title: Effect of nadroparin, a low-molecular-weight heparin, on clinical and angiographic restenosis after coronary balloon angioplasty: the FACT study. Fraxiparine Angioplastie Coronaire Transluminale.
abstract: 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.
  
  
  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.
authors.affiliation: Centre Hospitalier Regional et Universitaire Lille, France.
authors.forename: J M
authors.initials: JM
authors.lastname: Lablanche
authors.forename: E P
authors.initials: EP
authors.lastname: McFadden
authors.forename: N
authors.initials: N
authors.lastname: Meneveau
authors.forename: J R
authors.initials: JR
authors.lastname: Lusson
authors.forename: B
authors.initials: B
authors.lastname: Bertrand
authors.forename: J P
authors.initials: JP
authors.lastname: Metzger
authors.forename: V
authors.initials: V
authors.lastname: Legrand
authors.forename: G
authors.initials: G
authors.lastname: Grollier
authors.forename: C
authors.initials: C
authors.lastname: Macaya
authors.forename: B
authors.initials: B
authors.lastname: de Bruyne
authors.forename: A
authors.initials: A
authors.lastname: Vahanian
authors.forename: A
authors.initials: A
authors.lastname: Grentzinger
authors.forename: C
authors.initials: C
authors.lastname: Masquet
authors.forename: J E
authors.initials: JE
authors.lastname: Wolf
authors.forename: G
authors.initials: G
authors.lastname: Tobelem
authors.forename: S
authors.initials: S
authors.lastname: Fontecave
authors.forename: A
authors.initials: A
authors.lastname: Vacheron
authors.forename: P
authors.initials: P
authors.lastname: d'Azemar
authors.forename: M E
authors.initials: ME
authors.lastname: Bertrand
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging* / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D017762:Nadroparin / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D017762:Nadroparin