title: Cutting-balloon angioplasty versus balloon angioplasty as treatment for short atherosclerotic lesions in the superficial femoral artery: randomized controlled trial.
abstract: OBJECTIVE
  To evaluate the treatments of a short-segment atherosclerotic stenosis in the superficial femoral arteries with the cutting balloon angioplasty (CBA) versus conventional balloon angioplasty [percutaneous transluminal angioplasty (PTA)] in a randomized controlled trial.
  
  
  METHODS
  The study group comprised 60 patients (33 men, 27 women; average age 64 years) with a short (≤ 5 cm) focal SFA de novo atherosclerotic stenosis associated with a history of intermittent claudication or rest pain. The primary end point of this study was the rate of binary restenosis in the treated segment 12 months after the intervention. All patients were evenly randomized to either the PTA or CBA treatment arms. Follow-up angiograms and ankle-brachial index (ABI) measurements were performed after 12 months. The evaluation of the restenosis rates and factors influencing its occurrence were calculated by logistic regression analysis.
  
  
  RESULTS
  In the intention-to-treat analysis, restenosis rates after 2-month follow-up were 9 of 30 (30 %) in the PTA group and 4 of 30 (13 %) in the CBA group (p = 0.117). In the actual treatment analysis, after exclusion of patients who required nitinol stent placement for a suboptimal result after angioplasty alone (5 patients in the PTA group and none in the CBA group), restenosis rates were 9 of 25 (36 %) and 4 of 30 (13 %), respectively (p = 0.049). In the intention-to-treat analysis there were also significant differences in ABI values between the PTA and CBA groups at 0.77 ± 0.11 versus 0.82 ± 0.12, respectively (p = 0.039), at 12 months.
  
  
  CONCLUSIONS
  Based on the presented results of the trial, CBA seems to be a safer and more effective than PTA for treatment of short atherosclerotic lesions in the superior femoral artery.
authors.affiliation: Department of Interventional Radiology, Pomeranian Medical University, Al. Powst. Wielkopolskich 72, 70-111, Szczecin, Poland. wponcyl@poczta.onet.pl.
authors.forename: Wojciech
authors.initials: W
authors.lastname: Poncyljusz
authors.affiliation: Department of Interventional Radiology, Pomeranian Medical University, Al. Powst. Wielkopolskich 72, 70-111, Szczecin, Poland.
authors.forename: Aleksander
authors.initials: A
authors.lastname: Falkowski
authors.affiliation: Department of Biochemistry and Medical Chemistry, Pomeranian Medical University, Al. Powst. Wielkopolskich 72, 70-111, Szczecin, Poland.
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Safranow
authors.affiliation: Department of Biochemistry and Medical Chemistry, Pomeranian Medical University, Al. Powst. Wielkopolskich 72, 70-111, Szczecin, Poland.
authors.forename: Monika
authors.initials: M
authors.lastname: Rać
authors.affiliation: Interventional Radiology, Sacred Heart Medical Center, River Bend, Radiology Associates PC 445 Harlow Rd., Springfield, OR, 97477, USA.
authors.forename: Dariusz
authors.initials: D
authors.lastname: Zawierucha
mesh_terms: D015901:Angiography, Digital Subtraction / Q000379:methods; D000800:Angioplasty, Balloon / Q000379:methods*; D050197:Atherosclerosis / Q000000981:diagnostic imaging / Q000628:therapy*; D003251:Constriction, Pathologic / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging*; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D016896:Treatment Outcome; D014654:Vascular Patency / Q000502:physiology