Pb. Shah et al., BIVALIRUDIN COMPARED WITH HEPARIN DURING CORONARY ANGIOPLASTY FOR THROMBUS-CONTAINING LESIONS, Journal of the American College of Cardiology, 30(5), 1997, pp. 1264-1269
Objectives. We investigated whether bivalirudin is more effective than
heparin in preventing ischemic complications in high risk patients un
dergoing coronary angioplasty for thrombus-containing lesions detected
by angiography. Background. Heparin is administered during coronary a
ngioplasty to prevent closure of the dilated vessel. Bivalirudin (Hiru
log) is a direct thrombin inhibitor that can be safely substituted for
heparin during angioplasty. Bivalirudin has several theoretic advanta
ges over heparin as an anticoagulant agent. Methods. We performed an o
bservational analysis of the Hirulog Angioplasty Study in which 4,098
patients with unstable or postinfarction angina were randomized to rec
eive either bivalirudin or heparin during coronary angioplasty, The st
udy group for this analysis consisted of 567 patients who had thrombus
-containing lesions on angiography. The primary end point was death, m
yocardial infarction, emergency coronary artery bypass graft surgery o
r abrupt vessel closure before hospital discharge. Results. Patients w
ith thrombus containing lesions had a higher incidence of myocardial i
nfarction (5.1% vs. 3.2%, p = 0.03) and abrupt vessel closure (13.6% v
s, 8.3%, p < 0.001) than those without thrombus. In patients with thro
mbus containing lesions, however, the incidence of the primary end poi
nt was not different between the bivalirudin and heparin treatment gro
ups. Furthermore, no difference in the incidence of ischemic events at
6 months was seen between the treatment groups. Conclusions. Bivaliru
din is not more effective than heparin in preventing ischemic complica
tions in patients undergoing coronary angioplasty for thrombus-contain
ing lesions detected by angiography. Other approaches, perhaps involvi
ng potent antiplatelet agents, should be considered for patients with
thrombus-containing lesions. (C) 1997 by the American College of Cardi
ology.