Role of Embolic Protection Devices in Reducing Major Adverse Limb Events in Femoropopliteal Arterial Interventions in Patients with Critical Limb Ischemia: Results from the XLPAD Registry

Background. Embolic Protection devices (EPD) are frequently used during femoropopliteal arterial interventions, particularly with the use of atherectomy. It is presumed that EPDs reduce major adverse limb events including amputations. The use of EPD is however operator-dependent with no high level evidence for effectiveness. We review data from the XLPAD on the effectiveness of EPD in treating femoropopliteal arterial disease with critical limb ischemia (CLI).
Methods. We report on 414 consecutive patients with CLI and femoropopliteal arterial disease from the XLPAD registry (NCT01904851) treated with (n=98) and without (n=316) EPD. Demographics, procedural and clinical variables were collected. Odds ratios and their respective 95% confidence intervals (CI) for all-cause mortality, target limb revascularization (TLR), target vessel revascularization (TVR) and major amputation at 12-month follow up were calculated.
Results. The mean age was 68 ± 10.4 years (males 65.2%, diabetics 62.6%). The most used EPD was the NAV-6 (n= 82) filter. There were more chronic total occlusions (58% vs 43%) and calcified vessels (30% vs 25%) in the EPD group. No differences were detected between the EPD vs non EPD in terms of all-cause mortality (1.02% vs 5.06%; p = 0.141), TVR (12.24% vs 18.35%; p=0.209), and major amputation (2.04% vs 6.33%; p = 0.162) respectively at 12-month follow up. A low incidence of total amputations was seen at 1-year follow-up (9.18% vs. 18.99%, p = 0.034) with an adjusted odds ratio of 0.29 (95% CI 0.014-1.007, p = 0.0638). Interestingly, the use of atherectomy was also associated with a trend toward reduced amputation (odds ratio of 0.133 (95% CI, 0.00613-0.956, p=0.089)).
Conclusion. The use of EPD showed a trend in reducing total amputations but had no effect on total mortality, TVR or major amputations. A larger dataset or a randomized trial is needed to verify these findings.