March 13, 2019
Study Analyzes Patency Outcomes of DCB Angioplasty in Hemodialysis Circuits
March 14, 2019—Findings from a systematic review and meta-analysis assessing patency outcomes following drug-coated balloon (DCB) angioplasty in hemodialysis circuits were published by Sean A. Kennedy, MD, et al online ahead of print in Journal of Vascular and Interventional Radiology (JVIR).
The investigators concluded that there was a significant improvement in patency with DCB angioplasty in arteriovenous fistula (AVF) at 3, 6, 12, and 24 months. Additionally, there was a single comparative study that identified the benefit of DCB angioplasty use in the prosthetic arteriovenous graft (AVG). However, no significant benefit was identified with DCB angioplasty for central stenosis.
As summarized in JVIR, the investigators searched MEDLINE and EMBASE systems from inception to November 2018 to identify comparative studies assessing DCB angioplasty versus plain old balloon angioplasty (POBA) in hemodialysis circuits. There were 12 studies composed of 908 patients.
Pooled data show there was a significant improvement in target lesion patency rates among AVF after DCB angioplasty versus POBA at all time points:
- 92.5% vs 86.8% at 3 months (OR, 0.58; 95% CI, 0.36–0.94)
- 75.2% vs 56.3% at 6 months (OR, 0.4; 95% CI, 0.23–0.70)
- 52.5% vs 31.2% at 12 months (OR, 0.39; 95% CI, 0.25–0.61)
- 35.3% vs 9.8% at 24 months (OR, 0.2; 95% CI, 0.07–0.62)
This benefit persisted on subgroup analysis of randomized controlled trials (RCTs) only. Only one RCT assessed DCB angioplasty outcomes at 1 year in AVG procedures; therefore, a meta-analysis of results specific to AVG could not be performed.
In the meta-analysis, there was no significant difference in patency rates of hemodialysis-associated central vein stenosis between DCB angioplasty and POBA (odds ratio [OR], 0.28; 95% confidence interval, 0.07–1.14; P = .08). Using 12-month pooled mortality data of AVF studies, investigators reported that no significant difference in mortality rates between DCB angioplasty and POBA (7.6% vs 5.8%; P > .05). Same-day procedural complications were reported in only five (0.65%) of 773 patients across all studies that reported complications.
Discussing these findings with Endovascular Today, the study's lead investigator Deeraj Rajan, MD, commented, "Our meta-analysis points out the overall positive outcomes in AVFs but also highlights limited information on mortality and use within AVGs."
Dr. Rajan further stated, "The current literature overall paints a picture of positive outcomes but without stratification of outcomes based on lesion location. Also, there is only one published multicenter randomized study, with another forthcoming. Additional studies are likely needed before DCB's are considered first use devices over POBA."
Endovascular Today asked Dr. Rajan if covariate analyses were performed to isolate the effects of specific devices or the performance in any key patient subgroups. Dr. Rajan answered, "Unfortunately, we were not able to stratify outcomes to specific devices (we did examine this variable) or key patient subgroups, due to the number of cases published to date. Hopefully, with future published studies, a sufficient patient size will exist to evaluate these key questions."