Treatment with Bivalirudin (Hirulog) as Compared with Heparin during Coronary Angioplasty for Unstable or Postinfarction Angina

TLDR

Heparin is routinely used during coronary angioplasty, yet 5–10 % of patients experience ischemic or hemorrhagic complications. The study aimed to determine whether replacing heparin with the direct thrombin inhibitor bivalirudin could prevent these complications. A double‑blind, randomized trial enrolled 4,098 patients undergoing angioplasty for unstable or post‑infarction angina, assigning them to receive either heparin or bivalirudin immediately before the procedure and evaluating a composite primary endpoint of in‑hospital death, myocardial infarction, abrupt vessel closure, or rapid cardiac deterioration. In the overall cohort, bivalirudin did not significantly lower the primary composite endpoint compared with heparin but reduced bleeding, and in the post‑infarction angina subgroup it lowered the primary endpoint and bleeding while yielding similar 6‑month outcomes, demonstrating comparable efficacy to high‑dose heparin with a lower bleeding risk.

Abstract

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.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 were death in the hospital, myocardial infarction, abrupt vessel closure, or rapid clinical deterioration of cardiac origin.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).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.