Two-Year Outcomes of Orbital Atherectomy Combined With Drug-Coated Balloon Angioplasty for Treatment of Heavily Calcified Femoropopliteal Lesions

Abstract

Purpose: To examine whether the combination of orbital atherectomy (OA) and drug-coated balloons (DCB) can lead to superior procedural and 2-year outcomes compared with DCB only in heavily calcified femoropopliteal (FP) lesions. Materials and Methods: A retrospective chart review was conducted to identify patients treated with DCB only or OA+DCB for de novo FP lesions at a single center over a 4-year period (2014–2017). In the observation period, 113 patients met the inclusion criteria: 63 treated with DCB only (mean age 69.0±8.6 years; 62 men) vs 50 treated with OA+DCB (mean age 70.3±7.1 years; 48 men). The OA+DCB group had higher calcification rates (78% with severe calcification vs 37% in the DCB only group). Propensity score matching (PSM) was used to adjust for baseline differences between the 2 groups. Cox regression analysis was used to compare the follow-up outcomes between lesions treated with OA+DCB vs DCB only. Results: No difference in procedural complications or success was found. After PSM adjustment, the OA+DCB group was associated with lower bailout stenting rates (39.4% vs 66.7% in the DCB only group; p=0.026). The 2 groups had similar long-term outcomes, although the OA+DCB arm had a trend toward reduced TLR rates that did not reach statistical significance. The Kaplan-Meier estimates for 2-year freedom from TLR were 76.1% for the OA+DCB group vs 55.5% for the DCB only group (p=0.109). Conclusion: OA+DCB is a safe and effective combination for the treatment of calcified FP lesions. The combined therapy decreased the bailout stenting rates in the adjusted analysis. Larger cohorts and randomized trials are needed to examine OA efficacy in FP lesions.

Atherectomy plus drug-coated balloon versus drug-coated balloon only for treatment of femoropopliteal artery lesions: A systematic review and meta-analysis

“…This result also suggested that combination of DA and DCB was effective for the treatment of severely calcified femoropopliteal artery. 19 Foley 2017 16 Konstantinos 2018 20 Cai 2019 21 Kokkinidis 2020 17 1…”

“…Two studies were RCTs and four studies were retrospective cohort studies. Foley et al 16 and Kokkinidis et al 17 used the OA device. Zeller et al, 18 Stavroulakis et al, 19 Stavroulakis et al, 20 and Cai et al 21 used DA device during the operation.…”

Three-Year Outcomes of Orbital Atherectomy for the Endovascular Treatment of Infrainguinal Claudication or Chronic Limb-Threatening Ischemia

“… 56 – 58 Modification of calcified plaque and vessel preparation prior to endovascular intervention may decrease the risk of periprocedural complications, improve success rates, and achieve sustained patency over time. 25 , 41 , 48 , 59 The use of OA has been associated with improved angioplasty results, with low bailout stenting rates, 31 , 60 and has provided similar clinical outcomes (ie, dissection, slow-flow, vessel spasm, distal embolization) in patients with higher RC status at baseline and complex lesions vs patients with milder disease. 33 , 34 , 60 , 61 This system employs a 360° rotational device with a diamond-coated crown that orbits eccentrically within the vessel.…”

“…42 Orbital atherectomy (OA) is an effective device for vessel preparation before balloon angioplasty (BA) and was designed for the treatment of infrainguinal arteries with severe calcification. 31,41,[43][44][45][46][47][48] The current study investigated the short-and long-term outcomes of OA for the treatment of severe claudication and CLTI using a subgroup of patients from the LIBERTY study. 49 In addition to describing overall procedural safety and 3-year outcomes, the results were also stratified by Rutherford category.…”

Commentary: Be Innovative, Stay Clinical! Time for a Patient-Specific SFA Treatment Algorithm?

“…The recently published article by Kokkinidis et al 1 in the June 2020 issue of the JEVT provides compelling evidence that adds to the chorus of recent contributions critically investigating specific treatment strategies for the management of superficial femoral artery (SFA) occlusive disease. The authors should be congratulated for their rigorous methodology and exhaustive presentation of the outcomes.…”