First-in-man randomised comparison of the BuMA Supreme biodegradable polymer sirolimus-eluting stent versus a durable polymer zotarolimus-eluting coronary stent: the PIONEER trial

• Published in: EuroIntervention Vol. 13; no. 17; pp. 2026 - 2035
• Main Authors: von Birgelen, Clemens, Asano, Taku, Amoroso, Giovanni, Aminian, Adel, Brugaletta, Salvatore, Vrolix, Mathias, Hernandez-Antolín, Rosana, van de Harst, Pim, Iñiguez, Andres, Janssens, Luc, Smits, Pieter C, Wykrzykowska, Joanna J, Ribeiro, Vasco Gama, Pereira, Hélder, da Silva, Pedro Canas, Piek, Jan J, Onuma, Yoshinobu, Serruys, Patrick W, Sabaté, Manel
• Format: Journal Article
• Language: English
• Published: France 01.04.2018
• DOI: 10.4244/EIJ-D-17-00462
• ISSN: 1774-024X

A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA polymer coating with an electrografting base layer on a thin-strut (80 µm) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial aimed to assess the efficacy and safety of the novel device. This randomised, multicentre, single-blinded, non-inferiority trial compared the BuMA Supreme SES versus a contemporary durable polymer zotarolimus-eluting stent (ZES) in terms of angiographic in-stent late lumen loss (LLL) at nine-month follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with either SES (n=83) or ZES (n=87). At nine-month angiographic follow-up, in-stent LLL was 0.29±0.33 mm in the SES group and 0.14±0.37 mm in the ZES group (pnon-inferiority=0.45). The in-stent percent diameter stenosis and the binary restenosis rate of the two treatment arms were similar (19.2±12.0% vs. 16.1±12.6%, p=0.09, and 3.3% vs. 4.4%, p=1.00, respectively). At 12-month clinical follow-up, there was no difference between treatment arms with regard to the device-oriented composite clinical endpoint (4.9% vs. 5.7%; p=0.72). The PIONEER trial did not meet its primary endpoint in terms of in-stent LLL at nine-month follow-up. However, this result did not translate into any increase in restenosis rate or impairment in 12-month clinical outcomes.