Venous thromboembolism prevention with fondaparinux 1.5 mg in renally impaired patients undergoing major orthopaedic surgery

Patrick Mismetti; Charles-Marc Samama; Nadia Rosencher; Claude Vielpeau; Philippe Nguyen; Beatrice Deygas; Emilie Presles; Silvy Laporte; for The PROPICE Study Group

doi:10.1160/TH11-09-0640

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2012; 107(06): 1151-1160
DOI: 10.1160/TH11-09-0640

New Technologies, Diagnostic Tools and Drugs

Schattauer GmbH

Venous thromboembolism prevention with fondaparinux 1.5 mg in renally impaired patients undergoing major orthopaedic surgery

A real-world, prospective, multicentre, cohort study

Patrick Mismetti

¹EA3065 Université Jean Monnet, Saint Etienne, Service de Médecine et Thérapeutique, Unité de Pharmacologie Clinique, CHU Saint-Etienne, France

,

Charles-Marc Samama

²Hôtel-Dieu de Paris, Université Paris Descartes, Paris, France

,

Nadia Rosencher

³Service d'Anesthésie-Réanimation, Hopital Cochin (AP-HP), Université Paris Descartes, Paris, France

,

Claude Vielpeau

⁴Département de Chirurgie Orthopédique, CHRU de Caen, Caen France

,

Philippe Nguyen

⁵Laboratoire d'Hématologie, Université Champagne Ardenne, URCA EA 3801, CHU de Reims, Reims, France

,

Beatrice Deygas

⁶INSERM CIE3, CHU Saint-Etienne, Unité de Pharmacologie Clinique, CHU Saint-Etienne, France

,

Emilie Presles

⁶INSERM CIE3, CHU Saint-Etienne, Unité de Pharmacologie Clinique, CHU Saint-Etienne, France

,

Silvy Laporte

⁷EA3065, Université Jean Monnet, Saint-Etienne, Unité de Pharmacologie Clinique, CHU Saint-Etienne, INSERM CIE3, CHU Saint-Etienne, France

,

for The PROPICE Study Group

› Author Affiliations

Abstract

Summary

Despite 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

Keywords

Fondaparinux 1.5 mg - major orthopaedic surgery - prospective cohort - renal insufficiency - venous thromboembolism

Full Text

References

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