Final results from the DURABILITY II trial were presented at the VIVA conference in Las Vegas by Krishna Rocha-Singh. The data from the study support the use of a single, long self-expanding stent in femoropopliteal lesions up to 20cm in length. The study also showed a stent fracture rate under 1% at three years.
DURABILITY II was a prospective, multicentre, non-randomised, single-arm study to evaluate the safety and efficacy of a single EverFlex self-expanding nitinol stent (Covidien) in patients with Rutherford class 2–4 claudication and femoropopliteal atherosclerotic lesions up to 20cm compared to VIVA Physicians’s angioplasty objective performance criteria for safety and efficacy.
The study enrolled 287 patients (mean age 68 years, 66% male) at 44 centres in the USA and Europe. The mean lesion length was 8.9cm and included 48.1% occluded arteries with 43.2% calcified lesions. A single stent was implanted in 95% of subjects, and 5% received multiple stents. In addition, 73% of patients received stents ≥10cm and 46.2% received stents ≥15cm.
The duplex Doppler-assessed patency (peak systolic velocity ratio <2.0) rate at three years was 60%; freedom from loss of primary patency was significantly higher for lesions ≤8cm compared to lesions >8cm (71% vs. 50.5%, p=0.0001). No difference in patency was observed between single-stent and multiple-stent recipients.
The three-year freedom from target lesion revascularisation was 70%. When stratified by lesion length, the freedom from re-intervention was higher in lesions ≤8cm (80%) than for lesions >8cm (61%), p=0.0003). The stent fracture rate at three years was 0.9%.
Rocha-Singh concluded that the data from DURABILITY II demonstrate that implantation of a single, long EverFlex is a reasonable, durable treatment option in this challenging patient cohort.