课件：介入治疗时支架选择策略陈纪林.ppt

Objective: To demonstrate non-inferiority(and, if positive, superiority) of the NEVO? Stent compared with the TAXUS? Liberté? stent for the primary endpoint of 6-months in-stent late loss Major Inclusion Criteria: Single De nove lesions in native coronary arteries Lesion Length ≤ 28mm 2.5mm-3.5mm in diameter Major Exclusion Criteria: Acute myocardial infarction Ostial lesions Unprotected left main stem lesions Single De Novo Native Coronary Artery Lesion 28 mm in a 2.5-3.5mm diameter vessel 388 patients @ 40 sites in Europe, South America, Australia, New Zealand NEVO ? Sirolimus- Eluting Stent (N=202) TAXUS? Liberté? Paclitaxel-Eluting Stent (N=192) 1:1 Randomization Primary Endpoint: 6-Month In-Stent Late Loss IVUS in a subset of patients 30 Day 6 Mo. 1 Yr. 2 Yr. 3 Yr. 4 Yr. Clinical/MACE Angio/IVUS 5 Yr. 9 Mo. 3 Mo. First Patient Enrolled March 19, 2008 Enrollment Completed October 17, 2008 Primary Endpoint: 6-months in-stent late lumen loss (Angiographic) Secondary Endpoints: In-stent/in-segment binary restenosis, %diameter stenosis and MLD Device, Lesion, and procedure success Stent Thrombosis (ARC and protocol definition) including follow up to 5 years TLF/TVF/MACE and individual components including follow up to 5 years Stent malapposition and % volume obstruction (IVUS) Quality of life at baseline, 30 days, 6months and 1 year Specified subgroup analyses: Patients with diabetes mellitus ±0.31 ±0.46 N=180 N=162 64% P=0.075 2/180 13/162 7/180 14/162 86% 55% Superiority of the NEVO ? stent over the TAXUS? Liberté? stents was reached with a highly significant difference (P0.001) between stents (6- month late loss 0.13 ±0.31 vs. 0.36 ±0.46mm) No stent thrombosis were observed in the NEVO ? group while 2 late thromboses despite dual APT occurred in the TAXUS? Liberté? group While not powered for clinical endpoints, in this study the rates of death, MI, and revascularization as well as th