Efficacy of Rivaroxaban for thromboprophylaxis after Knee Arthroscopy (ERIKA)

Giuseppe Camporese; Enrico Bernardi; Franco Noventa; Mario Bosco; Giuseppe Monteleone; Luca Santoro; Cristiano Bortoluzzi; Stefano Freguja; Michela Nardin; Matteo Marullo; Giacomo Zanon; Claudio Mazzola; Guido Damiani; Pietro Maniscalco; Davide Imberti; Corrado Lodigiani; Cecilia Becattini; Chiara Tonello; Giancarlo Agnelli

doi:10.1160/TH16-02-0118

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 2016; 116(02): 349-355
DOI: 10.1160/TH16-02-0118

Stroke, Systemic or Venous Thromboembolism

Schattauer GmbH

Efficacy of Rivaroxaban for thromboprophylaxis after Knee Arthroscopy (ERIKA)

A phase II, multicentre, double-blind, placebo-controlled randomised study

Giuseppe Camporese

¹Unit of Angiology, Department of Cardiac, Thoracic and Vascular Sciences, University Hospital of Padua, Italy

,

Enrico Bernardi

²Department of Emergency and Accident Medicine, Hospital of Conegliano, Italy

,

Franco Noventa

³Department of Molecular Medicine, University Hospital of Padua, Italy

,

Mario Bosco

⁴Department of Anesthesiology and Critical Care Medicine, Catholic University, Rome, Italy

,

Giuseppe Monteleone

⁴Department of Anesthesiology and Critical Care Medicine, Catholic University, Rome, Italy

,

Luca Santoro

⁵Angiology, Catholic University, Rome, Italy

,

Cristiano Bortoluzzi

⁶Department of Internal Medicine, Hospital of Venice, Italy

,

Stefano Freguja

⁷Department of Orthopedics, Hospital of Venice, Italy

,

Michela Nardin

⁶Department of Internal Medicine, Hospital of Venice, Italy

,

Matteo Marullo

⁸Orthopedic and Traumatologic Department, IRCCS S. Matteo Hospital, Pavia, Italy

,

Giacomo Zanon

⁸Orthopedic and Traumatologic Department, IRCCS S. Matteo Hospital, Pavia, Italy

,

Claudio Mazzola

⁹Orthopedic and Traumatologic Department, Galliera Hospital of Genova, Italy

,

Guido Damiani

⁹Orthopedic and Traumatologic Department, Galliera Hospital of Genova, Italy

,

Pietro Maniscalco

¹⁰Orthopedic and Traumatologic Department, Hospital of Piacenza, Italy

,

Davide Imberti

¹¹Thrombosis Center, Department of Internal Medicine, Hospital of Piacenza, Italy

,

Corrado Lodigiani

¹²Thrombosis Center, Humanitas Clinical Institute IRCCS, Rozzano (MI), Italy

,

Cecilia Becattini

¹³Internal and Cardiovascular Medicine-Stroke Unit, University of Perugia, Italy

,

Chiara Tonello

¹Unit of Angiology, Department of Cardiac, Thoracic and Vascular Sciences, University Hospital of Padua, Italy

,

Giancarlo Agnelli

¹³Internal and Cardiovascular Medicine-Stroke Unit, University of Perugia, Italy

› Institutsangaben

Abstract

Summary

Without thromboprophylaxis, knee arthroscopy (KA) carries a low to moderate risk of venous thromboembolism. Over 5 million arthroscopies are performed worldwide yearly. It was our study objective to assess the efficacy and safety of rivaroxaban for thromboprophylaxis after therapeutic KA. Patients undergoing KA in nine Italian teaching or community hospitals were allocated to once-daily rivaroxaban (10 mg) or placebo for seven days in a phase II, multicentre, double-blind, placebo-controlled randomised trial. The primary efficacy outcome was a composite of all-cause death, symptomatic thromboembolism and asymptomatic proximal DVT at three months; major bleeding represented the primary safety outcome. All patients underwent whole-leg ultrasonography at day 7(+1), or earlier if symptomatic. A total of 241 patients were randomised (122 rivaroxaban, 119 placebo), and 234 completed the study. The primary efficacy outcome occurred in 1/120 of the rivaroxaban group and in 7/114 of the placebo group (0.8% vs 6.1%, respectively, p=0.03; absolute risk difference, −5.3%, 95% CI, −11.4 to −0.8; crude relative risk 0.14, 95% CI, 0.02 to 0.83; number-needed-to-treat=19). No major bleedings were observed. We found no association between different arthroscopic procedures and thrombotic events. Small sample size, high exclusion rate, and low number of anterior cruciate ligament reconstruction procedures are the main limitations of our study. In conclusion, a seven-day course of 10-mg rivaroxaban may be safely employed for thromboprophylaxis after KA. Whether prophylaxis after KA should be given to all patients, or to selected “high-risk” subjects, remains to be determined. A larger trial to verify our preliminary results is warranted.

Keywords

Venous thromboembolism - prophylaxis - arthroscopy - rivaroxaban - bleeding

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Referenzen

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