Efficacy of Rivaroxaban for thromboprophylaxis after Knee Arthroscopy (ERIKA)

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.

Thromboprophylactic Efficacy and Safety of Anticoagulants After Arthroscopic Knee Surgery: A Systematic Review and Meta-Analysis

“…After going through the titles and full tests, 7 RCT articles were assessed eligible according to the formulated inclusion and exclusion criteria (Figure 1). 20–26…”

“…Sample sizes of the included studies ranged from 105 to 1451. All the included trials used low-molecular-weight heparin, aspirin, or rivaroxaban as thromboprophylaxis measures in the treatment group, while different measures were used in the control groups including no treatment, 20,24,26 placebo, 21–23 or compression stockings. 25 Stockings instead of placebo were used in KANT study because of local prophylaxis policies.…”

“…All the trials chose cumulative incidence of DVT and pulmonary embolism (PE; symptomatic, asymptomatic, or both) as the efficacy end point, and incidence of major bleeding as the primary safety end point. Three trials 21,23,25 defined major and minor bleeding events according to the guideline of the Scientific and Standardisation Committee of the International Society on Thrombosis and Haemostasis (ISTH). 27 The definitions of major bleeding events in the other 4 trials were not entirely consistent or not clearly mentioned, and adjustments were made according to guideline of ISTH during data extraction.…”

“…All the included trials used ultrasound combined with volume of drainage to identify surgical site hematoma. Two trials 21,25 detailed DVT into symptomatic proximal DVT (SPD), symptomatic distal DVT (SDD), asymptomatic proximal DVT (APD), and asymptomatic distal DVT. These 2 trials took the cumulative incidence of mortality, SDD, SPD, and APD as the primary efficacy end point.…”

An unusual case of symptomatic deep vein thrombosis and pulmonary embolism after arthroscopic meniscus surgery

“…A multicenter, randomized, controlled trail including 1451 patients regarding prophylaxis with low-molecular-weight heparin for the 8 days after knee arthroscopy reveal it was not effective for the prevention of symptomatic venous thromboembolism, with the number needed to treat (NNT) of 374 [ 16 ]. And a randomised study including 241 patients about prophylaxis with Rivaroxaban for the 7 days after knee arthroscopy got the NNT of 8, reach the conclusion whether prophylaxis using Rivaroxaban after surgery should be given to all patients, or to selected “high-risk” subjects, remains to be determined [ 17 ].…”