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Risk of major bleeding in unselected patients with venous thromboembolism
A Bigaroni1, A Perrier, P de Moerloose
1Division of Angiology and Hemostasis, University Hospital of Geneva, Switzerland.
Insights
Major bleeding risk in patients treated for deep vein thrombosis (DVT) or pulmonary embolism (PE) with anticoagulants was 1.2%. Bleeding events occurred early, primarily in elderly patients with comorbidities, highlighting the need for careful anticoagulation management.
Area of Science:
- Cardiology
- Vascular Medicine
- Pharmacology
Background:
- Anticoagulant therapy is crucial for managing venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE).
- Assessing bleeding risk in unselected patient populations receiving anticoagulation is essential for safe and effective treatment.
Purpose of the Study:
- To determine the incidence of major bleeding events in a cohort of unselected outpatients treated for DVT or PE.
- To identify factors associated with bleeding complications during anticoagulant therapy.
Main Methods:
- Prospective screening of 1590 outpatients suspected of DVT or PE.
- Analysis of 410 patients who received anticoagulant treatment (heparin overlapped with oral anticoagulants) for confirmed VTE.
- 3-month follow-up to record major hemorrhagic events.
Main Results:
- A total of 410 patients were anticoagulated for confirmed VTE (300 PE, 111 DVT).
- Five patients (1.2%) experienced major bleeding events within 3 months, with two fatal outcomes.
- Bleeding occurred early in therapy, predominantly in elderly patients (median age 80) with comorbidities.
Conclusions:
- The bleeding rate in unselected outpatients is comparable to controlled trials.
- Early monitoring and careful management are critical, especially in elderly patients with comorbidities.
- Avoiding overtreatment is essential to minimize bleeding risk in anticoagulant therapy.
Purpose:
To evaluate the risk of major bleeding in unselected patients given anticoagulant treatment (heparin overlapped and followed by oral anticoagulants) because of deep vein thrombosis (DVT) or pulmonary embolism (PE).
Subjects And Methods:
We screened the database of 1590 outpatients suspected of DVT and PE in prospective diagnostic studies conducted in Geneva between 1992 and 1998.
Results:
Four hundred and eleven of 1590 patients (26%) were anticoagulated for confirmed venous thromboembolism (PE, 300; DVT, 111). One patient was excluded because of concomitant thrombolytic therapy. Five (1.2%; 95% confidence interval, 0.4-2.8) of the remaining 410 patients experienced a major hemorrhagic event during the 3-month follow-up, including two fatal events. All bleedings occurred during the first month of therapy (heparin, two; oral anticoagulants, two; combined treatment, one) and the median age of the patients who bled was 80 years. At least one serious comorbid condition associated with higher bleeding risk was present in four patients and, in one case, the bleeding was clearly related to an excessive intensity of anticoagulation.
Conclusion:
The rate of bleeding events in this population of unselected outpatients is similar to that reported in controlled therapeutic trials. The hemorrhagic events occurred early in the course of anticoagulant therapy and concerned old patients mostly affected by at least one comorbid condition. Particular care should be used to avoid the risk of overtreatment.