Coated Balloon Angioplasty Research Articles

Drug Coated Balloon Angioplasty for Coronary In-Stent Restenosis: A West Australian Single Centre Experience

Drug Coated Balloon Angioplasty for Coronary In-Stent Restenosis: A West Australian Single Centre Experience

Acute and Mid-Term Results of Atherectomy in Femoropopliteal Lesions.

The femoropopliteal arteries are commonly affected by atherosclerotic lesions. The use of atherectomy may increase the benefit of definitive therapy, such as drug-coated balloon (DCB) angioplasty. To analyze the 2-year safety and efficacy of atherectomy in general and stratified by directional atherectomy (DA) and front-cutting atherectomy (FA) for the treatment of atherosclerotic lesions of the femoropopliteal arteries. A retrospective analysis was performed including patients who underwent vessel preparation with atherectomy. The primary endpoint was the 2-year incidence of target lesion revascularization (TLR). Secondary endpoints included primary patency, changes in ankle-brachial index (ABI) and Rutherford-Becker class (RBC), and amputation rate up to 2 years. Nine hundred and fifty-five patients (37.8% female; mean age: 69.7±9.6 years) were included in this analysis. Eight hundred and twenty-one patients (86%) were claudicants, 134 patients (14%) had critical limb-threatening ischemia. Six hundred and forty-four lesions (67.4%) were in a native artery and 145 lesions (15.2%) were in-stent restenoses. In 166 patients (17.4%), atherectomy was performed in native and in-stent segments. Eight hundred and thirty-seven patients were treated with DA and 118 patients with FA. Five-hundred and seventy-four procedures (60.1%) were followed by DCB angioplasty, provisional stent rate was 20% overall. One hundred and fifty-four procedure-related adverse events (16.1%) were documented, four complications (0.4%) required surgical intervention. At 2 years, 279 patients (34.3%) required TLR. After DA, TLR rates were 9%, 19.5%, and 32.2% at 6, 12, and 24 months, respectively, and 14.2%, 29.4%, and 49%, at 6, 12, and 24 months after FA. After DA, primary patency rates were 75.9%, 57.4%, and 40.3% at 6, 12, and 24 months, respectively, and 64.9%, 44.8%, and 26%, at 6, 12, and 24 months, respectively, after FA. Mean ABI and mean RBC improved significantly during follow-up (p<0.001), 17 patients required amputation, 13 minor (1.6%) and four major (0.5%). Regression analysis shows that more calcified lesions are more likely to have a TLR. Compared with a vessel diameter of 4 mm or smaller, larger diameters are associated with fewer TLRs. In this retrospective analysis, atherectomy of femoropopliteal lesions shows satisfactory mid-term results. German Clinical Trials Register: DRKS00031245. The results of this analysis could influence the daily practice of the interventionalists. A combination of atherectomy as vessel preparation followed by drug coated balloon angioplasty appears to be promising, but would need to be investigated in randomised trials.

Role of drug coated balloon angioplasty in treatment of recurrent dysfunctional arteriovenous fistulae for hemodialysis.

Role of drug coated balloon angioplasty in treatment of recurrent dysfunctional arteriovenous fistulae for hemodialysis.

Role of drug coated balloon angioplasty in treatment of recurrent dysfunctional arteriovenous fistulae for hemodialysis

Objective This study aimed to evaluate the safety, clinical benefits, and patency outcomes of using paclitaxel drug-coated balloons (DCBs) for the treatment of recurrent dysfunctional arteriovenous fistulae (AVF) in hemodialysis patients. Study design A nonrandomized clinical trial was conducted involving 20 patients who had previously undergone percutaneous transluminal angioplasty (PTA) for failing or failed AVF. Patients were assessed based on clinical criteria, and interventions were performed using paclitaxel-coated balloons. Clinical outcomes, including thrill, bruit, and hemodialysis function, were evaluated, and duplex assessments were conducted after 3 and 6 months to determine recurrent stenosis. Statistical analysis was carried out using SPSS. Results The study included 20 end-stage renal disease (ESRD) patients with a mean age of 49.4±17 years. After 2 weeks’ postintervention, all patients had adequate bruit, 16 (80%) patients had adequate thrill, and 19 (95%) patients had adequate hemodialysis. After 6 months, 70% of patients exhibited adequate thrill, while adequate bruit, and hemodialysis were observed in 75% of patients. Duplex assessments showed minimal recurrent stenosis after 3 and 6 months, with only a few cases of new stenotic lesions. Postoperative complications were infrequent, including one unrelated death, and a small number of central venous occlusions and infections. The study indicated a significantly improved efficacy of drug-coated balloon angioplasty over traditional angioplasty in maintaining AVF patency. Conclusion Paclitaxel drug-coated balloons offer a promising approach for treating recurrent dysfunctional arteriovenous fistulae in hemodialysis patients. The study demonstrated favorable clinical outcomes, reduced restenosis rates, and improved patency compared with traditional angioplasty.

Outcomes of Paclitaxel Coated Balloon Angioplasty in Claudication

Patel, Avkash MD; Turner, Jason T MD; Zhou, Christopher; Colvard, Benjamin MD; Cho, Jae MD, FACS; Kumins, Norman H MD, FACS Author Information

Primary Patency Rate With Paclitaxel Coated Balloon Angioplasty Versus Covered Stenting of Failed Arteriovenous Grafts: a Retrospective Comparative Study

Primary Patency Rate With Paclitaxel Coated Balloon Angioplasty Versus Covered Stenting of Failed Arteriovenous Grafts: a Retrospective Comparative Study

Results of New Dual-Drug Coated Balloon Angioplasty versus POBA for Femoropopliteal Lesions

The study aimed to assess the 24-month safety and effectiveness of a new generation drug-coated balloon (DCB) (Elutax; AR Baltic Medical, Vilnius Lithuania-also marketed as Emperor in some European countries; Aachen Resonance, Germany, and AB Medica, Italy) for the treatment of patients with femoropopliteal lesions. From January 2019 to January 2020, DCB angioplasties using Elutax were performed on 53 consecutive patients (53 limbs) with femoropopliteal lesions (group A) and compared with a noncontemporary control group (group B) consisting of 71 patients (71 limbs) treated with plain old balloon angioplasty (POBA) between January 2017 and January 2018. Before performing the angioplasty, both groups underwent clinical examination, ultrasound evaluation, and computed tomography angiography to delineate subject clinical and baseline lesion characteristics. Primary end point was primary patency rate at 24 months. Secondary end points included clinically driven target lesion revascularization (CD-TLR), overall survival and limb salvage rates. In both groups technical success rate was 100% with bailout stenting performed in 16.9% (9/53) of lesions in group A, while stenting was necessary in 22.5% of lesions (16/71) in group B. Patients treated with Elutax exhibited lower 24-month restenosis/reocclusion rate and improved primary patency compared to those treated with POBA (restenosis/reocclusion rate: 9.4% vs. 25.3%, CI 95% 0.01-0.30, P=0.034; primary patency: 88.2% vs. 71.5%, log rank P=0.03). Twenty-four-month CD-TLR rate was 7.5% for DCB versus 18.3% for POBA. No device or procedure-related deaths occurred, and no 30-day mortality was observed in either group. During the follow-up period, the limb salvage rate was 94.9% for A group and 92.1% for B group. All minor amputations occurred in limbs presented with chronic limb threatening ischemia (CLTI). Overall survival was 91.7% for group A and 89.4% for group B. Paclitaxel+Dextran DCB angioplasty proved safe and effective in managing chronic lesions of femoropopliteal arteries. Our experience has shown superior primary patency rate for Elutax when compared to POBA.

Safety and efficacy of drug coated balloon angioplasty for intracranial atherosclerotic disease

BackgroundDrug coated balloon (DCB) angioplasty can provide sustained anti-restenotic efficacy without the limitations of permanent vascular implantation and is presumably ideal for treating intracranial atherosclerotic disease. However, the safety of...

TCTAP A-044 Novel Use of Shockwave Intravascular Lithotripsy With Drug Coated Balloon Angioplasty in De Novo Calcified Coronary Lesions

TCTAP A-044 Novel Use of Shockwave Intravascular Lithotripsy With Drug Coated Balloon Angioplasty in De Novo Calcified Coronary Lesions

Joint statement from the European Atherosclerosis Society and European Society of Vascular Medicine focuses on patients with peripheral arterial disease

Joint statement from the European Atherosclerosis Society and European Society of Vascular Medicine focuses on patients with peripheral arterial disease

Paclitaxel Coated Balloon Angioplasty vs. Plain Balloon Angioplasty for Haemodialysis Arteriovenous Access Stenosis: A Systematic Review and a Time to Event Meta-Analysis of Randomised Controlled Trials

A systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to determine the effectiveness and safety of drug coated balloon (DCB) angioplasty compared with uncoated plain balloon (PB) angioplasty in treating arteriovenous access stenosis. MEDLINE, Embase, Scopus, and the Cochrane Central Register of Controlled Trials were searched for RCTs comparing paclitaxel coated DCB and PB angioplasty for arteriovenous access stenosis. The last date of the literature search was 31 December 2020. Risk of bias of the retrieved studies was assessed with the Cochrane Collaboration tool for assessing risk of bias (RoB 2.0). The random effects model was used to estimate the risk of loss of target lesion patency (six and 12 months) and circuit patency (six and 12 months). Procedure related adverse events and mortality rate were also compared. Patency results were pooled using the time to event meta-analytical method and the quality of evidence was assessed according to the GRADE approach. Sixteen eligible trials, including 1 682 lesions, were included in the quantitative analysis for the efficacy and safety of paclitaxel coated DCBs. DCBs were associated with a lower risk of loss of target lesion patency at six months (HR 0.53, 95% CI 0.42 – 0.66) and 12 months (HR 0.60, 95% CI 0.47 – 0.76), and were also associated with improved six and 12 month circuit patency. Overall quality of evidence was moderate to low. Procedural complications were rare, and the risk of death up to 12 months was similar between the two groups (OR 1.03, 95% CI 0.68 – 1.56). Paclitaxel coated DCBs reduced the risk of loss of target lesion patency and circuit patency in arteriovenous access stenosis compared with PBs. Considering the heterogeneity of the included trials, there is a need to investigate optimal treatment regimens regarding drug dose and agent of the DCB and the treatment procedure.

Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study.

Drug coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation. Assess the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) prior to DCB angioplasty in patients with symptomatic severely calcified femoropopliteal PAD. REALITY (NCT02850107) prospectively enrolled subjects at 13 multinational centers with 8-36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty. The primary effectiveness endpoint was 12-month primary patency, and the primary safety endpoint was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and a Clinical Events Committee adjudicated events. A total of 102 subjects were enrolled; one lesion was treated per subject. The mean lesion length was 17.9 ± 8.1cm, 39.0% were chronic total occlusions (mean lesion length 22.6 ± 8.6cm); 86.2% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 8.8% (9/102) of subjects. Twelve-month primary patency rate was 76.7% (66/86) and freedom from CD-TLR rate was 92.6% (87/94). No device or procedure related deaths and one index-limb major amputation were reported. Plaque excision with DA in patients with symptomatic severely calcified femoropopliteal arterial disease prior to DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate.

Update in endovascular therapy of ischemic cerebrovascular disease

Endovascular therapy of ischemic cerebrovascular disease has developed rapidly in the past few years.The big breakthrough in acute ischemic stroke treatment is mechanical embolectomy,of which new devices,technologies,concepts and trials are bringing great benefits to more patients.Evidence becomes more substantial and reliable for endovascular stenting of carotid artery stenosis.New stents and embolic protection devices might further lower its peri-procedure risk of brain ischemia and improve its efficacy of stroke prevention.For patients with intracranial stenosis,stented-assisted angioplasty becomes safer when the Wingspan stent is used strictly by its current on-label indication.Drug coated balloon angioplasty also demonstrates attractive application prospects.Endovascular recanalization of non-acute occlusion of extracranial and intracranial arteries has been carried out prudently in its initial stage,more experiences are needed.

Drug Coated Balloon Angioplasty vs. Standard Percutaneous Transluminal Angioplasty in Below the Knee Peripheral Arterial Disease: A Systematic Review and Meta-Analysis

The aim was to review and analyse the literature on clinical outcomes of drug coated balloon (DCB) vs. standard percutaneous transluminal angioplasty (PTA) for the treatment of infrapopliteal arterial disease. This is a systematic review and meta-analysis. The MEDLINE, EMBASE and Cochrane Database of Systematic Reviews were searched for studies published between January 2008 and November 2018. Two authors independently performed the search, study selection, assessment of methodological quality and data extraction. Studies were eligible when reporting PTA and DCB outcomes in infrapopliteal arteries, published in English, human studies, and full text was available. Methodological quality was determined by MINORS and Cochrane risk of bias tool. GRADE methodology was used to rate the evidence for observed outcomes. The primary outcome was the 12 month limb salvage rate. Secondary outcomes were 12 month survival, amputation free survival (AFS), restenosis, and target lesion revascularisation (TLR) rates. Inclusion criteria for pooling data were randomised controlled trials and comparative studies with 12 month outcomes. Ten studies representing 1593 patients met the inclusion criteria. The quality was assessed as moderate or low. Data from five studies were pooled, and 12 month outcomes for DCB vs. PTA were limb salvage rate, 94.0% vs. 95.7% (odds ratio (OR), 0.92; 95% confidence interval (CI), 0.39–2.21); and survival rate, 89.8% vs. 92.9% (OR 0.69; 95% CI 0.39–1.21). Data from four studies were pooled, and 12 month outcomes for PTA vs. DCB were restenosis rate, 62.0% vs. 32.9% (OR 2.87; 95% CI 0.83–9.92); and TLR rate, 27.8% vs. 14.0% (OR 2.76; 95% CI 0.90–8.48). Pooled data from two studies showed 12 month AFS rate for DCB vs. PTA; 82.5% vs. 88.7% (OR 0.79; 95% CI 0.23–2.75). No statistically significant differences were found. Based on this systematic review and meta-analysis no significant differences in limb salvage, survival, restenosis, TLR, and AFS rates were found when DCB angioplasty was compared with standard PTA.

Efficacy of Rotational Atherectomy System Associated With Drug Coated Balloon Angioplasty in Limb Ischemia

Efficacy of Rotational Atherectomy System Associated With Drug Coated Balloon Angioplasty in Limb Ischemia

Drug-coated vs uncoated balloon angioplasty in the treatment of femoropopliteal arterial lesions

Background Inspite of immediate technical success, neointimal hyperplasia and restenosis remain the Achilles heel of endovascular interventions. Drug-coated balloons (DCBs) have shown promising outcomes regarding anti-restenotic efficacy in management of femoro-popliteal arterial lesions compared to uncoated balloon. Objectives To evaluate the efficacy of the paclitaxel-coated balloon versus uncoated balloon angioplasty in treatment of femoropopliteal lesions regarding primary patency and restenosis at 12 months. Patients and Methods Between Sept 2017 and Sept 2019, this prospective randomized study was performed at Menoufia University hospitals. Sixty patients suffering symptomatic lower limb ischemia (Rutherford category 3 to 5) were randomly assigned into group A (30 patients) that were treated by DCB angioplasty, and group B (30 patients) that were treated by uncoated balloon (UCB) angioplasty. The primary patency, mean diameter restenosis, and binary restenosis (≥50% diameter stenosis) of the treated lesions at 12 months were collected and analyzed. Results Baseline characteristics were comparable in both groups. The 12-month mean diameter restenosis was significantly lower in DCB group than UCB group (27.8±35.2% vs. 44.9±33.8% respectively, P Conclusions Treatment of symptomatic femoro-popliteal disease with paclitaxel coated balloon angioplasty is associated with superior anti-restenotic efficacy that provides a better primary patency rate compared to uncoated balloon angioplasty at 12 months.

Drug Coated Balloon Angioplasty in Peripheral Vasculature: Review of Literature

Drug-coated balloons (DCB) are commonly used to treat peripheral artery disease (PAD) and are often used in combination with or in place of a stent or rotational atherectomy. DCB’s are manufactured with the drug, Paclitaxel with the first-line indication of preventing restenosis of arteries following an intervention. Recent literature has suggested an increased mortality risk at years 2 and 5 post DCB angioplasty. Inspired by Katsanos et al. and their important work in researching outcomes for DCBs in PAD, we conducted a thorough review of all literature to compile an informed conclusion.

Abdominal Aortic Aneurysm Expansion Abrogation in a Preclinical Hypercholesterolemic LDLR-/- Pig Model by Anti-miR-29b Coated Balloon Angioplasty

Abdominal Aortic Aneurysm Expansion Abrogation in a Preclinical Hypercholesterolemic LDLR-/- Pig Model by Anti-miR-29b Coated Balloon Angioplasty

Propensity Score Matched Analysis Indicated That Insulin-dependent Diabetic Patients have More Benefit of Drug Coated Balloon Angioplasty in the Treatment of Chronic Limb Threatening Ischemia

Introduction - There is an increasing evidence on efficacy of drug coated balloons(DCB) in reducing restenosis and reocclusion after endovascular treatment of peripheral arterial disease(PAD), especially in the femoro-popliteal district but DCB use is discouraged by its high cost. The aim of the study was to identify subgroups of patients with chronic limb threatening ischemia (CLTI) that can benefit more from DCB than others and thus, perform a better resources management. Methods - A propensity score matched analysis was performed on a prospectively maintained database, including all patients treated for PAD between January-2014 and December-2017. Inclusion criteria were: CLTI, infrainguinal PAD and endovascular treatment. Patient's demographics and clinical characteristics were assessed. Limbs were stratified according to WIfI clinical stages. Clinical and Duplex follow-up was performed at 3,6 and every 6 month thereafter. A propensity score analysis was used to match all DCB treated patients to balloon angioplasty(BA) patients in a 1:1 nearest neighbour matching method. The matching variables were: age, diabetes, Rutherford stage, treated arterial segment (femoral, tibial and femoro-tibial) and type of lesion (primary vs. restenosis/reocclusion). Endpoints were: Limb Salvage(LS), Primary(PP), Assisted(AP) and Secondary Patency(SP), Patient Survival(S), wound healing (WH) and identification of subgroups susceptible to DCB on the basis of Kaplan-Meier analysis and Log-Rank test. Results - A total of 211 patients satisfying the inclusion criteria were treated in the study period. DCB was used in 60 cases (median age 72 years, male 76.7%). Sixty (median age 73 years, male 66.7%) out of 151 cases treated by POBA were selected, based on the propensity score matching. DCB and POBA groups were similar in terms of Coronary artery disease (47% Vs 50%. P=0.43), insulin-dependent diabetes(IDD) (40% Vs 27%. P=0.09), kidney disease (45% Vs 60%. P=0.07), Rutherford stages 5/6 (87% Vs 88%. P=0.41), and WIfI clinical stages (stage 3: 37% Vs 42%; stage 4: 31% Vs 27%; P=0.92). In the overall population, femoral, tibial and femoro-tibial lesions were treated in 44%, 49% and 7%, respectively. Lesion type was primary in 73% and restenosis/reocclusion in 27%. The mean follow-up was 21.5 months. WH was 54%, 75% and 85.7% at 6,12 and 24-month, respectively. LS was 87.2%, 86.1% and 84.7% at 6,12 and 24-month, respectively. PP, AP, SP, and S are reported in table 1. At Cox-regression analysis, IDD was an independent negative predictor of LS (HR=3.4, P=0.011). Within IDD patients, at 1-year, those treated by DCB had significantly higher rates of LS (81.1% Vs 56.3%, P=0.05), AP (80% Vs 50%, P=0.04) and SP (85% Vs 56%, P=0.029).Table 1endpoints at 6,12 and 24-monthPP (%)AP (%)SP (%)S (%)6-month8081.885.389.812-month73.575.183.185.624-month6872.481.174.6 Open table in a new tab Conclusion - The study results suggest a more beneficial effect of DCB in the treatment of infrainguinal PAD associated with CLTI in insulin-dependent diabetes patients. In a limited resources assets, insulin-dependent patients could represent a reasonable target for DCB technology.

Outcomes of Drug-Coated Balloon Angioplasty vs. Conventional Balloon Angioplasty for Endovascular Treatment of Common Femoral Artery Atherosclerotic Disease

BackgroundAtherosclerotic disease of the common femoral artery (CFA), commonly associated with multilevel disease affecting the femoropopliteal segment, can cause claudication or contribute to critical limb ischemia. Although endovascular therapy for the management of peripheral arterial disease (PAD) has been increasingly utilized, its role in CFA lesions remains controversial. The aim of this study was to investigate the safety and efficacy of drug (DCB) vs non drug coated balloon angioplasty (BA) at the CFA segment. MethodsIn this two-center study, we identified 154 patients treated either with DCB (n = 47) or BA (n = 107) for CFA lesions. Hazard ratios (HR) and the respective 95% confidence interval (CI) were synthesized to examine the association between the two groups in terms of target lesion revascularization (TLR), limb loss, and major adverse limb event (MALE) at 12 and 24 months of follow up. ResultsThis real-world population included a high percentage of patients with critical limb ischemia (43%) and moderate to severe lesion calcification (75%). Adjunctive atherectomy was performed in 97.9% of DCB cases (N = 46/47) and 44.7% of BA cases (N = 51/114). The overall procedural success rate was 95% without any differences between the two groups. Post-angioplasty dissections were observed in 15 cases [DCB: 8.5% (N = 4/47) vs BA: 9.7% (N = 11/113); p = .81], while distal embolization occurred in one patient in the DCB group and one in the BA group (p = .52). Provisional stenting was more commonly necessary in BA vs. DCB cases (12.3% vs 2.13%, p = .044). Physiologic assessment during follow up demonstrated a better mean 2-year ABI for the DCB group (mean: 0.9; SD: 0.2) vs BA group (mean: 0.6; SD: 0.4), although statistical significance was not reached (p = .06). No difference between the two groups was detected in terms of freedom from TLR (DCB: 75.5% vs BA: 86.8%; HR: 1.31; 95% CI: 0.46–3.67; p = .61), freedom from limb loss (DCB: 83.8% vs BA: 83.6%; HR: 1.04; 95% CI: 0.36–2.99; p = .94) or freedom from MALE (DCB: 83.5% vs BA: 78%; HR: 0.73; 95% CI: 0.26–1.99; p = .53) at 24 m of follow up. However, at the end of follow up more deaths were observed in patients treated with BA than DCB (DCB: 14.9% vs BA: 31.7%; p = .03). Patients who required provisional stenting were at higher risk for limb loss 2 years after the initial procedure (multivariate: HR: 4.54; 95% CI: 1.09–18.85; p = .04). ConclusionsBoth DCB and non-DCB strategies are effective modalities for revascularization of patients with CFA lesions. Larger prospective studies are necessary to determine the relative benefit, if any, of drug-eluting technologies for the treatment of common femoral artery disease.