Study end points
restenosis, ischemia-driven, stenosis
MYOCARDIAL INFARCTION, ENLARGEMENT, CARDIAC DEATH, MLD, RESTENOSIS, STENOSIS
The SV RCT primary end point was a non-inferiority comparison of Agent and SeQuent Please for the rate of TLF at 6 months (ischemia-driven revascularization of the target lesion [TLR], myocardial infarction [MI; Q-wave and non–Q-wave] related to the target vessel or cardiac death) [Quantitative coronary analysis (QCA) was performed at baseline, post-procedure and at the 6-month follow-up visit by an independent core laboratory (Beth Israel Deaconess Medical Center, Boston, MA, USA). Six-month angiographic end points included minimum lumen diameter, late lumen loss, % diameter stenosis and binary restenosis. Late lumen loss was calculated as the post-procedure MLD minus 6-month follow-up MLD. Late lumen enlargement (LLE) was defined as late lumen loss less than zero. Binary restenosis was a diameter stenosis of > 50%. Functional status of general health-related quality of life was measured by changes in EQ-5D scores at hospital discharge, 6 months and 1, 2 and 3 years after the index procedure.