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Angiographic and clinical performance of a paclitaxel-coated balloon compared to a second-generation sirolimus-eluting stent in patients with in-stent restenosis: the BIOLUX randomised controlled trial

EuroIntervention 2018;14:1096-1103 published online May 2018. DOI: 10.4244/EIJ-D-17-01079

1. Contilia Heart and Vascular Center, Elisabeth Krankenhaus Essen, Essen, Germany; 2. Segeberger Kliniken GmbH, Herzzentrum, Bad Segeberg, Germany; 3. Pauls Stradin Clinical University Hospital, University of Latvia, Riga, Latvia; 4. Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany; 5. Schwarzwald-Baar Klinikum Villingen-Schwenningen, Villingen-Schwenningen, Germany; 6. Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany; 7. Charité-Universitätsmedizin Berlin, Campus Mitte, Berlin, Germany; 8. Klinikum Coburg GmbH, Coburg, Germany; 9. Universitätsklinikum Münster, Münster, Germany; 10. Department of Cardiology, Munich University Clinic, Ludwig-Maximilians University, and German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Munich, Germany; 11. Städtisches Klinikum München GmbH, Klinikum Bogenhausen, Munich, Germany; 12. Universitätsklinikum Johannes Wesling, Minden, Germany; 13. Medizinisches Versorgungszentrum Prof. Mathey & Prof. Schofer, Hamburg, Germany; 14. Städtisches Klinikum München GmbH, Klinikum Schwabing München, Munich, Germany

Aims: Although several studies have shown positive outcomes after the use of drug-coated balloons (DCB) for in-stent restenosis (ISR), data on randomised controlled trials versus latest-generation drug-eluting stents (DES) are limited. Therefore, in this randomised trial, we sought to evaluate whether a butyryl-tri-hexyl citrate (BTHC)-based paclitaxel DCB is non-inferior to a biodegradable polymer sirolimus-eluting stent (BP-SES) therapy in patients with ISR in either a bare metal stent (BMS) or DES.

Methods and results: A total of 229 patients with ISR in BMS or DES from 13 German centres and one Latvian centre were 2:1 randomly allocated to DCB (n=157) or DES (n=72). The primary efficacy endpoint was defined as in-stent late lumen loss (LLL) at six months, and the primary safety endpoint was target lesion failure (TLF) at 12 months. LLL in the DCB arm was 0.03±0.40 mm compared to 0.20±0.70 mm in the DES arm (p=0.40). DCB proved to be non-inferior to DES (Δ = –0.17±0.52 mm, 97.5% CI –∞; –0.01]; p<0.0001). At 12 months, Kaplan-Meier TLF estimates were 16.7% in the DCB arm and 14.2% in the DES arm (p=0.65) and remained similar at 18 months (DCB versus DES: 17.4% versus 19.5%, p=0.88).

Conclusions: In patients with DES or BMS ISR, treatment with a paclitaxel DCB showed similar LLL at six months and TLF rates up to 18 months compared to a second-generation sirolimus DES.

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