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Paclitaxel-Coated Balloon Angioplasty for Early Restenosis of Central Veins in Hemodialysis Patients: A Single Center Initial Experience.

ABSTRACT: To report the results of angioplasty with paclitaxel-coated balloons for the treatment of early restenosis of central veins in hemodialysis patients.Sixteen patients (9 men and 7 women; mean age 65.8 ± 14.4 years; range, 40-82 years) with 16 episodes of early restenoses of central veins within 3 months (median patency duration 2.5 months) were enrolled from January 2014 to June 2015. Ten native central veins and 6 intra-stent central veins were treated with double paclitaxel-coated balloons (diameter 6-7 mm) plus a high pressure balloon (diameter 12-14 mm). The study outcomes included procedural success (< 30% residual stenosis) and primary patency of the treated lesion (< 50% angiographic stenosis without re-intervention).Procedural success was achieved in all 16 cases of central vein stenoses. The mean diameter of the central vein was 3.7 ± 2.4 mm before the procedure vs. 11.4 ± 1.8 mm after the initial procedure. There were no procedure-related complications. The mean diameters of the central veins at 6 months and 12 months were 7.8 ± 1.3 mm and 6.9 ± 2.7 mm, respectively. The primary patency rates at 6 months and 12 months were 93.8% and 31.2%, respectively. One patient had significant restenosis of the central vein at 3 months. The median primary patency period was 9 months for paclitaxel-coated balloons and 2.5 months for the last previous procedure with conventional balloons (p < 0.001).In our limited study, paclitaxel-coated balloons seem to improve the patency rate in cases of early restenosis of central veins. However, a further randomized control trial is necessary.

SUBMITTER: Hongsakul K

PROVIDER: S-EPMC5904467 | biostudies-other | 2018 May-Jun

REPOSITORIES: biostudies-other

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Paclitaxel-Coated Balloon Angioplasty for Early Restenosis of Central Veins in Hemodialysis Patients: A Single Center Initial Experience.

Hongsakul Keerati K Bannangkoon Kittipitch K Rookkapan Sorracha S Boonsrirat Ussanee U Kritpracha Boonprasit B

Korean journal of radiology 20180406 3

<h4>Objective</h4>To report the results of angioplasty with paclitaxel-coated balloons for the treatment of early restenosis of central veins in hemodialysis patients.<h4>Materials and methods</h4>Sixteen patients (9 men and 7 women; mean age 65.8 ± 14.4 years; range, 40-82 years) with 16 episodes of early restenoses of central veins within 3 months (median patency duration 2.5 months) were enrolled from January 2014 to June 2015. Ten native central veins and 6 intra-stent central veins were tre ...[more]

PMID: 29713218

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Project description:BackgroundNumerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease of the superficial femoral and popliteal arteries. However, the treatment effect compared with an uncoated balloon has differed greatly among the randomized trials, with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low-dose (2-µg/mm2 surface dose of paclitaxel) DCB.MethodsThis was a prospective, randomized, multicenter, single-blinded trial. Patients were randomized (3:1) to treatment with a low-dose DCB or an uncoated percutaneous transluminal angioplasty (PTA) balloon. The primary safety end point was a composite of freedom from device- and procedure-related death through 30 days after the procedure and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months after the procedure. The primary effectiveness end point was primary patency at 12 months.ResultsPatients were randomized to treatment with a DCB (222 patients, 254 lesions) or uncoated PTA balloon (72 patients, 79 lesions) after successful predilatation. Mean lesion length was 7.2 and 7.1 cm, and 19.2% and 19.0% of lesions represented total occlusions, respectively. The primary safety end point was met, and superiority was demonstrated; freedom from a primary safety event was 94.1% (193 of 205) with DCB and 83.3% (50 of 60) with PTA, for a difference of 10.8% (95% confidence interval, 0.9%-23.0%). The primary effectiveness end point was met, and superiority of DCB over PTA was achieved (83.9% [188 of 224] versus 60.6% [40 of 66]; P<0.001). Outcomes with DCB were also superior to PTA per the Kaplan-Meier estimate for primary patency (89.0% versus 65.0% at 365 days; log-rank P<0.001) and for rates of clinically driven target lesion revascularization (5.9% versus 16.7%; P=0.014).ConclusionsSuperiority with a low-dose DCB for femoropopliteal interventions was demonstrated over PTA for both the safety and effectiveness end points.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01858363.

Project description:BackgroundDrug-coated balloon angioplasty after directional coronary atherectomy (DCA) allows for a stentless strategy providing good short-term outcomes; however, late-phase restenosis and its mechanism remain unclear. Moreover, histopathological evaluation for late-phase restenosis post-drug-coated balloon angioplasty after DCA has never been reported.Case summaryWe report the first case of late-phase restenosis post-drug-coated balloon angioplasty after DCA, wherein tissue analysis using intravascular coronary imaging and histopathology suggested neovascularization in newly developed neointimal proliferation. A 52-year-old man with a history of dyslipidaemia presented with exertional angina pectoris. He underwent percutaneous coronary intervention (PCI) with drug-coated balloon angioplasty after DCA for the proximal left anterior descending artery. Although coronary angiography after nine months revealed no restenosis, he experienced recurrent chest discomfort after 25 months. Coronary angiography confirmed late-phase restenosis, and intravascular ultrasound showed progressively developed neointima above the underlying residual plaque. Optical coherence tomography suggested developing neovascularization within the neointima. Stentless PCI with drug-coated balloon angioplasty after DCA was re-performed, and collected restenotic sample. The histopathological evaluation confirmed less-cellular neointimal proliferation with rich neovascularization and concomitant diffuse vascular endothelial growth factor (VEGF) expression.DiscussionLate-phase restenosis post-drug-coated balloon angioplasty after DCA comprised less-cellular neointima, suggesting inhibition of cell proliferation by drug-coated balloon efficacy. However, diffuse VEGF expression and concomitant rich neovascularization with haemorrhage and inflammation might indicate neointimal proliferation. Further large-scale investigations of the restenotic mechanism should be performed to avoid long-term target vascular failure after drug-coated balloon angioplasty post-DCA.

Project description:The purpose of this article was to compare the efficiency and safety of drug-coated balloon angioplasty (DCB) and atherectomy with percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal in-stent restenosis (ISR). Pubmed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) (all up to March 2019) were searched systematically. Trial sequential analysis (TSA) was conducted. 5 studies with 599 participants were included. Compared with PTA, DCB significantly increased the rate of patency (6 months: RR 1.65, 95% CI 1.30 to 2.09, P < 0.01; 12 months: RR 2.38, 95% CI 1.71 to 3.30, P < 0.01) and the rate freedom from target lesion revascularization (TLR) (6 months: RR 1.18, 95% CI 1.09 to 1.28, P < 0.01; 12 months: RR 1.56, 95% CI 1.33 to 1.82, P < 0.01) at 6 and 12 months follow-up, and the TSA results showed these outcomes were reliable. The rate of clinical improvement by ≥1 Rutherford category in the DCB group was higher than that in the PTA group (6 months: RR 1.35, 95% CI 1.03 to 1.75, P = 0.03; 12 months: RR 1.46, 95% CI 1.17 to 1.82, P < 0.01) at 6 and 12 months. There is no statistically difference of ABI, all-cause mortality, and incidence of amputation between DCB group and PTA group (MD 0.03, 95% CI -0.03 to 0.08, P = 0.40; RR 1.24, 95% CI 0.46 to 3.34, P = 0.67; RR 0.32, 95% CI 0.01 to 7.61, P = 0.48). Compared with PTA, the rate of patency and freedom from TLR in the laser atherectomy (LD) group was higher than that in the PTA group (patency: 6 months: RR 1.28, 95% CI 1.01 to 1.64, P < 0.05, 12 months: RR 2.25, 95% CI 1.14 to 4.44, P < 0.05; freedom from TLR: 6 months: RR 1.27, 95% CI 1.05 to 1.53, P = 0.01, 12 months: RR 1.59, 95% CI 1.12 to 2.25, P = 0.01) at 6 and 12 months follow-up. In conclusion, DCB and LD had superior clinical (freedom from TLR and clinical improvement) and angiographic outcomes (patency rate) compared with PTA for the treatment of femoropopliteal ISR. Moreover, DCB and LD had a low incidence of amputation and mortality and were relatively safe methods.

Project description:ObjectivesThe long-term data on the use of drug-coated balloons (DCBs) for femoropopliteal atherosclerotic lesions in the real-world setting are limited, even more so for racially and geographically distinct populations. The present analysis reports the 5-year safety and effectiveness outcomes of a DCB in the Asian subset of the prospective, real-world IN.PACT Global Study.MethodsThe IN.PACT Global Study was a prospective, multicenter, international, single-arm study designed to assess the long-term safety and effectiveness of the IN.PACT Admiral DCB in real-world participants with femoropopliteal artery disease. The present analysis included 114 Asian participants (138 lesions) treated in South Korea and Singapore. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the safety endpoint (a composite of freedom from device- and procedure-related mortality through 30 days; and freedom from major target limb amputation and clinically driven target vessel revascularization within 60 months after the index procedure) and major adverse events.ResultsIn this prespecified Asian subset, there was a high incidence of diabetes mellitus (54.4%), hypertension (78.1%), coronary artery disease (43.9%), and concomitant below-the-knee vascular disease of target leg (39.5%). Mean lesion length was 17.4 ± 12.4 cm; 26.8% were in-stent restenosis, and more than half of the lesions were totally occluded (51.4%) and calcified (54.3%). The 5-year Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization was 77.1% (95% confidence interval: 67.0%-84.5%). The safety composite endpoint was 76.0%; the cumulative incidence of all-cause mortality was 19.9%, and no major target limb amputations were reported through 5 years.ConclusionsThis subset analysis of Asian participants from the IN.PACT Global Study demonstrated consistent results with the previously reported data of the IN.PACT Admiral DCB. The data confirm the durable clinical effectiveness and safety profile of the DCB through 5 years for femoropopliteal atherosclerotic disease in this real-world population.

Dataset Information

Paclitaxel-Coated Balloon Angioplasty for Early Restenosis of Central Veins in Hemodialysis Patients: A Single Center Initial Experience.

Publications

Paclitaxel-Coated Balloon Angioplasty for Early Restenosis of Central Veins in Hemodialysis Patients: A Single Center Initial Experience.

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