TY - JOUR
T1 - First-in-man randomized comparison of BuMA Supreme biodegradable polymer sirolimus-eluting versus durable polymer zotarolimus-eluting coronary stents: The PIONEER trial
AU - von Birgelen, Clemens
AU - Asano, Taku
AU - Amoroso, Giovanni
AU - Aminian, Adel
AU - Brugaletta, Salvatore
AU - Vrolix, Mathias
AU - Hernandez-Antolín, Rosana
AU - van de Harst, Pim
AU - Iñiguez, Andres
AU - Janssens, Luc
AU - Smits, Pieter C.
AU - Wykrzykowska, Joanna J.
AU - Ribeiro, Vasco Gama
AU - Periera, Helder
AU - Canas da Silva, Pedro
AU - Piek, Jan J.
AU - Onuma, Yoshinobu
AU - Serruys, Patrick W.
AU - Sabaté, Manel
PY - 2018
Y1 - 2018
N2 - A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA-polymer coating with electrografting base layer on a thin-strut (80µm) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial assessed the efficacy and safety of the novel device. This randomized, multi-center, single-blinded, non-inferiority trial compared BuMA Supreme SES versus contemporary durable polymer zotarolimus-eluting stents (ZES) in terms of angiographic in-stent late lumen loss (LLL) at 9-months follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with SES (n=83) or ZES (n=87). At 9-month angiographic follow-up, in-stent LLL was 0.29±0.33mm in SES and 0.14±0.37mm in ZES (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 a 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 9-month follow-up. However, this result did not translate into any increase in restenosis rate or impairment in 12-month clinical outcomes
AB - A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA-polymer coating with electrografting base layer on a thin-strut (80µm) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial assessed the efficacy and safety of the novel device. This randomized, multi-center, single-blinded, non-inferiority trial compared BuMA Supreme SES versus contemporary durable polymer zotarolimus-eluting stents (ZES) in terms of angiographic in-stent late lumen loss (LLL) at 9-months follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with SES (n=83) or ZES (n=87). At 9-month angiographic follow-up, in-stent LLL was 0.29±0.33mm in SES and 0.14±0.37mm in ZES (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 a 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 9-month follow-up. However, this result did not translate into any increase in restenosis rate or impairment in 12-month clinical outcomes
U2 - https://doi.org/10.4244/EIJ-D-17-00462
DO - https://doi.org/10.4244/EIJ-D-17-00462
M3 - Article
C2 - 28923787
SN - 1774-024X
VL - 13
SP - 2026
EP - 2035
JO - Eurointervention
JF - Eurointervention
IS - 17
ER -