A Prospective, Multicenter, Randomized Trial of YINYI® Polymer-Free Paclitaxel-Eluting Stent vs. Durable Polymer Sirolimus-Eluting Stent in the Treatment of Coronary Artery Disease (FREEDOM)
Principal Investigator: Yong Huo, MD, Peking University First Hospital
CRO: CCRF (Beijing) Inc.
Data Statistics Department: Department of Biostatistics, NCCD
Sponsor: Liaoning Biomedical Materials R&D Center Co., Ltd.
YINYI® Polymer-free Paclitaxel-Eluting Coronary Stent
Durable Polymer Sirolimus-Eluting Coronary Stent (Cypher, Firebird 2, Partner)
1626 patients in all
YINYI polymer-free PES vs. Durable polymer SES = 2:1
Target Vessel Failure (TVF) at 1 year
TVF = Target-vessel related death + MI + TVR
1) Definite/Probable stent thrombosis according to ARC (early, late, very late)
2) MACE at 30d, 1yr, 2yrs
3) All death, cardiac death at 30d, 1yr, 2yrs
4) Composite safety endpoint (cardiac death, MI, CVA) at 30d, 1yr, 2yrs
5) TVR, TLR at 30d, 1yr, 2yrs
As the first large-scale randomized trial of the polymer-free paclitaxel-eluting stent compared to the durable polymer sirolimus-eluting stents, the results at 1-year follow-up demonstrated: there is no significant difference in primary endpoint TVF, and also no significant difference in secondary endpoints TVR, stent thrombosis and composite safety endpoint. FREEDOM proved polymer-free stent is not only safe in long-term, but also efficacy.