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A Study in Routine Clinical Practice

Majida Zidane; Miranda T. Schram; Erwin W. Planken, MD, PhD; Wim H. Molendijk, MD, PhD; Frits R. Rosendaal, MD, PhD; Felix J. M. van der Meer, MD, PhD; Menno V. Huisman, MD, PhD

Arch Intern Med. 2000;160:2369-2373.

Background  The rate of major hemorrhage during the initial treatment with unfractionated heparin (UFH) in patients with deep venous thrombosis (DVT) and pulmonary embolism (PE) in routine clinical practice is understudied. In recent clinical trials an overall average of 3.8% was reported. However, the incidence of this complication in routine patient care might be higher owing to less strict patient selection and lack of standardization in the administration of heparin. We have determined major bleeding rates during heparin treatment for DVT or PE in routine practice and compared these rates with data from clinical trials.

Methods  Data on the occurrence of major hemorrhage were retrieved according to strict criteria from the records of patients who had received continuous intravenous UFH therapy to treat objectively documented DVT or PE in 3 hospitals.

Results  After exclusion of 29 patients because of lack of objective diagnosis of DVT or PE and 25 patients because of initial treatment with low-molecular-weight heparin, 424 consecutive patients were available for detailed analysis. Among them, 17 patients (4.0%; 95% confidence interval, 2.1%-5.9%) experienced major hemorrhage during UFH treatment, which in most patients occurred at the end of planned heparin therapy; one of the hemorrhages was fatal. Six patients (1.4%; 95% confidence interval, 0.3%-2.5%) developed clinically suspected recurrent venous thromboembolism (fatal in 1 case) during UFH treatment or within 7 days' cessation.

Conclusions  Administration of continuous intravenous UFH in patients with DVT or PE in routine clinical practice leads to a major bleeding rate of 4.0%. This rate is comparable to the rate of major bleeding in patients who received UFH in clinical trials. Our findings are relevant to the discussion of major bleeding rates in patients with DVT and PE treated in daily clinical practice with subcutaneous low-molecular-weight heparin and newer antithrombotic drugs.

From the Department of General Internal Medicine, Leiden University Medical Center (Mss Zidane, Schram, and Dr Huisman), the Departments of Internal Medicine, Diaconessenhuis Leiden (Dr Planken) and Rijnland Hospital, Leiderdorp (Dr Molendijk), and the Departments of Clinical Epidemiology (Dr Rosendaal) and Haematology (Drs Rosendaal and van der Meer), Leiden University Medical Center, Leiden, the Netherlands.

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