Venous thromboembolism prevention with fondaparinux 1.5 mg in renally impaired patients undergoing major orthopaedic surgery. A real-world, prospective, multicentre, cohort study

Autor: Patrick, Mismetti, Charles-Marc, Samama, Nadia, Rosencher, Claude, Vielpeau, Philippe, Nguyen, Beatrice, Deygas, Emilie, Presles, Silvy, Laporte, S, Ausset
Rok vydání: 2011
Předmět:
0301 basic medicine
Male
Time Factors
Arthroplasty
Replacement
Hip
030204 cardiovascular system & hematology
Fondaparinux
Kidney
0302 clinical medicine
Fracture Fixation
Risk Factors
Fracture fixation
Orthopedic Procedures
Prospective Studies
Renal Insufficiency
Prospective cohort study
Arthroplasty
Replacement
Knee
Aged
80 and over
education.field_of_study
Age Factors
Hematology
Venous Thromboembolism
Middle Aged
Pulmonary embolism
Treatment Outcome
Creatinine
Female
France
Cohort study
medicine.drug
medicine.medical_specialty
Population
Context (language use)
Hemorrhage
Risk Assessment
03 medical and health sciences
Polysaccharides
medicine
Humans
education
Aged
business.industry
Hip Fractures
Kidney metabolism
Anticoagulants
medicine.disease
Surgery
030104 developmental biology
Logistic Models
Multivariate Analysis
business
Biomarkers
Zdroj: Thrombosis and haemostasis. 107(6)
ISSN: 2567-689X
Popis: SummaryDespite the need for effective and safe thromboprophylactic drugs for patients with renal impairment, clinical trial data on anticoagulant agents are limited in this population. The study aim was to assess in the real-world setting the use of the once-daily 1.5 mg reduced dosage regimen of fondaparinux available for this context. In this prospective cohort study, patients with a creatinine clearance (CrCl) of 20–50 ml/ minute, undergoing total hip (THR) or knee (TKR) replacement or hip fracture surgery (HFS) received fondaparinux thromboprophylaxis. Main clinical outcomes were bleeding (major/clinically relevant nonmajor), symptomatic venous thromboembolism (VTE) and death. Overall, 442 patients (353 women; median age: 82 years; 39.4% in ASA class ≥3; mean ± SD CrCl: 39.0 ± 8.0 ml/minute; 78% with additional risk factors for bleeding), undergoing THR (43.7%), TKR (27.6%), or HFS (28.7%) received fondaparinux 1.5 mg for a mean ± SD duration of 16.0 ± 12.5 days. At postoperative day 10, the rates (95% confidence interval) of major bleeding, clinically relevant bleeding and symptomatic VTE were 4.5% (2.8–6.9), 0.5% (0.1–1.6) and 0.5% (0.05–1.62), respectively; no fatal bleeding, bleeding into a critical organ, pulmonary embolism or proximal deep-vein thrombosis occurred. Corresponding rates at one month were 5.2%, 0.7% and 0.7%. One-month mortality was 2.3% (0.9–3.6). This large clinical prospective study provides for the first time, under conditions reflecting “real-world” routine clinical practice, data on the bleeding and VTE risks of thromboprophylaxis with fondaparinux 1.5 mg after major orthopaedic surgery in renally impaired patients. It shows that these patients constitute a very elderly and fragile population.ClinicalTrials.gov number, NCT00555438
Databáze: OpenAIRE
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