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.

Abstract

AIMS:

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.

METHODS AND RESULTS:

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).

CONCLUSIONS:

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.

• Authors: Clemens von Birgelen, Taku Asano, Giovanni Amoroso, Adel Aminian, Salvatore Brugaletta, Mathias Vrolix, Rosana Hernandez-Antolín, Pim van de Harst, Andres Iñiguez, Luc Janssens, Pieter C Smits, Joanna J Wykrzykowska, Vasco Gama Ribeiro, Hélder Pereira, Pedro Canas da Silva, Jan J Piek, Yoshinobu Onuma, Patrick W Serruys, Manel Sabaté
• Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (EuroIntervention) Vol. 13 Issue 17 Pg. 2026-2035 (04 20 2018) ISSN: 1969-6213 [Electronic] France
• PMID: 28923787 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Immunosuppressive Agents
• zotarolimus
• Sirolimus

Topics

• Absorbable Implants (adverse effects)
• Aged
• Coronary Angiography (methods)
• Coronary Artery Disease (diagnosis, surgery)
• Coronary Restenosis (diagnosis, etiology)
• Coronary Vessels (diagnostic imaging)
• Drug-Eluting Stents (adverse effects)
• Female
• Humans
• Immunosuppressive Agents (pharmacology)
• Male
• Middle Aged
• Outcome Assessment, Health Care
• Percutaneous Coronary Intervention (adverse effects, instrumentation, methods)
• Prosthesis Design
• Sirolimus (analogs & derivatives, pharmacology)