title: 2-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease: Evidence From the SFA-Long Study.
abstract: The aim of this study was to appraise 2-year outcomes after percutaneous transluminal angioplasty of long femoropopliteal artery disease using paclitaxel-coated balloons (PCBs).
  
  
  
  Percutaneous transluminal angioplasty with PCBs for TransAtlantic Inter-Society Consensus types C and D femoropopliteal artery disease has provided favorable results ≤12 months but no prospective studies performed longer term follow-up assessment.
  
  
  
  Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency (i.e., freedom from the combined endpoint of clinically driven target lesion revascularization and >50% restenosis in the treated lesion as appraised by a duplex ultrasound peak systolic velocity ratio of >2.4) at 24 months. Secondary endpoints included major adverse events (the composite of death, target limb amputation, thrombosis at the target lesion, or clinically driven nontarget lesion revascularization), changes in Rutherford class, and quality of life ≤24 months post-procedure.
  
  
  
  A total of 105 patients (age 68 ± 9 years; 81.9% men) successfully treated with PCBs were included (treated lesion length was 251 ± 71 mm; 49.5% total occlusions). The 24-month follow-up data were available in 98 patients; they showed a primary patency rate of 70.4%, with major adverse events occurred in 10 patients (10.2%, 5 non-procedure-related deaths) and persistently significant clinical benefits in Rutherford class (51% of asymptomatic patients at 24 months).
  
  
  
  PCBs benefits on primary patency and target vessel revascularization satisfactorily extend over 24 months in patients undergoing percutaneous transluminal angioplasty for symptomatic femoropopliteal disease.
authors.affiliation: GVM Care & Research Interventional Cardiology Unit, Maria Cecilia Hospital, Cotignola, Italy. Electronic address: micariantonio@gmail.com.
authors.forename: Antonio
authors.initials: A
authors.lastname: Micari
authors.affiliation: GVM Care & Research Interventional Cardiology Unit, Maria Cecilia Hospital, Cotignola, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Nerla
authors.affiliation: GVM Care & Research Interventional Cardiology Unit, Maria Eleonora Hospital, Palermo, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Vadalà
authors.affiliation: GVM Care & Research Interventional Cardiology Unit, Maria Cecilia Hospital, Cotignola, Italy.
authors.forename: Fausto
authors.initials: F
authors.lastname: Castriota
authors.affiliation: GVM Care & Research Interventional Cardiology Unit, Maria Cecilia Hospital, Cotignola, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Grattoni
authors.affiliation: GVM Care & Research Interventional Cardiology Unit, Città di Lecce Hospital, Lecce, Italy.
authors.forename: Armando
authors.initials: A
authors.lastname: Liso
authors.affiliation: GVM Care & Research Interventional Cardiology Unit, Maria Pia Hospital, Torino, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Russo
authors.affiliation: GVM Care & Research Interventional, Italy, Cardiology Unit, ICLAS, Rapallo, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Pantaleo
authors.affiliation: GVM Care & Research Interventional Cardiology Unit, Santa Maria Hospital, Bari, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Roscitano
authors.affiliation: GVM Care & Research Interventional Cardiology Unit, Maria Cecilia Hospital, Cotignola, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Cremonesi
mesh_terms: D000368:Aged; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011788:Quality of Life; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: 24 months; drug-eluting balloons; long lesions; superficial femoral artery disease