Effects of probucol versus aspirin and versus brachytherapy on restenosis after femoropopliteal angioplasty: the PAB randomized multicenter trial.
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.
Gallino
Augusto
A
Division of Vascular Medicine, Ospedale San Giovanni, Bellinzona, Switzerland. agallino@bluewin.ch
Do
Dai-Do
DD
Alerci
Mario
M
Baumgartner
Iris
I
Cozzi
Luca
L
Segatto
Jeanne Marie
JM
Bernier
Jacques
J
Tutta
Paolo
P
Kellner
Frauke
F
Triller
Jürgen
J
Schneider
Ernst
E
Amann-Vesti
Beatrice
B
Studer
Gabriele
G
Jäger
Kurt
K
Aschwanden
Markus
M
Canevascini
Reto
R
Jacob
Augustinus L
AL
Kann
Roger
R
Greiner
Richard
R
Mahler
Felix
F
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
D011341:Probucol; D001241:Aspirin