Safety and efficacy of recombinant hirudin (CGP 39 393) versus heparin in patients with stable angina undergoing coronary angioplasty
| Autor: | Philip Close, H. R. Buller, A. A. Van Den Bos, J. J. M. M. Rijnierse, Gr. Heyndrickx, H. Suryapranata, P. W. Serruys, Freek J. Zijlstra, Jaap W. Deckers, GertJan Laarman |
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| Přispěvatelé: | Other departments |
| Rok vydání: | 1993 |
| Předmět: |
Male
medicine.medical_specialty medicine.drug_class medicine.medical_treatment Hirudin Hemorrhage Coronary Angiography Angina Pectoris Bolus (medicine) Double-Blind Method Fibrinolytic Agents Hirudin Therapy Physiology (medical) Internal medicine Angioplasty medicine Humans Myocardial infarction Angioplasty Balloon Coronary Blood Coagulation Aged medicine.diagnostic_test Heparin business.industry Anticoagulant Hirudins Middle Aged medicine.disease Thrombosis Recombinant Proteins Treatment Outcome Anesthesia Cardiology Female sense organs Cardiology and Cardiovascular Medicine business Densitometry Partial thromboplastin time medicine.drug |
| Zdroj: | Circulation, 88(5 Part 1), 2058-2066. Lippincott Williams and Wilkins |
| ISSN: | 1524-4539 0009-7322 |
| DOI: | 10.1161/01.cir.88.5.2058 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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