Thirty-six-month outcomes of drug-eluting balloon angioplasty in the infrapopliteal arteries

Abstract

Objectives To evaluate 36-month outcomes of drug-eluting balloons in infrapopliteal (=below-the-knee) arterial segments, we made a prospective registry enrolling patients (Rutherford class 2 to 5, ankle-brachial index 0.4-0.7) who were revascularized with drug-eluting balloon from August 2011 to December 2014. Methods Three hundred and seven infrapopliteal arteries were revascularized only with drug-eluting balloon. Endpoints included target lesion revascularization, primary patency rate, and changes in ankle-brachial index and Rutherford class. Results Both ankle-brachial index improvement and Rutherford reduction were statistically significant (p < 0.001). At 36 months control, ankle-brachial index improvement was 59.3% (p = 0.032). The clinically driven target lesion revascularization rate was 28% at 36 months. Limb salvage was accomplished in 73.6% of the critical limb ischemia cases, and complete wound healing was detected in 67.8% of cases with Rutherford category 5. Overall, the 1-year primary patency rate was 32.5%. Conclusions Drug-eluting balloons have shown successful performance in infrapopliteal arteries in mid-term, and evidence regarding clinical effectiveness and safety supports drug-eluting balloon angioplasty as the first line therapy in this segment.

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 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.…”

“…13,15,18,20 Simultaneous treatment of inflow lesions was performed in eight studies, one excluded patients with inflow lesions, 16 and one did not mention the presence or treatment of inflow lesions. 14 Characteristics and baseline data of the included studies are summarised in Table 4 and Table 5, respectively.…”

Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

“…Twenty-six studies, 12 retrospective and 14 prospective, fulfilled the inclusion criteria (Table 1). 9,10,35–58 A total of 2108 CLTI patients (mean age 71.3±4.4 years; 67% men) who were treated with DCB for peripheral atherosclerotic lesions were analyzed. Major risk factors were hypertension (91%, 1339/1478), diabetes (69%, 1138/1642), dyslipidemia (63%, 1101/1756), smoking (46%, 799/1754), coronary artery disease (41%, 602/1,468), and end-stage renal disease (26%, 389/1490).…”

Single versus Multiple Vessel Endovascular Tibial Artery Revascularization for Critical Limb Ischemia: A Review of the Literature

“…transluminal angioplasty or drug-eluting stent technology. [7][8][9] Long-segment tibial artery stenosis and occlusions in severe infrapopliteal atherosclerotic disease are traditionally treated with bypass surgery onto a tibial or pedal artery. However, the paradigm may be shifting depending on results of the BEST-CLI and bypass versus angioplasty in severe ischemia of the leg (BASIL)-2 trials.…”