title: Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA.
abstract: BACKGROUND
  Evidence from large, randomized, controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons (DCBs) is limited. Previously, the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty (PTA), yet durability of the treatment effect with DCBs remains unknown.
  
  
  OBJECTIVE
  This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions.
  
  
  METHODS
  We enrolled 331 patients with symptomatic (Rutherford 2 to 4) femoropopliteal lesions up to 18 cm in length. Patients were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The 24-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test.
  
  
  RESULTS
  At 24 months, patients treated with DCB showed significantly higher primary patency when compared with PTA (78.9% vs. 50.1%; p < 0.001). The rates of CD-TLR were 9.1% and 28.3% (p < 0.001) for the DCB and PTA groups, respectively. The overall mortality rate in the DCB group was 8.1% versus 0.9% in the PTA group (p = 0.008). There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up. The rate of vessel thrombosis was low (1.5% DCB vs. 3.8% PTA; p = 0.243), with no new events reported between 1 and 2 years. Both groups showed similar functional improvement at 2 years, although DCB patients achieved this level of function with 58% fewer reinterventions.
  
  
  CONCLUSIONS
  The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461).
authors.affiliation: UC Davis, Sacramento, California. Electronic address: jrlaird@ucdavis.edu.
authors.forename: John R
authors.initials: JR
authors.lastname: Laird
authors.affiliation: Kaiser Permanente-Moanalua Medical Center and Clinic, Honolulu, Hawaii.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Schneider
authors.affiliation: RodMed Klinikum, Rosenheim, Germany.
authors.forename: Gunnar
authors.initials: G
authors.lastname: Tepe
authors.affiliation: Medical University, Graz, Austria.
authors.forename: Marianne
authors.initials: M
authors.lastname: Brodmann
authors.affiliation: Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.affiliation: Wellmont Holston Valley Medical Center, Kingsport, Tennessee.
authors.forename: Christopher
authors.initials: C
authors.lastname: Metzger
authors.affiliation: Mount Sinai Medical Center, New York, New York.
authors.forename: Prakash
authors.initials: P
authors.lastname: Krishnan
authors.affiliation: Park-Krankenhaus and Universitätsklinikum Leipzig, Leipzig, Germany.
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.affiliation: GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Micari
authors.affiliation: Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.affiliation: Medtronic, Santa Rosa, California.
authors.forename: Hong
authors.initials: H
authors.lastname: Wang
authors.affiliation: Medtronic, Santa Rosa, California.
authors.forename: Melissa S
authors.initials: MS
authors.lastname: Hasenbank
authors.affiliation: Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
mesh_terms: D000368:Aged; D017130:Angioplasty / Q000592:standards / Q000639:trends; D000800:Angioplasty, Balloon / Q000592:standards / Q000639:trends*; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging*; D005500:Follow-Up Studies; D006801:Humans; D038622:Internationality; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011150:Popliteal Artery / Q000000981:diagnostic imaging*; D011446:Prospective Studies; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography
chemical_list: D017239:Paclitaxel
keywords: angioplasty; femoropopliteal artery; peripheral arterial disease; target lesion revascularization