Probucol and Multivitamins in the Prevention of Restenosis after Coronary Angioplasty
Jean-Claude Tardif, M.D., Gilles Côté, M.D., Jacques Lespérance, M.D., Martial Bourassa, M.D., Jean Lambert, Ph.D., Serge Doucet, M.D., Luc Bilodeau, M.D., Stanley Nattel, M.D., Pierre de Guise, M.D., for The Multivitamins and Probucol Study Group
Background Oxidizing metabolites generated at the site of coronaryangioplasty can induce chain reactions that may lead to restenosis.Antioxidants may counter oxidative stress and modify neointimalformation and vascular remodeling. Experimental data and smallclinical studies have suggested that antioxidants may preventrestenosis after angioplasty. In a double-blind, randomizedtrial, we studied whether drugs with antioxidant propertiesdecrease the incidence and severity of restenosis after angioplasty.
Methods One month before angioplasty, 317 patients were randomlyassigned to receive one of four treatments: placebo, probucol(500 mg), multivitamins (30,000 IU of beta carotene, 500 mgof vitamin C, and 700 IU of vitamin E), or both probucol andmultivitamins — all given twice daily. Patients were treatedfor four weeks before and six months after angioplasty. Patientsreceived an extra 1000 mg of probucol, 2000 IU of vitamin E,both probucol and vitamin E, or placebo 12 hours before angioplasty,according to their treatment assignments. Base-line and follow-upangiograms were interpreted by blinded investigators using aquantitative approach.
Results The mean (±SD) reduction in luminal diametersix months after angioplasty was 0.12±0.41 mm in theprobucol group, 0.22±0.46 mm in the combined-treatmentgroup, 0.33±0.51 mm in the multivitamin group, and 0.38±0.50mm in the placebo group (P = 0.006 for those receiving vs. thosenot receiving probucol, and P = 0.70 for those receiving vs.those not receiving vitamins). Restenosis rates per segmentwere 20.7 percent in the probucol group, 28.9 percent in thecombined-treatment group, 40.3 percent in the multivitamin group,and 38.9 percent in the placebo group (P = 0.003 for probucolvs. no probucol). The rates of repeated angioplasty were 11.2percent, 16.2 percent, 24.4 percent, and 26.6 percent, respectively(P = 0.009 for probucol vs. no probucol).
Conclusions The antioxidant probucol is effective in reducingthe rate of restenosis after balloon coronary angioplasty.
Source Information
From the Department of Medicine, Montreal Heart Institute (J.-C.T., G.C., J. Lespérance, M.B., S.D., L.B., S.N., P.G.), and the University of Montreal (J. Lambert), Montreal. Presented in part at the 69th Scientific Sessions of the American Heart Association, New Orleans, November 11, 1996.
Address reprint requests to Dr. Côté at the Research Center, Montreal Heart Institute, 5000 Bélanger St., Montreal, QC H1T 1C8, Canada.
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