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Previous Volume 333:764-769 September 21, 1995 Number 12 Next

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ABSTRACT

Background Heparin is often administered during and after coronary angioplasty to prevent closure of the dilated vessel. However, ischemic or hemorrhagic complications occur in 5 to 10 percent of treated patients. We studied whether these complications could be prevented when the direct thrombin inhibitor bivalirudin (Hirulog) was used in place of heparin.

Methods We performed a double-blind, randomized trial in 4098 patients undergoing angioplasty for unstable or postinfarction angina. Patients were assigned to receive either heparin or bivalirudin immediately before angioplasty. The primary end point was death in the hospital, myocardial infarction, abrupt vessel closure, or rapid clinical deterioration of cardiac origin.

Results In the total study group, bivalirudin did not significantly reduce the incidence of the primary end point (11.4 percent, vs. 12.2 percent for heparin) but did result in a lower incidence of bleeding (3.8 percent vs. 9.8 percent, P<0.001). In the prospectively stratified subgroup of 704 patients with postinfarction angina, bivalirudin therapy resulted in a lower incidence of the primary end point (9.1 percent vs. 14.2 percent, P = 0.04) and a lower incidence of bleeding (3.0 percent vs. 11.1 percent, P<0.001), but in a similar cumulative rate of death, myocardial infarction, and repeated revascularization in the six months after angioplasty (20.5 percent vs. 25.1 percent, P = 0.17).

Conclusions Bivalirudin was at least as effective as high-dose heparin in preventing ischemic complications in patients who underwent angioplasty for unstable angina, and it carried a lower risk of bleeding. Bivalirudin, as compared with heparin, reduced the risk of immediate ischemic complications in patients with postinfarction angina, but this difference was no longer apparent after six months.

Source Information

From the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston (J.A. Bittl, W.H.A., C.R.M., B.A.); the Department of Medicine, University Hospitals of Cleveland, Case Western Reserve University, Cleveland (J.S.); the Department of Medicine, Johns Hopkins Hospital, Baltimore (J.A. Brinker); the Department of Medicine, St. Louis University, St. Louis (B.R.C.); Biogen, Inc., Cambridge, Mass. (J.M., B.A.); and the Department of Medicine, Temple University School of Medicine, Philadelphia (E.D.).

Address reprint requests to Dr. Bittl at the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA 02115.

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