Johannes T H Nielen1,2, Pieter C Dagnelie3, Pieter J Emans4, Nicole Veldhorst-Janssen5, Arief Lalmohamed6,7, Tjeerd-Pieter van Staa6, Annelies E R C H Boonen8, Bart J F van den Bemt9,10, Frank de Vries6,5. 1. Department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands. j.t.h.nielen@uu.nl. 2. Department of Epidemiology, CAPHRI, Maastricht University, Maastricht, The Netherlands. j.t.h.nielen@uu.nl. 3. Department of Epidemiology, CAPHRI and CARIM, Maastricht University, Maastricht, The Netherlands. 4. Department of Orthopaedics, Maastricht University Medical Center +, Maastricht, The Netherlands. 5. Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Center +, Maastricht, The Netherlands. 6. Department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands. 7. Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands. 8. Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center +, Maastricht, The Netherlands. 9. Department of Pharmacy, Sint Maartenskliniek, Nijmegen, The Netherlands. 10. Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
Abstract
BACKGROUND: There has been much debate recently on the best type of thromboprophylaxis following elective total joint replacement surgery. OBJECTIVE: This study aims to compare rates of venous thromboembolism (VTE), gastro-intestinal (GI) bleeding and mortality events, with use of new oral anticoagulants (NOAC) or low-molecular-weight heparins (LMWHs) compared with aspirin in patients undergoing total joint replacement. METHODS: A population-based retrospective cohort study was performed using the Clinical Practice Research Datalink. Patients ≥18 years of age who had undergone total knee (n = 3261) or hip replacement (THR (n = 4016)) between 2008 and 2012 were included. Within this population, three cohorts were selected, based on their first prescription within the 35-day period after surgery: use of NOACs only, LMWHs only and aspirin only. Incidence rates were calculated, and Cox proportional hazard models were fitted to estimate the risk of VTE, GI bleeding and all-cause mortality with the use of NOACs and LMWHs compared with aspirin use after total knee replacement and THR. We statistically adjusted our analyses for lifestyle factors, comorbidities and concomitant drug use. RESULTS: Total knee replacement and THR patients currently on LMWHs had higher risk of VTE (HR = 17.2 (6.9-43.0) and HR = 39.5 (18.0-87.0), respectively), GI bleeding (HR = 20.9 (1.9-232.3) and HR = 2.0 (0.2-17.2), respectively) and all-cause mortality (HR = 4.3 (1.7-12.4) and HR = 4.0 (2.4-6.7), respectively). NOAC use was associated with an increased risk of GI bleeding in patients undergoing THR surgery. CONCLUSIONS: In contrast to previous studies, we found an increased risk of VTE, GI bleeding and all-cause mortality with the use of LMWHs compared with aspirin. Risk of GI bleeding was increased with the use of NOACs compared with aspirin use after THR surgery.
BACKGROUND: There has been much debate recently on the best type of thromboprophylaxis following elective total joint replacement surgery. OBJECTIVE: This study aims to compare rates of venous thromboembolism (VTE), gastro-intestinal (GI) bleeding and mortality events, with use of new oral anticoagulants (NOAC) or low-molecular-weight heparins (LMWHs) compared with aspirin in patients undergoing total joint replacement. METHODS: A population-based retrospective cohort study was performed using the Clinical Practice Research Datalink. Patients ≥18 years of age who had undergone total knee (n = 3261) or hip replacement (THR (n = 4016)) between 2008 and 2012 were included. Within this population, three cohorts were selected, based on their first prescription within the 35-day period after surgery: use of NOACs only, LMWHs only and aspirin only. Incidence rates were calculated, and Cox proportional hazard models were fitted to estimate the risk of VTE, GI bleeding and all-cause mortality with the use of NOACs and LMWHs compared with aspirin use after total knee replacement and THR. We statistically adjusted our analyses for lifestyle factors, comorbidities and concomitant drug use. RESULTS: Total knee replacement and THR patients currently on LMWHs had higher risk of VTE (HR = 17.2 (6.9-43.0) and HR = 39.5 (18.0-87.0), respectively), GI bleeding (HR = 20.9 (1.9-232.3) and HR = 2.0 (0.2-17.2), respectively) and all-cause mortality (HR = 4.3 (1.7-12.4) and HR = 4.0 (2.4-6.7), respectively). NOAC use was associated with an increased risk of GI bleeding in patients undergoing THR surgery. CONCLUSIONS: In contrast to previous studies, we found an increased risk of VTE, GI bleeding and all-cause mortality with the use of LMWHs compared with aspirin. Risk of GI bleeding was increased with the use of NOACs compared with aspirin use after THR surgery.
Authors: Robert V O'Toole; Deborah M Stein; Katherine P Frey; Nathan N O'Hara; Daniel O Scharfstein; Gerard P Slobogean; Tara J Taylor; Bryce E Haac; Anthony R Carlini; Theodore T Manson; Kuladeep Sudini; C Daniel Mullins; Stephen T Wegener; Reza Firoozabadi; Elliott R Haut; Michael J Bosse; Rachel B Seymour; Martha B Holden; Ida Leah Gitajn; Samuel Z Goldhaber; Alexander L Eastman; Gregory J Jurkovich; Heather A Vallier; Joshua L Gary; Conor P Kleweno; Joseph Cuschieri; Debra Marvel; Renan C Castillo Journal: BMJ Open Date: 2021-03-24 Impact factor: 2.692