cardiovascular-agents and nitinol

Treatment of superficial femoral artery (SFA) lesions remains challenging. We conducted a network meta-analysis of randomized controlled trials aiming to explore the efficacy of treatment modalities for SFA "de novo" lesions.. Eleven treatments for SFA occlusive disease were recognized. We used primary patency and binary restenosis at 12-month follow-up as proxies of efficacy for the treatment of SFA lesions.. A total of 33 studies (66 study arms; 4659 patients) were deemed eligible. In terms of primary patency, odds ratios (ORs) with 95% confidence intervals (CIs) were statistically significantly higher in drug-eluting stent (DES; OR, 10.05; 95% CI, 3.22-31.39), femoropopliteal bypass surgery (BPS; OR, 7.15; 95% CI, 2.27-22.51), covered stent (CS; OR, 3.56; 95% CI, 1.33-9.53), and nitinol stent (NS; OR, 2.83; 95% CI, 1.42-5.51) compared with balloon angioplasty (BA). The rank order from higher to lower primary patency in the multidimensional scaling was DES, BPS, NS, CS, drug-coated balloon, percutaneous transluminal angioplasty with brachytherapy, stainless steel stent, cryoplasty (CR), and BA. Combination therapy of NS with CR and drug-coated balloon were the two most effective treatments, followed by NS, CS, percutaneous transluminal angioplasty with brachytherapy, cutting balloon, stainless steel stent, BA, and CR in terms of multidimensional scaling values for binary restenosis.. DES has shown encouraging results in terms of primary patency for SFA lesions, whereas BPS still maintains its role as a principal intervention. On the contrary, BA and CR appear to be less effective treatment options.

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Brachytherapy; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Cryotherapy; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; Humans; Network Meta-Analysis; Odds Ratio; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency; Vascular Surgical Procedures

Amassed evidence from several randomized controlled trials and high quality meta-analyses clearly support the primary use of paclitaxel-coated balloons (PCB) in the superficial femoral artery over traditional plain balloon angioplasty or primary bare nitinol stenting with significantly lower vascular restenosis, less need for repeat procedures, improved quality of life and potential cost savings for the healthcare system. Stents may be reserved for bail-out in case of a suboptimal dilatation result, and for selected more complex lesions, or in case of critical limb ischemia in order to eliminate vessel recoil and maximize immediate hemodynamic gain. Debulking atherectomy remains unproven, but holds a lot of promise in particular in combination with PCBs, in order to improve compliance of the vessel wall by plaque removal, allow for a better angioplasty result and optimize drug transfer and bioavailability. The present overview summarizes and discusses current evidence about femoropopliteal PCB angioplasty compared to the historical standard of plain old balloon angioplasty and bare nitinol stents. Available evidence is appraised in the context of clinically meaningful results, relevant unresolved issues are highlighted, and future trends are discussed.

Topics: Alloys; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Cost-Benefit Analysis; Female; Femoral Artery; Health Care Costs; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Stents; Treatment Outcome; Vascular Access Devices

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

To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long.. The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0-58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI).. Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months.. In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.

Topics: Aged; Aged, 80 and over; Alloys; Angiography; Belgium; Cardiovascular Agents; Constriction, Pathologic; Critical Illness; Drug-Eluting Stents; Endovascular Procedures; Female; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

To report a randomized trial comparing the Legflow paclitaxel-eluting balloon (PEB) + Supera stenting to Supera stenting alone in patients with intermediate to long superficial femoral artery (SFA) lesions.. The multicenter RAPID trial ( controlled-trials.com ; identifier ISRCTN47846578) randomized (1:1) 160 patients (mean age 67 years; 102 men) with Rutherford category 2-6 ischemia to treatment with Legflow PEB + Supera stent or Supera stent alone in intermediate to long SFA lesions (mean lesion length 15.8±7.4 vs 15.8±7.6 cm, respectively). The efficacy outcome was primary patency, defined as freedom from restenosis on duplex ultrasound or angiography.. Baseline characteristics including the percentage of occlusions were similar between groups. In the intention-to-treat analysis, the estimated primary patency at 1 year was 68.3% (95% CI 56.7% to 79.9%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the Supera group (p=0.900). Per-protocol analysis showed a 12-month primary patency estimate of 74.7% (95% CI 63.1% to 86.3%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the control group (p=0.273). Secondary patency estimates at 12 months (per-protocol analysis) were 89.0% (95% CI 80.6% to 97.4%) vs 98.0% (95% CI 94.1% to 100%; p=0.484); the estimates for freedom from clinically driven target lesion revascularization (CD-TLR) were 83.0% (95% CI 72.8% to 93.2%) and 77.8% (95% CI 66.6% to 89.0%; p=0.277), respectively.. The short-term results from the multicenter RAPID randomized controlled trial indicate that the Legflow PEB is safe and feasible for the treatment of intermediate to long SFA lesions. In this trial, at least 70% of the patients suffered an occlusion. The PEB group had higher rates of primary patency and freedom from CD-TLR, although there were no statistically significant differences vs controls.

Topics: Aged; Alloys; Angiography; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Femoral Artery; Germany; Humans; Male; Middle Aged; Netherlands; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices; Vascular Patency

To report the 12-month results of the MAJESTIC clinical study of the self-expanding Eluvia paclitaxel-eluting stent in the treatment of femoropopliteal lesions.. The prospective, single-arm, multicenter trial (clinicaltrials.gov identifier NCT01820637) enrolled 57 patients (mean age 69±9 years; 47 men) with chronic lower limb ischemia referable to de novo or restenotic lesions in the native superficial femoral and/or proximal popliteal arteries. A third of the patients had diabetes. Mean lesion length was 70.8±28.1 mm, and diameter stenosis was 86.3%±16.2%; 26 (46%) lesions were occluded. Primary patency was defined as duplex ultrasound peak systolic velocity ratio ≤2.5 and the absence of target lesion revascularization (TLR) or bypass. Major adverse events (MAEs) included all-cause death through 1 month and target limb major amputation and TLR through 12 months.. All 57 patients had a single Eluvia stent implanted, employing pre- and postdilation in 93% (53/57) and 95% (54/57) of cases, respectively. Technical success was 97% (55/57; 2 failures due to residual stenosis >30%). At 12 months, primary patency was 96% (49/51) and the MAE rate was 4% (2/53); both MAEs were TLRs. No stent fractures were identified. There were no major amputations. One death occurred 368 days postprocedure, unrelated to the device or procedure. Improvements in the Rutherford category were sustained through 1 year, with 81% (43/53) exhibiting no symptoms (category 0) and 13% (7/53) presenting with mild claudication (category 1). Mean ABI improved from 0.73±0.22 at baseline to 1.02±0.20 at 12 months.. MAJESTIC results showed that patients whose femoropopliteal arteries were treated with the Eluvia drug-eluting stent sustained high patency and low MAE rates through 12 months.

Topics: Aged; Alloys; Ankle Brachial Index; Australia; Blood Flow Velocity; Cardiovascular Agents; Chronic Disease; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Europe; Female; Femoral Artery; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; New Zealand; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Regional Blood Flow; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

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

This study sought to evaluate the outcomes of drug-eluting stent treatment for femoropopliteal in-stent restenosis (ISR).. ISR after femoropopliteal interventions is an increasing problem. Although the role of drug-eluting stents in the treatment of coronary ISR is well defined, no published studies have examined drug-eluting stents in the treatment of femoropopliteal ISR.. This study examines 108 patients with 119 ISR lesions who were enrolled in the ZILVER-PTX single-arm study, a prospective, multicenter clinical trial of 787 patients. All patients were treated with paclitaxel-eluting nitinol stents.. Mean patient age was 68.3 ± 9.4 years; 61.1% of patients were men. Mean lesion length was 133.0 ± 91.7 mm; 33.6% of lesions were >150 mm long and 31.1% of lesions were totally occluded. Procedural success was achieved in 98.2% of lesions with 2.1 ± 1.2 stents placed per lesion. Primary patency was 95.7% at 6 months and 78.8% at 1 year. Freedom from target lesion revascularization was 96.2% at 6 months, 81.0% at 1 year, and 60.8% at 2 years. Forty patients experienced major adverse events, exclusively target lesion revascularization. Before treatment, 81.1% of patients had Rutherford scores ≥3; at 2 years, 60.9% of patients had Rutherford scores ≤1. Both ankle brachial index and walking impairment questionnaire scores significantly improved following treatment. The 1-year fracture rate of stents used in ISR lesions was 1.2%. No significant risk factors associated with loss of patency were identified.. Treatment of femoropopliteal ISR with paclitaxel-eluting stents results in favorable acute, midterm, and long-term outcomes. (Zilver PTX Global Registry [ZILVER-PTX]; NCT01094678).

Topics: Aged; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Canada; Cardiovascular Agents; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Europe; Exercise Test; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Prosthesis Failure; Recurrence; Registries; Republic of Korea; Risk Factors; Surveys and Questionnaires; Time Factors; Treatment Outcome; Vascular Patency

Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow(®) paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm.. A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5-15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera(®) stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention.. The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated balloons with nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting.. ISRCTN47846578.

Topics: Alloys; Amputation, Surgical; Angiography, Digital Subtraction; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Cardiovascular Agents; Clinical Protocols; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Equipment Failure; Femoral Artery; Hemodynamics; Humans; Hyperplasia; Limb Salvage; Neointima; Netherlands; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Prosthesis Failure; Recurrence; Research Design; Resins, Plant; Single-Blind Method; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices

This study sought to compare paclitaxel-eluting balloon (PEB) with conventional percutaneous transluminal angioplasty (PTA), followed by systematic implantation of a self-expanding nitinol bare-metal stent (BMS) in patients at risk for restenosis.. PTA is an effective strategy for treating atherosclerosis of the femoropopliteal axis (FPA). Whereas PEB have shown advantage over uncoated balloons in the treatment of simple lesions, it is unknown whether these results are applicable to complex degrees of FPA atheroma.. A total of 104 patients (110 FPA lesions in 110 limbs) were randomly assigned to either PEB + BMS or PTA + BMS. The primary endpoint was 12-month binary restenosis. Secondary endpoints were freedom from target lesion revascularization and major amputation. Post hoc subanalyses were performed for the comparison of long (≥100 mm) versus short lesions and true lumen versus subintimal approach.. Mean lesion length was 94 ± 60 versus 96 ± 69 mm in the PEB + BMS and PTA + BMS groups (p = 0.8), respectively. The primary endpoint occurred in 9 (17%) versus 26 (47.3%) of lesions in the PEB + BMS and PTA + BMS groups (p = 0.008), respectively. A near-significant (p = 0.07) 1-year freedom from target lesion revascularization advantage was observed in the PEB + BMS group. No major amputation occurred. No significant difference was observed according to lesion characteristics or technical approach.. Pre-dilation with PEB angioplasty prior to BMS implantation, as compared to PTA + BMS in complex FPA lesions, reduces restenosis and target lesion revascularization at 12-month follow-up. Restenosis reduction is maintained irrespective of lesion length and recanalization technique. (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery [DEBATE-SFA]; NCT01556542).

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Disease-Free Survival; Equipment Design; Female; Femoral Artery; Humans; Italy; Kaplan-Meier Estimate; Limb Salvage; Male; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Radiography; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

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

Zilver PTX nitinol self-expanding drug-eluting stent with paclitaxel coating is effective for treatment of superficial femoral artery (SFA) disease. However, as with any stent, it induces a measure of vascular inflammatory response. The current clinical trial (NCT02734836) aimed to assess vascular patency, remodeling, and inflammatory markers with intravascular optical coherence tomography (OCT) in patients with SFA disease treated with Zilver PTX stents.. Serial OCT examinations were performed in 13 patients at baseline and 12-month follow-up. Variables evaluated included neointimal area, luminal narrowing, thrombus area, stent expansion as well as measures of inflammation including, peri-strut low-intensity area (PLIA), macrophage arc, neovascularization, stent strut apposition and coverage.. Percentage of malapposed struts decreased from 10.3 ± 7.9% post-intervention to 1.1 ± 2.2% at 12-month follow-up, but one patient showed late-acquired stent malapposition (LASM). The percent of uncovered struts at follow-up was 3.0 ± 4.5%. Average expansion of stent cross-sectional area from baseline to follow-up was 35 ± 19%. The average neointimal area was 7.8 ± 3.8 mm. At 12-month follow-up, OCT analysis of Zilver PTX stent shows outward remodeling and minimal neointimal growth, but evidence of inflammation including PLIA, neovessels, thrombus and macrophages.. Thirteen patients with PAD had paclitaxel-coated stents implanted in their SFAs and were then imaged with OCT at baseline and 12-month follow-up. OCT proxy metrics of inflammation were quantified.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Cardiovascular Agents; Drug-Eluting Stents; Female; Femoral Artery; Humans; Inflammation; Male; Middle Aged; Neointima; Paclitaxel; Peripheral Arterial Disease; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Self Expandable Metallic Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Patency; Vascular Remodeling

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

The aim of this study was to elucidate the vascular responses to paclitaxel-eluting stent (Zilver PTX stent) in superficial femoral artery lesion at different elapsed times using angioscopy. Patients who received Zilver PTX stent implantation from five centers were enrolled. We performed angioscopic examinations at 2, 6, and 12 months after implantation and evaluated neointimal coverage (NIC) grade, intra-stent thrombus (IS-Th) grade, and presence of yellow plaque. NIC grade 0 was defined as stent struts exposed; grade 1, struts transparently visible although covered; grade 2, struts embedded in the neointima, but translucent; and grade 3, struts fully embedded and invisible. IS-Th was graded as follows: grade 0 (none), 1 (focal), and 2 (diffusely spread). Angioscopic follow-up evaluation was performed at 2 months (25 patients, 42 lesions), 6 months (18 patients, 23 stents), and 12 months (14 patients, 24 stents) after stent implantation. Dominant NIC grade significantly increased over time; however, 16.3% of the cases had NIC grade 1 or 2 at 12 months. IS-Th grade decreased; however IS-Th and yellow plaque were persistently observed in 62.5% and 83.3% cases, respectively, at 12 months. An ongoing healing response was observed at 12 months after implantation; however, thrombogenic findings were noted. Prolonged dual antiplatelet therapy could potentially enhance the clinical utility of Zilver PTX.

Topics: Aged; Aged, 80 and over; Alloys; Angioscopy; Cardiovascular Agents; Cell Proliferation; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Male; Middle Aged; Neointima; Paclitaxel; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Wound Healing

Purpose The present study aimed to determine the safety and efficacy of a drug-coated balloon inflated within a thin-strut self-expanding bare-metal stent in patients with severe and complex femoropopliteal occlusive disease. Methods This prospective study used the Pulsar-self-expanding stent and Passeo-18 Lux drug-coated balloon in patients with severe and complex femoropopliteal occlusive disease. The primary endpoint was the 12-month primary patency, and the secondary endpoints included 24-month primary patency, assisted primary patency, secondary patency, and clinically associated target lesion revascularisation. Results The study included 44 patients (51 limbs). The mean age of the patients was 67.6 ± 10.2 years, with 73% men. Chronic limb severity was classified as Rutherford Category III in 41% of the patients, stage IV in 31%, and stage V in 27%. Lesions were predominantly Trans-Atlantic Inter-Society Consensus (TASC 2007) D (51%) and C (45%), with 32 (63%) chronic total occlusions. Procedural success was obtained in all cases. The mean lesion length was 200 ± 74.55 mm (95% CI = 167.09-208.01) with a mean number of stents per limb used of 1.57 ± 0.70 (95% CI = 1.37-1.76). Distal embolisation occurred in two patients. The primary patency rates at the 12- and 24-month follow-up were 94% (95% CI = 82.9-98.1) and 88% (95% CI = 75.7-94.5), respectively. The assisted primary was 94% (95% CI = 82.9-98.1) and secondary patency was 96% (95% CI = 85.2-99.0) at 24-month follow-up. The cumulative stent fracture rate at the 24-month follow-up was 10%. Freedom from clinically driven target lesion revascularisation was 94% (95% CI = 83-98%) at 12-month follow-up and 88% (95% CI = 76-94%) at 24-month follow-up, with two patients requiring a bypass graft. Conclusion Our novel approach involving the combination of a thin-strut bare-metal stent and a drug-coated balloon may be safe and effective, with sustainable and promising clinical outcomes up to 24 months after treatment.

Topics: Aged; Alloys; Angioplasty, Balloon; Australia; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Self Expandable Metallic Stents; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Patency

To evaluate the 1- and 2-year patency and reintervention rates with the Zilver PTX drug-eluting stent (DES) in long complex femoropopliteal disease.. A retrospective review was conducted of 89 consecutive patients (mean age 68.7±9.8 years; 86 men) with femoropopliteal occlusive disease (Rutherford category 2-6) treated with the Zilver PTX between December 2012 and December 2013. Mean lesion length for the entire cohort was 24.2±11.3 cm (median 24.0, range 4-48). The patient population was dichotomized into a short lesion (≤20 cm) group (n=41; mean lesion length 13.3±5.6 cm) and the full DES jacket (>20 cm) group (n=48; mean lesion length 33.0±6.5 cm). Primary endpoints were duplex-derived restenosis (peak systolic velocity ratio >2.5), clinically driven reintervention, and major amputation.. The incidence of restenosis was lower in the short lesion group at 1 year (19% vs 40% for the longer lesions, p=0.050) and 2 years (39% vs 54%, respectively; p=0.331). The short lesion group had significantly lower rates of reintervention at both 1 year (2% vs 21% in long lesions, p=0.009) and 2 years (12% vs 33%, p=0.019).. Treatment of femoropopliteal lesions >20 cm with the Zilver PTX appears to be a clinically effective therapy for patients with symptomatic peripheral artery disease. However, there is an increase in restenosis and a need for reintervention that continues to progress up to 2 years.

Topics: Aged; Alloys; Angioplasty, Balloon; Cardiovascular Agents; Drug-Eluting Stents; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

Prospective single-arm study, aimed at evaluating safety and effectiveness at 12 and 24 months of the paclitaxel-eluting nitinol stent (Zilver PTX), and focused in particular on the treatment of complex lesions and/or diabetic patients.. Between May 2010 and March 2012, 67 patients (78% males) were treated by Zilver PTX, because of stenosis or occlusions of the superficial femoral artery in one of two centers. The mean age of patients was 70.1±8 years. Thirty-two of 67 (48%) were diabetics, 14 (21%) active smokers and 11 (14.6%) had chronic renal failure (end stage renal disease). The average length of lesions was 104±60 mm. Occlusion was complete in 46.3% of cases, whereas severely calcified lesions were present in 30% of patients (18.8% in diabetics and 31.4% in non-diabetics). Twenty-six patients (39%) had type C or D lesions according to TASC 2.. One hundred-two stents were used (1.7±0.9 per patients); median 1 (range 1-4). All patients had successful stent placement. Primary patency, evaluated by Kaplan-Meier method was 88±0.06% at 12 months, and 68±0.1% at 24 months. In particular, the difference between diabetics (D) and non-diabetics (non-D) was not significant (P=0.07, Log-Rank). Patients turned from 4.2±1.3 to 1.6±1.3 Rutherford class. There were 5 deaths due to systemic comorbidities. There also were 3 major amputations, all of them also in the D group. Among the other patients, differences between D and non-D patients were not significant in terms of wound healing, bipedal stay and spontaneous ambulation. The mean follow-up length was 28±5 months (range 24-36 months). There was only one patient who had fracture and stent migration (1.5%). In 13 diabetic patients, tibial PTA was also associated. Additional treatment was required in 6 D and 1 non-D.. The use of Zilver PTX is safe and effective in the treatment of SFA lesions. In particular, both stent patency and functional results on the basis of both clinical and instrumental tools were similar in D and non-D, suggesting a particularly favorable activity of PTX in a subpopulation of diabetics. Further studies are required to confirm these results, which seem to be particularly promising in diabetic patients.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Cardiovascular Agents; Diabetic Angiopathies; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Italy; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Retreatment; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

To identify intravascular ultrasound (IVUS) measurements that can predict angiographic in-stent restenosis (ISR) following nitinol stent implantation in superficial femoral artery (SFA) lesions.. A retrospective review was conducted of 97 patients (mean age 72.9±8.9 years; 63 men) who underwent IVUS examination during endovascular treatment of 112 de novo SFA lesions between July 2012 and December 2014. Self-expanding bare stents were implanted in 46 lesions and paclitaxel-eluting stents in 39 lesions. Six months after stenting, follow-up angiography was conducted to assess stent patency. The primary endpoint was angiographic ISR determined by quantitative vascular angiography analysis at the 6-month follow-up. Variables associated with restenosis were sought in multivariate analysis; the results are presented as the odds ratio (OR) and 95% confidence interval (CI).. At follow-up, 27 (31.8%) angiographic ISR lesions were recorded. The lesions treated with uncoated stents were more prevalent in the ISR group compared with the no restenosis group (74.1% vs 44.8%, p=0.02). Lesion length was longer (154.4±79.5 vs 109.0±89.3 mm, p=0.03) and postprocedure minimum stent area (MSA) measured by IVUS was smaller (13.9±2.8 vs 16.3±1.6 mm(2), p<0.001) in the ISR group. Multivariate analysis revealed that bare stent use (OR 7.11, 95% CI 1.70 to 29.80, p<0.01) and longer lesion length (OR 1.08, 95% CI 1.01 to 1.16, p=0.04) were predictors of ISR, while increasing postprocedure MSA (OR 0.58, 95% CI 0.41 to 0.82, p<0.01) was associated with lower risk of ISR. Receiver operating characteristic analysis identified a MSA of 15.5 mm(2) as the optimal cutpoint below which the incidence of restenosis increased (area under the curve 0.769).. Postprocedure MSA can predict ISR in SFA lesions, which suggests that adequate stent enlargement during angioplasty might be required for superior patency.

Topics: Aged; Aged, 80 and over; Alloys; Angiography; Angioplasty, Balloon; Area Under Curve; Cardiovascular Agents; Chi-Square Distribution; Constriction, Pathologic; Drug-Eluting Stents; Female; Femoral Artery; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Predictive Value of Tests; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; ROC Curve; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

Efficacy of endovascular therapy (EVT) with nitinol stents for femoropopliteal (FP) lesions is limited by restenosis. Oral cilostazol reduces angiographic restenosis rate; however, treatment duration remains unclear. In a retrospective analysis of a multicenter database of 3471 consecutive limbs in 2737 patients (mean age: 72 ± 9 years; 61% diabetic; and 26% on regular dialysis) undergoing EVT for FP lesions between January 2004 and December 2011, we compared Kaplan-Meier estimated primary patency after EVT followed or not by cilostazol treatment. We used Cox hazard regression analysis to assess temporal association between cilostazol treatment and post-EVT restenosis. Five-year primary patency was higher in the cilostazol group than in the noncilostazol group (57% vs 47%, P < .0001). Cilostazol treatment was inversely associated with restenosis for the first 2 years following EVT (P < .05); however, no significant association was observed thereafter. Cilostazol use therefore appears efficacious in preventing restenosis up to 2 years after EVT for FP lesions.

Topics: Administration, Oral; Aged; Aged, 80 and over; Alloys; Cardiovascular Agents; Cilostazol; Databases, Factual; Endovascular Procedures; Female; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Proportional Hazards Models; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Stents; Tetrazoles; Time Factors; Treatment Outcome; Vascular Patency

To compare the vascular response after paclitaxel-coated nitinol drug-eluting stent (Zilver PTX) implantation for superficial femoral artery lesions after 6 and 12 months using optical coherence tomography (OCT).. Serial OCT examinations were performed in 5 patients (4 men; mean age 78.4 ± 6.8 years) with 9 Zilver PTX stents at 6- and 12-month follow-up. Variables evaluated included neointimal thickness and apposition on each strut, the incidence of extrastent lumen (ESL), peristrut low-intensity area (PLIA), and neovascularization at 1-mm intervals.. A total of 249 matched cross-section images were evaluated and included 4788 and 4826 struts at 6 and 12 months, respectively. Mean neointimal thickness significantly increased from 480 to 540 µm between 6 and 12 months (p < 0.001). The percentage of uncovered struts tended to decrease at 12 months (3% vs. 2.3%, p = 0.054), whereas the percentage of malapposed struts were similar at both examinations (0.2% vs. 0.2%, p > 0.99). Although the incidence of ESL in cross sections was not different (35% vs. 31%, p = 0.29), median ESL area significantly increased from 6 to 12 months [0.12 (0.04-0.36) vs. 0.31 (0.14-0.59) mm(2), p = 0.003)]. The presence of PLIA (29% vs. 44%, p < 0.001) and neovascularization (14% vs. 27%, p < 0.001) increased from 6 to 12 months.. These findings suggest that delayed vascular healing and persistent peristent inflammation may be present even at 12 months after Zilver PTX implantation.

Topics: Aged; Aged, 80 and over; Alloys; Cardiovascular Agents; Drug-Eluting Stents; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Neointima; Paclitaxel; Peripheral Arterial Disease; Predictive Value of Tests; Retrospective Studies; Risk Factors; Sensitivity and Specificity; Tomography, Optical Coherence; Treatment Outcome

The indication for use of drug-eluting stents (DES) in lower limb arteries is still undefined. We report our series of patients treated with Zilver PTS DES, in treating in-stent restenosis (ISR) and Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC) C/D femoropopliteal lesions.. The Zilver PTX DES is a self-expanding nitinol stent with a polymer-free Paclitaxel coating. Patients with symptomatic de novo TASC C/D lesions or IRS lesions of femoropopliteal segment were eligible for enrollment. We evaluated patients at one month, six months and one year after treatment. We used clinical evaluation criteria and US Doppler for primary and secondary patency-free rates.. From November 2010 to November 2012, we treated 69 patients with DES Zilver PTX. Indication to treat was given in 36 lesions (52%) by an ISR and in 33 cases (48%) by a TASC C/D lesion. Lesions were staged in the superficial femoral artery (SFA) level in 59 patients (85.6%), in the popliteal artery in 6 patients (8.7%), in a femoropopliteal bypass in 4 patients (5.7%). The mean follow-up was 5.3 months (range 1-24). At 12 months the overall primary patency was 85.5%, secondary patency 89.8% and limb salvage 100%.. Zilver PTX DES seems to be effective in treating TASC C/D lesions and ISR in femoropopliteal lesions at short term. Therefore DES should be recommended when treating those complex lesions.

Topics: Aged; Aged, 80 and over; Alloys; Cardiovascular Agents; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Endovascular Procedures; Female; Humans; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Recurrence; Time Factors; Treatment Outcome; Ultrasonography, Doppler; Vascular Patency

This study was designed to investigate the immediate and one-year outcomes of polymer-free paclitaxel coated drug-eluting stent (DES) implantation in a consecutive series of patients presenting with stenosis of infrainguinal bypass grafts.. Between January 2011 and January 2012, 11 patients with failing infrainguinal bypass grafts were treated in two institutions. Clinical status and Duplex scan parameters were recorded at baseline and over a follow-up period of one year.. DES implantation was successfully performed in all patients. Ten patients received a single stent and one patient received two stents. At one year, one patient showed total bypass graft occlusion (9%). In all the remaining patients, Duplex scan examination documented patency of the treated grafts.. DES implantation in failing infrainguinal bypass grafts can be safely performed and provides satisfactory clinical outcomes. The patency rate of 91% favourably compares with those obtained with other endovascular treatments such as plain balloon or cutting balloon angioplasty.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Constriction, Pathologic; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Italy; Lower Extremity; Male; Middle Aged; Paclitaxel; Prosthesis Design; Prosthesis Failure; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

To evaluate the pharmacokinetics and safety of the Zilver PTX Drug-Eluting Stent (Cook Medical, Bloomington, Indiana) in a normal porcine artery model.. Pharmacokinetic analyses were performed using 18 pigs, each implanted with four paclitaxel-coated stents. Paclitaxel remaining on the stents, delivered locally (to artery wall), regionally (to adjacent and downstream muscle), and systemically (to plasma), was determined at various times through 56 days. For safety evaluation, local, regional, and systemic responses were grossly and histologically assessed at 1 month, 3 months, and 6 months in 21 additional pigs and compared with the responses to bare metal stents in 21 separate pigs.. Stents delivered approximately 95% of the total paclitaxel within 24 hours after deployment. Nonetheless, there were sustained paclitaxel levels in the artery wall through 56 days, maintained at approximately 20% of the peak level through 14 days. Very little paclitaxel was distributed regionally or systemically, becoming undetectable in plasma at 10 hours. Complete necropsy, hematology, and serum chemistry revealed no adverse effects associated with the paclitaxel-coated stents. Within 3 months, vessels with both paclitaxel-coated and bare metal stents showed comparable, complete healing.. The Zilver PTX stent appears to be safe, achieves sustained paclitaxel levels in the artery wall, and shows complete vessel healing comparable to bare metal stents within 3 months.

Topics: Alloys; Animals; Arteries; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Female; Male; Materials Testing; Models, Animal; Paclitaxel; Prosthesis Design; Risk Assessment; Sus scrofa; Wound Healing

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.

Topics: Aged; Alloys; Arterial Occlusive Diseases; Canada; Cardiovascular Agents; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Endovascular Procedures; Europe; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Popliteal Artery; Prospective Studies; Prosthesis Design; Recovery of Function; Recurrence; Republic of Korea; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Patency

To evaluate safety and results of the Freepac drug-eluting balloon (DEB) technology for the treatment of chronic femoropopliteal steno-occlusions.. In a multicentre registry we enrolled 66 patients with symptomatic femoropopliteal stenosis and/or occlusion <15 cm (Rutherford stages 2 to 4). Patients were treated first with an undersized uncoated balloon and then with an appropriate sized DEB. In case of unsatisfactory results, nitinol stents were implanted. Clinical evaluations and echo-duplex were performed at baseline, at discharge, and at three months after intervention. Procedural success was 100%. Stents were implanted in 10.8% of the patients. At three months follow-up, the mean ankle-brachial index (ABI) significantly improved from 0.58 ± 0.13 to 0.82 ± 0.25, thus resulting in a Rutherford class improvement (p <0.01) and amelioration of the claudication distance (102 ± 87 vs. 403 ± 160 meters) (p<0.001). No serious adverse events occurred during the follow-up.. The results of this registry demonstrate the safety of mediated paclitaxel elution for the prevention of restenosis in the superficial femoral and popliteal arteries after angioplasty. This technique was associated with encouraging results in terms of clinical improvement as well as a lack of adverse events, including target lesion revascularisation, at three months.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug Delivery Systems; Equipment Design; Female; Femoral Artery; Humans; Italy; Male; Middle Aged; Paclitaxel; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Registries; Stents; Time Factors; 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 evaluate the local reaction of the aortic wall induced by basic fibroblast growth factor (bFGF) released from a gelatin hydrogel coated on the outer surface of a stent-graft for the purpose of biological fixation.. A total of 18 nitinol-based, polyester-covered stent-grafts were implanted in 6 porcine aortas for 1 month. The implanted stent-grafts were divided into 3 groups: the control group (uncoated), the hydrogel group (coated with hydrogel containing water), and the bFGF group (coated with hydrogel containing bFGF). After stent-graft implantation, the results of intravascular ultrasound (IVUS) and qualitative and quantitative microscopic examinations were compared among the groups.. In the bFGF group, a thin white lamellar tissue was observed on IVUS images. Significantly more new intimal tissue formation was observed in all the bFGF group animals than in the other 2 groups, and alpha smooth muscle (SM) actin-positive cells (alphaSMCs) were detected in this new tissue. The alphaSMCs within the fabric of tightly woven grafts were significantly more abundant in the bFGF group than in the other groups.. The local controlled release of bFGF from the stent-graft significantly accelerated the proliferation of new intimal tissue between the aorta and the stent-graft and within the graft materials. These findings suggest that a graft can be fixed biologically to the aortic wall, which may contribute to the shrinkage of aneurysms following stent-grafting.

Topics: Actins; Alloys; Angiography, Digital Subtraction; Animals; Aorta; Biocompatible Materials; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Cell Proliferation; Delayed-Action Preparations; Drug-Eluting Stents; Fibroblast Growth Factor 2; Gelatin; Hydrogels; Models, Animal; Polyesters; Prosthesis Design; Recombinant Proteins; Research Design; Swine; Tunica Intima; Ultrasonography, Interventional