scholarly journals Venous Thromboembolism in Orthopaedic Surgery

10.5772/31770 ◽  
2012 ◽  
Author(s):  
Justin R. ◽  
Michael H.
1996 ◽  
Vol 76 (06) ◽  
pp. 0887-0892 ◽  
Author(s):  
Serena Ricotta ◽  
Alfonso lorio ◽  
Pasquale Parise ◽  
Giuseppe G Nenci ◽  
Giancarlo Agnelli

SummaryA high incidence of post-discharge venous thromboembolism in orthopaedic surgery patients has been recently reported drawing further attention to the unresolved issue of the optimal duration of the pharmacological prophylaxis. We performed an overview analysis in order to evaluate the incidence of late occurring clinically overt venous thromboembolism in major orthopaedic surgery patients discharged from the hospital with a negative venography and without further pharmacological prophylaxis. We selected the studies published from January 1974 to December 1995 on the prophylaxis of venous thromboembolism after major orthopaedic surgery fulfilling the following criteria: 1) adoption of pharmacological prophylaxis, 2) performing of a bilateral venography before discharge, 3) interruption of pharmacological prophylaxis at discharge in patients with negative venography, and 4) post-discharge follow-up of the patients for at least four weeks. Out of 31 identified studies, 13 fulfilled the overview criteria. The total number of evaluated patients was 4120. An adequate venography was obtained in 3469 patients (84.1%). In the 2361 patients with negative venography (68.1%), 30 episodes of symptomatic venous thromboembolism after hospital discharge were reported with a resulting cumulative incidence of 1.27% (95% C.I. 0.82-1.72) and a weighted mean incidence of 1.52% (95% C.I. 1.05-1.95). Six cases of pulmonary embolism were reported. Our overview showed a low incidence of clinically overt venous thromboembolism at follow-up in major orthopaedic surgery patients discharged with negative venography. Extending pharmacological prophylaxis in these patients does not appear to be justified. Venous thrombi leading to hospital re-admission are likely to be present but asymptomatic at the time of discharge. Future research should be directed toward improving the accuracy of non invasive diagnostic methods in order to replace venography in the screening of asymptomatic post-operative deep vein thrombosis.


2012 ◽  
Vol 107 (06) ◽  
pp. 1151-1160 ◽  
Author(s):  
Patrick Mismetti ◽  
Charles-Marc Samama ◽  
Nadia Rosencher ◽  
Claude Vielpeau ◽  
Philippe Nguyen ◽  
...  

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


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 36-36 ◽  
Author(s):  
Alexander GG Turpie ◽  
Michael Rud Lassen ◽  
Ajay K Kakkar ◽  
Bengt Eriksson ◽  
Frank Misselwitz ◽  
...  

Abstract Four multinational, randomized, double-blind, double-dummy phase III studies (RECORD1, 2, 3 and 4) investigated the oral, direct Factor Xa inhibitor rivaroxaban for the prevention of venous thromboembolism (VTE) in patients undergoing major orthopaedic surgery. A total of 12,729 patients were randomized to receive oral rivaroxaban 10 mg once daily (od) starting 6–8 hours after surgery, or subcutaneous enoxaparin 40 mg od starting the evening before surgery (RECORD1–3), or 30 mg bid starting 12–24 hours after wound closure or adequate hemostasis (RECORD4). In both RECORD1 and 2, patients undergoing total hip replacement (THR) were given rivaroxaban for 31–39 days. Enoxaparin was given for 31–39 days in RECORD1 or 10–14 days in RECORD2. In RECORD3 and 4, patients undergoing total knee replacement (TKR) received prophylaxis for 10–14 days. All patients were followed up for 30–35 days after the last dose of study medication. All outcomes, including symptomatic outcomes, were adjudicated by the same independent, blinded committees for all four studies. In each of the studies, the rivaroxaban regimens tested significantly reduced the incidence of the primary efficacy outcome (total VTE; the composite of any deep vein thrombosis [DVT], non-fatal pulmonary embolism [PE], and all-cause mortality) compared with enoxaparin regimens tested, with similar rates of bleeding in both groups. The rivaroxaban regimens also consistently reduced the incidence of major VTE (the composite of proximal DVT, non-fatal PE, and VTE-related death) in all four trials compared with the enoxaparin regimens tested. This pre-specified pooled analysis was performed on all randomized patients who received at least one dose of double-blind study medication to evaluate the effect of rivaroxaban on the composite of symptomatic VTE (comprising DVT or PE) and death, and bleeding. These primary outcomes were analyzed at day 12±2 in the active treatment pool (i.e. during the enoxaparin-controlled period common to all studies, to allow for unbiased comparison with enoxaparin), and for the total study duration pool (planned treatment period and 30–35 days follow-up). The results are shown in the table. Rivaroxaban significantly reduced the incidence of symptomatic VTE and death compared with enoxaparin regimens at day 12±2 (0.47% vs 0.97%; p=0.001) and for the total study duration (0.81% vs 1.63%; p<0.001). Rivaroxaban was not associated with a statistically significant increased risk of major bleeding (Table). These data demonstrate that in the regimens tested, rivaroxaban reduced the composite of major clinical outcomes compared with enoxaparin regimens, with no significant increase in the risk of major bleeding in patients undergoing major orthopaedic surgery. Rivaroxaban n=6183 n (%) Enoxaparin n=6200 n (%) p-value *Total study duration pool: active study drug period and 30–35 days follow-up including the placebo phase in RECORD2. †Bleeding after initiation of study medication, regardless of onset after last dose of study medication. ‡Post hoc analysis. p-values refer to Cox regression with treatment and study as covariates (two-sided Wald-test). Symptomatic VTE and death (primary outcome) 29 (0.5) 60 (1.0) 0.001 Day 12±2 active treatment pool 50 (0.8) 101 (1.6) <0.001 Total study duration pool* Death 6 (0.1) 10 (0.2) 0.320 Day 12±2 active treatment pool 13 (0.2) 25 (0.4) 0.055 Total study duration pool* PE or death 12 (0.2) 24 (0.4) 0.049 Day 12±2 active treatment pool 29 (0.5) 47 (0.8) 0.039 Total study duration pool* Major bleeding 21 (0.3) 13 (0.2) 0.175 Day 12±2 active treatment pool 27 (0.4) 17 (0.3) 0.135 Total study duration pool† Any bleeding 409 (6.6) 384 (6.2) 0.376 Day 12±2 active treatment pool 452 (7.3) 415 (6.7) 0.207 Total study duration pool† Composite of major clinical outcomes (death, myocardial infarction, stroke, symptomatic VTE, and major bleeding)*‡ 96 (1.6) 139 (2.2) 0.004


Thrombosis ◽  
2010 ◽  
Vol 2010 ◽  
pp. 1-5
Author(s):  
Richard J. Friedman

Venous thromboembolism is a serious complication after total hip or knee surgery, and there is a well-established clinical need for thromboprophylaxis. However, in a large number of cases adequate administration of thromboprophylaxis does not seem to occur after total joint arthroplasty. A major challenge in the management of thromboprophylaxis is to balance the benefits of treatment with the risks, including bleeding complications. Another potential barrier to the optimal use of thromboprophylaxis could be the inconvenience of currently available agents. Many surgeons therefore adopt a conservative approach towards thromboprophylaxis. Simplifying therapy with more convenient, efficacious, and safe anticoagulants could change attitudes to anticoagulant use and improve adherence to thromboprophylactic guidelines.


The Lancet ◽  
2003 ◽  
Vol 362 (9395) ◽  
pp. 1582 ◽  
Author(s):  
Gordon DO Lowe ◽  
Peter AG Sandercock ◽  
Frits R Rosendaal

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