OBJECTIVE: Prevention of deep venous thrombosis (DVT) and associated pulmonary embolism following major orthopedic surgeries is challenging, and there is an increased interest in developing new treatment strategies. We compared 2 switch-therapy modalities-enoxaparin to rivaroxaban and enoxaparin to dabigatran-and enoxaparin monotherapy for preventing DVT after total knee arthroplasty (TKA) and total hip arthroplasty (THA). METHODS: This was a prospective, non-blinded, randomized controlled study. We selected 180 eligible patients out of 247 patients undergoingTKA or THA. During the preoperative checkup, patients were randomized to receive either enoxaparin (enoxaparin group) or switch-therapy regimens, comprising enoxaparin during hospitalization and rivaroxaban (rivaroxaban group) or dabigatran (dabigatran group) during the outpatient period. All patients were evaluated for DVT using Doppler ultrasonography (USG) 6 weeks postoperatively. The primary efficacy outcome was the prevention of symptomatic or Doppler ultrasonography (USG)-proven DVT, whereas the primary safety outcome was the incidence of bleeding during the DVT-prophylaxis period. RESULTS: Doppler USG at 6 weeks after surgery revealed no signs of DVT in any patient. During the hospitalization period, only 2 major bleeding events were reported (1 [1.6%] in the enoxaparin group and 1 [1.6%] in the dabigatran group). No major bleeding events were reported during the outpatient follow-up period in any group. Differences among the 3 groups regarding bleeding events were not statistically significant (p>0.05). CONCLUSION: When using switch-therapy modalities, clinicians can take advantage of the safety of enoxaparin during the hospitalization period and ease of use of new oral anticoagulant drugs during the outpatient period.
RCT Entities:
OBJECTIVE: Prevention of deep venous thrombosis (DVT) and associated pulmonary embolism following major orthopedic surgeries is challenging, and there is an increased interest in developing new treatment strategies. We compared 2 switch-therapy modalities-enoxaparin to rivaroxaban and enoxaparin to dabigatran-and enoxaparin monotherapy for preventing DVT after total knee arthroplasty (TKA) and total hip arthroplasty (THA). METHODS: This was a prospective, non-blinded, randomized controlled study. We selected 180 eligible patients out of 247 patients undergoing TKA or THA. During the preoperative checkup, patients were randomized to receive either enoxaparin (enoxaparin group) or switch-therapy regimens, comprising enoxaparin during hospitalization and rivaroxaban (rivaroxaban group) or dabigatran (dabigatran group) during the outpatient period. All patients were evaluated for DVT using Doppler ultrasonography (USG) 6 weeks postoperatively. The primary efficacy outcome was the prevention of symptomatic or Doppler ultrasonography (USG)-proven DVT, whereas the primary safety outcome was the incidence of bleeding during the DVT-prophylaxis period. RESULTS: Doppler USG at 6 weeks after surgery revealed no signs of DVT in any patient. During the hospitalization period, only 2 major bleeding events were reported (1 [1.6%] in the enoxaparin group and 1 [1.6%] in the dabigatran group). No major bleeding events were reported during the outpatient follow-up period in any group. Differences among the 3 groups regarding bleeding events were not statistically significant (p>0.05). CONCLUSION: When using switch-therapy modalities, clinicians can take advantage of the safety of enoxaparin during the hospitalization period and ease of use of new oral anticoagulant drugs during the outpatient period.
Authors: Panayiotis K Karampinas; Panayiotis D Megaloikonomos; Kalliopi Lampropoulou-Adamidou; Eleftherios G Papadelis; Andreas F Mavrogenis; John A Vlamis; Spyros G Pneumaticos Journal: Eur J Orthop Surg Traumatol Date: 2018-09-17
Authors: Andréa Senay; Milanne Trottier; Josée Delisle; Andreea Banica; Benoit Benoit; G Yves Laflamme; Michel Malo; Hai Nguyen; Pierre Ranger; Julio C Fernandes Journal: Vasc Health Risk Manag Date: 2018-05-08
Authors: Anderson Reus Trevisol; Eduardo Felipe Mandarino Coppi; Julia Pancotte; Emanuelly Casal Bortoluzzi; Gabriel Pozzobon Knop Journal: Rev Bras Ortop Date: 2018-07-27