EFFECT OF NADROPARIN, A LOW-MOLECULAR-WEIGHT HEPARIN, ON CLINICAL ANDANGIOGRAPHIC RESTENOSIS AFTER CORONARY BALLOON ANGIOPLASTY - THE FACTSTUDY

Background Experimental studies suggest that the antiproliferative eff ect of heparin after arterial injury is maximized by pretreatment. No previous studies of restenosis have used a pretreatment strategy. We d esigned this study to determine whether treatment with nadroparin, a l ow-molecular-weight heparin, started 3 days before the procedure and c ontinued for 3 months, affected angiographic restenosis or clinical ou tcome after coronary angioplasty. Methods and Results In a prospective multicenter, double-blind, randomized trial, elective coronary angiop lasty was performed on 354 patients who were treated with daily subcut aneous nadroparin (0.6 mL of 10 250 anti-Xa IU/mL) or placebo injectio ns started 3 days before angioplasty and continued for 3 months. Angio graphy was performed just before and immediately after angioplasty and at follow-up. The primary study end point was angiographic restenosis , assessed by quantitative coronary angiography 3 months after balloon angioplasty. Clinical follow-up was continued up to 6 months. Clinica l and procedural variables and the occurrence of periprocedural compli cations did not differ between groups. At angiographic follow-up, the mean minimal lumen diameter and the mean residual stenosis in the nadr oparin group (1.37+/-0.66 mm, 51.9+/-21.0%) did not differ from the co rresponding values in the control group (1.48+/-0.59 mm, 48.8+/-18.9%) . Combined major cardiac-related clinical events (death, myocardial in farction, target lesion revascularization) did not differ between grou ps (30.3% versus 29.6%). Conclusions Pretreatment with the low-molecul ar-weight heparin nadroparin continued for 3 months after balloon angi oplasty had no beneficial effect on angiographic restenosis or on adve rse clinical outcomes.