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Title: Carotid Stenting with Distal Protection in High-Surgical-Risk Patients: One-Year Results of the ASTI Trial

Abstract

PurposeThis prospective, multicenter, nonrandomized study evaluated the periprocedural and 1-year outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Adapt Carotid Stent plus FilterWire EZ distal protection catheter (Boston Scientific Corporation, Natick, MA).Materials and MethodsThe study enrolled 100 patients (32 symptomatic, 63 asymptomatic, 5 unknown) at high risk for carotid endarterectomy due to prespecified anatomical criteria and/or medical comorbidities. Thirty-day and 1-year follow-up included clinical evaluation, carotid duplex ultrasound, and independent neurologic and NIH stroke scale assessments. One-year endpoints included the composite rate of major adverse events (MAE), defined as death, stroke, and myocardial infarction (MI) and the rates of late ipsilateral stroke (31–365 days), target lesion revascularization, and in-stent restenosis.ResultsOf the 100 enrolled patients, technical success was achieved in 90.9 % (90/99). The 30-day MAE rate (5.1 %) consisted of major stroke (2.0 %) and minor stroke (3.1 %); no deaths or MIs occurred. The 1-year MAE rate (12.2 %) consisted of death, MI, and stroke rates of 4.4, 3.3, and 8.9 %, respectively. Late ipsilateral stroke (31–365 days) rate was 1.1 %. Symptomatic patients had higher rates of death (11.1 vs. 1.7 %) and MI (7.4 vs. 1.7 %), but lower rates of major (7.4 vs. 10.0 %) and minor stroke (0.0 vs. 6.7 %), compared with asymptomatic patients.ConclusionResultsmore » through 1 year postprocedure demonstrated that carotid artery stenting with Adapt Carotid Stent and FilterWire EZ is safe and effective in high-risk-surgical patients.« less

Authors:
 [1];  [2];  [3];  [4];  [5];  [6]
  1. A.Z. Sint-Blasius, Department of Vascular Surgery (Belgium)
  2. Park Hospital, Center for Vascular Medicine-Angiology and Vascular Surgery (Germany)
  3. Klinikum Dortmund GmbH (Germany)
  4. Sankt Gertrauden-Krankenhaus (Germany)
  5. Klinikum Neuperlach (Germany)
  6. One Boston Scientific Place, Boston Scientific Corporation (United States)
Publication Date:
OSTI Identifier:
22470033
Resource Type:
Journal Article
Resource Relation:
Journal Name: Cardiovascular and Interventional Radiology; Journal Volume: 38; Journal Issue: 2; Conference: BSIR 2014: Britisch Society of Interventional Radiology 2014 annual meeting, Liverpool (United Kingdom), 12-14 Nov 2014; Other Information: Copyright (c) 2015 Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE); http://www.springer-ny.com; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CAROTID ARTERIES; COMPARATIVE EVALUATIONS; DEATH; HAZARDS; MYOCARDIAL INFARCTION; PATIENTS; SAFETY; SURGERY

Citation Formats

Bosiers, Marc, E-mail: marc.bosiers@telenet.be, Scheinert, Dierk, E-mail: dierk.scheinert@gmx.de, Mathias, Klaus, E-mail: k.mathias@asklepios.com, Langhoff, Ralf, E-mail: ralf.langhoff@sankt-gertrauden.de, Mudra, Harald, E-mail: haraldmudra@aol.com, and Diaz-Cartelle, Juan, E-mail: juan.diazcartelle@bostonscientific.com. Carotid Stenting with Distal Protection in High-Surgical-Risk Patients: One-Year Results of the ASTI Trial. United States: N. p., 2015. Web. doi:10.1007/S00270-014-1000-4.
Bosiers, Marc, E-mail: marc.bosiers@telenet.be, Scheinert, Dierk, E-mail: dierk.scheinert@gmx.de, Mathias, Klaus, E-mail: k.mathias@asklepios.com, Langhoff, Ralf, E-mail: ralf.langhoff@sankt-gertrauden.de, Mudra, Harald, E-mail: haraldmudra@aol.com, & Diaz-Cartelle, Juan, E-mail: juan.diazcartelle@bostonscientific.com. Carotid Stenting with Distal Protection in High-Surgical-Risk Patients: One-Year Results of the ASTI Trial. United States. doi:10.1007/S00270-014-1000-4.
Bosiers, Marc, E-mail: marc.bosiers@telenet.be, Scheinert, Dierk, E-mail: dierk.scheinert@gmx.de, Mathias, Klaus, E-mail: k.mathias@asklepios.com, Langhoff, Ralf, E-mail: ralf.langhoff@sankt-gertrauden.de, Mudra, Harald, E-mail: haraldmudra@aol.com, and Diaz-Cartelle, Juan, E-mail: juan.diazcartelle@bostonscientific.com. 2015. "Carotid Stenting with Distal Protection in High-Surgical-Risk Patients: One-Year Results of the ASTI Trial". United States. doi:10.1007/S00270-014-1000-4.
@article{osti_22470033,
title = {Carotid Stenting with Distal Protection in High-Surgical-Risk Patients: One-Year Results of the ASTI Trial},
author = {Bosiers, Marc, E-mail: marc.bosiers@telenet.be and Scheinert, Dierk, E-mail: dierk.scheinert@gmx.de and Mathias, Klaus, E-mail: k.mathias@asklepios.com and Langhoff, Ralf, E-mail: ralf.langhoff@sankt-gertrauden.de and Mudra, Harald, E-mail: haraldmudra@aol.com and Diaz-Cartelle, Juan, E-mail: juan.diazcartelle@bostonscientific.com},
abstractNote = {PurposeThis prospective, multicenter, nonrandomized study evaluated the periprocedural and 1-year outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Adapt Carotid Stent plus FilterWire EZ distal protection catheter (Boston Scientific Corporation, Natick, MA).Materials and MethodsThe study enrolled 100 patients (32 symptomatic, 63 asymptomatic, 5 unknown) at high risk for carotid endarterectomy due to prespecified anatomical criteria and/or medical comorbidities. Thirty-day and 1-year follow-up included clinical evaluation, carotid duplex ultrasound, and independent neurologic and NIH stroke scale assessments. One-year endpoints included the composite rate of major adverse events (MAE), defined as death, stroke, and myocardial infarction (MI) and the rates of late ipsilateral stroke (31–365 days), target lesion revascularization, and in-stent restenosis.ResultsOf the 100 enrolled patients, technical success was achieved in 90.9 % (90/99). The 30-day MAE rate (5.1 %) consisted of major stroke (2.0 %) and minor stroke (3.1 %); no deaths or MIs occurred. The 1-year MAE rate (12.2 %) consisted of death, MI, and stroke rates of 4.4, 3.3, and 8.9 %, respectively. Late ipsilateral stroke (31–365 days) rate was 1.1 %. Symptomatic patients had higher rates of death (11.1 vs. 1.7 %) and MI (7.4 vs. 1.7 %), but lower rates of major (7.4 vs. 10.0 %) and minor stroke (0.0 vs. 6.7 %), compared with asymptomatic patients.ConclusionResults through 1 year postprocedure demonstrated that carotid artery stenting with Adapt Carotid Stent and FilterWire EZ is safe and effective in high-risk-surgical patients.},
doi = {10.1007/S00270-014-1000-4},
journal = {Cardiovascular and Interventional Radiology},
number = 2,
volume = 38,
place = {United States},
year = 2015,
month = 4
}
  • Purpose: To report the local control and overall survival outcomes after lumpectomy followed by accelerated partial breast irradiation in high-risk patients as defined by the current inclusion criteria for the National Surgical Adjuvant Breast and Bowel B-39/Radiation Therapy Oncology Group 0413 Intergroup trial. Methods and Materials: Between 2000 and 2005, 273 women with early-stage breast cancer were treated using either multicatheter interstitial brachytherapy (n = 247) or MammoSite (n = 26). Patients received 32-34 Gy in 8-10 twice-daily fractions using high-dose-rate {sup 192}Ir brachytherapy. All patients met the initial inclusion criteria for the Intergroup trial and were separated into twomore » groups: high-risk patients (representing the cohort that remained eligible for the Intergroup trial) who satisfied one or more of the 'high-risk' criteria (age <50 years, estrogen receptor negative, and/or positive lymph nodes; n = 90), and low-risk patients who comprised the remainder of the cohort (n = 183). The outcomes of the two cohorts were analyzed and compared. Results: The median follow-up of the entire cohort was 48.5 months. No significant difference was found in outcomes at 5 years between the low- and high-risk groups, with a local control rate of 97.8% vs. 93.6%, crude local recurrence rate of 2.2% (n = 4) vs. 4.4% (n = 4), and overall survival rate of 92.1% vs. 89.5%, respectively. Conclusion: At 5 years, no statistically significant difference was found in outcomes for patients deemed to be at greater risk in the current National Surgical Adjuvant Breast and Bowel B-39/Radiation Therapy Oncology Group 0413 Intergroup trial. These clinical data support the inclusion of this 'high-risk' population in this important ongoing study.« less
  • The purpose of this study was to evaluate the feasibility, safety and midterm outcome of elective implantation of the Carotid Wallstent (registered) in patients considered to be at high surgical risk. In a prospective study, 54 carotid artery stenoses in 51 patients were stented over a 24-month period. Three patients underwent bilateral carotid artery stenting. Institutional inclusion criteria for invasive treatment of carotid occlusive disease (carotid endarterectomy or carotid artery stenting) are patients presenting with a 70% or more symptomatic stenosis and those with an 80% or more asymptomatic stenosis having a life-expectancy of more than 1 year. All patientsmore » treated by carotid artery stenting were considered at high risk for carotid endarterectomy because of a hostile neck (17 patients-31.5%) or because of severe comorbidities (37 patients-68.5%). No cerebral protection device was used. Of the 54 lesions, 33 (61.1%) were symptomatic and 21 (38.8%) were asymptomatic. Follow-up was performed by physical examination and by duplex ultrasonography at 1 month, 6 months, 1 year and 2 years after the procedure. All 54 lesions could be stented successfully without periprocedural stroke. Advert events during follow-up (mean 13.9 {+-} 5.7 months) were non-stroke-related death in 6 patients (11.1%), minor stroke in 4 stented hemispheres(7.4%), transient ipsilateral facial pain in 1 patient (1.8%),infection of the stented surgical patch in 1 patient (1.8%) and asymptomatic in stent restenosis in 4 patients (7.4%). The percutaneous implantation of the Carotid Wallstent (registered) , even without cerebral protection device, appears to be a safe procedure with acceptable clinical and ultrasonographic follow-up results in patients at high surgical risk. But some late adverse events such as ipsilateral recurrence of non-disabling (minor) stroke or in stent restenosis still remain real challenging problems.« less
  • Purpose: This study was designed to investigate the risk factors and complications of difficult retrieval (DR) of embolic protection devices (EPDs) in carotid artery stenting (CAS). Methods: A total of 195 consecutive patients who underwent CAS between December 2007 and March 2010 in a general hospital were enrolled and divided into two groups: with DR and without DR. The risk factors of DR were analyzed with univariate and multivariate analyses. The complications of DR were recorded and analyzed. Results: A total of 30 (15.4%) patients with DR of EPDs were observed, of whom EPDs were successfully retrieved in 29, andmore » in 1 was it taken out by surgical treatment. The retrieval time was significantly longer in patients with DR (490.5 {+-} 143.9 s) than in patients without DR (157.2 {+-} 15.7 s, p = 0.000). Vasospasm was observed more frequently in patients with DR than in patients without DR (55.2% vs. 14.5%, p = 0.000). Intracranial compilations were more frequent in patients with DR than in those without DR (17.2% vs. 0.6%, p = 0.000). Calcified plaques, degree of residual stenosis, types of the stents, and tortuosity index (TI > 80 Degree-Sign) were all associated with DR. A logistic regression analysis indicated that calcified plaques (odds ratio (OR) = 6.5; p = 0.000) and TI > 80 Degree-Sign (OR = 18.8; p = 0.000) were independent predictors of DR. Conclusions: Calcified plaques and TI > 80 Degree-Sign may be related to DR in patients with CAS. DR may lengthen the retrieving time and increase the complications of the procedure.« less
  • Purpose. To report 5-year contrast-enhanced magnetic resonance imaging findings of the REST trial recruits who underwent either uterine artery embolization (UAE) or myomectomy. Methods. A total of 157 patients were randomized to UAE or surgery (hysterectomy or myomectomy). Ninety-nine patients who had UAE and eight patients who had myomectomy were analyzed. MRI scans at baseline, 6 months, and 5 years were independently interpreted by two radiologists. Dominant fibroid diameter, uterine volume, total fibroid infarction (complete 100 %, almost complete 90-99 %, partial <90 %), and new fibroid formation were the main parameters assessed and related to the need for reintervention.more » Results. In the UAE group, mean {+-} standard deviation uterine volume was 670 {+-} 503, 422 {+-} 353, and 292 {+-} 287 mL at baseline, 6 months, and 5 years, respectively. Mean dominant fibroid diameter was 7.6 {+-} 3.0, 5.8 {+-} 2.9, and 5 {+-} 2.9 cm at baseline, 6 months, and 5 years. Fibroid infarction at 6 months was complete in 35 % of women, almost complete in 29 %, and partial in 36 %. Need for reintervention was 19, 10, and 33 % in these groups, respectively (p = 0.123). No myomectomy cases had further intervention. At 5 years, the prevalence of new fibroid was 60 % in the myomectomy group and 7 % in the UAE group (p = 0.008). Conclusion. There is a further significant reduction in both uterine volume and dominant fibroid diameter between 6 months and 5 years after UAE. Complete fibroid infarction does not translate into total freedom from a subsequent reintervention. New fibroid formation is significantly higher after myomectomy.« less
  • We studied the deliverability and safety of a braided, self-expanding, closed-cell nickel-titanium (NiTi) stent (E-volution, Jotec GmbH, Hechingen, Germany) especially designed for the endovascular treatment of carotid artery bifurcation stenosis with special regard to in-stent stenosis and thrombosis compared with a laser-cut reference nitinol stent in a porcine model of percutaneous vascular interventions. We aimed to assess histopathologic response in minipig carotid and subclavian arteries. Eight minipigs received a total of 42 stents: 14 reference stents and 28 E-volution stents. Eleven of the E-volution stents were additionally coated with heparin. Control angiography was obtained immediately before and after vascular interventionmore » as well as 4 weeks after the procedure. Primary endpoints were 28 days of angiographic analyses as well as histomorphometric analysis, including injury score, inflammation score, luminal diameter, vessel diameter, maximal neointimal thickness, and area of in-stent stenosis. Secondary end points were procedural success, 28-day mortality, and stent thrombosis. All stents could be delivered successfully without procedural complications, morbidity, or mortality during our observation time. As confirmed by histology, no in-stent thrombosis was observed. Compared with common carotid arteries, subclavian arteries are significantly more vulnerable to developing in-stent stenosis caused by neointima proliferation (p < 0.05). Compared with the use of 1 single stent/artery, serial application of two stents leads to a more excessive but not significantly different neointimal proliferation (p > 0.05). The E-volution stent, especially when heparin coated, is in line with the comparison to the laser-cut reference stent displaying similar results of angiographic, histologic, and histomorphometric analyses (p > 0.05). Compared with the reference laser-cut stent, the self-expanding nitinol stent (E-volution) with its advanced braiding technology is feasible and safe. In our opinion, the high radial resistive force and the advanced braided design with tight stent-strut interstices may be beneficial in terms of plaque stabilization. Further studies are necessary and warranted.« less