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

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.

Functional comparison between the BuMA Supreme biodegradable polymer sirolimus-eluting stent and a durable polymer zotarolimus-eluting coronary stent using quantitative flow ratio: PIONEER QFR substudy

“…The PIONEER trial was a randomised trial which compared the biodegradable polymer-based cobalt-chromium (CoCr) platform sirolimus-eluting BuMA™ Supreme (SINOMED, Tianjin, China) stent with an electrografting base layer (B-SES) with the durable polymer-coated zotarolimus-eluting Resolute™ stent (R-ZES) (Medtronic, Minneapolis, MN, USA) and aimed to demonstrate the non-inferiority of the B-SES to the R-ZES in terms of nine-month angiographic in-stent LLL. In the current trial, the B-SES did not meet the primary endpoint of non-inferiority 14 . Although the B-SES was significantly inferior to the R-ZES in terms of in-stent LLL (0.29±0.34 mm vs. 0.14±0.37 mm, p inferiority =0.004), the incidence of device-oriented cardiovascular events (DoCE) at 12 months was not different between the groups (4.9% vs. 5.7% p=1.00).…”

“…The current study was a post hoc substudy of the PIONEER trial comparing the B-SES with the R-ZES in patients with coronary artery disease to demonstrate non-inferiority of the B-SES to the R-ZES in terms of nine-month angiographic in-stent LLL. The details of the protocol and the main results of the trial have already been reported elsewhere 14 . The inclusion and exclusion criteria are described in the Supplementary Appendix.…”

The 2010s in clinical drug-eluting stent and bioresorbable scaffold research: a Dutch perspective

“…In the PIONEER II trial, 170 patients were allocated to implantation of a biodegradable polymer-coated BuMA Supreme SES or Resolute ZES. After 9 months, the angiographic primary non-inferiority endpoint of in-stent late lumen loss was not met, but this result did not translate into impairment in 12-month clinical outcome [ 38 ]. The NIREUS trial assessed the BioNIR ridaforolimus-eluting stent and randomised 302 patients to treatment with this device or Resolute Integrity ZES.…”

Percutaneous Coronary Intervention: Developments in the Last 12 Months

“…At the 9-month follow-up, this primary endpoint was not met. 23 PIONEER III, which is powered for clinical endpoints, is currently enrolling. Baseline and follow-up OCT and FFR were performed in a pre-specified subgroup of patients.…”