Angiographic and clinical impact of balloon inflation time in percutaneous coronary interventions with sirolimus-coated balloon: A subanalysis of the EASTBOURNE study

Abstract

Introduction

Percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) is an attractive strategy for the treatment of obstructive coronary artery disease (CAD). The implantation technique strongly influences the outcome of DCB PCI: accurate and adequate lesion preparation, short delivery time and sufficient DCB inflation time are deemed crucial to warrant adequate drug transfer and mitigate the risk of immediate vessel recoil and flow-limiting dissections. However, the optimal DCB inflation time is unclear, current consensus documents suggesting 30–60 s based on Experts' opinion. However, clinical studies comparing the prognostic role of different inflation times are scarce and mainly involve paclitaxel-coated balloons. In this study we aimed to assess the impact of different inflation times in patients undergoing PCI with a sirolimus-coated balloon (SCB).

Methods

We conducted a post-hoc analysis of the prospective, multicenter, EASTBOURNE study, classified into two study groups according to balloon inflation time: long (>30 s) versus short (≤30 s). The primary endpoint was target lesion revascularization (TLR) at 24-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, non-fatal myocardial infarction (MI), and BARC 2–5 bleedings. Furthermore, angiographic endpoints (the rate of bailout stenting and post-procedural TIMI flow <3) were also addressed.

Results

A total of 2289 lesions (2092 in the long inflation group, 197 in the short inflation group) were included in the analysis. Median balloon inflation time was 60 s in the long inflation and 30 s in the short inflation group. The two study groups experienced a similar rate of TLR [6.2 % in the short versus 6.3 % in the long inflation group, p = 1.00] as well MACE (p = 0.683), death (p = 0.102), non-fatal MI (p = 0.822), and BARC 2–5 bleedings (p = 0.252). These results were consistent when considering subpopulations with different target lesion phenotypes (in-stent restenosis, de-novo lesions, large and small vessels). Interesting, the rate of bailout stent implantation and post-procedural TIMI flow <3 was higher in the short SCB inflation time, as compared to the standard strategy.

Conclusions

Short vs. long SCB inflation time is associated with a higher need of bailout stenting after PCI with SCB, with similar clinical outcomes at 24-month follow-up.