Effects of Probucol versus Aspirin and versus Brachytherapy on Restenosis after Femoropopliteal Angioplasty: The PAB Randomized Multicenter Trial

• Published in: Journal of endovascular therapy Vol. 11; no. 6; pp. 595 - 604
• Main Authors: Gallino, Augusto, Do, Dai-Do, Alerci, Mario, Baumgartner, Iris, Cozzi, Luca, Segatto, Jeanne Marie, Bernier, Jacques, Tutta, Paolo, Kellner, Frauke, Triller, Jürgen, Schneider, Ernst, Amann-Vesti, Beatrice, Studer, Gabriele, Jäger, Kurt, Aschwanden, Markus, Canevascini, Reto, Jacob, Augustinus L., Kann, Roger, Greiner, Richard, Mahler, Felix
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.12.2004; Allen Press Inc
• Subjects: Aged; Aged, 80 and over; Analysis of Variance; Angioplasty, Balloon - adverse effects; Angioplasty, Balloon - methods; Arterial Occlusive Diseases - diagnosis; Arterial Occlusive Diseases - therapy; Aspirin - therapeutic use; Brachytherapy; Female; Femoral Artery - drug effects; Femoral Artery - radiation effects; Follow-Up Studies; Humans; Intermittent Claudication - diagnosis; Intermittent Claudication - therapy; Male; Popliteal Artery - drug effects; Popliteal Artery - radiation effects; Probability; Probucol - therapeutic use; Recurrence; Reference Values; Risk Assessment; Single-Blind Method; Treatment Outcome; Vascular Patency - physiology; restenosis; femoropopliteal segment; brachytherapy; peripheral vascular disease; multicenter trial; angioplasty; probucol
• ISSN: 1526-6028; 1545-1550
• DOI: 10.1583/04-1269MR.1

Purpose: 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 2×2 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.