 53-93 y) underwent iliac stent implantation for the acute onset (within 12 days before presentation) of ipsilateral ischemic symptoms. Diagnostic angiography revealed occlusion of the common and external iliac arteries (n = 3) or external iliac artery (n = 4). Patients with rest pain (n = 6) were treated with unfractionated heparin. RESULTS: All acute occlusions were traversed by the guide wire with relative ease. Recanalization with stent implantation was successful in all cases without distal embolization. Five patients showed noticeable clinical improvement. Two elderly patients with isolated patent profunda segments with no demonstrable distal runoff vessels did not have long-term clinical improvement despite successful iliac recanalization. CONCLUSIONS: This small case series suggests that primary stent implantation for acute iliac occlusions with a patent common femoral artery under intravenous heparin protection may be a reasonable endovascular alternative to thrombolysis for patients who cannot tolerate the time delay to achieve thrombolysis or who have contraindications to thrombolysis. The safety of this technique may be comparable to that of primary stent implantation for chronic occlusions, but larger series would be necessary to confirm this.

Endofibrosis of iliac arteries in high-performance athletes: diagnostic approach and minimally invasive endovascular treatment.

The aim of this article is to report our experience in the diagnosis of two cases of iliac artery endofibrosis or arteriopathy, a rare entity occurring in high-performance athletes, presenting with intermittent claudication (right-sided in both) after maximal exercise. External iliac artery endofibrosis or arteriopathy is a likely diagnosis in competitive athletes free of cardiovascular risk factors who present with leg claudication. Arteriography and a papaverine-assisted mean pressure gradient across the iliac arteries of more than 10 mmHg is a useful diagnostic approach. Moreover, balloon angioplasty of the iliac artery in that patient, in whom a pressure gradient was detected, resulted in symptomatic relief for 2 months followed by mild symptom recurrence. Thus, although balloon angioplasty is feasible and safe, it might not be adequate to treat this entity and, thus, its value remains undefined.

Is there any benefit from staged carotid and coronary revascularization using carotid stents? A single-center experience highlights the need for a randomized controlled trial.

BACKGROUND AND PURPOSE: To assess the benefits of carotid artery stenting before coronary artery bypass surgery to reduce the risk of stroke occurring during the cardiac procedure. METHODS: A prospective cohort study was performed in patients undergoing carotid artery stenting before coronary artery bypass surgery, or combined bypass and valve replacement procedures, to assess the procedures effectiveness in stroke prevention. Outcome measures including 30-day post stenting and cardiac surgery neurological complication and all-cause mortality rates were assessed. RESULTS: A total of 52 patients were included. Two patients underwent aortic valve replacements at the same time as coronary revascularization. No neurological complications occurred because of the stenting procedure. One cardiac death not related to coronary artery bypass surgery occurred in the 30-day follow-up period for the stent procedure. An additional 6 (11.5%) outcome events (3 strokes and 3 deaths) occurred in the 30-day follow-up period after the cardiac procedure. Three patients died of cardiac causes while awaiting their cardiac bypass procedure. CONCLUSIONS: Our results are comparable to those in patients that undergo staged or combined carotid endarterectomy before cardiac surgery. Our small cohort study adds to the limited world literature on the subject but is not sufficiently powered to recommend alterations in practice.