Author + information
- Received October 21, 1994
- Revision received April 7, 1995
- Accepted May 22, 1995
- Published online October 1, 1995.
- Michael J. Brack, MDa,
- Simon Ray, MDa,*,
- Anoop Chauhan, MDa,†,
- Johnathan Fox, MRCPa,*,
- Peter J.B. Hubner, FRCPa,‡,
- Peter Schofield, FRCPa,†,
- Alex Harley, FRCPa,*,
- Anthony H. Gershlick, FRCPa,‡,*,
- On behalf of the SHARP Trial Investigatorsa
- ↵*Address for correspondence: Dr. Anthony H. Gershlick, Department of Cardiology, Glenfield General Hospital, Groby Road. Leicester LE3 9QP. England, United Kingdom.
Objectives. 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.
This project was supported by Project Grant 91/18 from The British Heart Foundation. London, England, United Kingdom. Heparin was supplied by CP Pharmaceuticals Ltd., Clwyd, Wales, United Kingdom.
- Received October 21, 1994.
- Revision received April 7, 1995.
- Accepted May 22, 1995.
- American College of Cardiology