Device Effectiveness for Femoropopliteal Artery Disease Treatment: Analysis of K-VIS ELLA Registry

Endovascular treatment of lesions in femoropopliteal territory (FPA) has become the main therapeutic option, seeing as it is less invasive and has faster recovery. It has used different devices, such as conventional bare metal stents (BMS), balloon angioplasty (POBA), and drug coated balloons (DCB), as well as drug eluting stents (DES). However, real world data is limited and are seldom well represented in studies.

Efectividad de los distintos dispositivos para el tratamiento de lesiones femoropopliteas: Análisis del registro K-VIS ELLA

The aim of these Korean multicenter retrospective (2006-2014) and prospective (2010 to now) studies was to compare the efficacy of each of these therapies in the treatment of femoropopliteal lesions in the real world.

Primary end point was target lesion revascularization (TLR), defined as reintervention within 5mm proximal or distal to the originally treated segment. Secondary end points included loss of patency, major adverse limb events (MALEs) and all cause death.

2,774 limbs were looked at, 826 were treated with POBA, 943 with BMS, 778 with DCB and 227 with DES. Patient mean age was 71 and they were mostly men. Most patients were in Rutherford category 4-6 (41% of patients) and lesions were type C/D according to TASC II (59%). After inverse probability to balance groups, the accumulated incidence of TLR was significantly different between them, with BMS showing the highest incidence (26.5% vs. 25.7% with POBA, 15.9% with DCB and DES). Risk of TLR was significantly lower in the DCB group (HR: 0.44; CI 95%: 0.30-0.64; P < 0.001) or DES (HR: 0.51; CI 95%: 0.29-0.87; P = 0.014) vs. BMS.

There were no differences between DCB and DES patients (P=0.613), or POB vs BMS (P=0.626). As regards MALE risk, when compared against BMS, it resulted lower for DCB (HR: 0.44; 95% CI: 0.30-0.63; P < 0.001) and DES (HR: 0.55; 95% CI: 0.32-0.95; P = 0.030), while POBA did not show differences. This same pattern was observed when looking at patency. There were no differences in all-cause mortality across groups. DCB patients presented favorable results when treating complex FPA lesions (TASCII type C/D) and long segments (>150 mm).

There were no significant differences when comparing DCB vs. DES (P = 0.613) patients, neither when comparing POB vs. BMS (P = 0.626). Also, MALE risk when compared against BMS stenting was lower for DCB (HR: 0.44; CI 95%: 0.30-0.63; P < 0.001) and DES (HR: 0.55; CI 95%: 0.32-0.95; P = 0.030), while POBA patients showed no significant differences. This same pattern was observed when looking at patency. There were no differences in all-cause mortality across groups. The DCB group presented favorable results when treating complex FPA lesions (TASCII type C/D) and long segments (>150 mm).

Conclusion

This real world registry on FPA lesions showed that the use of DCB and DES was associated to better outcomes vs. POBA or BMS as regards TLR, MALE and patency at 2 years. The use of DCB was superior to BMS in preventing TLR, regardless lesion complexity, while DES superiority over BMS was attenuated in complex lesions.