Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions.

van Walraven, Laurens A; Vitória Kalil, M D; van der Veen, Daphne; Bosiers, Michel J; Deloose, Koen; Holewijn, Suzanne; Zeebregts, Clark J; Reijnen, Michel M P J (2024). Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions. (In Press). Journal of vascular surgery Elsevier 10.1016/j.jvs.2024.03.449

Text 1-s2.0-S0741521424009364-main_.pdf - Accepted Version Restricted to registered users only until 10 April 2025. Available under License Publisher holds Copyright. Download (1MB) | Request a copy

OBJECTIVE

In two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn, SECS) or drug-eluting stents (ZilverPTX, DES) are related to similar clinical outcomes at one-year follow-up.

METHODS

In a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at one-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality.

RESULTS

A total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up there were no significant differences in primary patency (ITT 63.4% vs 71.1%: p=0.183 and PP 60.8% vs 71.1%; p=0.100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; p=0.054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS 85.6% versus DES 95.1%; p=0.038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%, p=0.481). No major amputations were performed in the SECS group and two in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after one-year follow-up (p=0.106). Based on diagnosis (IC versus CLTI) no differences between IC and CLTI patients were observed in primary, secondary patency and freedom from TLR.

CONCLUSIONS

Treatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at one-year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery.

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