Circulation, Vol 88, 2058-2066, Copyright © 1993 by American Heart Association
AA van den Bos, JW Deckers, GR Heyndrickx, GJ Laarman, H Suryapranata, F Zijlstra, P Close, JJ Rijnierse, HR Buller and PW Serruys
BACKGROUND. Enhanced thrombin activity has been associated with acute and
long-term complications following balloon angioplasty (percutaneous
transluminal coronary angioplasty (PTCA). We evaluated, in a 2-to-1
randomized, double-blind trial, the effects of recombinant hirudin, CGP 39
393, relative to unfractionated sodium heparin on periprocedural events,
bleeding, early angiographic outcome, and coagulation in 113 patients with
stable angina undergoing PTCA. METHODS AND RESULTS. Prior to PTCA, 20 mg
CGP 39 393 was administered as a bolus, followed by continuous infusion at
a rate of 0.16 mg.kg-1 x h-1, or 10,000 IU sodium heparin was administered
as a bolus and continued at a rate of 12 IU.kg-1 x h-1 for 24 hours.
Infusion was adjusted to activated partial thromboplastin time (APTT)
levels. ST segment was monitored for 24 hours, and angiograms were analyzed
with quantitative technique (QCA). In 74 CGP 39 393- and 39 heparin-treated
patients, 132 lesions were dilated. Myocardial infarction and/or emergency
coronary bypass surgery occurred in 1 (1.4%) CGP 39 393 patient compared
with 4 (10.3%) heparin patients (relative risk, 7.6; 95% confidence
interval, 0.9, 65.6). At 24 hours, complete perfusion was present in 91%
heparin and 100% CGP 39 393 patients. Significant ST segment displacement
was found in 11% of heparin versus 4% of CGP 39 393 subjects. Bleeding
occurred only at the puncture site in 4 CGP 39 393-treated patients. QCA
did not reveal significant differences between the groups. APTT values were
more often in the target range and more stable in CGP 39 393 patients.
Levels of thrombin-antithrombin III complexes, prothrombin fragment F1+2,
and fibrinopeptide A indicated that CGP 39 393 was an effective inhibitor
of thrombin activity. CONCLUSIONS. CGP 39 393 can safely be administered to
patients undergoing elective PTCA for stable anginal symptoms and may have
a more favorable anticoagulant profile than heparin.
ARTICLES
Safety and efficacy of recombinant hirudin (CGP 39 393) versus heparin in patients with stable angina undergoing coronary angioplasty
Department of Cardiology, Hospital De Klokkenberg, Breda, The Netherlands.
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