Drug-eluting balloon (DEB) versus plain old balloon angioplasty (POBA) in the treatment of failing dialysis access: A prospective randomized trial

Abstract

Objective To compare the efficacy of angioplasty using drug-eluting balloons (DEB) compared with plain old balloon angioplasty (POBA) to reduce the rate of restenosis. Methods This prospective, single-centre, single-blinded, 1:1 randomized, clinical trial enrolled patients that had primary or restenotic lesions in native upper extremity arteriovenous (AV) fistulas or at the graft-venous anastomosis. Patients were randomized to angioplasty with a POBA or a DEB. The primary effectiveness endpoints were freedom from target lesion revascularization (TLR) and functional status of access circuit at 12 months. Results A total of 42 (28 male, 14 female; age range, 42–83 years) patients were enrolled. Patients were followed for 12 months. No significant differences were detected between the POBA and DEB groups regarding total number of TLR procedures (31 versus 36, respectively), freedom from TLR (3 versus 4, respectively) and functional status of the access circuit at 12 months (14 of 20 patients [70%] versus 17 of 22 patients [77%], respectively). Conclusion This clinical trial did not demonstrate any significant differences between DEB angioplasty and standard balloon angioplasty when treating dysfunctional haemodialysis access.

Comparison of drug‐coated balloon angioplasty versus common balloon angioplasty for arteriovenous fistula stenosis: A systematic review and meta‐analysis

“…Eighty‐five articles were retained after title/abstract curation (excluding 433 records). Thereafter, we read the full text and analyzed 15 RCTs 9,10,13–25 involving a total of 1525 patients for quantitative synthesis (Supporting Information: Figure ). The main characteristics of the included RCTs (country, design, sample size, age, intervention, follow‐up, and main results) are described in Table 1.…”

“…Pooled analysis of 14 studies 9,10,14–25 ( n = 1489) using a forest plot demonstrated that the primary patency rate in the DCB group ( n = 750) was higher than that in the CB group ( n = 739) at 6 months after balloon expansion (OR = 2.31, 95% CI: 1.69, 3.15, p < .01, Supporting Information: Figure ). No significant heterogeneity was observed ( I 2 = 32.90%).…”

“…Pooled analysis of 13 studies 9,10,[13][14][15][17][18][19][20][21][23][24][25] (n = 910) using a forest plot demonstrated that the primary patency rate at 12 months after balloon expansion in the DCB group (n = 457) was higher than that in the CB group (n = 453) (OR = 2.09, 95% CI: 1.50, 2.91, p < .01, Supporting Information: Figure S13). No significant heterogeneity was observed (I 2 = 9.28%).…”

“…Seven studies 9,13,[16][17][18]23,24 assessed the incidence of all-cause mortality at 12 months after balloon expansion between the two groups in a total of 774 patients, with 382 assigned to DCB groups and 392 assigned to CB groups (OR = 0.99, 95% CI: 0.60, 1.64, p = .97, Figure 4). No significant heterogeneity was observed (I 2 = 0%).…”

Comparison of drug-coated balloon angioplasty versus common balloon angioplasty in hemodialysis patients with arteriovenous fistula stenosis: A meta-analysis of randomised controlled trials

“…Pooled analysis of 14 studies 9,10,[17][18][19][20][21][22][23][24][25][26][27][28] (n = 1489) demonstrated that the forest plot of the 6-month primary patency rate in the DCB group (n = 750) was higher than that in the CB group (n = 739) at 6 months after balloon expansion (OR = 2.31, 95% CI: 1.69, 3.15, P < 0.01, Supplementary Figure S3). No signi cant heterogeneity was observed (I 2 = 32.90%).…”