Treatment of juxta-anastomotic stenoses for failing distal radiocephalic arteriovenous fistulas: Drug-coated balloons versus angioplasty

Abstract

The aim of our study is to report the results of two types (type A, type B) paclitaxel drug-coated balloon compared with standard percutaneous transluminal angioplasty in the treatment of juxta-anastomotic stenoses of mature but failing distal radiocephalic hemodialysis arteriovenous fistulas. Two groups of 26 and 44 patients treated with two different drug-coated balloon are compared with a control group of 86 treated with standard percutaneous transluminal angioplasty. A color Doppler ultrasound was performed to evaluate stenosis and for treatment planning. We assess primary patency, defined as the absence of dysfunction of the arteriovenous fistulas, patent lesion or residual stenosis < 30% and no need for further reintervention of target lesion. Primary patency and secondary patency are evaluated after 12 months with color Doppler ultrasound for the whole arteriovenous fistulas, defined as absolute (absolute primary patency, absolute secondary patency) and target lesion. Postprocedural technical and clinical success was 100%. After 12 months, absolute primary patency is 81.8% for type A, 84.1% type B, and 54.7% for standard percutaneous transluminal angioplasty; target lesion primary patency is 92% type A, 86.4% type B, and 62.8% standard percutaneous transluminal angioplasty; absolute secondary patency is 95.4% type A, 95.5% type B, and 80.7% standard percutaneous transluminal angioplasty; target lesion secondary patency is 100% type A, 97.7% type B, and 80.7% standard percutaneous transluminal angioplasty. All the patients treated with drug-coated balloon (type A + type B) have an absolute primary patency of 83.3%, a target lesion primary patency of 87.9%, an absolute secondary patency of 95.5%, and a target lesion secondary patency of 98.4%. Our study confirms that the use of drug-coated balloon, indiscriminately among different brands, improves primary patency with statistically significant difference in comparison with standard percutaneous transluminal angioplasty and decreases reintervention of target lesion in juxta-anastomotic stenoses of failing distal arteriovenous fistulas maintaining the radiocephalic fistula as long as possible.

Paclitaxel-Coated Balloon versus Plain Balloon Angioplasty for Dysfunctional Autogenous Radiocephalic Arteriovenous Fistulas: A Prospective Randomized Controlled Trial

“…To date, multiple observational and randomized controlled studies have evaluated the use of DCBs for prolonging patency, but caution should be taken when interpreting the results due to clinical heterogeneity resulting from the non-uniform level of intervention ( 8 9 11 12 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 ). In a retrospective study in 2014, Patanè et al ( 9 ) presented a case series of 26 patients who had juxta-anastomotic radiocephalic stenosis treated using DBA.…”

“…The results appeared excellent, with TLPP rates at 6 months, 1 year, and 2 years of 96.1%, 90.9%, and 57.8%, respectively, and TLSP rates at 1 year and 2 years of 100% and 94.7%, respectively. In a recent retrospective report by the same team ( 28 ), two groups of 26 and 44 patients treated with two different DCBs were compared with a control group of 86 patients treated with PBA. TLPP rates at 12 months were higher in the two DCB groups (In.Pact Amphirion, Medtronic: 90.9%; Lutonix, BD: 86.4%) than in the PBA group (62.8%, p = 0.002).…”

A retrospective comparison analysis of results of drug-coated balloon versus plain balloon angioplasty in treatment of juxta-anastomotic de novo stenosis of radiocephalic arteriovenous fistulas

“…In another study, two brands of DCB versus PB were compared in patients with juxta-anastomotic stenosis of mature but failing distal radiocephalic AVFs and all patients treated with DCB-PTA had statistically significantly higher primary patency, TLPP, secondary patency, and target lesion secondary patency rates. 33 The aforementioned study is the first scientific study using an homogeneous population and evaluating only autogenous native mature radiocephalic AVFs and stenosis of the juxta-anastomotic region for 12 months. In a randomized study comparing DCB-PTA versus PB-PTA, however, no significant difference was found in the anatomic success rates between the DCB and PB groups (89.9% vs 78.3%; p = 0.13) and both groups achieved 100% clinical success, although the restenosis rate at 6 months was 34.0% in the DCB group and 62.9% in the PB group (p = 0.01).…”

Comparative Effectiveness of Drug-Coated Balloon vs Balloon Angioplasty for the Treatment of Arteriovenous Fistula Stenosis: A Meta-analysis

“…The remaining 68 articles were submitted to full-text review. Ultimately, 12 articles [13][14][15][16][17][18][19][20][21][22][23][24] comprising 979 patients met the selection criteria and were included in the current meta-analysis ( Figure 1). Characteristics of all included studies are summarized in Table 1.…”

“…Of the 11 studies [13][14][15][16][17][18][19][21][22][23][24] reporting 12-month TLR in each group (Figure 2B), the pooled rates for DCBA and BA were 43.5% (141/324) vs 63.4% (232/366), respectively. The pooled OR was 0.45 (95% CI 0.21 to 0.97, Z=2.03, p=0.04), reflecting significant reduction in 12-month TLR for DCBA.…”