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
1  Unit of Angiology, Department of Cardiac, Thoracic and Vascular Sciences, University Hospital of Padua, Italy
,
Enrico Bernardi
2  Department of Emergency and Accident Medicine, Hospital of Conegliano, Italy
,
Franco Noventa
3  Department of Molecular Medicine, University Hospital of Padua, Italy
,
Mario Bosco
4  Department of Anesthesiology and Critical Care Medicine, Catholic University, Rome, Italy
,
Giuseppe Monteleone
4  Department of Anesthesiology and Critical Care Medicine, Catholic University, Rome, Italy
,
Luca Santoro
5  Angiology, Catholic University, Rome, Italy
,
Cristiano Bortoluzzi
6  Department of Internal Medicine, Hospital of Venice, Italy
,
Stefano Freguja
7  Department of Orthopedics, Hospital of Venice, Italy
,
Michela Nardin
6  Department of Internal Medicine, Hospital of Venice, Italy
,
Matteo Marullo
8  Orthopedic and Traumatologic Department, IRCCS S. Matteo Hospital, Pavia, Italy
,
Giacomo Zanon
8  Orthopedic and Traumatologic Department, IRCCS S. Matteo Hospital, Pavia, Italy
,
Claudio Mazzola
9  Orthopedic and Traumatologic Department, Galliera Hospital of Genova, Italy
,
Guido Damiani
9  Orthopedic and Traumatologic Department, Galliera Hospital of Genova, Italy
,
Pietro Maniscalco
10  Orthopedic and Traumatologic Department, Hospital of Piacenza, Italy
,
Davide Imberti
11  Thrombosis Center, Department of Internal Medicine, Hospital of Piacenza, Italy
,
Corrado Lodigiani
12  Thrombosis Center, Humanitas Clinical Institute IRCCS, Rozzano (MI), Italy
,
Cecilia Becattini
13  Internal and Cardiovascular Medicine-Stroke Unit, University of Perugia, Italy
,
Chiara Tonello
1  Unit of Angiology, Department of Cardiac, Thoracic and Vascular Sciences, University Hospital of Padua, Italy
,
Giancarlo Agnelli
13  Internal and Cardiovascular Medicine-Stroke Unit, University of Perugia, Italy
› Author Affiliations
Financial support: Bayer SpA provided the study drugs and covered the insurance costs.
Further Information

Publication History

Received: 12 February 2016

Accepted after major revision: 05 April 2016

Publication Date:
09 March 2018 (online)

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.