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Dierk Scheinert,
Konstantinos Katsanos,
Thomas Zeller,
Renate Koppensteiner,
Philip Commeau, Marc Bosiers,
Hans Krankenberg,
Iris Baumgartner,
Dimitris Siablis,
Johannes Lammer,
Mariella Van Ransbeeck,
Ayesha C Qureshi,
Hans-Peter Stoll
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ABSTRACT: The study investigated the efficacy and safety of a balloon expandable, sirolimus-eluting stent (SES) in patients with symptomatic infrapopliteal arterial disease.
Results of infrapopliteal interventions using balloon angioplasty and/or bare stents are limited by a relatively high restenosis rate, which could be potentially improved by stabilizing the lesion with a SES.
Two hundred patients (total lesion length 27 ± 21 mm) were randomized to infrapopliteal SES stenting or percutaneous transluminal balloon angioplasty (PTA). The primary endpoint was 1-year in-segment binary restenosis by quantitative angiography.
Ninety-nine and 101 patients (mean age 73.4 years; 64% diabetics) were randomized to SES and PTA, respectively (8 crossover bailout cases to SES). At 1 year, there were lower angiographic restenosis rates (22.4% vs. 41.9%, p = 0.019), greater vessel patency (75.0% vs. 57.1%, p =0.025), and similar death, repeat revascularization, index-limb amputation rates, and proportions of patients with improved Rutherford class for SES versus PTA.
SES implantation may offer a promising therapeutic alternative to PTA for treatment of infrapopliteal peripheral arterial disease.
Journal of the American College of Cardiology 12/2012; 60(22):2290-5. · 14.16 Impact Factor
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Eugenio Stabile,
Pallav Garg,
Alberto Cremonesi, Marc Bosiers,
Bernhard Reimers,
Carlo Setacci,
Piergiorgio Cao,
Andrej Schmidt,
Horst Sievert,
Patrick Peeters,
Dimitry Nikas,
Martin Werner,
Gianmarco de Donato,
Giambattista Parlani,
Fausto Castriota,
Marius Hornung,
Laura Mauri,
Paolo Rubino
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ABSTRACT: Carotid endarterectomy (CEA) is the standard revascularization therapy to prevent stroke in patients with carotid artery disease. Carotid artery stenting (CAS) could be considered a potential alternative in patients at high surgical risk. Recent clinical trials have challenged this concept due a relatively high incidence of post-CAS adverse events, which occurred in low volume centers. The aim of this study was to evaluate the outcomes associated with neuroprotected CAS in selected high volume centers.
From January 2007 to December 2007, 1,611 patients underwent neuroprotected CAS in eight European Centers. For each patients, clinical, procedural, and one month follow-up data from all patients have been collected. An independent clinical events committee adjudicated the events.
Overall in hospital death was 0.06% (one patient), whereas in-hospital stroke was 0.49% (eight patients). Between hospital discharge and 30 days three additional patients died (0.18%) and 10 patients experienced a stroke (0.67%). Overall 30 days mortality was 0.24% (four patients) and stroke incidence 1.12% (18 patients). The 30 day stroke/death rate was 1.36%.
CAS is a reasonable alternative to CEA to treat carotid artery atherosclerosis in well-experienced high volume centers. These data suggest that future prospective trials comparing CAS and CEA outcomes should include only centers highly experienced in both treatment modalities.
Catheterization and Cardiovascular Interventions 05/2012; 80(2):329-34. · 2.29 Impact Factor
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ABSTRACT: Critical limb ischemia, the most severe form of peripheral arterial disease, results in extremity amputation if left untreated. Endovascular recanalization of stenotic or occluded infrapopliteal arteries has recently emerged as an effective form of therapy, although the duration of patency is typically limited by restenosis. Recently, it has been suggested that drug-eluting stents originally developed for the coronary arteries might also be effective in preventing restenosis in the infrapopliteal arteries. This prospective, randomized, controlled clinical trial tested the hypothesis that treatment of infrapopliteal arterial occlusive lesions with an everolimus-eluting stent (Xience V) would provide superior patency to treatment with a bare-metal stent (Multi-Link Vision).
A sample size of 140 patients was planned to be enrolled at five European investigative sites. The primary end point was arterial patency at 12 months, defined as the absence of ≥50% restenosis based on quantitative analysis of contrast angiography.
Between March of 2008 and September of 2009, 74 patients were treated with Xience V and 66 patients were treated with Vision. After 12 months, the primary patency rate after treatment with Xience V was 85% compared with 54% after treatment with Vision (P = .0001). Treatment with Xience V significantly reduced mean in-stent diameter stenosis (21% ± 21% vs 47% ± 27%; P < .0001) and mean in-stent late lumen loss (0.78 ± 0.63 vs 1.41 ± 0.89 mm; P = .001). There were no differences in the percentage of patients receiving a designation of Rutherford class 0 or 1 at the 12-month follow-up visit (56% for Vision, vs 60% for Xience V; P = .68). Major extremity amputations were rare in both groups (two for Vision and one for Xience V). The use of the Xience V stent significantly reduced the need for repeat intervention: freedom from target lesion revascularization was 91% for Xience V vs 66% for Vision (P = .001).
Treatment of the infrapopliteal occlusive lesions of critical limb ischemia with everolimus-eluting stents reduces restenosis and the need for reintervention compared with bare metal stents.
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 12/2011; 55(2):390-8. · 3.52 Impact Factor
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Michael D Dake,
Dierk Scheinert,
Gunnar Tepe,
Jörg Tessarek,
Fabrizio Fanelli, Marc Bosiers,
Christof Ruhlmann,
Zaza Kavteladze,
Aaron E Lottes,
Anthony O Ragheb,
Thomas Zeller
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ABSTRACT: To report a prospective, single-arm, multicenter clinical study evaluating the Zilver PTX drug-eluting stent for treating the above-the-knee femoropopliteal segment (NCT01094678; http://www.clinicaltrials.gov ).
The Zilver PTX drug-eluting stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. Patients with symptomatic (Rutherford category 2-6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment were eligible for enrollment. Between April 2006 and June 2008, 787 patients (578 men; mean age 66.6±9.5 years) were enrolled at 30 international sites.
Nine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1722 Zilver PTX stents; the mean lesion length was 99.5±82.1 mm. The 12-month Kaplan-Meier estimates included an 89.0% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularization. There were no paclitaxel-related adverse events reported. The 12-month stent fracture rate was 1.5%. The ankle-brachial index, Rutherford score, and walking distance/speed scores significantly improved (p<0.001) from baseline to 12 months.
These results indicate that the Zilver PTX drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment. At 1 year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy.
Journal of Endovascular Therapy 10/2011; 18(5):613-23. · 2.86 Impact Factor
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ABSTRACT: A novel self-expanding drug-eluting stent was designed to slowly release everolimus to prevent restenosis following peripheral arterial intervention. The purpose of the first-in-human Superficial Femoral Artery Treatment with Drug-Eluting Stents (STRIDES) trial was to evaluate the safety and efficacy of this device for the treatment of symptomatic superficial femoral and proximal popliteal arterial occlusive disease.
One hundred four patients were enrolled at 11 European investigative centers in a prospective, nonrandomized, single-arm trial. The patients had severe symptomatic vascular disease, including a significant proportion of patients with critical limb ischemia (17%), diabetes (39%), and single-vessel outflow (26%). The mean lesion length was 9.0 ± 4.3 cm. Ninety-nine percent of patients were available for 12-month follow-up, including duplex imaging in 90% and arteriography in 83%. Clinical improvement, defined as a sustained decrease in Rutherford-Becker clinical category, was achieved in 80% of patients. Primary patency (freedom from ≥50% in-stent restenosis) was 94 ± 2.3% and 68 ± 4.6% at 6 and 12 months, respectively. Plain radiographic examination of 122 implanted devices at 12 months revealed no evidence for stent fracture.
The everolimus-eluting self-expanding nitinol stent can be successfully implanted in patients with severe peripheral arterial disease with favorable outcomes and clinical improvements observed in the majority of patients.
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 06/2011; 54(2):394-401. · 3.52 Impact Factor
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ABSTRACT: This study investigated the results with primary stenting using the Protégé EverFlex 200-mm-long self-expanding nitinol stent (ev3 Endovascular Inc, Plymouth, Minn) in femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C and D lesions of at least 150 mm in length.
Between March 2008 and June 2009, 100 patients (66 men) presenting with 100 symptomatic TASC C and D femoropopliteal lesions were treated with at least one 200-mm-long Protégé EverFlex stent. The intention of this study was to treat all lesions with as few stents as possible. The primary study end point was primary patency at 12 months, defined as the absence of hemodynamically significant stenosis on duplex ultrasound imaging (systolic velocity ratio <2.4) at the target lesion and without target lesion revascularization (TLR) ≤12 months. Stent fracture occurrence was assessed at the 12-month follow-up by conventional x-ray imaging.
Average patient age was 70 years. Preoperative symptom assessment reported 71 patients (71%) had claudication vs 29 (29%) with critical limb ischemia. Average lesion length was 242 mm (range, 160-450 mm), and 27 patients (27%) presented with popliteal involvement. A total of 158 Protégé EverFlex stents were used to treat 100 lesions. Kaplan-Meier estimation reported a 12-month freedom from target lesion revascularization of 68.2% and a primary patency rate of 64.8%. Stent fractures occurred in six patients (6.0%) when x-ray images taken immediately after the procedure were compared with those taken after 1 year.
The results of our Durability-200 study show an acceptable primary patency rate after 1 year was obtained in this patient cohort with TASC C and D femoropopliteal lesions.
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 05/2011; 54(4):1042-50. · 3.52 Impact Factor
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Sebastian Sixt,
Aljoscha Rastan,
Dierk Scheinert,
Hans Krankenberg,
Hermann Steinkamp,
Andrej Schmidt,
Horst Sievert,
Erich Minar, Marc Bosiers,
Patrick Peeters,
Jörn O Balzer,
Thilo Tübler,
Christian Wissgott,
Oscar Gerardo Carpio Cancino,
Uwe Schwarzwälder,
Thomas Zeller
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ABSTRACT: The present study was carried out to provide information about outcome of the Jetstream atherectomy device for treatment of infrainguinal arteries. From February 2006 to February 2007, 172 patients with Rutherford class 1 to 5 lower limb ischemia were enrolled at 9 study sites. The endpoints were evaluation of quality of life according to the walking impairment questionnaire (WIQ) besides technical parameters. In the total study cohort, the WIQ scale maintained improved up to 12-month follow-up. Furthermore, target lesion revascularization rate was 26% (42/162), ankle-brachial index (ABI) increased from 0.59 ± 0.21 at baseline to 0.82 ± 0.27 (P < 0.05), and mean Rutherford class dropped from 3.0 ± 0.9 at baseline to 1.5 ± 1.3 at 1 year (P < .05). The results of this prospective, multicenter, clinical study demonstrate that the Jetstream atherectomy device is a potential treatment alternative for the endovascular management to improve clinical outcome in patients with peripheral arterial occlusive disease.
Angiology 05/2011; 62(8):645-56. · 1.51 Impact Factor
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Sebastian Sixt,
Dierk Scheinert,
Aljoscha Rastan,
Hans Krankenberg,
Hermann Steinkamp,
Andrej Schmidt,
Horst Sievert,
Erich Minar, Marc Bosiers,
Patrick Peeters,
Jörn O Balzer,
Thilo Tübler,
Christian Wissgott,
Christopher Nielsen,
Uwe Schwarzwälder,
Thomas Zeller
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ABSTRACT: To compare the safety and efficacy of a rotational aspiration atherectomy system (Jetstream) for the treatment of infrainguinal arteries in diabetic versus nondiabetic patients.
A total of 172 patients with Rutherford stage 1-5 lower limb ischemia were treated with rotational aspiration atherectomy between February 2006 and February 2007. Of these, 80 patients with type 2 diabetes mellitus (DM: 46.5%) were compared with 92 nonDM (53.5%) patients. Overall, 210 target lesions (99 DM; 111 nonDM) were treated, located in the superficial femoral (67% DM; 61% nonDM), popliteal (25% DM; 30% nonDM), and tibial (8% DM; 9% nonDM) arteries. Lesion characteristics were comparable in both groups, mean lesion length was 28.5 mm (DM) and 26.2 mm (nonDM); total occlusions were present in 29% (DM) and 32% (nonDM), and 15% (DM) and 14% (nonDM) were restenotic.
In the entire cohort, device success was 99% (all but two lesions). The major adverse event (MAE) rate (death, index limb amputation, myocardial infarction, target lesion revascularization [TLR] and target vessel revascularization) in DM at 30 days was 2.5% (n = 2 planned amputations) and 0% in nonDM. At 6 and 12 months, MAE in DM was seen in 13.8% (11/80) and 25% (20/80) compared with 21.7% (20/92) and 31.5% (29/92) in nonDM, respectively. TLR rate through 12 months was 20% (16/80) in DM and 28% in nonDM (26/92). Overall, 1 year restenosis rate was 38.2% based on duplex. The ankle-brachial index, mean Rutherford categories, and walking impairment questionnaire did not differ between groups at baseline and were increased significantly in both study cohorts at 12 months.
Jetstream-assisted atherectomy in infrainguinal arteries is safe and effective in DM compared with nonDM patients. In this short-lesion cohort, vessel patency in diabetics was as good as for non-DM at 1 year. TLR and MAE were higher by trend in nonDM, although planned amputations were seen only in DM. The clinical benefit was similar in both groups.
Annals of Vascular Surgery 05/2011; 25(4):520-9. · 1.03 Impact Factor
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Marco Roffi,
Horst Sievert,
William A Gray,
Christopher J White,
Giovanni Torsello,
Piergiorgio Cao,
Bernhard Reimers,
Klaus Mathias,
Carlo Setacci,
Claudio Schönholz, [......], Marc Bosiers,
Alex Abou-Chebl,
Issam D Moussa,
Harald Mudra,
Sriram S Iyer,
Dierk Scheinert,
Jay S Yadav,
Marc R van Sambeek,
David R Holmes,
Alberto Cremonesi
The Lancet Neurology 02/2010; 9(4):339-41; author reply 341-2. · 23.46 Impact Factor
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Thomas Zeller,
Hans Krankenberg,
Hermann Steinkamp,
Aljoscha Rastan,
Sebastian Sixt,
Andrej Schmidt,
Horst Sievert,
Erich Minar, Marc Bosiers,
Patrick Peeters,
Jörn O Balzer,
William Gray,
Thilo Tübler,
Christian Wissgott,
Uwe Schwarzwälder,
Dierk Scheinert
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ABSTRACT: To report a safety and efficacy study of a novel rotational atherectomy system with aspiration capabilities for the treatment of infrainguinal arterial lesions.
From February 2006 to January 2007, 172 patients (88 women; mean age 72 years, range 51-93; 47% diabetics) with Rutherford class 1-5 lower limb ischemia were enrolled at 9 study sites. Inclusion criteria were atherosclerotic stenoses >70% and up to 10 cm long in the femoropopliteal segment or up to 3 cm long in the infrapopliteal vessels (reference vessel diameter 3.0-5.0 mm). In the study, 210 lesions (mean length 2.7 cm) were treated with the Pathway PV System, including total occlusions (31%), lesions with a moderate to high calcium score (51%), and post-angioplasty (non-stent) restenotic lesions (15%). The primary study endpoint was the 30-day major adverse event (MAE) rate.
Device success was 99% (208/210 lesions). MAE at 30 days was 1% (2 preplanned amputations). Clinically driven target lesion revascularization rates at 6 and 12 months were 15% (25/172) and 26% (42/162), respectively. The 1-year restenosis rate was 38.2% based on duplex imaging. The ankle-brachial index increased significantly from 0.59+/-0.21 at baseline to 0.82+/-0.27 (p<0.05) at 12 months. Mean Rutherford class improved from 3.0+/-0.9 at baseline to 1.5+/-1.3 at 1 year (p<0.05).
The use of the Pathway PV System in atherosclerotic lesions appears to be safe and effective in improving stenosis severity, even in the presence of challenging lesion conditions. Vessel patency following intervention appears to be good up to 12 months, and these results translate into clinical benefit.
Journal of Endovascular Therapy 12/2009; 16(6):653-62. · 2.86 Impact Factor
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ABSTRACT: The study investigates the safety and efficacy of primary stenting of infrapopliteal lesions using the Chromis Deep stent (Invatec, Roncadelle, Italy) in patients presenting with critical limb ischaemia (CLI).
Fifty patients with infrapopliteal arterial occlusive disease were included in the study from March until November 2007. All patients presented with CLI, 42 (84.0%) and 8 (16.0%) were diagnosed as Rutherford class 4 and 5, respectively. Procedural success was achieved in all 50 patients. Fifty study lesions were treated with angioplasty using the Amphirion Deep balloon and followed by the insertion of 58 Chromis Deep stents. After intervention patients were followed at 1, 6 and 12 month intervals with clinical examination and arterial duplex study. The survival of the studied population was 79.8%, the limb salvage was 91.5% and primary patency of treated vessel was 52.9% at 12 months.
Primary stenting using the balloon-expandable Chromis Deep stent in combination with the Amphirion Deep balloon is a safe treatment strategy for infrapopliteal lesions in patients with CLI.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 09/2009; 5(3):318-24. · 3.29 Impact Factor
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Marc Bosiers,
Giovanni Torsello,
Hans-Martin Gissler,
Johannes Ruef,
Stefan Müller-Hülsbeck,
Thomas Jahnke,
Patrick Peeters,
Kim Daenens,
Johannes Lammer,
Herman Schroë,
Klaus Mathias,
Renate Koppensteiner,
Frank Vermassen,
Dierk Scheinert
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ABSTRACT: To evaluate the long-term efficacy and integrity of the PROTEGE EverFlex stent in superficial femoral artery (SFA) lesions in symptomatic patients with peripheral artery disease (PAD).
A prospective, multicenter, nonrandomized study enrolled 151 subjects (111 men; mean age 67.8 years, range 42-93) undergoing percutaneous treatment of de novo, restenotic, or reoccluded SFA lesions between August 11, 2006, and June 26, 2007. Subjects were scheduled to receive a single stent and be evaluated through 12 months following the implant procedure. Occlusions were present in 40% of the patients. Mean lesion length was 96.4 mm (range 10-150).
A total of 161 stents (158 EverFlex) were implanted in the 151 patients: single stents in 93.4% (141/151) and a second stent in 6.6% (10/151). One-year follow-up information was available for 88.7% (134/151) of the study participants; of the remaining 17 subjects, 6 subjects withdrew from the study, 2 were lost to follow-up, and 9 died. Freedom from restenosis data were available for 99.3% (133/134) of the subjects who completed a 12-month follow-up visit. The mean Rutherford classification fell from 2.8+/-0.8 (range 1-5) at baseline to 0.6+/-1.1 (range 0-5) at 12 months. The mean ankle-brachial index rose from 0.6+/-0.2 (range 0-1.4) at baseline to 0.9+/-0.2 (range 0-1.2) at 12 months. The rates for freedom from >50% restenosis at 6 and 12 months were 91.3% (95% CI 84.9% to 95.2%) and 72.2% (95% CI 63.8% to 79.6%), respectively. The freedom from target lesion revascularization rate at 12 months was 79.1% (95% CI 71.2% to 85.6%). The 1-year stent fracture rate was 8.1% (95% CI 4.0% to 14.4%).
The high freedom from >50% restenosis and low fracture rate at 12 months suggests that the PROTEGE EverFlex stent offers a safe and acceptably efficacious means of treating SFA lesions in symptomatic subjects with PAD.
Journal of Endovascular Therapy 06/2009; 16(3):261-9. · 2.86 Impact Factor
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ABSTRACT: Arterial occlusive disease at the level of the femoral bifurcation mostly occurs in combination with inflow and/or outflow lesions. Surgical endarterectomy of the femoral bifurcation is a well-proven low-risk and easy surgical intervention with known durable success, while, although proven to be safe, evidence is lacking about the durability of the endovascular approach. Based on the evidence at hand, the surgical approach should be recommended for the vast majority of patients and the endovascular approach should only be indicated as the first strategy in selected cases presenting with factors that might compromise the outcome of surgery in the groin. If feasible, the hybrid approach with endarterectomy at the level of the bifurcation and endovascular repair of the inflow and outflow lesions is preferred in patients with multilevel disease.
Catheterization and Cardiovascular Interventions 05/2009; 74(4):627-33. · 2.29 Impact Factor
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Marc Bosiers,
Patrick Peeters,
Olivier D'Archambeau,
Jeroen Hendriks,
Ernst Pilger,
Christoph Düber,
Thomas Zeller,
Andreas Gussmann,
Paul Lohle,
Erich Minar,
Dierk Scheinert,
Klaus Hausegger,
Karl-Ludwig Schulte,
Jürgen Verbist,
Koen Deloose,
J Lammer
CardioVascular and Interventional Radiology 04/2009; · 2.09 Impact Factor
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Marc Bosiers,
Patrick Peeters,
Olivier D'Archambeau,
Jeroen Hendriks,
Ernst Pilger,
Christoph Düber,
Thomas Zeller,
Andreas Gussmann,
Paul N M Lohle,
Erich Minar,
Dierk Scheinert,
Klaus Hausegger,
Karl-Ludwig Schulte,
Jürgen Verbist,
Koen Deloose,
J Lammer
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ABSTRACT: Endoluminal treatment of infrapopliteal artery lesions is a matter of controversy. Bioabsorbable stents are discussed as a means to combine mechanical prevention of vessel recoil with the advantages of long-term perspectives. The possibility of not having a permanent metallic implant could permit the occurrence of positive remodeling with lumen enlargement to compensate for the development of new lesions. The present study was designed to investigate the safety of absorbable metal stents (AMSs) in the infrapopliteal arteries based on 1- and 6-month clinical follow-up and efficacy based on 6-month angiographic patency. One hundred seventeen patients with 149 lesions with chronic limb ischemia (CLI) were randomized to implantation of an AMS (60 patients, 74 lesions) or stand-alone percutaneous transluminal angioplasty (PTA; 57 patients, 75 lesions). Seven PTA-group patients "crossed over" to AMS stenting. The study population consisted of patients with symptomatic CLI (Rutherford categories 4 and 5) and de novo stenotic (>50%) or occlusive atherosclerotic disease of the infrapopliteal arteries who presented with a reference diameter of between 3.0 and 3.5 mm and a lesion length of <15 mm. The primary safety endpoint was defined as absence of major amputation and/or death within 30 days after index intervention and the primary efficacy endpoint was the 6-month angiographic patency rate as confirmed by core-lab quantitative vessel analysis. The 30-day complication rate was 5.3% (3/57) and 5.0% (3/60) in patients randomized for PTA alone and PTA followed by AMS implantation, respectively. On an intention-to-treat basis, the 6-month angiographic patency rate for lesions treated with AMS (31.8%) was significantly lower (p = 0.013) than the rate for those treated with PTA (58.0%). Although the present study indicates that the AMS technology can be safely applied, it did not demonstrate efficacy in long-term patency over standard PTA in the infrapopliteal vessels.
CardioVascular and Interventional Radiology 12/2008; 32(3):424-35. · 2.09 Impact Factor
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ABSTRACT: Data regarding the long-term efficacy of carotid artery stenting (CAS) are still scarce. As demonstrated by several major randomized controlled trials (RCT) comparing the efficacy of carotid endarterectomy (CEA) vs medical therapy, even after successful carotid revascularization late ipsilateral stroke occurs in 5-13% at 5 years. Therefore, major concerns also remain about the durability of the CAS procedure in terms of stroke prevention. The purpose of this study was to review long-term results after carotid stent implantation in a large cohort of patients.
This retrospective investigation involved 3179 CAS procedures performed at four European carotid high-volume centers. Echo-duplex scan using modified velocity criteria to recognize in-stent restenosis (ISR) and neurological examinations of all patients were carried out every 6 months after the procedure. Life-table analysis was used to determine freedom from mortality, stroke-related death, ipsilateral fatal/major stroke, and any ipsilateral stroke. Freedom from ISR and from reintervention were also reported. The secondary aim was to identify predictive risk factors for neurological complications and ISR.
At 5 years freedom from mortality, stroke-related death, ipsilateral fatal/major stroke, and any stroke rate were 82%, 93.5%, 93.3%, and 91.9%, respectively. The only predictor for neurological complications was the presence of neurological symptoms before CAS (hazard ratio 1.38 [CI 1.05, 1.82] P = .02). Freedom from restenosis at 1, 3, and 5 years was, respectively, 98.4%, 96.1%, and 94%. Uni- and multi-variate analyses showed that stent characteristics (material/design/free-cell area) were not significantly associated with time to in-stent restenosis or time to reintervention.
Our long-term results in a large cohort of patients validated CAS as a durable procedure for stroke prevention. The annual rate of neurological complications after CAS was comparable to that of conventional surgery as demonstrated by large RCTs involving both symptomatic patients (North American Symptomatic Carotid Endarterectomy Trial [NASCET] and European Carotid Surgery Trial [ECST]) and asymptomatic patients (Asymptomatic Carotid Atherosclerosis Study [ACAS] and Asymptomatic Carotid Surgery Trial [ACST]).
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 11/2008; 48(6):1431-40; discussion 1440-1. · 3.52 Impact Factor
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ABSTRACT: The importance of angioplasty and stenting in the treatment of carotid artery disease cannot be underestimated. Successful carotid stenting does not only depend on the operator's skills and experience but also on an adequate selection of cerebral protection devices, and carotid stents can help avoid neurological complications. A broad spectrum of carotid devices is currently on the market, and because each of them has its own advantages and disadvantages, it is virtually impossible to claim that one specific device is the best. The individual characteristics of each specific protection system or stent may make it an attractive choice in one circumstance but render it a less desirable option in other situations. The applicability depends primarily on the arterial anatomy and the specific details of the lesion being treated. But certainly, personal preferences and familiarity with a specific device may legitimately influence the decision to choose one over another.
Perspectives in Vascular Surgery and Endovascular Therapy 10/2008; 20(3):272-9.
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Stroke 07/2008; 39(8):e129; author reply e133. · 5.73 Impact Factor
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ABSTRACT: Since major meta-analyses of randomized controlled trials in interventional cardiology showed the potential of drug-eluting stents in decreasing restenosis and reintervention rates after coronary artery stenting, one of the next steps in the treatment of arterial occlusive disease is the transfer of the active coating technology towards peripheral arterial interventions. In this manuscript, we aim to provide a literature overview on available peripheral (lower limb, renal, and supra-aortic) drug-eluting stent applications, debate the cost implications, and give recommendations for future treatment strategies.
Vascular Health and Risk Management 02/2008; 4(3):553-9.
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ABSTRACT: Background: Use of stents following angioplasty for infragenicular lesions appears to be superior to angioplasty alone. We investigated the safety and efficacy of MULTI-LINK VISION stent (Abbott Vascular, Brussels, Belgium) for the treatment of infragenicular lesions in patients with critical limb ischaemia (CLI). Methods and results: During the period between February 2005 and October 2005, fifty patients with CLI (Rutherford 4 and 5) due to infragenicular disease were included in the study. The studied patient population included 28 males (56.0%) and 22 females (44.0%) with a mean age of 76 years (range 59-90 years). The medical history was significant for hypertension in 43 patients (86.0%), diabetes in 23 (46%) and hypercholesterolaemia in 37 (74%) patients. Fourteen patients (28%) admitted to the use of nicotine. Thirty-four (68%) belonged to Rutherford class 4 and 16 were class 5 (32%). All patients underwent clinical evaluation before and after the intervention. A pre-procedure Duplex ultrasound examination followed by angiography and intervention were performed on all patients included in the study. Sixty-two lesions were treated with angioplasty followed by insertion of 68 MULTI-LINK VISION stents. After intervention, patients were followed at one, six and 12 month intervals with clinical examination and arterial duplex study. The survival of the studied population was 83.3%, the limb salvage was 89.3% and primary patency of treated vessel was 62.8% at 12 months. Conclusions: Treatment of infragenicular lesions in CLI with MULTI-LINK VISION stent is safe and effective with satisfactory limb salvage. The primary patency was acceptable, but less compared to dedicated below the knee devices.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 02/2008; 3(4):470-4. · 3.29 Impact Factor
