Drug-eluting Balloon Catheters Research Articles

JET+PCB strategy in the treatment of superficial femoral artery occlusion: a case report

Сritical limb ischemia (CLI) is becoming more and more common among patients worldwide. This is a comorbid condition, which is accompanied by chronic pain, sometimes trophic ulcers and gangrene, as well as a decrease in the quality of life. Despite the chronic nature of ischemia, the absence of treatment is accompanied by a high incidence of limb amputation and death. Patients with lower limb atherosclerosis had the higher risk of cardiovascular events and death. This publication proposes to consider minimally invasive interventional arterial revascularization in a 63-year-old patient with intermittent claudication, stage III critical limb ischemia, with a history of bilateral superficial femoral artery (SFA) stenting. Control lower limb angiography showed bilateral SFA occlusion and thrombosis. Taking into account the restenosis of the previously implanted stent, JET+PCB strategy was considered: first stage — rotational atherectomy followed by SFA angioplasty with a drug-eluting balloon catheter. The correct choice of minimally invasive surgery method in combination with non-pharmacological (smoking cessation, training walking) and pharmacological methods made it possible to restore viability and preserve the lower limb without negative consequences for the patient's health.

1197 RandomSTOP Vessel Prep Trials – Real Life or Alternative Reality?

Abstract Aim During the last ten years there have been two notable studies within vessel preparation for peripheral vascular disease; the DEFINITIVE AR prospective multi-centre randomised study (evaluating the use of atherectomy prior to drug-eluting balloon catheters (DCB)) and the DISRUPT PAD III randomized control trial (evaluating the use of intravascular lithotripsy (IVL)). This study aimed to analyse a true cohort of vascular patients who underwent vessel prep and whether this reflects those included in the studies. Method Data was collected on patients with SFA disease in 14 countries across 17 centres. We applied the inclusion criteria for the DEFINITIVE AR and DISRUPT PAD III studies to our cohort. Results Data was collected on n = 974 patients who received at least one form of vessel prep. Of these patients, 202 (20.7%) underwent atherectomy and 22 (2.26%) underwent lithotripsy. 50.1% (n = 103) of those who underwent atherectomy would have been eligible to participate in the DEFINITVE AR study. 18% (n = 4) of patients who underwent lithotripsy would have been eligible to participate in the DISRUPT PAD III trial. Conclusions Both the DEFINITIVE AR and DISRUPT PAD III trials have shown promising results however in this large multicentre study we have shown that the study participants reflect only a small percentage of the patients seen within a real vascular ward. We would advise caution when interpreting the results from these studies considering the disparity, we have shown between the study cohorts and the real life vascular population.

Advances in Design and Development of Lumi-Solve: A Novel Drug-Eluting Photo-Angioplasty Device.

The Lumi-Solve photo-angioplasty drug eluting balloon catheter (DEBc) may afford safety advantages over current DEBc. Lumi-Solve utilises the guidewire (GW) port and lumen to deliver fibre-optic UV365nm light to the angioplasty balloon which may be problematic. We explore and evaluate alternative Lumi-Solve design options to circumvent fibre-optic use of the GW port and lumen which may enhance efficacy and clinical utility. Effects of guidewire shadowing (GWS) on visible and UV365nm light transmission were evaluated and modelled in-silico. To evaluate the effect of a dedicated intra-balloon fibre-optic port, modified angioplasty balloons and sections of translucent polyethylene terephthalate (PET) GW port tubing were utilised. Investigation of the effect of GWS on chemical and biological photo-activation of balloon surface drug was performed utilising LCMS analysis and inhibition of histone deacetylase activity (HDACi) was measured in human umbilical vein endothelial cells (HUVEC). Parallel fibre-optic and GW port configurations generated a GWS of approximately 18.0% of the evaluable balloon surface area and attenuated both visible and UV light intensity by 20.0-25.0% and reduced chemical photo-activation of balloon surface drug and HDACi by at least 40-45%. Alternative fibre-optic port configurations including a spiral design significantly mitigated GWS effects on UV light transmission. To avoid use of the GW port and its associated complications a dedicated third port and lumen for the Lumi-Solve fibre-optic may be required. To maximize balloon surface chemical and biological photo-activation, non-parallel, intra-balloon, fibre-optic lumen trajectories, including a spiral design may be useful.

O067 Vessel prep trials – real life or alternative reality?

Abstract Introduction During the last ten years there have been two notable studies within vessel preparation for peripheral vascular disease; the DEFINITIVE AR prospective multi-centre randomised study (evaluating the use of atherectomy prior to drug-eluting balloon catheters (DCB)) and the DISRUPT PAD III randomized control trial (evaluating the use of intravascular lithotripsy (IVL)). This study aimed to analyse a true cohort of vascular patients who underwent vessel prep and whether this reflects those included in the studies. Methods Data were collected on patients with SFA disease in 14 countries across 17 centres. We applied the inclusion criteria for the DEFINITIVE AR and DISRUPT PAD III studies to our cohort. Results Data were collected on n=974 patients who received at least one form of vessel prep. Of these patients, 202 (20.7%) underwent atherectomy and 22 (2.26%) underwent lithotripsy. 50.1% (n=103) of those who underwent atherectomy would have been eligible to participate in the DEFINITVE AR study. 18% (n=4) of patients who underwent lithotripsy would have been eligible to participate in the DISRUPT PAD III trial. Conclusion Both the DEFINITIVE AR and DISRUPT PAD III trials have shown promising results however in this large multicentre study we have shown that the study participants reflect only a small percentage of the patients seen within a real vascular ward. We would advise caution when interpreting the results from these studies considering the disparity we have shown between the study cohorts and the real life vascular population.

A prospective randomized trial of the use of drug-eluting balloon catheters for the treatment of a lateral branch in patients with true bifurcation lesions

Background. Endovascular interventions for bifurcation lesions of the coronary arteries account for approximately 15-20% of all coronary interventions. Despite the use of drug-eluting stents, the management of bifurcation lesions remains challenging, especially in the setting of lateral branch involvement. Although the Provisional stenting strategy is the preferred method for most patients, several studies have shown that dual-stent techniques may be advantageous in this patient population. However, as a general approach, the European Bifurcation Club recommends that percutaneous coronary interventions be performed with a minimum number of stents.Aim. To evaluate the safety and efficacy of using a paclitaxel-coated balloon in the treatment of a lateral branch in patients with true bifurcation coronary disease.Methods. This work was performed as a result of a clinical analysis and evaluation of the results of treatment of 80 patients with coronary artery disease, who underwent stenting of a true bifurcation lesion in the period from 2020 to 2021. All patients were randomized in a 1:1 ratio to main branch stenting followed by lateral branch dilatation with drug-eluting balloons and provisional stenting. A direct angiographic analysis was carried out before and after the intervention, and control coronary angiography was performed 12 months later with an assessment of the results obtained. All patients underwent a comprehensive clinical, laboratory and instrumental examination.Results. Pre-procedure reference main branch diameters were 2.97 ± 0.41 mm and 3.12 ± 0.38 mm in the Provisional and drug-eluting balloons groups, respectively. The degree of stenosis of the main branch before percutaneous coronary interventions was 65.2 ± 14.1% and decreased to 13.3 ± 6.6% after intervention in the Provisional stenting group. This was comparable to the results of percutaneous coronary interventions in the group of patients who used drug-eluting balloons 63.8 ± 12.3% and 12.9 ± 5.8%, respectively. The minimum diameter of the main branch after percutaneous coronary interventions increased from 1.04 ± 0.34 mm to 2.72 ± 0.44 mm in the Provisional stenting group and subsequently decreased to 2.18 ± 0.33 mm, according to control coronary angiography after 12 months. At the same time, patients who underwent intervention using drug-eluting balloons had a smaller loss of the lumen of the main branch 0.41 ± 0.33 mm versus 0.63 ± 0.32 mm (p = 0.003). In addition, late loss of lumen both in the lateral branch (0.51 ± 0.22 mm versus 0.33 ± 0.24 mm) and total in both branches of the bifurcation (1.06 ± 0.29 mm versus 0.79 ± 0.27 mm) was statistically greater with Provisional stenting.Conclusion. Treatment of bifurcation lesions using the Provisional technique with drug-eluting lateral branch dilatation has shown better results than with conventional balloons.

Drug-eluting balloon catheters in the treatment of left main coronary artery bifurcation lesions

<h3></h3> В статье представлен обзор современных исследований по применению баллонных катетеров с лекарственным покрытием при чрескожных коронарных вмешательствах. Имеются многочисленные данные, подтверждающие эффективность и безопасность их использования у пациентов с рестенозами стентов, а также при поражениях артерий малого диаметра. Доказательная база их применения у пациентов с бифуркационными стенозами коронарных артерий остается ограниченной. Тем не менее, существующие исследования демонстрируют отсутствие преимуществ двухстентовых методик бифуркационного стентирования перед одностентовыми с применением баллонных катетеров с лекарственным покрытием. Однако остаются нерешенными вопросы отбора пациентов для подобных вмешательств при бифуркационных стенозах ствола левой коронарной артерии, технические аспекты процедуры стентирования, целесообразность применения внутрисосудистых методов исследования для оптимизации результатов лечения, недостаточно сведений об отдаленных результатах лечения таких пациентов.

TCT-398 Drug-Eluting Balloon Catheters in the Treatment of Left Main Coronary Artery Bifurcation Lesions: 4-Year Follow-Up

TCT-398 Drug-Eluting Balloon Catheters in the Treatment of Left Main Coronary Artery Bifurcation Lesions: 4-Year Follow-Up

Drug-eluting balloon catheters in the treatment of left main coronary artery bifurcation lesions: 4-years follow-up

Abstract Aim To evaluate the long-term results of the use of drug-eluting balloon catheters in patients with Left Main (LM) bifurcation stenosis. Methods The analysis involved 142 patients with true bifurcations of the Left Main. Randomization in 2 main groups: Group I (n=52) included patients, who received kissing- dilatation with traditional NC balloon catheters and Group II (n=52), who had a kissing-dilatation of the main bifurcation artery with a traditional NC balloon catheters, and a side branch - with drug-eluting balloon catheters. In retrospectively, the third (III) control group (n=38) was formed, where the two-stent technique was performed. All patients from main groups had previously performed “Provisional T” stenting and final “kissing balloons” dilation technique. Coronary angiography and OCT were performed to evaluate the results of all patients. Inclusion criteria: true LM bifurcation stenoses according to QCA and OCT; SYNTAX score &amp;lt;32. Primary endpoints: incidence of MACE - death, MI, re-interventions. Secondary endpoints: the incidence of restenosis and late stent thrombosis. Results The long-term results after 4-years were observe in 46 patients from Group I and 48 patients from Group II. Restenosis of the side branch of more than 50% according to QCA was detected in 12 patients (26.0%) from Group I and in 5 patients (10.4%) from Group II (p&amp;lt;0.05). In-stent restenosis of the main vessel of more than 50% according to QCA was detected in 4 patients (8.6%) from Group I and in 1 patients (2.1%) from Group II (p&amp;lt;0.05). In patients from group I, the average MLA in the side branch after 4-years compared with data after PCI was 5.58±1.34 and 4.12±1.21 mm2, respectively (p&amp;lt;0.05), in the main branch – 6.34±1.56 and 5.88±1.14 mm2, respectively (p&amp;gt;0.05). In patients from Group II, the average MLA were, respectively, 5.38±1.24 and 5.01±1.14 mm2 in side branch (p&amp;gt;0.05) and 6.68±1.75 and 6.36±1.22 mm2 in main branch (p&amp;gt;0.05). When comparing the data of MLA in the side branch in groups I and II, there was a significant difference (4.12±1.21 vs. 5.01±1.14 mm2; p&amp;lt;0.05).The repeat revascularization, in connection with the detected ischemia was performed in 7 patients (15.2%) from Group I and in 1 patients (2.1%) from Group II (p&amp;lt;0.05). In the Group I was observed non-fatal myocardial infarction in 2 patients (4.3%). The total incidence of MACE were 19.5 vs. 2.1% in groups I and II respectively (χ2=7.321; p&amp;lt;0.001). The survival without MACE was 97.9 and 80.5%, respectively (p=0.0219). Conclusions The use of dug-eluting balloon catheters for the “Provisional T” stenting in patients with true LM bifurcation stenosis, associated with good prognosis and demonstrated significantly lower frequency of MACE and side branch restenosis, according to OCT data, compared with patients who used traditional NC balloon catheters for “kissing-dilatation” and two-stent technique strategy. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Russian academic excellence project 5-100

Design, Development, In Vitro and Preliminary In Vivo Evaluation of a Novel Photo-Angioplasty Device: Lumi-Solve.

Paclitaxel (PTX)-coated drug eluting balloon catheters (DEBc) used in the management of neointimal hyperplasia (NIH) have been associated with safety concerns. Alternative coating agents and targeted delivery systems may improve safety and DEBc efficacy. Utilizing a multi-platform approach we designed, developed and evaluated Lumi-Solve, a novel DEBc, coated with ultraviolet (UV) 365nm-activated caged metacept-3 (c-MCT-3), an epigenetic agent from the histone deacetylase inhibitor (HDACi) class. In vitro catheter and contrast media transmission of UV365nm was evaluated spectroscopically. UV365nm conversion of c-MCT-3 to MCT-3 was evaluated chromatographically. Cellular toxicity and HDACi activity of c-MCT-3 ∓UV365nm was evaluated in vitro. In vivo UV365nm conversion of c-MCT-3 to MCT-3 was evaluated in an ovine carotid artery model. Catheter material and dilute contrast media did not attenuate UV365nm transmission or c-MCT-3 activation. c-MCT-3 demonstrated less cellular toxicity than MCT-3 and PTX. UV365nm-activated c-MCT-3 demonstrated HDACi activity. In vivo activation of c-MCT-3 produced MCT-3. Lumi-Solve, a novel DEBc device developed utilizing a combination of chemical, fibre-optic and catheter based technology platforms, demonstrated potential for targeted delivery of bioactive HDACi to the blood vessel wall supporting direct application to the management of NIH and warranting additional in vivo studies.

Endovascular balloon angioplasty for infrainguinal arterial occlusive disease: Efficacy analysis.

Background We present early and mid-term clinical outcomes of endovascular revascularization for femoropopliteal involvement of peripheral arterial disease. Methods A total of 128 patients (113 males, 15 females; mean age: 63.4±9.9 years; range, 32 to 87 years) who underwent percutaneous transluminal angioplasty for femoropopliteal lesions between August 2016 and April 2018 were analyzed retrospectively. Treatment with Luminor® paclitaxel-coated drug-eluting balloon catheter or bailout therapy with iVolution® self-expanding nitinol stent were performed. Overall patency rates and freedom from reintervention rates were analyzed using the Kaplan-Meier analysis. The primary patency and freedom from reintervention to target lesion rates at 12 and 24 months were evaluated. Results Technical success was achieved in 133 (93%) of the interventions with a median follow-up of 11 (range, 1 to 35) months. At 12 and 24 months, the mean overall patency rates were 85.6±3.7% and 66.8±6.7%, respectively and the mean freedom from reintervention to target lesion rates were 91.6±2.9% and 78.1±6.3%, respectively. The primary patency and freedom from reintervention to target lesion rates were significantly higher in the bailout stenting group than the drug-eluting balloon group at 12 months (97.3±2.7% vs. 94.8±6.1%, respectively, p=0.025 and 97.1±2.9% vs. 84.2±5.5%, respectively, p=0.005) and at 24 months (76.9±7.9% vs. 55.8±13.4%, respectively, p=0.025 and 85.2±7.0% vs. 70.2±13.6%, respectively, p=0.005). Conclusion Endovascular procedures including drug-eluting balloon and bailout stenting seem to be effective alternative treatment modalities for treatment of infrainguinal peripheral arterial disease and can be also used in patients with long lesions and/or total occlusion of femoropopliteal arteries.

Use of endovascular drug-coated devices in lesions of femoropopliteoltibial arteries

Endovascular intervention is one of the main methods of treatment in atherosclerotic lesions of the infrainguinal segment in patients with chronic lower limb ischaemia. Recent years have witnessed active use of drug-eluting techniques, significantly improving the long-term outcomes of peripheral reconstructions. This article is a review of publications on the results of using modern drug-eluting balloon catheters and stents in the femoropopliteoltibial position. The accumulated data will help solve the main problems of the classic balloon angioplasty, reducing the incidence of restenosis, improving primary patency, and decreasing the need for repeat interventions in the remote period of follow-up.

Synthesis and biological evaluation of a novel photo-activated histone deacetylase inhibitor

Hydroxamic acid-based histone deacetylase inhibitors (HDACi) are a class of epigenetic agents with potentially broad therapeutic application to several disease states including post angioplasty mediated neointimal hyperplasia (NIH). Precise spatiotemporal control over the release of HDACi at the target blood vessel site is required for the safe and successful therapeutic use of HDACi in the setting of drug eluting balloon catheter (DEBc) angioplasty treatment of NIH. We aimed to develop and characterise a novel photoactive HDACi, as a potential coating agent for DEBc.Metacept-3 1 was caged with a photo-labile protecting group (PPG) to synthesise a novel UV365nm active HDACi, caged metacept-3 15. Conversion of caged metacept-3 15 to active/native metacept-3 1 by UV365nm was achievable in significant quantities and at UV365nm power levels in the milliwatt (mW) range.In vitro evaluation of the biological activity of pre and post UV365nm activation of caged metacept-3 15 identified significant HDACi activity in samples exposed to short duration, mW range UV365nm. Toxicity studies performed in human umbilical vein endothelial cells (HUVEC’s) identified significantly reduced toxicity of caged metacept-3 15 pre UV365nm exposure compared with native metacept-3 1 and paclitaxel (PTX).Taken together these findings identify a novel photo-activated HDACi, caged metacept-3 15, with pharmacokinetic activation characteristics and biological properties which may make it suitable for evaluation as a novel coating for targeted DEBc angioplasty interventions.

An Engineered Gene Nanovehicle Developed for Smart Gene Therapy to Selectively Inhibit Smooth Muscle Cells: An In Vitro Study.

In-stent restenosis is a serious concern for patients treated through the stenting procedure, although this can be solved using drug-eluting stents and/or drug-eluting balloon catheters. However, the chemical agents released from the drug-eluting layer for inhibiting smooth muscle cell (SMC) migration are inevitably associated with damage to vascular endothelial cell (ECs). The present in vitro study used a distinct strategy, in which a smart gene (phEGR1-PKCδ, an engineered plasmid consists of an SMC-specific promoter (human early growth response 1, hEGR1 promoter) ligated with a gene encoding apoptosis-inducing protein (protein kinase C-delta, PKCδ) was incorporated into a novel gene vehicle (Au cluster-incorporated polyethylenimine/carboxymethyl hexanoyl chitosan, PEI-Au/CHC) to form the PEI-Au/CHC/phEGR1-PKCδ complex, which was proposed for the selective inhibition of SMC proliferation. It was found that the cell viability of SMCs receiving the PEI-Au/CHC/phEGR1-PKCδ complex under simulated inflammation conditions was significantly lower than that of the ECs receiving the same treatment. In addition, the PEI-Au/CHC/phEGR1-PKCδ complex did not demonstrate an inhibitory effect on EC proliferation and migration under simulated inflammation conditions. Finally, the PEI-Au/CHC/phEGR1-PKCδ complexes coated onto a balloon catheter used in percutaneous transluminal coronary angioplasty (PTCA) could be transferred to both the ECs and the SMC layer of Sprague Dawley (SD) rat aortas ex vivo. These preliminary in vitro results suggest that the newly developed approach proposed in the present study might be a potential treatment for reducing the incidence rate of in-stent restenosis and late thrombosis in the future.

A Novel Epigenetic Drug-Eluting Balloon Angioplasty Device: Evaluation in a Large Animal Model of Neointimal Hyperplasia

Drug-eluting balloon catheters (DEBc) coated with paclitaxel (PTX) have been associated with potential safety concerns. An efficacious but less toxic balloon coating may reduce these outcomes. We evaluated a novel DEBc, Epi-Solve, coated with metacept-3 (MCT-3), a member of the histone deacetylase inhibitor (HDACi) class of epigenetic agents, in a large animal model of neointimal hyperplasia (NIH). Plain balloon angioplasty (PABA) catheters were ultrasonically coated with MCT-3 to generate Epi-Solve DEBc. An ovine model of NIH formation was established utilising partial left common carotid artery (LCA) ligation. Twenty-eight days post neointima (NI) induction, PABA, Epi-Solve or PTX-coated DEBc were deployed at the site of induced NI formation. Twenty-eight days post-intervention, ligated vessels were evaluated for attenuation of NI formation, gene expression profiles and immunohistochemical analysis. Epi-Solve DEBc demonstrated attenuation of NIH over no intervention and a trend to inhibition of NIH over PABA. Gene expression analysis and immunohistochemical studies identified significant anti-proliferative and anti-inflammatory signatures and reduced vascular endothelial cell activation compared to PABA. Epi-Solve is a novel HDACi-coated DEBc which demonstrates significant anti-proliferative and anti-inflammatory signatures and reduced vascular endothelial cell activation compared to PABA in an ovine model and may afford endothelial protection.

Prognostic Analysis of Drug-Eluting Balloon Catheter and Drug-Eluting Stent for In-Stent Restenosis of Drug-Eluting Stent

Although the development of Drug-eluting stent (DES) improved the ISR significantly more than the Bare metal stent (BMS), the coronary stent restenosis (ISR) treatment still has a high recurrence rate. This study is compared the efficacy of DEB with that of DES implantation in patients with ISR. Among 4,316 patients who underwent coronary stent implantation at the Chonnam National University Hospital between November 2012 and December 2016, 187 patients developed ISR on follow-up coronary angiography (66.3 ± 11.0 years, 123 males) were enrolled and divided into two groups according to revascularization method as group I (DEB group; n= 127) and group II (DES group; n= 60). Primary end point was defined as major adverse cardiac events (MACEs), composite of cardiac death (CD), myocardial infaction (MI), target lesion revascularization (TLR) and stent thrombosis (ST) during two-year follow-up between the two groups. There were no differences in the baseline characteristics and angiographic findings except that prevalence of device length was shorter (21.1 ± 5.3 vs. 25.3 ± 9.6 mm, p<0.002) in group I.Two-year MACE were not different in the two groups (8.7%vs.10.0%, p=0.789). The incidences of cardiac death (0%vs.0%, p=1.000), MI (1.6%vs.6.7%, p=0.085), TLR(8.7% vs. 10.0%, p=0.789) and ST (0% vs. 0%, p=1000). DEB demonstrated comparable risk reduction for MACEs compared with DES in patients with ISR during two-year follow-up. DEB might be good alternative for the treatment of ISR in patients with ISR

Changing payment instruments and the utilisation of new medical technologies.

This paper empirically investigates the impact of additional reimbursement instruments on the diffusion of new technologies in inpatient care. Using 2010-2014 German panel data on hospital level for every patient undergoing coronary angioplasty, this study examines the utilisation of drug-eluting balloon catheters (DEB) over time while additional payment instruments changed. Hypothesising that the utilisation of DEB increased abruptly when a new reimbursement instrument came into force, we estimate a fixed effects regression comparing years with a change and years where the reimbursement instrument remained the same. The model is adjusted for patient age and severity of the disease. The utilisation of DEB increased from 8407 in 2010 to 19,065 in 2014. Hospitals used significantly more DEB when an additional payment instrument changed compared to years when it remained the same. The increase was roughly twice as large. In short, hospitals are incentivised to utilise new technologies if the reimbursement changes to an instrument that is designed in a more reliable way, e.g. including less bureaucracy or guaranteeing fixed prices.

TCT-290 Drug-Eluting Balloon Catheters in the Endovascular Treatment of Patients with True Left Main Bifurcation Lesions

128 patients were included in the study. All patients underwent «Provisional T» stenting of the LM coronary artery with the final kissing-dilatation technique. The patients were randomized into 2 groups. Group I (n = 64) included patients who had a kissing-dilatation performed with traditional NC

Treatment of coronary in-stent restenosis: a systematic review.

Coronary stent implantation has significantly improved percutaneous coronary intervention and enabled the management of early complications of plain balloon angioplasty. However, a new complication has accompanied these improvements: in-stent restenosis (ISR) arising from neointimal hyperplasia. ISR after coronary angioplasty is currently one of the main limitations of this method, leading to the recurrence of exertional angina pectoris or acute coronary syndromes. The clinical incidence of ISR after bare-metal stent (BMS) implantation is approximately 20%–35%. The use of drug-eluting stents (DES) has led to a further decrease in the occurrence of ISR to 5%–10%. Evidence resulting from controlled clinical studies suggests that DES and drug-eluting balloon catheters (DEB) provide the best clinical and angiographic results in the treatment of ISR. We undertook a systematic review of the pathophysiology, diagnostics and treatment options for BMS- and DES-ISR. We discuss recent randomised studies, comparing different DES or DEB used for BMS or DES-ISR treatment, as well as the use of new biovascular scafolds and the topic of scafold restenosis.

Drug-eluting balloon catheters for lower limb peripheral arterial disease: the evidence to date.

A significant proportion of patients with severe lower limb peripheral arterial disease require revascularization. Over the past decade, an endovascular-first approach even for complex disease has gained widespread use among vascular specialists. An important limitation of percutaneous transluminal balloon angioplasty or stenting remains the occurrence of restenosis. Drug-coated balloons have emerged as an exciting technology developed to overcome the limitations of standard balloon angioplasty and stenting. Drug-eluting devices inhibit neointimal growth of vascular smooth muscle cells with the potential of preventing restenosis. This review provides a synopsis of the up-to-date evidence on the role of drug-coated balloons in the treatment of lower limb peripheral arterial disease. Bibliographic searches were conducted using MEDLINE, EMBASE, and the Cochrane Library electronic database. Eleven randomized clinical trials, two systematic reviews, and a published registry providing the best available evidence were identified. Current evidence suggests that angioplasty with drug-coated balloon is reliable, safe, and efficient in increasing patency rates and reducing target lesion revascularization and restenosis. However, it remains unknown whether these improved results can translate into beneficial clinical outcomes, as current randomized clinical trials have failed to demonstrate a significant benefit in limb salvage and mortality. Further randomized trials focusing on clinical and functional outcomes of drug-eluting balloons and on cost versus clinical benefit are required.

Treatment of Coronary In-stent Restenosis with Drug-eluting Balloon Catheter: Real-world Outcome and Literature Review

Treatment of Coronary In-stent Restenosis with Drug-eluting Balloon Catheter: Real-world Outcome and Literature Review