Speaker: A/Prof Tan Chieh Suai

Hospital: Department of Renal Medicine, Singapore General Hospital

Abstract

The IMPRESSION study, a multicenter randomized trial in Singapore, compared sirolimus-coated balloons (SCB) with plain balloons for arteriovenous fistula (AVF) stenosis. Results demonstrated superior 6-month primary patency in the SCB group (70.2% vs. 57.0%, P=0.037) with comparable safety profiles.

Introduction

Dialysis access dysfunction frequently requires intervention, yet restenosis remains a challenge. SCBs deliver sirolimus locally to inhibit neointimal hyperplasia, potentially improving outcomes.

Case Analysis

Study Design: 170 patients with AVF stenosis were randomized to SCB (n=84) or plain balloon (n=86).

Inclusion Criteria: Mature AVF, successful pre-dilation (<30% residual stenosis).

Key Results:

6-month primary patency: 70.2% (SCB) vs. 57.0% (control), P=0.037.

Safety: 30-day adverse events were 2.4% in SCB vs. 0% in control (non-inferior).

Product Highlights

Sirolimus-Coated Balloon: Inhibits mTOR pathway to reduce restenosis, compatible with standard angioplasty techniques.

Advantages: Ease of use, extends patency without additional procedural complexity.

Conclusion

SCBs significantly improve 6-month AVF patency with acceptable safety, offering a promising option for dialysis access maintenance. A multinational FDA IDE study is planned to validate these findings.