Effect of combination of non-slip element balloon and drug-coating balloon for in-stent restenosis lesions (ELEGANT study)

Abstract

BackgroundIn-stent restenosis (ISR) remains a problematic issue of coronary intervention. The non-slip element balloon (NSE) is a balloon catheter with 3 longitudinal nylon elements which are attached proximally and distally to the balloon component. The expectation is that this design of balloon is able to achieve a larger lumen area due to the elements, as well as reducing balloon slippage. We investigated whether NSE pre-dilatation improves angiographic outcomes compared to a high pressure non-compliant balloon pre-dilatation, followed by a drug-coating balloon (DCB) for treatment of ISR lesions with optical coherence tomographic imaging (OCT). MethodsPatients were eligible for the study if one or more in-stent restenosis lesions were treated with a paclitaxel-coating balloon. Patients were randomized to NSE pre-dilatation (NSE group) or high pressure non-compliant balloon pre-dilatation (POBA group) in a 1:1 fashion in 17 hospitals. The primary endpoint was in-segment late loss [post minimal lumen diameter (MLD)−follow-up MLD] at 8 months. ResultsOne hundred and five patients were allocated to each group. Balloon slippage (7.9% versus 22.9%, p=0.002) and geographical miss (6.9% versus 21.9%, p=0.002) were observed less in the NSE group compared to the POBA group. Acute gain was significantly larger in the NSE group (1.17±0.42mm versus 1.06±0.35mm, p=0.04), but post minimum stent lumen area analyzed by OCT was similar between the two groups (3.85±1.67mm2 versus 3.81±1.93mm2, p=0.64). At 8 months, average lesion length was significantly shorter than the POBA group (5.78±3.26mm versus 6.97±4.59mm, p=0.04), but average in-segment late loss was similar between the two groups (0.28±0.45mm versus 0.27±0.38mm, p=0.75). ConclusionEight-month angiographic outcomes were similar between NSE and non-compliant balloon pre-dilatation with DCB for treatment of ISR lesions. However, NSE pre-dilatation has advantages such as reduction of balloon slippage and geographical miss during the procedure.