A single stent strategy in XXXX with lifestyle limiting claudication: 3-year results from the Durability II trial.

@entity1 @entity174 @entity3657 @entity75 @entity731
OBJECTIVES: To evaluate longer-term safety and efficacy of a single self-expanding stent up to 20 cm in length in @entity1 with @entity731 of the superficial femoral (SFA) and proximal popliteal arteries. BACKGROUND: Angioplasty and stenting are options for revascularization of symptomatic @entity3657 . While angioplasty alone is effective in short lesions, outcomes in longer lesions (i.e., mean 8.7 cm) show suboptimal patency rates of 33% at one year. METHODS: Two hundred eighty-seven @entity1 (mean age 68 years, 66% male) were treated with the EverFlex    Self-Expanding Peripheral Stent System. @entity1 were followed through 3 years with yearly core lab adjudicated duplex ultrasonography for patency, radiographic assessment of stent @entity174 , and resting ankle brachial indices. RESULTS: Overall freedom from loss of primary patency at 3 years was 60.0%. Patency was significantly higher for lesions  <=8 cm compared with lesions >8 cm (71.0 vs. 50.5%, P   <   0.0001). There was no significant difference in patency between single-stent and multistent recipients (60.4 vs. 52.4%, P   =   0.343). The three-year freedom from clinically driven @entity75 revascularization was 70.0%. At 3 years, the overall stent @entity174 rate was 0.9%. CONCLUSIONS: DURABILITY II is the first investigational device exemption trial to report 3-year duplex Doppler defined stent patency and CD-TLR outcomes in long SFA and proximal popliteal lesions and demonstrated acceptable stent patency and freedom from CD-TLR with a low @entity174 rate. These data suggest that use of a single long stent provides reasonable long-term outcomes when intervention is required for symptomatic SFA and proximal popliteal arterial disease.    2015 Wiley Periodicals, Inc.
