One Year Primary Patency of Infrapopliteal Angioplasty Using Drug- Eluting Balloons: Single Center Experience at King Hussein Medical Center

Abstract

Objective:Conventional percutaneous transluminal angioplasty (PTA) for long lesions in the below-the-knee (BTK) arteries in patients presenting with critical limb ischemia (CLI) has high restenosis rates at 1 year. Our goal is to evaluate whether paclitaxel drug-eluting balloons (DEB) have higher 1 year primary patency rates compared to conventional PTA.Methods:This is a single-center, prospective, randomized trial that was conducted from June 2013 to December 2015. The aim of the study was to compare 1 year primary patency rates of DEB and PTA in BTK arteries in CLI patients. Inclusion criteria were patients presenting with CLI (Rutherford class 4 or greater), stenosis or occlusion ≥30 mm of at least one tibial artery, and agreement to 12-month evaluation. Exclusion criteria were life expectancy <1 year, allergy to paclitaxel, and contraindication to combined antiplatelet treatment. Follow-up was performed by clinical assessment, ankle brachial pressure index, Doppler ultrasound imaging, and conventional angiogram if indicated. Primary end point was 1 year primary patency, and secondary end points were target lesion revascularization (TLR) and major amputation. Statistical analysis was performed using Fischer's exact test.Results:Ninety-three patients with 106 lesions in the BTK arteries were enrolled in this study. One year primary patency was achieved in 26 (65%) and seven (17%) in the DEB and PTA groups (P = 0.006), respectively. TLR was performed in nine lesions (23%) and 29 lesions (71%) in DEB and PTA groups (P = 0.009), respectively. Major amputations occurred in one limb (2%) and two limbs (4%) in DEB and PTA groups (P = 0.6), respectively.Conclusion:Paclitaxel DEB has significantly higher 1 year primary patency rate associated with significantly less TLR than conventional PTA, following endovascular recanalization of BTK arteries in patients presenting with CLI.

Editor's Choice – Drug Coated Balloon Angioplasty vs. Standard Percutaneous Transluminal Angioplasty in Below the Knee Peripheral Arterial Disease: A Systematic Review and Meta-Analysis

“…The importance of a dedicated multidisciplinary wound care team is supported by the results of the studies in this systematic review. The best limb salvage rates were seen in the studies of Liistro et al 12 and Haddad et al, 11 both of which describe the use of a dedicated multidisciplinary wound care team.…”

“…62,63 Taking a closer look at the results of this study, TLR rates were lower for DCB compared with PTA in the studies with a longer inflation time. 11,13 This suggests that prolonged inflation time improves patency rates in DCB compared with PTA.…”

“…All patients received aspirin (100 mg daily) and clopidogrel (75 mg daily), but some had dual therapy for four weeks whereas others had it for 12 weeks. One study 11 showed significantly less restenosis and lower TLR rates with DCB compared with PTA and these patients received dual antiplatelet therapy for 12 weeks. However, two other studies 12,13 had similar outcomes, but these patients received dual antiplatelet therapy for only four weeks.…”

“…The full text reading resulted in 10 articles 11e20 that met the inclusion criteria ( Fig. 1), consisting of three prospective case series, 14,15,18 one retrospective case series, 17 four randomised trials, 11,12,19,20 and two retrospective comparative studies. 13,16 Reasons for exclusion were not in English, 21 no DCB, 22 article type, 23e40 full text not available, 41,42 other outcomes (one each describing number of DCB procedures performed, 43 haemodynamic parameters to diagnose CLI, 44 and number of PTAs performed 45 ), comparing DCB with drug eluting stent, 46 duplicates, 15,47e50 overlapping data, 51,52 and fewer than 50 below the knee angioplasties.…”

“…Included patients were classified as Rutherford category 3 or higher, except for one study that included four patients with Rutherford category 2. 20 Different types of DCB were used: including Lutonix 014 DCB Catheter (Lutonix, Minneapolis, MN, USA), 15 Lutonix DCB (Bard Lutonix, New Hope, MN, USA), 16,17 Passeo-18 Lux DEB (Biotronik AG, Buelach, Switzerland), 20 Luminor 14/35 paclitaxel eluting peripheral dilatation balloon catheters (iVascular SLU, Barcelona, Spain), 13 Luminor 14 DEB (iVascular, Barcelona, Spain), 11 IN.PACT Amphirion DEB (Medtronic, Minneapolis, MN, USA), 12,18,19 leg flow paclitaxel coated balloons (Cardionovum Sp.z.o.o, Warsaw, Poland), 14 and Elutax Aachen resonance (Aachen Resonance Holding AG, Aachen, Germany). 16 All studies included the anterior tibial, posterior tibial, and peroneal arteries.…”