title: The Subcutaneous Heparin and Angioplasty Restenosis Prevention (SHARP) trial. Results of a multicenter randomized trial investigating the effects of high dose unfractionated heparin on angiographic restenosis and clinical outcome.
abstract: OBJECTIVE
  We sought to determine whether 12,500 IU of unfractionated heparin given subcutaneously twice daily for 4 months after percutaneous transluminal coronary angioplasty beneficially influences the subsequent rate of angiographic restenosis and the incidence of clinical events.
  
  
  BACKGROUND
  Heparin has been shown to exhibit powerful antiproliferative effects against smooth muscle cells in several animal models.
  
  
  METHODS
  A randomized trial with blinded data analysis was undertaken to assess the effect of unfractionated subcutaneous heparin on angiographic restenosis after coronary angioplasty. After successful angioplasty, patients were randomized to receive no heparin or 12,500 IU of heparin given subcutaneously twice daily for 4 months. Quantitative coronary angiography was performed before angioplasty, immediately after angioplasty and at follow-up ("early" [before 4 months] or electively [at 4 months]).
  
  
  RESULTS
  The study group comprised 339 patients, 167 randomly assigned to receive heparin, 172 to receive no heparin. Repeat cardiac catheterization was performed in 90% of randomized patients. At early and elective restudy (mean 4.2 months), the mean +/- SD difference in minimal lumen diameter between the postangioplasty and follow-up measurement was -0.55 +/- 0.58 mm for the no heparin group and -0.43 +/- 0.59 mm for the heparin group (p = NS). Clinical events during the follow-up period did not differ significantly between groups: fatal myocardial infarction (1 patient in each group), coronary bypass grafting (5 patients in each group), repeat angioplasty (12 in the no heparin, 6 in the heparin group), angina at 4-month assessment (33% in the no heparin, 32% in the heparin group).
  
  
  CONCLUSIONS
  Long-term treatment with high dose subcutaneous heparin (12,500 IU twice daily) for 4 months did not favorably influence angiographic or clinical outcome after coronary angioplasty.
authors.affiliation: Blackpool Victoria Hospital, England, United Kingdom.
authors.forename: M J
authors.initials: MJ
authors.lastname: Brack
authors.forename: S
authors.initials: S
authors.lastname: Ray
authors.forename: A
authors.initials: A
authors.lastname: Chauhan
authors.forename: J
authors.initials: J
authors.lastname: Fox
authors.forename: P J
authors.initials: PJ
authors.lastname: Hubner
authors.forename: P
authors.initials: P
authors.lastname: Schofield
authors.forename: A
authors.initials: A
authors.lastname: Harley
authors.forename: A H
authors.initials: AH
authors.lastname: Gershlick
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D006328:Cardiac Catheterization; D017023:Coronary Angiography / Q000379:methods; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000517:prevention & control / Q000628:therapy*; D004334:Drug Administration Schedule; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009131:Muscle, Smooth, Vascular / Q000187:drug effects; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; C006871:calcium heparin; D006493:Heparin