1. Thromboprophylaxis after Knee Arthroscopy and Lower-Leg Casting
- Author
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Adrichem, R.A. van, Nemeth, B., Algra, A., Cessie, S. le, Rosendaal, F.R., Schipper, I.B., Nelissen, R.G.H.H., Cannegieter, S.C., POT-KAST POT-CAST Grp, APH - Methodology, and Epidemiology and Data Science
- Subjects
Adult ,Male ,medicine.medical_specialty ,Knee Joint ,Hemorrhage ,030204 cardiovascular system & hematology ,Research Support ,law.invention ,Arthroscopy ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,medicine ,Journal Article ,Humans ,Single-Blind Method ,030212 general & internal medicine ,Non-U.S. Gov't ,Medicine(all) ,Leg ,Knee arthroscopy ,medicine.diagnostic_test ,business.industry ,Incidence ,Incidence (epidemiology) ,Research Support, Non-U.S. Gov't ,Anticoagulants ,Venous Thromboembolism ,General Medicine ,Heparin ,Heparin, Low-Molecular-Weight ,Middle Aged ,Surgery ,Multicenter Study ,Casts, Surgical ,Anticoagulant therapy ,Anesthesia ,Randomized Controlled Trial ,Female ,business ,Venous thromboembolism ,Major bleeding ,medicine.drug - Abstract
Background The use of thromboprophylaxis to prevent clinically apparent venous thromboembolism after knee arthroscopy or casting of the lower leg is disputed. We compared the incidence of symptomatic venous thromboembolism after these procedures between patients who received anticoagulant therapy and those who received no anticoagulant therapy. Methods We conducted two parallel, pragmatic, multicenter, randomized, controlled, open-label trials with blinded outcome evaluation: the POT-KAST trial, which included patients undergoing knee arthroscopy, and the POT-CAST trial, which included patients treated with casting of the lower leg. Patients were assigned to receive either a prophylactic dose of low-molecular-weight heparin (for the 8 days after arthroscopy in the POT-KAST trial or during the full period of immobilization due to casting in the POT-CAST trial) or no anticoagulant therapy. The primary outcomes were the cumulative incidences of symptomatic venous thromboembolism and major bleeding within 3 months after the procedure. Results In the POT-KAST trial, 1543 patients underwent randomization, of whom 1451 were included in the intention-to-treat population. Venous thromboembolism occurred in 5 of the 731 patients (0.7%) in the treatment group and in 3 of the 720 patients (0.4%) in the control group (relative risk, 1.6; 95% confidence interval [CI], 0.4 to 6.8; absolute difference in risk, 0.3 percentage points; 95% CI, -0.6 to 1.2). Major bleeding occurred in 1 patient (0.1%) in the treatment group and in 1 (0.1%) in the control group (absolute difference in risk, 0 percentage points; 95% CI, -0.6 to 0.7). In the POT-CAST trial, 1519 patients underwent randomization, of whom 1435 were included in the intention-to-treat population. Venous thromboembolism occurred in 10 of the 719 patients (1.4%) in the treatment group and in 13 of the 716 patients (1.8%) in the control group (relative risk, 0.8; 95% CI, 0.3 to 1.7; absolute difference in risk, -0.4 percentage points; 95% CI, -1.8 to 1.0). No major bleeding events occurred. In both trials, the most common adverse event was infection. Conclusions The results of our trials showed that prophylaxis with low-molecular-weight heparin for the 8 days after knee arthroscopy or during the full period of immobilization due to casting was not effective for the prevention of symptomatic venous thromboembolism. (Funded by the Netherlands Organization for Health Research and Development; POT-KAST and POT-CAST ClinicalTrials.gov numbers, NCT01542723 and NCT01542762 , respectively.).
- Published
- 2017