A new oral direct thrombin inhibitor, dabigatran etexilate, compared with enoxaparin for prevention of thromboembolic events following total hip or knee replacement: the BISTRO II randomized trial
TL;DR: In this paper, a multicenter, parallel-group, double-blind study, 1973 patients undergoing total hip or knee replacement were randomized to 6-10 days of oral Dabigatran etexilate (50, 150,mg twice daily, 300,mg once daily, 225, mg twice daily), starting 1-4 h after surgery, or subcutaneous enoxaparin (40 mg once daily) starting 12 h prior to surgery.
About: This article is published in Journal of Thrombosis and Haemostasis.The article was published on 2005-01-01 and is currently open access. It has received 390 citations till now. The article focuses on the topics: Dabigatran.
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TL;DR: The ASRA consensus statements represent the collective experience of recognized experts in the field of neuraxial anesthesia and anticoagulation and are based on case reports, clinical series, pharmacology, hematology, and risk factors for surgical bleeding.
1,319 citations
TL;DR: Oral dabigatran etexilate was as effective as enoxaparin in reducing the risk of venous thromboembolism after total hip replacement surgery, with a similar safety profile.
1,103 citations
TL;DR: Dabigatran etexilate (220 mg or 150‰mg) was at least as effective as enoxaparin and had a similar safety profile for prevention of VTE after total knee replacement surgery.
991 citations
TL;DR: The data suggest that dabigatran etexilate is a promising novel oral DTI with predictable PK and PD characteristics and good tolerability, and further investigation of dabig atran e Texilate for the treatment and prophylaxis of patients with arterial and venous thromboembolic disorders, acute coronary syndromes and other medical conditions is warranted.
Abstract: Aims
The novel direct thrombin inhibitor (DTI), dabigatran etexilate (Boehringer Ingelheim Pharma GmbH & Co. KG), shows potential as an oral antithrombotic agent. Two double-blind, randomized trials were undertaken to investigate the pharmacokinetics (PK), pharmacodynamics (PD) and tolerability of orally administered dabigatran etexilate in healthy male subjects.
855 citations
TL;DR: Individual benefit-risk might be improved by tailoring dabigatran dose after considering selected patient characteristics, and the risk of ischemic stroke and bleeding outcomes were correlated with dabig atran plasma concentrations.
760 citations
References
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TL;DR: This article discusses the prevention of venous thromboembolism (VTE) and is part of the Seventh American College of Chest Physicians Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines.
3,064 citations
TL;DR: The article describes the antithrombotic effect ofVKAs, the monitoring of anticoagulation intensity, the clinical applications of VKA therapy, and the optimal therapeutic range of VKAs, and provides specific management recommendations.
1,616 citations
TL;DR: In technique for lower extremity phlebography the patient is in a semi-upright position, supporting his weight on the contralateral foot, and the dye injection is made into a dorsal pedal vein and no tourniquet is used.
Abstract: In technique for lower extremity phlebography the patient is in a semi-upright position, supporting his weight on the contralateral foot. The dye injection is made into a dorsal pedal vein and no tourniquet is used. Fluoroscopy is used to maximize efficiency of the filming. More than 300 phlebograms have been made with this method. The four cardinal signs of phlebothrombosis are constant filling defects, abrupt termination of the dye column, nonfilling of the entire deep venous system or portions thereof, and diversion of flow. Pitfalls in interpretation occur when artifacts are created by bearing weight on the leg under study, by tourniquets, by an improper injection site, or by incomplete mixing of the contrast material as it flows through the veins.
763 citations
TL;DR: In patients undergoing orthopedic surgery, 2.5 mg of fondaparinux sodium once daily, starting 6 hours postoperatively, showed a major benefit over enoxaparin, achieving an overall risk reduction of VTE greater than 50% without increasing the risk of clinically relevant bleeding.
Abstract: Background Orthopedic surgery remains a condition at high risk of venous thromboembolism (VTE). Fondaparinux, the first of a new class of synthetic selective factor Xa inhibitors, may further reduce this risk compared with currently available thromboprophylactic treatments. Methods A meta-analysis of 4 multicenter, randomized, double-blind trials in patients undergoing elective hip replacement, elective major knee surgery, and surgery for hip fracture (N = 7344) was performed to determine whether a subcutaneous 2.5-mg, once-daily regimen of fondaparinux sodium starting 6 hours after surgery was more effective and as safe as approved enoxaparin regimens in preventing VTE. The primary efficacy outcome was VTE up to day 11, defined as deep vein thrombosis detected by mandatory bilateral venography or documented symptomatic deep vein thrombosis or pulmonary embolism. The primary safety outcome was major bleeding. Results Fondaparinux significantly reduced the incidence of VTE by day 11 (182 [6.8%] of 2682 patients) compared with enoxaparin (371 [13.7%] of 2703 patients), with a common odds reduction of 55.2% (95% confidence interval, 45.8% to 63.1%; P P = .008), the incidence of clinically relevant bleeding (leading to death or reoperation or occurring in a critical organ) did not differ between groups. Conclusion In patients undergoing orthopedic surgery, 2.5 mg of fondaparinux sodium once daily, starting 6 hours postoperatively, showed a major benefit over enoxaparin, achieving an overall risk reduction of VTE greater than 50% without increasing the risk of clinically relevant bleeding.
729 citations
TL;DR: The results of ventilation-perfusion (V-Q) imaging and pulmonary angiography were retrospectively analyzed in 146 patients with suspected pulmonary embolism to define the frequency of PE associated with various scintigraphic patterns.
Abstract: The results of ventilation-perfusion (V-Q) imaging and pulmonary angiography were retrospectively analyzed in 146 patients with suspected pulmonary embolism (PE) to define the frequency of PE associated with various scintigraphic patterns. When the radionuclide images demonstrated at least two moderate-sized or one large area of V-Q mismatch, the probability of PE was 92%. However, only one of three patients with a single moderate-sized V-Q mismatch had PE, while small V-Q mismatches were not associated with PE in any of 19 patients. Matched V-Q abnormalities in lung regions that were radiographically normal were infrequently due to PE (4.8%). When a perfusion defect was substantially smaller than a corresponding radiographic abnormality, the frequency of PE was low (7.7%). Conversely, when a perfusion defect was substantially larger than the corresponding radiographic abnormality, there was a high probability of PE (87%). Matched perfusion and radiographic abnormalities indicated an intermediate probability of PE (27%). Patients with suspected pulmonary embolism may be classified into groups with low, intermediate, or high probability of pulmonary embolism on the basis of size and number of perfusion defects and a careful comparison of perfusion defects with ventilatory and radiographic findings.
276 citations