Comparison Between Interwoven Nitinol and Drug Eluting Stents for Endovascular Treatment of Femoropopliteal Artery Disease

Abstract

Objectives: Information on performance of different stent platforms in endovascular revascularisation of femoropopliteal lesions is controversial and scarce.

Methods: Interwoven nitinol (INS, Supera) were compared with drug eluting (DES, Zilver PTx) stents with primary intervention for femoropopliteal lesions. The primary endpoint was time to clinically driven target lesion revascularisation (CD-TLR) within 12 months. Secondary endpoints were time to death, amputation and composite of death, amputation and CD-TLR. Due to the retrospective analysis, inverse probability treatment weighted (IPTW) Cox models were calculated to reach more similar patient populations with weights for the average treatment effect of the population. The two sensitivity analyses were propensity score matching and adjustment for covariates.

Results: At 12 months, the cumulative incidence of CD-TLR in the INS group (13%) and DES group (18%) did not differ (HR 1.36, 95% CI 0.56-3.31). A significant interaction between stents used and grade of calcification was observed (p = .006). HR for CD-TLR was 6.4 (95% CI 1.3-32.5) in none to mildly calcified favouring INS, and 0.3 (95% CI 0.1-1.3) for moderate to severely calcified lesions favouring DES. Stent efficiency did not differ comparing treatment of popliteal lesions (HR 0.80; 95% CI 0.21-3.13). Sensitivity analyses confirmed the primary efficacy outcome for either adjusted (HR 1.16; 95% CI 0.51-2.62) or matched analysis (HR 1.35; 95% CI 0.50-3.62)). Interaction of stents with calcification grade was lost for adjusted (HR 0.28; 95% CI 0.06-1.19) and matched analysis (HR 0.53; 95% CI 0.10-2.91).

Conclusion: Both stents (INS and DES) showed comparable results regarding CD-TLR in femoropopliteal lesions, so that one stent could not be favoured over the other, even for calcified or popliteal artery lesions.

Keywords: drug eluting stents; femoropopliteal segment; lower extremity revascularisation; patency; peripheral artery disease; self expanding interwoven nitinol stent.