Purpose: To evaluate the effect of drug-coated balloon (DCB) with high-dose paclitaxel for the treatment of restenotic dysfunctional arteriovenous fistulae (AVFs).
Materials and methods: In this single-arm, multicenter, prospective, observational study, 334 patients who underwent DCB angioplasty using IN.PACT AV (Medtronic, Plymouth, Minnesota) for the first time for restenotic lesions of dysfunctional AVFs between April 2021 and March 2022 were registered. Outcomes were compared with the outcomes of plain angioplasty performed previously, leading up to the restenosis.
Results: Procedural success, defined as <30% residual stenosis, was achieved in 96.7% of cases. During a median follow-up of 7.4 months, 179 target lesion reinterventions (TLRs) were observed, and the 6-month freedom from TLR was 73.2% (68.2%-78.2%). When compared with the previous plain angioplasty, the median time to reintervention was significantly longer with DCB (9.1 [8.0-10.6] vs 3.2 [3.0-3.4] months; P < .001). Baseline characteristics that were independently associated with TLR were as follows: months from the last intervention (adjusted hazard ratio, 0.50 [95% confidence interval, 0.40-0.62] per doubling; P < .001), partial lesion coverage by DCB (2.13 [1.10-4.12]; P = .024), and residual stenosis after DCB (2.19 [1.53-3.12] per 15% increase; P < .001) with its time interaction (0.91 [0.86-0.97] per month; P = .003). Of the 179 TLRs, 84 used DCB once again. The median time to reintervention was significantly longer for TLR using DCB (7.1 [6.2-9.7] vs 3.3 [3.1-4.0] months; P < .001).
Conclusions: DCB with high-dose paclitaxel is effective at both the initial treatment of restenotic lesions of dysfunctional AVFs and during TLR after DCB use. Partial lesion coverage by DCB and residual stenosis may compromise patency.
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