Dabigatran etexilate and LMWH for the prevention of venous thromboembolism in 532 patients undergoing hip surgery.

OBJECTIVE: Patients undergoing total hip replacement (THR) are at high risk of venous thromboembolism (VTE) and according to guidelines they should receive pharmacological prophylaxis. We would like to compare the efficacy, adherence and safety of dabigatran and low molecular weight heparins (LMWH) for the prevention of VTE in patients who underwent THR. PATIENTS AND METHODS: This study enrolled patients undergoing THR treated with dabigatran (110 mg loading dose then 220 mg/day for 34 days) or the LMWH dalteparin (2500 IU, 6-8 hours before surgery then 5000 IU/day for 35 days). The primary endpoint was adherence to treatment. RESULTS: Of the 532 patients screened and enrolled in the study, 407 (mean age 57.7 ± 12.3 years) completed the study (211 dabigatran, 196 LMWH). Over the 35 days of treatment, adherence was comparable between dabigatran and LMWH: 10.9% and 14.3% of patients receiving dabigatran and LMWH treatment missed > 1 dose of the drug, respectively. There was a lower need for external support in patients who received dabigatran (8.5% vs 58.2%; p < 0.0001) and a lower number of patients receiving dabigatran required support by a professional nurse (1.4% vs 17.3% of patients with LMWH; p < 0.0001). Dabigatran and LMWH were similarly well tolerated; however, fewer patients receiving dabigatran reported bleeding events. CONCLUSIONS: This study demonstrates that dabigatran is associated with high adherence. A lower need for external support in patients who received dabigatran may provide an added benefit compared with other oral treatments for VTE prophylaxis.

Autotransfusion in major orthopaedic surgery: experience with 1785 patients.

Using a prospective audit, we have evaluated the efficacy of an integrated autotransfusion regimen which comprised predepositing and intra- and postoperative blood salvage in major orthopaedic surgery. We examined prospectively the records of 1785 patients (1198 females, 5867 males, mean age 62 (range 16-90) yr, preoperative haemoglobin concentration 13.4 (SD 1.4) g dl-1) undergoing total hip arthroplasty (THA, 1229 patients), THA after removal of internal fixation devices (RFD + THA, 18 patients), total knee arthroplasty (TKA, 263 patients), revision surgery of the hip (HR cup + stem revision, 197 patients; cup revision, 53 patients; stem revision, 16 patients) and total knee revision (TKR, nine patients). We estimated that the number of predonations (MSBOS = maximum surgery blood order schedule) was 2 u. for THA, TKA and TKR, and 3 u. for partial or total hip revision and total hip arthroplasty with fixation removal. We found that it was possible to obtain the MSBOS in 1597 patients (89.5%). Homologous red blood cell (HRBC) transfusions were carried out in 131 patients (7.3%). We found that the need to use HRBC was significantly associated with failure to meet the number of MSBOS, female sex, lower preoperative haemoglobin concentration, use of calcium heparin for antithrombosis prophylaxis, more extensive surgery, higher ASA rating and co-existing diseases such as coronary artery disease.

[Assessment of complications of major orthopedic surgery: comparison of indobufen, calcium heparin, and low molecular heparin]. / Valutazione delle complicanze in chirurgia ortopedica maggiore: confronto tra indobufene, eparina calcica ed eparina a basso peso molecolare.

OBJECTIVE: Evaluation of incidence of postoperative thrombotic and haemorrhagic complications in autotrasfused patients undergoing blood predepositing, hemodilution, intra and postoperative blood saving and treated with indobufen, heparin calcine and low molecular weight heparin (enoxeparin). EXPERIMENTAL DESIGN: Comparative study. Length of follow up: 6 months. SETTING: Three division of Orthopaedic Surgery related to 1st Anaesthesiology and Intensive Care Unit of Rizzoli Orthopaedic Institute. PATIENTS: 980 consecutive patients admitted to hospital from 1-1-1992 to 30-6-1994 (321 males and 159 females), aged between 20 and 90 years (mean 62 +/- 11 years), with basal hemoglobin at 13.4 +/- 1.4 g/dI (range 6.7-17.9), who had undergone antithromboembolic prophylaxis with indobufen (Indo, 668), heparin calcine (CaHe, 200) and low molecular weight heparin (LMWH). INTERVENTIONS: Total hip (714) and knee (121) arthroprosthesis and hip replacements (cup 33, stem 10, cup and stem 102). MEASUREMENTS: The incidence of death, thromboembolic complications (pulmonary embolism, deep vein thrombosis), hemorrhage (hematoma and homologous transfusions), cardiac ischaemia. ANOVA and contingency tables (CT) were used for statistical. RESULTS: The absence of complications was significantly greater in patients treated with indobufen (Indo 94.3% vs CaHe 83.5% vs LMWH 85.7%, CT: p = 0.0001); the incidence of thromboembolic complications was significantly higher in patients treated with heparin calcine and low molecular weight heparin; in patients treated with heparin calcine the incidence of haemorrhagic complications was significantly higher. Due to bleeding brought about by the use of heparin calcine, one patient with coronary heart disease suffered from anemia and severe hypotensions by myocardiac infarction and cardiogenous shock which led to the patient's death. The use of homologous transfusions was significantly higher in patients treated with heparin calcine (Indo 4.2% vs CaHe 14.5% vs LMWH 4.5%, CT: p = 0.0001). CONCLUSIONS: In patients undergoing autotransfusion and hemodilution, indobufen has a lower of haemorrhagic complications compared to heparine calcine and low molecular weight heparin and it is more effective in the prevention of thrombotic complications at clinical evidence.