ami介入治疗时支架选择策略陈纪林-课件，幻灯PPT.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% 中国医学科学院 阜外心血管病医院 陈纪林 教授 Study No. of patients Mean age (years) Typeof DES Primary endpoint Length of thienopyridine therapy (months) Mean length of follow-up (months) BASKET-AMI2 216 62.2 PESSES Cardiac death, myocardial infarction, or reintervention 6 18.0 Di Lorenzo3 270 64.0 PESSES Death, myocardial infarction, or reintervention 6 12.0 HAAMU-STENT4 164 63.0 PES Angiographic late lumen loss 12 16.7 MISSION5 310 59.2 SES Angiographic late lumen