title: Return to theatre following total hip and knee replacement, before and after the introduction of rivaroxaban: a retrospective cohort study.
abstract: Rivaroxaban has been recommended for routine use as a thromboprophylactic agent in patients undergoing lower-limb arthroplasty. However, trials supporting its use have not fully evaluated the risks of wound complications. This study of 1048 total hip/knee replacements records the rates of return to theatre and infection before and after the change from a low molecular weight heparin (tinzaparin) to rivaroxaban as the agent of chemical thromboprophylaxis in patients undergoing lower-limb arthroplasty. During a period of 13 months, 489 consecutive patients undergoing lower-limb arthroplasty received tinzaparin and the next 559 consecutive patients received rivaroxaban as thromboprophylaxis. Nine patients in the control (tinzaparin) group (1.8%, 95% confidence interval 0.9 to 3.5) returned to theatre with wound complications within 30 days, compared with 22 patients in the rivaroxaban group (3.94%, 95% confidence interval 2.6 to 5.9). This increase was statistically significant (p = 0.046). The proportion of patients who returned to theatre and became infected remained similar (p = 0.10). Our study demonstrates the need for further randomised controlled clinical trials to be conducted to assess the safety and efficacy of rivaroxaban in clinical practice, focusing on the surgical complications as well as the potential prevention of venous thromboembolism.
authors.affiliation: Wansbeck General Hospital, Woodhorn Lane, Ashington, Northumberland NE63 9JJ, UK. jensen@doctors.org.uk
authors.forename: C D
authors.initials: CD
authors.lastname: Jensen
authors.forename: A
authors.initials: A
authors.lastname: Steval
authors.forename: P F
authors.initials: PF
authors.lastname: Partington
authors.forename: M R
authors.initials: MR
authors.lastname: Reed
authors.forename: S D
authors.initials: SD
authors.lastname: Muller
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects*; D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects*; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use; D006622:Hip Prosthesis / Q000009:adverse effects; D006801:Humans; D007720:Knee Prosthesis / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use*; D011182:Postoperative Care / Q000379:methods; D011183:Postoperative Complications / Q000517:prevention & control; D016459:Prosthesis-Related Infections / Q000209:etiology; D012086:Reoperation; D012189:Retrospective Studies; D000069552:Rivaroxaban; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D013923:Thromboembolism / Q000517:prevention & control*; D000078222:Tinzaparin
chemical_list: D005343:Fibrinolytic Agents; D006495:Heparin, Low-Molecular-Weight; D009025:Morpholines; D013876:Thiophenes; D000078222:Tinzaparin; D000069552:Rivaroxaban