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PurposeTo experimentally investigate a new homogenously paclitaxel/resveratrol-coated balloon catheter in terms of transport of the coating to the treated tissue and local effects including histology and functional tests.MethodsAdherence of the coating to the balloon was explored by in vitro simulation of its passage to the lesion. Paclitaxel and resveratrol transfer to the vessel wall was investigated in porcine coronary and peripheral arteries. Matrix-assisted laser desorption/ionization (MALDI) was used for direct microscopic visualization of paclitaxel in arterial tissue. Inhibition of neointimal proliferation and tolerance of complete coating and resveratrol-only coating was investigated in pigs 4 weeks after treatment, and the effect of resveratrol on inflammation and healing after 3 and 7 days.ResultsDrug loss on the way to the lesion was < 10% of dose, while 65 ± 13% was detected at the site of balloon inflation. After treatment similar proportions of drug were detected in coronary and peripheral arteries, i.e., 7.4 ± 4.6% of dose or 125 ± 74 ng/mg tissue. MALDI showed circumferential deposition. Inhibition of neointimal proliferation by paclitaxel/resveratrol coating was significant (p = 0.001) whereas resveratrol-only coating did not inhibit neointimal proliferation. During the first week after treatment of peripheral arteries with resveratrol-only balloons, we observed nominally less inflammation and fibrin deposition along with a significant macrophage reduction and more pronounced re-endothelialization. No safety issues emerged including left ventricular ejection fraction for detection of potential distal embolization after high-dose treatment of coronary arteries.ConclusionsPaclitaxel/resveratrol-coated balloons were effective and safe in animal studies. Beyond acting as excipient resveratrol may contribute to vascular healing.

In this trial, patients with femoropopliteal artery disease were assigned to standard angioplasty or treatment with a paclitaxel-coated balloon. At 12 months, primary patency was seen more frequently with the drug-coated balloon than with standard angioplasty. Atherosclerotic disease in the femoral and popliteal (femoropopliteal) arteries compromises perfusion to the legs and feet. Although treatment with percutaneous transluminal angioplasty is effective in initially restoring blood flow, restenosis from vessel recoil and neointimal hyperplasia occur in more than 60% of patients within 1 year after the procedure. 1 Stents act as scaffolds to prevent recoil and reduce the incidence of restenosis, 2 – 9 but the permanent presence of an intravascular prosthesis may limit subsequent therapeutic options. Stent fracture, although infrequent, can have negative consequences. 10 – 13 Results with drug-eluting stents in peripheral vessels have varied, 14 – 18 although a recent study showed . . .

In this randomized trial, patients undergoing hemodialysis who had native upper-extremity arteriovenous fistula stenosis received drug-coated or standard balloon angioplasty after initial successful transluminal angioplasty. The drug-coated balloon was superior to the standard balloon and was noninferior with respect to access circuit-related serious adverse events.

AbstractObjectiveTo determine which primary endovascular revascularisation strategy represents the most clinically effective treatment for patients with chronic limb threatening ischaemia who require endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.DesignThree arm, open label, pragmatic, multicentre, randomised, phase 3 superiority trial (BASIL-3).Setting35 UK NHS vascular units.ParticipantsPatients with chronic limb threatening ischaemia who required endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.InterventionsParticipants were randomly assigned (1:1:1) to femoro-popliteal plain balloon angioplasty with or without bare metal stenting (PBA±BMS), drug coated balloon angioplasty with or without bare metal stenting (DCBA±BMS), or drug eluting stenting (DES) as their first revascularisation strategy.Main outcome measuresThe primary outcome was amputation free survival defined as time to first major amputation or death from any cause. Secondary outcomes included the composite components of the primary outcome, major adverse limb events, major adverse cardiac events, and other prespecified clinical and patient reported outcome measures. Serious adverse events were collected up to 30 days after the first revascularisation procedure.ResultsBetween 29 January 2016 and 31 August 2021, 481 participants were randomised (167 (35%) women, mean age 71.8 years (standard deviation 10.8)). Major amputation or death occurred in 106 of 160 (66%) participants in the PBA±BMS group, 97 of 161 (60%) in the DCBA±BMS group, and 93 of 159 (58%) in the DES group (adjusted hazard ratios: PBA±BMS v DCBA±BMS: 0.84, 97.5% confidence interval 0.61 to 1.16, P=0.22; PBA±BMS v DES: 0.83, 0.60 to 1.15, P=0.20). No differences in serious adverse events were reported between the groups.ConclusionsNeither DCBA±BMS nor DES conferred significant clinical benefit over PBA±BMS in the femoro-popliteal segment in patients with chronic limb threatening ischaemia undergoing endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.Trial registrationISRCTN registry ISRCTN14469736

Purpose To evaluate longer outcomes of primary nitinol stenting for the treatment of femoropopliteal lesions up to 15 cm long after these stents were found to have superior short-term patency vs. balloon angioplasty. Methods Two hundred and six patients (143 men; mean age 67 years) with intermittent claudication due to superficial femoral and proximal popliteal artery lesions were randomized (2:1) to treatment with nitinol stents or balloon angioplasty at 24 US and European centers and followed for 3 years. In that time, 15 patients died, 20 withdrew consent, and 10 were lost to follow-up, leaving 161 (78.2%) patients for 36-month assessment. Results The 12-month freedom from target lesion revascularization (TLR) was 87.3% for the stent group vs. 45.2% for the angioplasty group (p<0.0001). At 3 years, there was no difference in survival (90.0% vs. 91.7%, p=0.71) or major adverse events (75.2% vs. 75.2%, p=0.98) between the stent and angioplasty groups. Duplex ultrasound was not mandated after the first year, so stent patency could not be ascertained beyond 1 year, but freedom from TLR at 3 years was significantly better in the stent group (75.5% vs. 41.8%, p<0.0001), as was clinical success (63.2% vs. 17.9%, p<0.0001). At 18 months, a 4.1% (12/291) stent fracture rate was documented. Conclusion In this multicenter trial, primary implantation of a nitinol stent for moderate-length lesions in the femoropopliteal segment of patients with claudication was associated with better long-term results vs. balloon angioplasty alone.

Purpose To test the ability of a drug-eluting balloon (DEB) to reduce recurrent in-stent restenosis (ISR) in diabetic patients with femoropopliteal stents. Methods A prospective all-comers study [Drug-Eluting Balloon in Peripheral Intervention for In-Stent Restenosis (DEBATE-ISR); ClinicalTrials.gov identifier NCT01558531] of symptomatic diabetic patients with femoropopliteal ISR undergoing treatment with paclitaxel-eluting balloons was designed to compare their 12-month recurrent restenosis rate with that of historical diabetic controls. From January 2010 to December 2011, 44 consecutive diabetic patients (32 men; mean age 74±11 years) were treated with DEBs and enrolled in the study. The control group comprised 42 diabetic patients (23 men; mean age 76±7 years) treated with a conventional balloon for femoropopliteal ISR from 2008 to 2009. Results No significant differences in terms of clinical, angiographic, or procedural characteristics were observed between the study groups. Lesion length was 132±86 mm in the DEB group vs. 137±82 mm in the BA group. Procedural success, defined as a residual stenosis <30% in the restenotic segment (stent +5 mm at proximal and distal edges), was obtained in all treated lesions. At 1-year follow-up, 6 patients died (3 in each group), and 1 patient in the BA group underwent major amputation. Recurrent restenosis, assessed by angiography (66%) or ultrasound (34%), occurred in 8/41 (19.5%) patients in the DEB group vs. 28/39 (71.8%) in the BA group (p<0.001). Target lesion revascularization for symptomatic recurrent restenosis was performed in 6/44 (13.6%) patients in the DEB vs.13/42 (31.0%) in the BA group (p=0.045). Conclusion Using DEB for treating femoropopliteal ISR led to a significant reduction in recurrent restenosis and repeat angioplasty at 1-year follow-up as compared to historical controls.

While the efficacy and safety of drug-coated balloons (DCBs) for treating short femoropopliteal lesions are well-established, evidence on long-term outcomes for long lesions remains limited. This study aims to compare the 2-year clinical outcomes of DCB angioplasty between long and short femoropopliteal lesions and identify risk factors for patency loss. This real-world and single-center cohort study included 234 patients with de novo stenosis or restenosis or occlusion of the femoropopliteal arteries (115 long lesions > 15 cm, 141 short lesions ≤ 15 cm) who underwent successful DCB treatment from January 2019 to December 2021 at Peking Union Medical College Hospital. The primary safety endpoint was defined as freedom from major adverse events (death, target limb amputation or thrombosis). The primary effectiveness endpoint was defined as 2-year primary patency, defined as freedom from both clinically driven target lesion revascularization (CD-TLR) and restenosis. Primary patency was significantly lower in long lesions (48.3% vs. 62.5%, p = 0.005), while freedom from CD-TLR rate showed no difference (83.6% vs. 87.4%, p = 0.25). Long lesions exhibited higher rates of occlusions (p < 0.001), in-stent restenosis (p = 0.025), and advanced ischemia (Rutherford Clinical Category (RCC) 4–6, p = 0.038). Multivariate analysis identified lesion length > 15 cm (p = 0.017) and RCC 4–6 (p = 0.026) as independent predictors of patency loss. Within the long lesion subgroup, only RCC 4–6 maintained prognostic significance (p = 0.027), and no significant predictors emerged in the short lesion group. Major adverse events occurred in 12.4% of patients, predominantly in long lesions with severe comorbidities. While DCB angioplasty achieved acceptable 2-year safety outcomes, long femoropopliteal lesions (> 15 cm) demonstrated significantly inferior primary patency compared to short lesions (48.3% vs. 62.5%, p = 0.005). Advanced ischemia (RCC 4–6) is a risk factor for patency loss.

Key Points Nonstent-based local drug delivery with drug-coated balloons (DCBs) can achieve rapid transfer of a drug to surrounding tissue, and durable antirestenotic efficacy Theoretical advantages of DCBs over drug-eluting stents (DESs) include broad surface contact, homogenous drug distribution, absence of stent footprint or polymer residue, and restoration of normal vessel anatomy and function Preclinical studies have shown that DCB delivery of paclitaxel combined with a hydrophilic spacer (excipient) results in clinically effective local tissue drug concentrations and sustained inhibition of neointimal growth Among patients with coronary bare-metal or drug-eluting stent restenosis, DCBs show similar results to standard-of-care treatment (repeat stenting with a DES) and obviate the need for further stent implants Among patients with de novo coronary artery disease, convincing data from randomized trials to support DCB therapy is lacking, and the use of DCBs for this indication requires further investigation In peripheral artery disease, DCB therapy has proven superior to balloon angioplasty for treatment of de novo femoropopliteal and below-the-knee disease De novo stenosis of coronary or peripheral arteries as well as restenosis of previously stented vessels are increasingly prevalent clinical problems. In this Review, Byrne and colleagues summarize the evidence for the use of novel balloon catheters covered with antiproliferative drug both to restore vessel patency and to provide long-lasting inhibition of cell regrowth. Nonstent-based local drug delivery during percutaneous intervention offers potential for sustained antirestenotic efficacy without the limitations of permanent vascular implants. Preclinical studies have shown that effective local tissue concentrations of drugs can be achieved using drug-coated balloon (DCB) catheters. Matrix coatings consisting of a mixture of lipophilic paclitaxel and hydrophilic spacer (excipient) are most effective. Clinical applications most suited to DCB therapy are those for which stent implantation is not desirable or less effective, such as in-stent restenosis, bifurcation lesions, or peripheral artery stenoses. Randomized trials have shown superiority of DCBs over plain-balloon angioplasty for both bare-metal and drug-eluting coronary in-stent restenosis, and similar efficacy as repeat stenting with a drug-eluting stent (DES). Bycontrast, randomized trials of DCBs in de novo coronary stenosis have, to date, not shown similar efficacy to standard-of-care DES therapy. In peripheral artery disease, DCB therapy has proven superior to plain-balloon angioplasty for treatment of de novo femoropoliteal and below-the-knee disease, and shown promising results for in-stent restenosis. Overall, however, despite many years of clinical experience with DCBs, the number of large, high-quality, randomized clinical trials is low, and further data are urgently needed across the spectrum of clinical indications.

Arteriovenous fistula (AVF) and arteriovenous graft (AVG) stenosis are common complications among hemodialysis patients, necessitating repeated interventions due to neointimal hyperplasia and restenosis. Percutaneous transluminal angioplasty (PTA), while a standard treatment, faces challenges in long-term efficacy. The DKutting Scoring Balloon, a novel advancement in scoring balloon technology, incorporates triangular scoring elements and non-compliant balloon material to create controlled micro-incisions in the vessel wall, aiming to enhance procedural precision, reduce vessel trauma, and lower restenosis rates. In the largest study of its kind, this retrospective analysis conducted at Beijing Haidian Hospital evaluated the device's performance across 428 patients with significant AVF and AVG stenosis. The findings indicate primary patency rates of 98.1%, 90.8%, and 78.0% at 1, 3, and 6 months, respectively. Subgroup analyses revealed patency rates of 79.9% for AVF and 75.4% for AVG at 6 months, demonstrating its effectiveness even in resistant and recurrent cases. Importantly, no major adverse events were reported, underscoring the device's safety profile. These observational findings suggest that the DKutting Scoring Balloon may offer favorable outcomes compared to those typically reported with conventional PTA, though these results should be interpreted as hypothesis-generating and further randomized controlled trials are recommended to corroborate these findings and optimize its integration into clinical practice.

To compare the efficacy and safety between paclitaxel coated balloon (PCB) angioplasty and conventional balloon (CB) angioplasty in the treatment of dysfunctional arteriovenous fistula (AVF). We searched four major electronic databases (PubMed, EMBASE, Web of Science and the Cochrane Library) for randomized controlled trials (RCTs) published from inception through November 28, 2021. Outcomes of interest included target lesion primary patency (TLPP), technical success and all-cause mortality. The STATA package version 15.1 was utilized to undertake meta-analyses. Fourteen RCTs totaling 1535 patients were analyzed. The available data showed that there were no significant differences of TLPP rates at 3, 6, 9 and 12 months between the PCB group and the CB group (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.93-1.07, p = 1.000, I 2  = 33.5%, Cochrane Q test p = 0.185, fixed-effect model; RR 1.17, 95% CI 0.99-1.39, p = 0.065, I 2  = 75.4%, Cochrane Q test p = 0.000, random-effect model; RR 0.81, 95% CI 0.35-1.89, p = 0.625, I 2  = 62.8%, Cochrane Q test p = 0.045, random-effect model; RR 1.19, 95% CI 0.97-1.47, p = 0.096, I 2  = 40.5%, Cochrane Q test p = 0.071, random-effect model). In addition, two groups had similar technical success rates (RR 1.00, 95% CI 0.97-1.03, p = 1.000, I 2  = 0.0%, Cochrane Q test p = 0.596, fixed-effect model) and all-cause mortality rates (RR 1.00, 95% CI 0.54-1.84, p = 1.000, I 2  = 0.0%, Cochrane Q test p = 0.599, fixed-effect model). PCB angioplasty did not appear to convey any obvious advantage over CB angioplasty in the treatment of dysfunctional AVF. However, further multi-center, large-scale and well-designed RCTs are needed to prove outcomes.