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Encouraging results found for self-expanding stent in long lesions
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A new single self-expanding stent that is up to 20 cm in length is safe and effective in patients with atherosclerotic disease for the treatment of long lesions of the superficial femoral artery and proximal popliteal arteries at 1 year, researchers reported.
The nonrandomized, prospective DURABILITY II trial evaluated safety and efficacy of the Protégé EverFlex Self-Expanding Peripheral Stent System (Covidien) in 287 patients (66% male; mean age, 68 years) with stenotic, restenotic or occluded lesions >4 cm and <18 cm at 44 investigational sites in the United States and Europe.
Systemic comorbidities included hypertension (88%), hyperlipidemia (86%), diabetes (43%) and prior superficial femoral artery intervention (41%). The mean lesion length was 89 mm, and the mean normal-to-normal lesion length was 110 mm.
Overall, 303 stents were implanted, with 95% of patients receiving a single stent. No major adverse events were reported at 30 days.
At 1 year, primary outcome of duplex ultrasound stent patency was 67.7%, and the mean ankle-brachial index increased by 0.25. Walking Improvement Questionnaire scores improved in the following: pain, +33.7; distance, +37.1; speed, +18.6; and stair climbing, +24.7. Primary patency was 77.2%; primary assisted patency was 86.9%; and secondary patency was 87.3%. Rutherford scores improved in 83.5% of patients and the stent fracture rate was 0.4%.
Researchers wrote that the study included clinical outcomes and patient-reported outcomes, which informs decision-making more than just patency.
“Taken together, these data suggest that longer stents, specifically designed for the [superficial femoral artery], provide an important new single stent treatment option,” they said.
Disclosure: Matsumura reports receiving research grants from Covidien.
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