Comparison of drug-coated balloon versus plain balloon angioplasty for autogenous hemodialysis access dysfunction: A prospective cohort study

Document Type : Original Article

Authors

1 Department of Vascular Surgery, Faculty of Medicine, Ain Shams University, Cairo, eGYPT

2 Department General Surgery, Faculty of Medicine, Menoufia University, Menoufia, Egypt

3 Department of aVascular Surgery, Faculty of Medicine, Ain Shams University, Cairo, eGYPT

Abstract

Background: Both drug-coated balloon (DCB) angioplasty and conventional plain balloon angioplasty can be implemented
to treat hemodialysis dysfunction. The present study aims to compare the safety and efficacy of these two approaches by
conducting a prospective cohort study.
Objective: The study aims to evaluate DCB safety and arteriovenous fistula effectiveness in relation to plain balloon for
hemodialysis access dysfunction.
Patients and Methods: All patients were allocated and blinded, randomized during the period of study into two groups.
Group A: patients were operated on with drug-eluting balloons (n=40), while group B patients were operated on with
standard balloons (n=40). The results of both groups were analyzed and compared.
Results: DCB was used to treat 40 patients (mean age, 49.48±8 years) with failed arteriovenous fistulas. These patients
were compared with a reference group of 40 patients, mean age 50.6±9.4 years, who had just simple balloon PTA.
Regular PTA balloons were used to dilate every case of stenosis. In the research group, DCBs were used for medication
delivery after hemodynamic success (30% residual stenosis). The 6-, 12-, and 24-month follow-up intervals were used.
Comparisons were made between primary, primary assisted, and secondary patency. At 0.05, the statistical significance
was established. When primary patency was evaluated between the two groups, it was shown that the study group (DCB)
had substantially greater results at 12 months (75.0 vs. 52.5%; P=0.036) and 24 months (52.5 vs. 30.0%; P=0.041). At 24
months, there were notable variations in secondary patency (52.5 vs. 30.0; P=0.041).
Conclusion: In addition to lowering the number of interventions and improving target lesion primary patency over the
first 12 and 24 months, DCB also improves secondary patency at the 24-month mark.

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