Endovascular Treatment of Femoropopliteal Tosaka III In Stent Re-stenosis

Femoropopliteal in stent re-stenosis (ISR) remains a significant challenge following endovascular peripheral artery occlusive disease procedures, with Tosaka III lesions representing the most complex form of complete occlusive re-stenosis. Limited prospective, observational study data have focused on endovascular treatment of femoropopliteal Tosaka III ISR.

The FP-RESTORE study was a prospective, observational study involving 13 Chinese hospitals from April 2021. It enrolled 322 consecutive patients (353 limbs) with femoropopliteal Tosaka III ISR undergoing endovascular intervention. Primary endpoints were clinically driven target lesion revascularisation (CD-TLR) and major adverse limb events (MALE) at 24 months. Competing risk regression analysis was performed to identify independent predictors of adverse outcomes.

Of the enrolled patients, the mean age was 71.6 ± 9.1 years, with 54.67% presenting Rutherford grade > 3. Average occlusive lesion length was 22.0 ± 10.5 cm, with suspected thrombotic components presenting in 46.74% of lesions. Technical success rates were 96.88%. Ankle brachial index (ABI) improved statistically significantly from 0.33 ± 0.2 to 0.77 ± 0.22 post-operatively; ABI improved by more than 0.2 after the procedure and this was observed in 85.8% of patients. The follow up rate was 86.0% with a median follow up duration of 24.5 months. At 24 months, the CD-TLR rate was 21.4% (95% confidence interval [CI] 16.82 - 25.93%) and MALE rate was 27.2% (95% CI 22.26 - 32.21%). The all cause mortality rate was 14.3%. Independent predictors of CD-TLR and MALE included multiple previous procedures and popliteal artery (P2 and P3) involvement.

Endovascular treatment for femoropopliteal Tosaka III ISR achieved acceptable immediate and 24 month outcomes. Multiple previous procedures and popliteal artery involvement were key predictors of adverse events, suggesting valuable guidance for risk stratification and treatment modification in this challenging patient population.