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(Circulation. 1997;96:3396-3402.)
© 1997 American Heart Association, Inc.

Articles

Effect of Nadroparin, a Low-Molecular-Weight Heparin, on Clinical and Angiographic Restenosis After Coronary Balloon Angioplasty

The FACT Study

Jean-Marc Lablanche, MD; Eugène P. McFadden, MRCPI; Nicolas Meneveau, MD; Jean René Lusson, MD; Bernard Bertrand, MD; Jean-Philippe Metzger, MD; Victor Legrand, MD; Gilles Grollier, MD; Carlos Macaya, MD; Bernard de Bruyne, MD; Alec Vahanian, MD; Alain Grentzinger, MD; Christiane Masquet, MD; Jean-Eric Wolf, MD; Gerard Tobelem, MD; Sylvie Fontecave, MD; André Vacheron, MD; Pascal d'Azemar, MD; ; Michel E. Bertrand, MD

From the Centre Hospitalier Regional et Universitaire Lille, France (J.-M.L., E.P.M., M.E.B.); Centre Hospitalier Regional et Universitaire Besançon, France (N.M.); Centre Hospitalier Regional et Universitaire, Clermont-Ferrand, France (J.R.L.); Centre Hospitalier Regional et Universitaire, Grenoble, France (B.B.); Groupe Hospitalier Necker-Enfants Malades, Paris, France (J.-P.M., A.V.); Centre Hospitalier Universitaire de Liège, Belgium (V.L.); Centre Hospitalier Regional, Caen, France (G.G.); San Carlos University Hospital, Madrid, Spain (C.M.); O.L. Vrouwziekenhuis, Aalst, Belgium (B. de B.); Hôpital Tenon, Paris, France (A.V.); Centre Hospitalier Universitaire de Brabois, Vandoeuvre Les Nancy, France (A.G.); Hôpital Lariboisière, Paris, France (C.M., G.T.); Centre Hospitalier Universitaire, Dijon, France (J.-E.W.); Sanofi Research, Paris, France (S.F., P d'A.).

Correspondence to J.-M. Lablanche, MD, Service de cardiologie C, Hopital Cardiologique, 59037 Lille, France.

Background Experimental studies suggest that the antiproliferative effect of heparin after arterial injury is maximized by pretreatment. No previous studies of restenosis have used a pretreatment strategy. We designed this study to determine whether treatment with nadroparin, a low-molecular-weight heparin, started 3 days before the procedure and continued for 3 months, affected angiographic restenosis or clinical outcome after coronary angioplasty.

Methods and Results In a prospective multicenter, double-blind, randomized trial, elective coronary angioplasty was performed on 354 patients who were treated with daily subcutaneous nadroparin (0.6 mL of 10 250 anti-Xa IU/mL) or placebo injections started 3 days before angioplasty and continued for 3 months. Angiography 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. Clinical and procedural variables and the occurrence of periprocedural complications did not differ between groups. At angiographic follow-up, the mean minimal lumen diameter and the mean residual stenosis in the nadroparin group (1.37±0.66 mm, 51.9±21.0%) did not differ from the corresponding values in the control group (1.48±0.59 mm, 48.8±18.9%). Combined major cardiac-related clinical events (death, myocardial infarction, target lesion revascularization) did not differ between groups (30.3% versus 29.6%).

Conclusions Pretreatment with the low-molecular-weight heparin nadroparin continued for 3 months after balloon angioplasty had no beneficial effect on angiographic restenosis or on adverse clinical outcomes.

Key Words: angioplasty • anticoagulants • aspirin • heparin