Angiographic and clinical performance of a paclitaxel coated balloon compared to a 2nd generation sirolimus eluting stent in patients with in-stent restenosis- the BIOLUX randomized controlled trial.

AIMS: The optimal treatment of in-stent restenosis (ISR) remains unknown. This study evaluates the efficacy and safety of a paclitaxel coated balloon compared to a 2nd generation sirolimus eluting stent in patients with ISR in bare metal stents (BMS) or drug eluting stents (DES).

METHODS AND RESULTS: A total of 229 patients with ISR from 13 German centers and one Latvian center were 2:1 randomly allocated to DCB (n=157) or DES (n=72). The primary efficacy endpoint was defined as late lumen loss (LLL) at 6 month, and the primary safety endpoint was target lesion failure (TLF) at 12 months. LLL in the DCB arm was 0.03 ± 0.40mm compared to 0.20 ± 0.70mm in the DES arm (p=0.40). DCB proved non-inferior to DES (Δ = -0.17 ±0.52mm (97.5% CI [-∞;-0.01]); p < 0.0001). At 12 months primary safety endpoint rates were 16.7% in the DCB arm and 14.2% in the DES arm (p=0.65). TLF rates remained similar at 18 months (DCB versus DES; 19.5% versus 18.6%, p=0.88).

CONCLUSIONS: In patients with DES or BMS ISR, paclitaxel coated balloon treatment showed similar LLL at 6 months and TLF rates up to 18 months compared to 2nd generation sirolimus eluting stents.