Drug-coated vs uncoated percutaneous transluminal angioplasty in infrapopliteal arteries: Six-month results of the lutonix BTK trial

Jihad A. Mustapha, Marianne Brodmann, Patrick J. Geraghty, Fadi Saab, Richard A. Settlage, Michael R. Jaff

Research output: Contribution to journalArticlepeer-review

64 Scopus citations


Objectives. We hypothesized that a drug-coated balloon (DCB) could improve treatment efficacy while maintaining safety when compared with percutaneous transluminal angioplasty (PTA) for the treatment of atherosclerotic infrapopliteal arterial lesions. Methods. A total of 442 patients with angiographically significant lesions were randomized (2:1) to DCB or PTA. The primary safety and efficacy endpoints were freedom from major adverse limb events and perioperative death (MALE-POD) at 30 days, and freedom from vessel occlusion, clinically driven target-lesion revascularization (CD-TLR), and above-ankle amputation measured at 6 months. Success was achieved if safety between groups was non-inferior (margin 12%), and efficacy was statistically significant either for the overall intention-to treat (ITT) or the proximal-segment DCB groups (ie, the proximal two-thirds of the below-knee arterial pathways). Results. Freedom from MALE-POD for the DCB group (99.3%) was non-inferior to PTA (99.4%; non-inferiority P<.001). Proportional analysis of the primary efficacy endpoint was statistically significant for the proximal-segment DCB group (76%) vs PTA (62.9%; one-sided P<.01; Bayesian P-value for success of .0085) while not statistically significant for the overall ITT group (74.5% for DCB vs 63.5% for PTA; one-sided P=.02). Kaplan-Meier analyses demonstrated superior efficacy for DCB in both the overall ITT and proximal-segment groups at 6 months. Primary patency and CD-TLR, hypothesis-tested secondary endpoints, were also statistically better for the DCB group compared with PTA at 6 months (one-sided P<.025). Conclusions. DCB treatment for symptomatic infrapopliteal arterial lesions produced non-inferior safety at 30 days and a statistically significant difference in the primary efficacy endpoint when compared with PTA at 6 months.

Original languageEnglish
Pages (from-to)205-211
Number of pages7
JournalJournal of Invasive Cardiology
Issue number8
StatePublished - 2019


  • Drug-coated balloon angioplasty
  • Infrapopliteal disease
  • Paclitaxel-coated balloon
  • Percutaneous transluminal angioplasty
  • Peripheral artery disease
  • Peripheral vascular disease


Dive into the research topics of 'Drug-coated vs uncoated percutaneous transluminal angioplasty in infrapopliteal arteries: Six-month results of the lutonix BTK trial'. Together they form a unique fingerprint.

Cite this