title: Effects of probucol versus aspirin and versus brachytherapy on restenosis after femoropopliteal angioplasty: the PAB randomized multicenter trial.
abstract: OBJECTIVE
  To evaluate the effect of probucol and/or of endovascular brachytherapy (EVBT) on restenosis after percutaneous transluminal angioplasty (PTA) of femoropopliteal arteries.
  
  
  METHODS
  A total of 335 patients (206 men; mean age 72+/-9 years) with intermittent claudication were randomized according to a 2x2 factorial design to 1 of the 4 groups: probucol, placebo, EVBT, and EVBT+probucol. Probucol (1 g/d) or placebo were given in double-blinded fashion 1 month before and for 6 months after PTA. Gamma irradiation (192Iridium, 14 Gy, 5-mm reference depth) was randomly applied in an unblinded manner from a noncentered endoluminal catheter. All patients received aspirin (100 mg/d). Primary endpoint was restenosis (>50% diameter reduction) detected by duplex ultrasound 6 months after PTA. Secondary endpoints included clinical and hemodynamic assessment.
  
  
  RESULTS
  Restenosis in patients undergoing EVBT was 17% (23/133) versus 35% (50/142) in patients without EVBT (p<0.001); in patients treated with probucol versus placebo, the rates were 23% (31/135) and 30% (43/140, p<0.001). Three quarters (77%, 102/133) of patients were free of claudication after EVBT therapy versus 61% (87/142) without EVBT (p<0.05). Need for target vessel revascularization was 6% (8/133) with EVBT versus 14% (20/142) without EVBT (p<0.01). Late thrombotic occlusions occurred in 4% (6/133), exclusively in patients treated with EVBT after stent implantation.
  
  
  CONCLUSIONS
  Endovascular brachytherapy significantly reduces restenosis, improves symptoms, and reduces reinterventions after PTA of femoropopliteal arteries. Probucol reduces restenosis but has no additive effect when combined with brachytherapy.
authors.affiliation: Division of Vascular Medicine, Ospedale San Giovanni, Bellinzona, Switzerland. agallino@bluewin.ch
authors.forename: Augusto
authors.initials: A
authors.lastname: Gallino
authors.forename: Dai-Do
authors.initials: DD
authors.lastname: Do
authors.forename: Mario
authors.initials: M
authors.lastname: Alerci
authors.forename: Iris
authors.initials: I
authors.lastname: Baumgartner
authors.forename: Luca
authors.initials: L
authors.lastname: Cozzi
authors.forename: Jeanne Marie
authors.initials: JM
authors.lastname: Segatto
authors.forename: Jacques
authors.initials: J
authors.lastname: Bernier
authors.forename: Paolo
authors.initials: P
authors.lastname: Tutta
authors.forename: Frauke
authors.initials: F
authors.lastname: Kellner
authors.forename: Jürgen
authors.initials: J
authors.lastname: Triller
authors.forename: Ernst
authors.initials: E
authors.lastname: Schneider
authors.forename: Beatrice
authors.initials: B
authors.lastname: Amann-Vesti
authors.forename: Gabriele
authors.initials: G
authors.lastname: Studer
authors.forename: Kurt
authors.initials: K
authors.lastname: Jäger
authors.forename: Markus
authors.initials: M
authors.lastname: Aschwanden
authors.forename: Reto
authors.initials: R
authors.lastname: Canevascini
authors.forename: Augustinus L
authors.initials: AL
authors.lastname: Jacob
authors.forename: Roger
authors.initials: R
authors.lastname: Kann
authors.forename: Richard
authors.initials: R
authors.lastname: Greiner
authors.forename: Felix
authors.initials: F
authors.lastname: Mahler
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000800:Angioplasty, Balloon / Q000009:adverse effects* / Q000379:methods; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000628:therapy*; D001241:Aspirin / Q000627:therapeutic use*; D001918:Brachytherapy; D005260:Female; D005263:Femoral Artery / Q000187:drug effects / Q000528:radiation effects; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000628:therapy; D008297:Male; D011150:Popliteal Artery / Q000187:drug effects / Q000528:radiation effects; D011336:Probability; D011341:Probucol / Q000627:therapeutic use*; D012008:Recurrence; D012016:Reference Values; D018570:Risk Assessment; D016037:Single-Blind Method; D016896:Treatment Outcome; D014654:Vascular Patency / Q000502:physiology
chemical_list: D011341:Probucol; D001241:Aspirin