A Randomized Trial Comparing Interwoven and Self-Expandable Nitinol Stents in Trans-Atlantic Inter-Society Consensus II C and D Femoropopliteal Arterial Disease

Abstract

Background

Peripheral artery disease (PAD) is a global concern due to rising rates of type II diabetes and risk factors like smoking, predominantly affecting the femoral-popliteal segment. The prevalence ranges from 3% to 12%, depending on age and socioeconomic status. To compare outcomes of interwoven nitinol stent [Supera™] and self-expandable nitinol stent [Jaguar™] in treating (TASC II) C and D femoropopliteal occlusive disease on a bailout basis (stenting as a corrective measure when an angioplasty fails or causes complications like flow-limiting dissection or recoil more than 30% or higher pressure gradient across a stenotic area (≥10 mm Hg) after repeated dilatation.)

Methods

This prospective, randomized controlled trial at a tertiary care hospital included patients with symptomatic femoropopliteal arterial disease. Participants with TASC II C and D lesions were randomized using a simple randomization method to minimize allocation bias and ensure comparability using computer-generated random number sequences to receive either Supera or Jaguar stents under standard endovascular techniques, ensuring that treatment allocation remained unbiased.

Results

The Supera stent demonstrated superior outcomes with lower restenosis rates (20% vs. 55%, P = 0.022) and reduced target lesion revascularization (TLR) (20% vs. 55%, P = 0.022) compared to the Jaguar stent. One-year follow-up showed higher Ankle-Brachial Index (ABI) scores in the Supera group (mean 0.77 vs. 0.63, P = 0.003), indicating improved patency. Complications, including stent fractures (5%) and migrations (5%) were only observed in the Jaguar group. Minor amputation rates were significantly higher in the Jaguar group (25% vs. 10%, P = 0.212). Major amputations and mortality rates were similar between groups.

Conclusion

Interwoven nitinol stents (Supera) outperformed self-expandable nitinol stents in treating complex femoropopliteal disease, with better midterm outcomes, lower restenosis rates, reduced TLR, and fewer mechanical complications. Although both stent types managed limb salvage effectively, Supera stents offered better procedural durability and patency.