Bioabsorbable stent implantation vs. common femoral artery endarterectomy: early results of a randomized trial.

PURPOSE

To compare clinical and hemodynamic outcome in patients undergoing treatment of common femoral artery (CFA) atherosclerotic lesions by bioabsorbable stent implantation (BASI group) or by common femoral artery endarterectomy (CFE group).

METHODS

A randomized, controlled, single-center, open-label trial was initiated to compare outcomes of BASI or CFE in patients with chronic atherosclerotic occlusive lesions in the CFA. From May 2011 to April 2013, 116 consecutive patients were recruited; after excluding 36 patients, 80 patients (52 men; mean age 72.2±9.6 years) were enrolled 1:1 and are the subject of this intention-to-treat interim analysis (40 patients in each group). The primary endpoint was surgical site infections; secondary outcome measures were technical success, hemodynamic improvement, clinical improvement, patency, limb salvage, and survival.

RESULTS

There was no statistically significant difference between both groups regarding demographic data, cardiovascular risk factors, or CFA occlusions. The CFE patients presented with 7 surgical site infections (all minor) vs. none in the BASI group (p=0.002) and a longer mean postoperative hospital stay of 7 vs. 2 days for BASI patients (p<0.001). Technical success rates were 97.5% and 100% for the BASI and CFE groups, respectively. Postoperative ankle-brachial index means were comparable (p=0.38). The 30-day primary patency rates were 92.5% and 100% for the BASI and CFE groups, respectively (p=0.038). There were 6 reconstruction failures in CFE patients vs. none in the BASI group (p=0.02); 5 failures involved initial CFA occlusions. At 1 year, the primary and secondary patency rates were 80% vs. 100% (p=0.007) and 84% vs. 100% (p=0.01) for BASI and CFE patients, respectively. Limb salvage was equivalent, and survival rates were 88% and 90% for BASI vs. CFE patients (p=0.51) at 1 year.

CONCLUSION

This interim analysis suggests that BASI is not an option for CFA occlusion and is only a limited option for CFA stenosis. Clinical and hemodynamic results are comparable for BASI and CFE. An increased rate of redo procedures in the BASI patients outweighs lower surgical site infection rates compared to CFE. Short-term patency rates are significantly worse in patients undergoing CFA stenting with BASI.