title: Rivaroxaban for thromboprophylaxis after total hip or knee arthroplasty: a meta-analysis with trial sequential analysis of randomized controlled trials.
abstract: Venous thromboembolism (VTE) is the most widespread severe complication after total hip arthroplasty (THA) and total knee arthroplasty (TKA). We conducted this meta-analysis to further validate the benefits and harms of rivaroxaban use for thromboprophylaxis after THA or TKA. We thoroughly searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials. Trial sequential analysis (TSA) was applied to test the robustness of our findings and to obtain a more conservative estimation. Of 316 articles screened, nine studies were included. Compared with enoxaparin, rivaroxaban significantly reduced symptomatic VTE (P = 0.0001) and symptomatic deep vein thrombosis (DVT; P = 0.0001) but not symptomatic pulmonary embolism (P = 0.57). Furthermore, rivaroxaban was not associated with an increase in all-cause mortality, clinically relevant non-major bleeding and postoperative wound infection. However, the findings were accompanied by an increase in major bleeding (P = 0.02). The TSA demonstrated that the cumulative z-curve crossed the traditional boundary but not the trial sequential monitoring boundary and did not reach the required information size for major bleeding. Rivaroxaban was more beneficial than enoxaparin for preventing symptomatic DVT but increased the risk of major bleeding. According to the TSA results, more evidence is needed to verify the risk of major bleeding with rivaroxaban.
authors.affiliation: Department of Orthopaedics, Xinqiao Hospital, Third Military Medical University, Xinqiao Road, Shapingba District, Chongqing 400037, China.|Department of Orthopaedics, Tianjin Medical University General Hospital, 154 Anshan Road, Heping District, Tianjin 300052, China.
authors.forename: Guang-Zhi
authors.initials: GZ
authors.lastname: Ning
authors.affiliation: Department of Orthopaedics, Tianjin Medical University General Hospital, 154 Anshan Road, Heping District, Tianjin 300052, China.
authors.forename: Shun-Li
authors.initials: SL
authors.lastname: Kan
authors.affiliation: Department of Orthopaedics, Tianjin Medical University General Hospital, 154 Anshan Road, Heping District, Tianjin 300052, China.
authors.forename: Ling-Xiao
authors.initials: LX
authors.lastname: Chen
authors.affiliation: Department of Orthopaedics, Xinqiao Hospital, Third Military Medical University, Xinqiao Road, Shapingba District, Chongqing 400037, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Shangguan
authors.affiliation: Department of Orthopaedics, Tianjin Medical University General Hospital, 154 Anshan Road, Heping District, Tianjin 300052, China.
authors.forename: Shi-Qing
authors.initials: SQ
authors.lastname: Feng
authors.affiliation: Department of Orthopaedics, Xinqiao Hospital, Third Military Medical University, Xinqiao Road, Shapingba District, Chongqing 400037, China.
authors.forename: Yue
authors.initials: Y
authors.lastname: Zhou
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects / Q000379:methods*; D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects / Q000379:methods*; D017984:Enoxaparin / Q000009:adverse effects / Q000627:therapeutic use; D065427:Factor Xa Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D000069552:Rivaroxaban / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000209:etiology / Q000517:prevention & control*; D020246:Venous Thrombosis / Q000209:etiology / Q000517:prevention & control
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D065427:Factor Xa Inhibitors; D000069552:Rivaroxaban