Outcome Definitions
restenosis
RESTENOSIS
The study was extended to a 5-year follow-up for the primary outcome measure: primary patency, defined as no evidence of binary restenosis or occlusion within the target lesion based on a duplex-derived peak systolic velocity ratio (PSVR) < 2.4 and no clinically-driven target lesion revascularization (TLR). In the bypass arm, patency was defined as no evidence of binary restenosis or occlusion at the anastomoses or over the entire length of the bypass graft based on a PSVR < 2.4 and no clinically-driven reintervention to restore flow in the bypass.Secondary outcomes, which were analyzed at 5-year follow-up, included freedom from TLR-rate, overall survival rate and freedom from amputation rate. The latter was stratified to claudicants and CLTI patients in both groups.