sirolimus and nitinol

Device technology in interventional cardiology is continuously evolving. Self-expandable (SE) coronary artery stents were the first device to be implanted within a human coronary artery. However, because of their initial limitations, balloon-expandable (BE) stents were predominantly developed and used in the last 30 years. Unfortunately, in challenging anatomical settings such as bifurcation lesions, large, ectatic or aneurysmal vessels, tapered vessels or vasoconstricted arteries, outcomes with BE stents are not always optimal. The Stentys (Stentys SA, Paris, France) SE nitinol stents were initially developed for the treatment of coronary bifurcation lesions. The understanding of the underlying mechanism involved in incomplete stent apposition and subsequent stent thrombosis led to the introduction of self-apposing stents in the treatment of acute coronary syndrome in order to overcome the limitations of drug-eluting stents in presence of high thrombus burden. In this regard, Stentys allows a progressive stent expansion which could reduce the rates of incomplete stent apposition by conforming to vascular remodeling. Enhancing the advantages of this technology by adding the release of an antiproliferative drug to prevent restenosis is even more attractive and potentially effective. Recently, the results of the new Stentys sirolimus-eluting stent have been reported. This article provides an overview of the pathobiological rational, device characteristics and results of the new Stentys self-expandable sirolimus-eluting stent.

Topics: Acute Coronary Syndrome; Alloys; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus

Several randomized controlled trials (RCTs) have shown the superiority of some of these technologies over balloon angioplasty, but direct comparisons between these treatment options are lacking. The authors conducted a network meta-analysis of RCTs comparing bare nitinol stents, covered nitinol stents, paclitaxel- or sirolimus-eluting stents (PES or SES), and paclitaxel-coated balloons (PCB) with plain balloon angioplasty or with each other in the femoropopliteal artery (PROSPERO registry: CRD42013004845).. Sixteen RCTs comprising 2532 patients with 4227 person-years of follow-up were analyzed on an intention-to-treat basis. Bayesian random effects Poisson and binomial models were used for mixed treatment comparisons (WinBUGS). Clinical heterogeneity was accounted for by incorporating a meta-regression model on trial-specific baseline risk. End points included technical success, vascular restenosis, target lesion revascularization, and major amputations. Pairwise odds ratios and rate ratios (ORs and RRs) of absolute treatment effects were calculated, and the probabilities of each treatment being best are reported. Summary estimates are reported as the posterior median and associated credible intervals (CrIs) that serve the same purpose as confidence intervals in the context of the Bayesian framework. Extensive sensitivity, meta-regression, and network consistency analyses were performed to evaluate heterogeneity.. Technical success was highest with covered stents (pooled OR, 13.6; 95% CrI, 3.3-31.1, probability best 82%) followed by uncovered stents (pooled OR, 7.0; 95% CrI, 2.6-129, probability best 18%) when compared with balloon angioplasty (reference treatment). Vascular restenosis was lowest with PES (RR, 0.43; 95% CrI, 0.16-1.18, probability best 45%) followed by PCB (RR, 0.43; 95% CrI, 0.26-0.67, probability best 42%). Target lesion revascularization was lowest with PCB (RR, 0.36; 95% CrI, 0.23-0.55, probability best 56%) followed by PES (RR, 0.42; 95% CrI, 0.16-1.06, probability best 33%). Major amputations were rare in all treatment and control groups (pooled amputation rate of 0.7 events per 100 person-years).. Immediate technical success is better with the use of covered stents, whereas paclitaxel-eluting stents and paclitaxel-coated balloons offer the best long-term results in the femoropopliteal artery.

Topics: Alloys; Amputation, Surgical; Angioplasty, Balloon; Bayes Theorem; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug-Eluting Stents; Equipment Design; Femoral Artery; Humans; Limb Salvage; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Sirolimus; Stents; Treatment Outcome; Vascular Access Devices

Infrainguinal occlusive disease is a complex problem necessitating the cooperation of both medical and surgical therapies to aid limb salvage and alleviate symptoms. Endovascular therapies are varied, with no treatment clearly outweighing the other in terms of efficacy and durability. Angioplasty for focal stenosis has gained ground as the treatment of choice when indicated. There has also been a rapid evolution in stent technology, from early stainless steel wall stents to today's drug eluting nitinol stents. In this article, we examine the literature on these new technologies and treatment options and make recommendations based on the best data available.

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Inguinal Canal; Sirolimus; Stents; Treatment Outcome; Vascular Patency

The superficial femoral artery (SFA) is a unique vessel in terms of its anatomy, its function and its interventional requirements; it has no comparison in any other arterial vascular bed. It is a long conduction vessel with a high flow resistance underlying several different hemodynamic conditions. In the past 15 years the unique characteristics of the SFA have resulted in poor interventional outcomes, with mid-term restenosis rates in the order of 50%--outcomes that are worse than in any other arterial vascular bed. In view of the clinical importance of SFA treatment, which comprises about 50% of all interventions at peripheral arterial lesions, considerable efforts have been made with a variety of interventional techniques to achieve progress. Only the use of self-expanding nitinol stents appears to improve the mid-term results of catheter-based interventional SFA treatment.

Topics: Alloys; Angiography; Anti-Bacterial Agents; Arterial Occlusive Diseases; Catheterization; Femoral Artery; Follow-Up Studies; Humans; Immunosuppressive Agents; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Retrospective Studies; Sirolimus; Stents; Time Factors; Tomography, X-Ray Computed; Treatment Outcome

The number of peripheral procedures is increasing at a rapid pace and in a variety of vessels. This review will discuss current findings in carotid intervention and drug-eluting stents in superficial femoral arteries (SFA).

Topics: Alloys; Carotid Artery Diseases; Coronary Restenosis; Drug-Eluting Stents; Endarterectomy, Carotid; Femoral Artery; Humans; Immunosuppressive Agents; Risk Factors; Sirolimus; Stents; Vascular Patency

Topics: Aged; Alloys; Disease-Free Survival; Drug-Eluting Stents; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Patient Safety; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Reproducibility of Results; Sirolimus; Treatment Outcome

The aim of this study was to evaluate the Sparrow sirolimus-eluting stent (Sparrow-SES) against the Sparrow bare-metal stent (Sparrow-BMS) and conventional balloon-expandable bare-metal stent (BMS: Driver/Micro-Driver stent, Medtronic Vascular, Santa Rosa, CA).. The Sparrow stent (Biosensors International, Singapore) consists of a guide wire-based, self-expandable, ultra-thin nitinol stent. The performance of this device with sirolimus in a fully biodegradable polymer has not been determined.. A total of 74 patients were included in this intravascular ultrasound (IVUS) sub-study of the CARE II trial, which was a prospective, randomized, multicenter trial in the treatment of single de novo native coronary artery lesions in vessels ranging from 2.0 mm to 2.75 mm in diameter (Sparrow-SES: n = 31, Sparrow-BMS: n = 22, BMS: n = 21).. Stent volume index (VI) was significantly increased 8-month later in Sparrow-SES and Sparrow-BMS, but not in BMS (4.0 ± 1.0 to 4.6 ± 1.0 mm(3) /mm, p<0.0001, 4.0 ± 0.6 to 4.4 ± 0.8 mm(3) /mm, p<0.05, and 5.2 ± 1.0 to 5.1 ± 0.9 mm(3) /mm, p=0.421, respectively). % neointimal obstruction in Sparrow-SES was significantly smaller than those in Sparrow-BMS and BMS at follow-up (17.6 ± 9.4 vs. 36.2 ± 13.8 and 39.9 ± 11.1%, p<0.001). Sparrow-SES showed a mean 15% stent expansion and good suppression of neointimal proliferation, resulting in a significantly lower percentage of change in lumen VI during follow-up period (Sparrow-SES: -6.2 ± 16.2%, Sparrow-BMS: -30.4 ± 11.6%, BMS: -40.4 ± 10.0%, p<0.001).. The self-expanding Sparrow-SES demonstrated chronic stent expansion, good suppression of neointimal proliferation and resulted in a more preserved lumen in stented small vessels compared with the Sparrow-BMS and conventional balloon expandable BMS.

Topics: Aged; Alloys; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional

To assess the efficacy of the AXXESS stent on the treatment of left main coronary artery (LMCA) bifurcation lesions using IVUS.. The treatment of LMCA bifurcation lesions remains challenging even with the use of drug-eluting stents. The AXXESS system is a biolimus A9-eluting self-expanding stent, dedicated to the treatment of bifurcation lesions.. Data were obtained from the AXXENT trial, a prospective, single-arm, multicenter study designed to evaluate the efficacy of the AXXESS stent on the treatment of LMCA bifurcation lesions. IVUS was available in 26 cases at 6-months follow-up. Volumetric and cross-sectional analyses within the AXXESS stent, and cross-sectional analyses at the ostia of left anterior descending (LAD) and left circumflex coronary arteries (LCX) were performed.. Within the AXXESS stent, percent neointimal volume obstruction was (3.0 +/- 4.1)% with a minimal lumen area of 10.3 +/- 2.6 mm(2). AXXESS stent volume showed an 12.4% increase at follow-up compared with postprocedure (P = 0.04). Lumen area was significantly smaller in the LCX ostium compared with the LAD ostium at follow-up (3.6 +/- 1.3 mm(2) vs. 5.5 +/- 2.0 mm(2), P = 0.0112). There was greater neointimal formation in the LCX ostium compared with the LAD ostium (1.37 +/- 1.20 mm(2) vs. 0.30 +/- 0.36 mm(2), P = 0.0003).. The AXXESS stent in the LMCA showed enlargement through 6-months follow-up and significant neointimal suppression. Greater neointimal formation and relatively inadequate stent expansion may contribute to luminal narrowing in the LCX ostium.

Topics: Aged; Alloys; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional; United States

To review clinical outcomes of patients with chronic limb ischemia and TASC type C lesions treated with sirolimus-eluting versus bare SMART nitinol self-expanding stents.. Data were obtained from a randomized, multicenter, double-blinded study conducted in 2 phases. All 93 patients had chronic limb ischemia and superficial femoral artery (SFA) occlusions or stenoses (average lesion length 8.3 cm). In total, 47 patients (31 men; mean age 66.3+/-9.1 years, range 50-84) received the sirolimus-eluting SMART stent and 46 patients (36 men; mean age 65.9 +/-10.8 years, range 38-83) received a bare SMART nitinol stent. Both groups were followed for a mean 24 months.. Both the sirolimus-eluting and the bare SMART stents were effective in revascularizing the diseased SFA and in sustaining freedom from restenosis. For both types of stents, improvements in ankle-brachial indices (ABI) and symptoms of claudication were maintained over 24 months (median 24-month ABI 0.96 for the sirolimus group versus 0.87 for the bare stent group, p>0.05). At 24 months, the restenosis rate in the sirolimus group was 22.9% versus 21.1% in the bare stent group (p>0.05). The cumulative in-stent restenosis rates according to duplex ultrasound were 4.7%, 9.0%, 15.6%, and 21.9%, respectively, at 6, 9, 18, and 24 months; the rates did not differ significantly between the treatment groups. The TLR rate for the sirolimus group was 6% and for the bare stent group 13%; the TVR rates were somewhat higher: 13% and 22%, respectively. Mortality rates did not differ significantly between the groups.. These data demonstrate that the sirolimus-eluting and the bare SMART stent are effective, safe, and free from restenosis in a majority of patients for up to 24 months. Because the restenosis rate in the bare stent group is unexpectedly low, no significant difference could be found between the sirolimus-eluting and the bare SMART stents.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Anti-Bacterial Agents; Atherosclerosis; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Double-Blind Method; Drug Carriers; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Prospective Studies; Prosthesis Failure; Recurrence; Safety; Sirolimus; Stents; Treatment Outcome

To investigate further the safety and efficacy of the sirolimus-eluting S. M.A.R.T. Nitinol Self-expanding Stent by comparison with a bare stent in superficial femoral artery (SFA) obstructions.. This randomized, double-blind study involved 57 patients (29 in the sirolimus-eluting stent group and 28 in the bare stent group) with chronic limb ischemia and SFA occlusions (66.7%) or stenoses (average lesion length, 81.5 mm +/- 41.2). Stent implantation followed standard interventional techniques and a maximum of two stents could be implanted. The primary endpoint was the in-stent mean lumen diameter at 6 months as determined by quantitative angiography.. Both stent types were effective in revascularizing the diseased SFA and allowing sustained patency for at least 6 months. There was no statistically significant difference between treatment groups in the in-stent mean lumen diameter at 6 months (4.94 mm +/- 0.69 and 4.76 mm +/- 0.54 mm for sirolimus-eluting and bare stent groups, respectively; P = .31). Although the diameter of the target lesion tended to be larger and percent stenosis tended to be lower with the sirolimus-eluting stent, there were no statistically significant differences between treatments in terms of any of the variables. The mean late loss values were 0.38 mm +/- 0.64 and 0.68 mm +/- 0.97 for the sirolimus-eluting stent group and the bare stent group, respectively (P = .20). The binary restenosis rates, with a cutoff of 50% at 6 months, were zero in the sirolimus-eluting stent group and 7.7% in the bare stent group (P = .49). Clinical outcomes matched angiographic outcomes with improvements in ankle-brachial index and symptoms of claudication. There was no significant difference between treatments in terms of adverse events.. Although there is a trend for greater efficacy in the sirolimus-eluting stent group, there were no statistically significant differences in any of the variables.

Topics: Aged; Alloys; Angiography; Arterial Occlusive Diseases; Double-Blind Method; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Leg; Male; Recurrence; Sirolimus; Statistics, Nonparametric; Stents; Treatment Outcome

Stent implantation for obstructive femoropopliteal artery disease has been associated with poor long-term outcomes. This study evaluated the effectiveness of shape memory alloy recoverable technology (SMART) nitinol self-expanding stents coated with a polymer impregnated with sirolimus (rapamycin) versus uncoated SMART stents in superficial femoral artery obstructions.. Thirty-six patients were recruited for this double-blind, randomized, prospective trial. All patients had chronic limb ischemia and femoral artery occlusions (57%) or stenoses (average lesion length, 85+/-57 mm). Patients were eligible for randomization after successful guidewire passage across the lesion. Eighteen patients received sirolimus-eluting SMART stents and 18 patients received uncoated SMART stents. The primary end point of the study was the in-stent mean percent diameter stenosis, as measured by quantitative angiography at 6 months. The in-stent mean percent diameter stenosis was 22.6% in the sirolimus-eluting stent group versus 30.9% in the uncoated stent group (P=0.294). The in-stent mean lumen diameter was significantly larger in the sirolimus-eluting stent group (4.95 mm versus 4.31 mm in the uncoated stent group; P=0.047). No serious adverse events (death or prolonged hospitalization) were reported.. The use of sirolimus-eluting SMART stents for superficial femoral artery occlusion is feasible, with a trend toward reducing late loss compared with uncoated stents. The coated stent also proved to be safe and was not associated with any serious adverse events.

Topics: Aged; Alloys; Arterial Occlusive Diseases; Double-Blind Method; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Radiography; Sirolimus; Stents; Treatment Outcome

To compare the effectiveness and safety of self-expandable, sirolimus-eluting Stentys stents (SES) and second-generation drug-eluting stents (DES-II) for the treatment of the unprotected left main (ULM).. SES may provide a valuable option to treat distal ULM, particularly when significant caliber gaps with side branches are observed.. Patients from the multicenter SPARTA (clinicaltrials.gov: NCT02784405) and FAILS2 registries were included. Propensity-score with matching was performed to account for the lack of randomization. Primary end-point was the rate of major adverse cardiovascular events (MACE, a composite of all cause death, myocardial infarction, target lesion revascularization [TLR], unstable angina and definite stent thrombosis [ST]). Single components of MACE were the secondary end-points.. Overall, 151 patients treated with SES and 1270 with DES-II were included; no differences in MACE rate at 250 days were observed (9.8% vs. 11.5%, P = 0.54). After propensity score with matching, 129 patients treated with SES and 258 with DES-II, of which about a third of female gender, were compared. After a follow-up of 250 days, MACE rate did not differ between the two groups (9.9% vs. 8.5%, P = 0.66), as well as the rate of ULM TLR (1.6% vs. 3.1%, P = 0.36) and definite ST (0.8% vs. 1.2%, P = 0.78). These results were consistent also when controlling for the treatment with provisional vs. 2-stents strategies for the ULM bifurcation.. SES use for ULM treatment was associated with a similar MACE rate compared to DES-II at an intermediate-term follow-up. SES might represent a potential option in this setting.

Topics: Aged; Aged, 80 and over; Alloys; Cardiovascular Agents; Comparative Effectiveness Research; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Self Expandable Metallic Stents; Sirolimus; Time Factors; Treatment Outcome

Topics: Alloys; Antibiotics, Antineoplastic; Coronary Stenosis; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Self Expandable Metallic Stents; Sirolimus; Treatment Outcome

Topics: Alloys; Antineoplastic Agents; Coronary Stenosis; Drug-Eluting Stents; Humans; Paclitaxel; Percutaneous Coronary Intervention; Sirolimus; Stents; Treatment Outcome

Topics: Alloys; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Prosthesis Design; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

A 56 year-old woman underwent percutaneous coronary intervention for a lesion in a small mid-left anterior descending coronary artery (reference vessel diameter by quantitative coronary angiography: 2.11 mm) with a novel drug-eluting stent specifically designed for small vessels, the CardioMind Sparrow stent delivery system. This is a self-expandable sirolimus-eluting nitinol stent directly mounted into a 0.014-inch coronary guidewire. The stent has a very thin strut thickness (67 micron), limiting its radiopacity. A specific X-ray stent-enhancing visualization technique, "StentBoost", allowed clear visualization and understanding of the steps needed for an appropriate release and deployment of the aforementioned stent.

Topics: Alloys; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Middle Aged; Prosthesis Design; Radiographic Image Enhancement; Radiography, Interventional; Sirolimus; Treatment Outcome

This study was conducted to determine the influence of lesion preparation using the AngioSculpt balloon on final stent expansion. Stent expansion remains an important predictor of restenosis and subacute thrombosis, even in the drug-eluting stent (DES) era. In these patients, the role of different predilation strategies has yet to be established. Two hundred ninety-nine consecutive de novo lesions treated with 1 >2.5-mm DES (Cypher or Taxus) under intravascular ultrasound guidance without postdilation, using 3 implantation strategies, were studied: (1) direct stenting without predilation (n = 145), (2) predilation with a conventional semi-compliant balloon (n = 117), and (3) predilation with the AngioSculpt balloon (n = 37). Stent expansion was defined as the ratio of intravascular ultrasound-measured minimum stent diameter and minimum stent area to the manufacturer's predicted stent diameter and area. These ratios were larger after AngioSculpt predilation, and a greater percentage of stents had final minimum stent areas >5.0 mm(2) (another commonly accepted criterion of adequate DES expansion). Lesion morphology, stent and lesion length, and reference vessel size did not affect DES expansion. In conclusion, in this observational, nonrandomized study, pretreatment with the AngioSculpt balloon enhanced stent expansion and minimized the difference between predicted and achieved stent dimensions.

Topics: Aged; Alloys; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Vessels; Endosonography; Equipment Design; Female; Humans; Male; Middle Aged; Paclitaxel; Pressure; Prospective Studies; Sirolimus; Stents; Surface Properties; Ultrasonography, Interventional

To test the feasibility of self-expanding drug-coated nitinol stents for prevention of restenosis in an animal model. Stent implantation in the carotid artery (CA) has been shown to be feasible for treatment of CA stenosis. Even though the restenosis rate in CA is reported to be lower than in the coronary and peripheral arteries, problems may arise with increasing numbers of treated patients and lengthier follow-up.. After predilatation with 8-mm balloons, 8 Goettinger minipigs were randomly selected to receive a sirolimus-eluting self-expanding nitinol stent (7 mm/80 mm) as well as the same stent without sirolimus/polymer coating in the right or left CA. Aspirin was given starting 3 days before the intervention and administered for an additional 4 weeks. Clopidogrel was administered for 10 days.. After 6 weeks, 2 subacute occlusions were observed in both groups. In the remaining vessels, the neointima was significantly reduced by sirolimus/polymer-coated stents (5.9+/-2.5 versus 0.7+/-1.0 mm2).. Sirolimus self-expanding nitinol stents may be an effective tool in reducing neointimal formation in CA.

Topics: Alloys; Angioplasty, Balloon, Coronary; Animals; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Atherosclerosis; Carotid Arteries; Clopidogrel; Coronary Angiography; Coronary Restenosis; Disease Models, Animal; Male; Polymers; Sirolimus; Stents; Swine; Ticlopidine; Time Factors; Ultrasonics

The purpose of this study was to evaluate the long-term effects of the DEVAX AXXESS biolimus eluting stent (BES) in a porcine coronary model, compared with those of bare metal stent (BMS) and polymer only stent (POS) controls.. Excessive neointimal growth has been identified as a major cause of late failure of percutaneous coronary interventions. The effect of drug eluting from self-expanding stents for prevention of neointimal hyperplasia has not been studied before. The DEVAX AXXESS is a self-expanding nickel titanium stent, coated with antiproliferative compound-biolimus.. Twenty juvenile farm swine, 25-35 kg in weight, 3-6 months in age were used. Each animal received a stent to the left anterior descending artery, left circumflex or right coronary arteries as permitted per anatomy. The chronic vascular response after BES implantation was compared with that after BMS and POS implantation at 28, 90, and 180 days follow-up.. The 28-day outcome by quantitative coronary angiography (QCA) showed significant increase in minimal luminal diameter (MLD) in the BES (MLD: 2.90 +/- 0.97, 2.39 +/- 0.90, 1.59 +/- 0.91; P = 0.009) compared with BMS and POS, respectively. By histomorphometric analysis, there was also a corresponding significant reduction in neointimal tissue proliferation in the BES (average neointimal area: 2.78 +/- 0.07, 5.46 +/- 0.66, 8.42 +/- 0.85; P = 0.002) compared with that in BMS and POS controls, respectively at 28-days follow-up. At 90 and 180 days, the mean neointimal area was not significantly different between the BES and the controls.. BES favorably modulates the neointimal tissue formation for 28 days, in the porcine coronary model. Long-term inhibition of neointimal hyperplasia is not sustained most likely because of the delayed cellular proliferation and inflammation in the vessel wall.

Topics: Alloys; Animals; Coated Materials, Biocompatible; Coronary Angiography; Hyperplasia; Immunosuppressive Agents; Models, Animal; Polyesters; Prosthesis Design; Sirolimus; Stents; Swine; Time Factors; Tunica Intima

To present a patient in whom severe external carotid artery (ECA) stenosis causing ocular ischemia was treated with a drug-eluting stent.. A 55-year-old woman with severe, diffuse atherosclerosis presented with impaired left ocular perfusion and amaurosis fugax. Duplex ultrasonography and angiography documented bilateral occlusion at the origin of the internal carotid arteries, bilateral subtotal ECA stenoses, and subtotal distal left common carotid artery (CCA) restenosis following endarterectomy. Percutaneous revascularization of the left ECA and CCA stenoses was performed using a short coronary balloon-expandable sirolimus-eluting stent and a self-expanding nitinol stent, respectively. The procedure was uneventful, and the ocular symptoms resolved. At 6 months, the patient remained asymptomatic, with angiographically patent stents.. Drug-eluting stenting may be a novel option to treat symptomatic ECA stenosis.

Topics: Alloys; Amaurosis Fugax; Angiography, Digital Subtraction; Blood Vessel Prosthesis Implantation; Carotid Artery, Common; Carotid Stenosis; Coated Materials, Biocompatible; Endarterectomy, Carotid; Eye; Female; Humans; Immunosuppressive Agents; Ischemia; Middle Aged; Postoperative Complications; Reoperation; Sirolimus; Stents; Vascular Patency