Single-Center Experience With Lutonix Drug-Coated Balloons in Infrapopliteal Arteries.
OBJECTIVE
To examine patient outcomes following the use of the Lutonix drug-coated balloon (DCB) in patients undergoing endovascular intervention in below-the-knee (BTK) arteries.


METHODS
A retrospective chart review identified 248 patients who were treated for symptomatic peripheral artery disease with the Lutonix DCB between May 2013 and October 2014. Forty patients were lost to follow-up, leaving 208 patients (mean age 74.1±9.7 years; 138 men) with evaluable data for outcome analysis. The patient cohort suffered from either severe claudication (38.6%) or critical limb ischemia (CLI; 61.4%) in 220 limbs. Almost two-thirds (140, 63.6%) of the 220 target lesions were total occlusions, and 37 (17.8%) of all patients had occlusion of all 3 BTK vessels before intervention.


RESULTS
Over a median 9-month follow-up, target lesion revascularization occurred in 15.9% of patients with an average time to first reintervention of 8 months. In total, 39 amputations were performed in 31 limbs. However, 17 of these amputations were preplanned minor amputations below the ankle; only 9 (4.1%) major amputations occurred corresponding to 6.6% of the CLI cohort. Freedom from the composite of death or major amputation was estimated as 92% and 85% at 6 and 12 months, respectively, by Kaplan-Meier analysis. In the full cohort, improvement of at least 1 Rutherford category was seen in 130 (59.1%) limbs after 1 year or at the last follow-up, with 104 (80.0%) of those limbs showing an improvement of ≥2 categories.


CONCLUSIONS
From this single-center experience, the Lutonix DCB shows therapeutic promise in a disease state where new treatment options are needed.
Department of Interventional Angiology, Medical Faculty, University of Leipzig, Germany sabine.steiner@yahoo.com.
Sabine
S
Steiner
Department of Interventional Angiology, Medical Faculty, University of Leipzig, Germany.
Andrej
A
Schmidt
Department of Interventional Angiology, Medical Faculty, University of Leipzig, Germany.
Yvonne
Y
Bausback
Department of Interventional Angiology, Medical Faculty, University of Leipzig, Germany.
Sven
S
Bräunlich
Department of Interventional Angiology, Medical Faculty, University of Leipzig, Germany.
Matthias
M
Ulrich
Department of Interventional Angiology, Medical Faculty, University of Leipzig, Germany.
Ursula
U
Banning-Eichenseer
Department of Interventional Angiology, Medical Faculty, University of Leipzig, Germany.
Dierk
D
Scheinert
D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D005260:Female; D005858:Germany; D006801:Humans; D007383:Intermittent Claudication / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D007511:Ischemia / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D012008:Recurrence; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
amputation; balloon angioplasty; critical limb ischemia; drug-coated balloon; drug-eluting balloon; infrapopliteal arteries; occlusion; paclitaxel; peripheral vascular disease; restenosis; stenosis