Efficacy of rivaroxaban for thromboprophylaxis after knee arthroscopy (ERIKA): A phase ii, multicentre, double-blind, placebo-controlled randomised study

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, C. TonelloM. Bosco, G. Monteleone, L. Santoro, A. Santoliquido, A. Di Giorgio, E. Nicolardi, G. Biondi, C. Fieri, D. Dall’Acqua, A. De Matthaeis, L. Giannotta, M. Masciangelo, G. Taccardo, R. De Vitis, A. Militerno, S. Serpieri, V. Cilli, C. Bortoluzzi, S. Freguja, M. Nardin, R. Parisi, M. Marullo, A. Azzaretti, G. Zanon, C. Mazzola, G. Damiani, A. Gori, P. Cassola, P. Volpi, C. Bait, The ERIKA Study Group

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)349-355
Number of pages7
JournalThrombosis and Haemostasis
Volume116
Issue number2
DOIs
Publication statusPublished - Aug 1 2016

Fingerprint

Arthroscopy
Knee
Placebos
Hemorrhage
Safety
Numbers Needed To Treat
Anterior Cruciate Ligament Reconstruction
Thromboembolism
Venous Thromboembolism
Community Hospital
Teaching Hospitals
Sample Size
Rivaroxaban
Cause of Death
Ultrasonography
Leg
Randomized Controlled Trials

Keywords

  • Arthroscopy
  • Bleeding
  • Prophylaxis
  • Rivaroxaban
  • Venous thromboembolism

ASJC Scopus subject areas

  • Hematology

Cite this

Efficacy of rivaroxaban for thromboprophylaxis after knee arthroscopy (ERIKA) : A phase ii, multicentre, double-blind, placebo-controlled randomised study. / Camporese, Giuseppe; Bernardi, Enrico; Noventa, Franco; Bosco, Mario; Monteleone, Giuseppe; Santoro, Luca; Bortoluzzi, Cristiano; Freguja, Stefano; Nardin, Michela; Marullo, Matteo; Zanon, Giacomo; Mazzola, Claudio; Damiani, Guido; Maniscalco, Pietro; Imberti, Davide; Lodigiani, Corrado; Becattini, Cecilia; Tonello, Chiara; Agnelli, Giancarlo; Tonello, C.; Bosco, M.; Monteleone, G.; Santoro, L.; Santoliquido, A.; Di Giorgio, A.; Nicolardi, E.; Biondi, G.; Fieri, C.; Dall’Acqua, D.; De Matthaeis, A.; Giannotta, L.; Masciangelo, M.; Taccardo, G.; De Vitis, R.; Militerno, A.; Serpieri, S.; Cilli, V.; Bortoluzzi, C.; Freguja, S.; Nardin, M.; Parisi, R.; Marullo, M.; Azzaretti, A.; Zanon, G.; Mazzola, C.; Damiani, G.; Gori, A.; Cassola, P.; Volpi, P.; Bait, C.; The ERIKA Study Group.

In: Thrombosis and Haemostasis, Vol. 116, No. 2, 01.08.2016, p. 349-355.

Research output: Contribution to journalArticle

Camporese, G, Bernardi, E, Noventa, F, Bosco, M, Monteleone, G, Santoro, L, Bortoluzzi, C, Freguja, S, Nardin, M, Marullo, M, Zanon, G, Mazzola, C, Damiani, G, Maniscalco, P, Imberti, D, Lodigiani, C, Becattini, C, Tonello, C, Agnelli, G, Tonello, C, Bosco, M, Monteleone, G, Santoro, L, Santoliquido, A, Di Giorgio, A, Nicolardi, E, Biondi, G, Fieri, C, Dall’Acqua, D, De Matthaeis, A, Giannotta, L, Masciangelo, M, Taccardo, G, De Vitis, R, Militerno, A, Serpieri, S, Cilli, V, Bortoluzzi, C, Freguja, S, Nardin, M, Parisi, R, Marullo, M, Azzaretti, A, Zanon, G, Mazzola, C, Damiani, G, Gori, A, Cassola, P, Volpi, P, Bait, C & The ERIKA Study Group 2016, 'Efficacy of rivaroxaban for thromboprophylaxis after knee arthroscopy (ERIKA): A phase ii, multicentre, double-blind, placebo-controlled randomised study', Thrombosis and Haemostasis, vol. 116, no. 2, pp. 349-355. https://doi.org/10.1160/TH16-02-0118
Camporese, Giuseppe ; Bernardi, Enrico ; Noventa, Franco ; Bosco, Mario ; Monteleone, Giuseppe ; Santoro, Luca ; Bortoluzzi, Cristiano ; Freguja, Stefano ; Nardin, Michela ; Marullo, Matteo ; Zanon, Giacomo ; Mazzola, Claudio ; Damiani, Guido ; Maniscalco, Pietro ; Imberti, Davide ; Lodigiani, Corrado ; Becattini, Cecilia ; Tonello, Chiara ; Agnelli, Giancarlo ; Tonello, C. ; Bosco, M. ; Monteleone, G. ; Santoro, L. ; Santoliquido, A. ; Di Giorgio, A. ; Nicolardi, E. ; Biondi, G. ; Fieri, C. ; Dall’Acqua, D. ; De Matthaeis, A. ; Giannotta, L. ; Masciangelo, M. ; Taccardo, G. ; De Vitis, R. ; Militerno, A. ; Serpieri, S. ; Cilli, V. ; Bortoluzzi, C. ; Freguja, S. ; Nardin, M. ; Parisi, R. ; Marullo, M. ; Azzaretti, A. ; Zanon, G. ; Mazzola, C. ; Damiani, G. ; Gori, A. ; Cassola, P. ; Volpi, P. ; Bait, C. ; The ERIKA Study Group. / Efficacy of rivaroxaban for thromboprophylaxis after knee arthroscopy (ERIKA) : A phase ii, multicentre, double-blind, placebo-controlled randomised study. In: Thrombosis and Haemostasis. 2016 ; Vol. 116, No. 2. pp. 349-355.
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T2 - A phase ii, multicentre, double-blind, placebo-controlled randomised study

AU - Camporese, Giuseppe

AU - Bernardi, Enrico

AU - Noventa, Franco

AU - Bosco, Mario

AU - Monteleone, Giuseppe

AU - Santoro, Luca

AU - Bortoluzzi, Cristiano

AU - Freguja, Stefano

AU - Nardin, Michela

AU - Marullo, Matteo

AU - Zanon, Giacomo

AU - Mazzola, Claudio

AU - Damiani, Guido

AU - Maniscalco, Pietro

AU - Imberti, Davide

AU - Lodigiani, Corrado

AU - Becattini, Cecilia

AU - Tonello, Chiara

AU - Agnelli, Giancarlo

AU - Tonello, C.

AU - Bosco, M.

AU - Monteleone, G.

AU - Santoro, L.

AU - Santoliquido, A.

AU - Di Giorgio, A.

AU - Nicolardi, E.

AU - Biondi, G.

AU - Fieri, C.

AU - Dall’Acqua, D.

AU - De Matthaeis, A.

AU - Giannotta, L.

AU - Masciangelo, M.

AU - Taccardo, G.

AU - De Vitis, R.

AU - Militerno, A.

AU - Serpieri, S.

AU - Cilli, V.

AU - Bortoluzzi, C.

AU - Freguja, S.

AU - Nardin, M.

AU - Parisi, R.

AU - Marullo, M.

AU - Azzaretti, A.

AU - Zanon, G.

AU - Mazzola, C.

AU - Damiani, G.

AU - Gori, A.

AU - Cassola, P.

AU - Volpi, P.

AU - Bait, C.

AU - The ERIKA Study Group

PY - 2016/8/1

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N2 - 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.

AB - 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.

KW - Arthroscopy

KW - Bleeding

KW - Prophylaxis

KW - Rivaroxaban

KW - Venous thromboembolism

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