Comparison of Primary Patency Rate between Drug- Coated Balloon and Plain Balloon Angioplasty in Hemodialysis Access

Abstract

Objective: Hemodialysis adequacy in end-stage renal disease patients plays a crucial role in their quality of life. Repeated stenosis at the anastomotic site of arteriovenous fistula and synthetic arteriovenous graft are a major cause of access failure resulting in hospitalization, catheter usage, and contributing substantially to increased health care costs. Although standard plain balloon angioplasty (PBA) is successful, the patency rate over time is often poor. Drug-coated balloons (DCB) delivering an anti-restenosis agent, Paclitaxel, may improve patency. In this study, we aimed to investigate whether there is an increase in primary patency rate in drug-coated balloon angioplasty compared to conventional plain balloon angioplasty.Materials and Methods: We performed a retrospective analysis of 55 patients with stenotic arteriovenous fistulas (AVF), and arteriovenous grafts (AVG) treated with DCB or PBA. Thirty-five patients were treated with drug-coated balloons, while twenty patients were treated with the standard plain balloon angioplasty. Follow up assessment was scheduled at three months, six months, and nine months. Our primary outcome was the primary patency rate, defined as the interval from the time of intervention until hemodialysis inadequacy.Results: There were 55 patients including twenty-one males and thirty-four females participated in the study. The average age of the 55 patients was 65.43 ± 12.89 years. Thirty (54.5%) patients were diabetes mellitus and 40 (72.7%) patients had hypertension. Seven patients (12.7%) had dyslipidemia. Eight patients (14.5%) had ischemic heart disease. And four patients (7.3%) had hyperparathyroidism. No significant differences in patency rate were found between gender, age group and patients’ underlying diseases. The proportion of primary patency rate comparing between the DCB and PBA treatment was 96.3% versus 73.9% at 6 months (P=0.017) and 92.6% versus 40% at 9 months (P<0.001). After multivariable analysis was performed (adjusted for sex, age, and underlying diseases), we found that stenosis was more likely to occur in patients who had undergone plain balloon angioplasty rather than drug-coated balloon angioplasty (HR 15.75; 95% CI 2.5%-99.1%, P=0.003).Conclusion: Drug-coated balloon angioplasty, when compared with plain balloon angioplasty, achieves a more desirable primary patency rate at 6 months and 9 months after the procedure.