Efficacy Of Drug-coated Balloon Angioplasty Research Articles

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.

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Cohort

Multicenter, prospective single-arm IN.PACT Global Study from 2012 to 2014 There were 1406 patients with claudication (89%) or rest pain (11%) with complex femoropopliteal occlusive lesions who were treated with IN.PACT Admiral drug-coated balloon (DCB) angioplasty (Medtronic, Dublin, Ireland). Mean lesion length was 12 cm, and a third of the lesions were occluded. The Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization through 36 months was significantly lower in patients with chronic limb-threatening ischemia (68%) compared with claudicants (78%). Predictors of clinically driven target lesion revascularization through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, and chronic limb-threatening ischemia. DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease to treat complex lesions in a real-world population is associated with sustained clinical efficacy and low rates of reintervention at 3 years after the initial procedure.

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort

Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.

Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI.

TCT-269 The Efficacy of Drug-Coated Balloon Angioplasty for De Novo Small Coronary Artery Disease

The aim of this study is to evaluate the efficacy of drug-coated balloon angioplasty (DCB) for de novo small coronary stenosis (reference vessel diameter <2.5 mm). We retrospectively evaluated 164 consecutive patients who underwent percutaneous coronary intervention (PCI) with DCB at Nagoya Heart

Paclitaxel density and clinical efficacy of drug-coated balloon angioplasty for femoropopliteal artery disease: meta-analysis and adjusted indirect comparison of 20 randomised trials.

Paclitaxel density and clinical efficacy of drug-coated balloon angioplasty for femoropopliteal artery disease: meta-analysis and adjusted indirect comparison of 20 randomised trials.

Safety and Long-Term Efficacy of Drug-Coated Balloon Angioplasty following Rotational Atherectomy for Severely Calcified Coronary Lesions Compared with New Generation Drug-Eluting Stents.

Objectives This study sought to assess the safety and long-term efficacy of drug-coated balloons (DCB) following aggressive intracoronary image-guided rotational atherectomy (iRA) for severe coronary artery calcification (CAC), and to compare this strategy with new generation drug-eluting stents (nDES) following iRA. Background Ischemic events following the treatment of CAC is still relatively high. Thus, more innovative strategies are required. Methods We evaluated 123 consecutive patients (166 lesions) with de novo CAC undergoing an iRA (burr size; 0.7 of the mean reference diameter by intracoronary imaging) followed by DCB (DCB-iRA; 54 patients, 68 lesions) or nDES (nDES-iRA; 69 patients, 98 lesions). Follow-up angiography was obtained at > 6 months. Results The target vessels (right coronary and circumflex), bifurcation (67.6% versus 47.9%), reference diameter (2.28mm versus 2.49mm), and lesion length (11.89mm versus 18.78mm) were significantly different between the two groups. The median follow-up was 732 days. TLR and TVR in DCB-iRA and nDES-iRA at 3 years were similar: 15.6% versus 16.3% (P=0.99) and 15.6% versus 23.3% (P=0.38). In 41 well-matched lesion pairs after propensity score analysis, the cumulative incidence of TLR and TVR in DCB-iRA and nDES-iRA at 3 years was 12.9% versus 16.3% (P=0.70) and 12.9% versus 26.1% (P=0.17), respectively. On QCA analysis, although the acute gain was smaller in DCB-iRA (0.85 mm versus 1.53 mm, P<0.001), the minimum lumen diameter at follow-up was similar (1.69 mm versus 1.87 mm, P=0.29). The late lumen loss was lower (0.09 mm versus 0.52 mm, P=0.009) in DCB-iRA. Conclusions DCB-iRA is feasible for CAC.