scholarly journals Venous thromboembolism prophylaxis in major orthopaedic surgery: A multicenter, prospective, observational study

Author(s):  
Faik Altıntaş
2003 ◽  
Vol 21 (7) ◽  
pp. 477-496 ◽  
Author(s):  
Sean D Sullivan ◽  
Susan R Kahn ◽  
Bruce L Davidson ◽  
Lars Borris ◽  
Patrick Bossuyt ◽  
...  

2014 ◽  
Vol 112 (09) ◽  
pp. 503-510 ◽  
Author(s):  
Céline Chapelle ◽  
Laurent Bertoletti ◽  
Jean-Christophe Lega ◽  
Michel Cucherat ◽  
Paul Zufferey ◽  
...  

SummaryTwo enoxaparin dosage regimens are used as comparators to evaluate new anticoagulants for thromboprophylaxis in patients undergoing major orthopaedic surgery, but so far no satisfactory direct comparison between them has been published. Our objective was to compare the efficacy and safety of enoxaparin 3,000 anti-Xa IU twice daily and enoxaparin 4,000 anti-Xa IU once daily in this clinical setting by indirect comparison meta-analysis, using Bucher’s method. We selected randomised controlled trials comparing another anticoagulant, placebo (or no treatment) with either enoxaparin regimen for venous thromboembolism prophylaxis after hip or knee replacement or hip fracture surgery, provided that the second regimen was assessed elsewhere versus the same comparator. Two authors independently evaluated study eligibility, extracted the data, and assessed the risk of bias. The primary efficacy outcome was the incidence of venous thomboembolism. The main safety outcome was the incidence of major bleeding. Overall, 44 randomised comparisons in 56,423 patients were selected, 35 being double-blind (54,117 patients). Compared with enoxaparin 4,000 anti-Xa IU once daily, enoxaparin 3,000 anti-Xa IU twice daily was associated with a reduced risk of venous thromboembolism (relative risk [RR]: 0.53, 95% confidence interval [CI]: 0.40 to 0.69), but an increased risk of major bleeding (RR: 2.01, 95% CI: 1.23 to 3.29). In conclusion, when interpreting the benefit-risk ratio of new anticoagulant drugs versus enoxaparin for thromboprophylaxis after major orthopaedic surgery, the apparently greater efficacy but higher bleeding risk of the twice-daily 3,000 anti-Xa IU enoxaparin regimen compared to the once-daily 4,000 anti-Xa IU regimen should be taken into account.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12021-12021
Author(s):  
Yukari Tsubata ◽  
Takamasa Hotta ◽  
Kosuke Hamai ◽  
Naoki Furuya ◽  
Toshihide Yokoyama ◽  
...  

12021 Background: Venous thromboembolism (VTE) is a well-known kind of cancer-associated thrombosis and a common complication of malignancy. However, little is known about the incidence of VTE and the effectiveness of direct oral anticoagulants (DOACs) associated with lung cancer chemotherapy. Methods: The Rising-VTE/NEJ037 study was a multicenter, prospective, observational study with 40 participating Japanese institutions. A total of 1,021 patients diagnosed with lung cancer that was unsuitable for radical resection or radiation were enrolled and followed up for two years. The diagnosis of VTE was confirmed through a central review by two radiologists. Patients with VTE at the time of lung cancer diagnosis started treatment with edoxaban. The primary endpoint of this trial was the rate of newly diagnosed VTE after enrollment or the recurrence rate 6 months after the start of treatment with edoxaban. Results: Of the 1,021 enrolled patients, data were available for 1,008 patients. The median age was 70 years (range: 30-94 years), and 70.8% were males. Eighty-six percent of patients had non-small cell lung cancer, and 13.6% had small cell lung cancer. Histological types included adenocarcinoma (N = 641, 63.6%), squamous cell carcinoma (N = 187, 18.6%), and others (N = 42, 4.2%). Sixty-two patients (6.2%) had VTE at the time of lung cancer diagnosis, and 42 patients (4.2%) developed VTE during two years follow-up, making a total of 104 patients (10.3%). No cases of VTE recurrence were found 6 months after the start of treatment with edoxaban. Major and minor bleeding occurred in 95 patients (9.4%) and increased to 23% in the edoxaban treatment group. The two-year survival probability was 0.43 in the non-VTE group and 0.48 in the VTE with edoxaban treatment group, showing no difference. Conclusions: This study shows a high cumulative incidence of VTE, suggesting that attention should be paid to VTE during treatment for lung cancer. Treatment with edoxaban was highly effective in preventing recurrence of VTE, and there was no difference in survival with or without VTE, but treatment should be considered more carefully because of the high bleeding rate associated with DOAC. Clinical trial information: jRCTs061180025.


Sign in / Sign up

Export Citation Format

Share Document