A Multicenter, Randomized Trial of YINYI? Polymer-Free Paclitaxel - Eluting Stent vs. Polymer Sirolimus - Eluting Stent in the Emergency PCI


Principal Investigator: Leifeng Wang, MD, Beijing Chao-yang Hospital
Sponsor: Liaoning Biomedical Materials R&D Center Co., Ltd.


YINYI? Polymer-free Paclitaxel-Eluting Coronary Stent
Polymer-based Sirolimus-Eluting Coronary Stent (Firebird 2, Partner, Excel and others)


1584 patients in all
YINYI polymer-free PES vs. Durable polymer SES = 3:1

Primary Endpoint

Ischemic driven TLR (i-TLR) at 1 year

Secondary Endpoints

1.PCI success rate (separately record the facts of device performance and lesion condition)
2.Emergency intervention efficiency (separately record the time from Onset to Admission, Admission to Cath lab, Cath lab to Open artery, Admission to Open artery), analysis the time efficiency and influencing factors
3.Definite/Probable stent thrombosis according to ARC (acute, sub-acute, late)
4.Make detailed record to the doses and adjust points of DAPT, especially pay attention to the stent thrombosis in those patients who have stopped the DAPT due to special cases
5.MACE at 30d, 6m, 1yr
6.All death and cardiac death at 30d, 6m, 1yr
7.Composite safety endpoint (cardiac death, myocardial infarction, stent thrombosis) at 30d, 6m, 1yr, especially record the composite safety including stent thrombosis and the reason of earlier interruption of antiplatelet drugs caused by patient's disease at each follow-up point
8.TVR and TVF at 30d, 6m, 1yr. TVF = Target-vessel related death, re-MI (Q wave and non-Q wave), TLR (Re-PCI or CABG)

Clinical Results

Coming soon…