PROBUCOL AND MULTIVITAMINS IN THE PREVENTION OF RESTENOSIS AFTER CORONARY ANGIOPLASTY

Background Oxidizing metabolites generated at the site of coronary ang ioplasty can induce chain reactions that may lead to restenosis. Antio xidants may counter oxidative stress and modify neointimal formation a nd vascular remodeling. Experimental data and small clinical studies h ave suggested that antioxidants may prevent restenosis after angioplas ty. In a double-blind, randomized trial, we studied whether drugs with antioxidant properties decrease the incidence and severity of resteno sis after angioplasty. Methods One month before angioplasty, 317 patie nts were randomly assigned to receive one of four treatments: placebo, probucol (500 mg), multivitamins (30,000 IU of beta carotene, 500 mg of vitamin C, and 700 IU of vitamin E), or both probucol and multivita mins - all given twice daily. Patients were treated for four weeks bef ore and six months after angioplasty Patients received an extra 1000 m g of probucol, 2000 IU of vitamin E, both probucol and vitamin E, or p lacebo 12 hours before angioplasty, according to their treatment assig nments. Base-line and follow-up angiograms were interpreted by blinded investigators using a quantitative approach. Results The mean (+/-SD) reduction in luminal diameter six months after angioplasty was 0.12+/ -0.41 mm in the probucol group, 0.22+/-0.46 mm in the combined-treatme nt group, 0.33+/-0.51 mm in the multivitamin group, and 0.38+/-0.50 mm in the placebo group (P = 0.006 for those receiving vs. those not rec eiving probucol, and P = 0.70 for those receiving vs. those not receiv ing vitamins). Restenosis rates per segment were 20.7 percent in the p robucol group, 28.9 percent in the combined-treatment group, 40.3 perc ent in the multivitamin group, and 38.9 percent in the placebo group ( P = 0.003 for probucol vs. no probucol). The rates of repeated angiopl asty were 11.2 percent, 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 reducing the rate of restenosis after balloon coronary angioplasty. (C) 1997, Massachusetts Medical So ciety.