(rivaroxaban)
This information is intended for US healthcare professionals to access current scientific information about Janssen products. It is prepared by Janssen Medical Information and is not intended for promotional purposes, nor to provide medical advice.
Last Updated: 07/24/2024
XARELTO | ||||||
---|---|---|---|---|---|---|
CrCl, mL/min | ≥30 | 15-29 | <15 | |||
Estimated drug half-life, h | 6-15 | 9 | 13 (off dialysis) | |||
Procedural bleed risk | ||||||
Low | ≥24 hours | ≥36 hours | No data. Consider measuring anti-Xa level and/or withholding ≥48 hours | |||
Uncertain, intermediate, or high | ≥48 hours | No data. Consider measuring anti-Xa level and/or withholding ≥72 hours | ||||
Abbreviations: CrCl, creatinine clearance. Note: The duration for withholding is based upon estimated half-life withholding times of 2 to 3 half-lives for low procedural bleeding risk and 4 to 5 drug half-lives for uncertain, intermediate, or high procedural bleeding risk. |
The ACC/AHA guidelines additionally suggest that monitoring prothrombin time (PT) for XARELTO and apixaban in the periprocedural setting may be helpful. A PT consistent with control levels suggests a low serum concentration of the anticoagulant.3 Proposals from the Working Group on Perioperative Thrombosis and Hemostasis (GIHP) state that an activated partial thromboplastin time (aPTT) ratio ≤1.2 indicates a XARELTO plasma concentration less than 30 ng/mL. An aPTT ratio between 1.2 and 1.5 corresponds to plasma concentrations between 30-200 ng/mL, and in these cases, delaying the procedure by 12 hours is recommended. An aPTT ratio greater than 1.5 corresponds to concentrations greater than 200 ng/mL, and a minimum of 24 hours is suggested to reach the hemostatic threshold of 30 ng/mL.19
Sherwood et al (2014)8
VENTURE-AF9
Kawabata et al (2016)14
The PAUSE17
Tafur et al (2020)31
EINSTEIN-Jr32
Sánchez van Kammen et al (2022)33
Li et al (2023)34
Events, mean±SD | Group A | Group B | Group C | P Valueb | ||
---|---|---|---|---|---|---|
A vs B | B vs C | |||||
Operative time (min) | 193.52±52.08 | 189.20±51.30 | 194.04±59.40 | 0.383 | 0.366 | |
Number of fusion segments | 1.46±0.68 | 1.36±0.54 | 1.44±0.57 | 0.075 | 0.150 | |
Intraoperative blood loss (mL) | 412.78±171.63 | 297.64±118.94 | 307.06±133.42 | 0.000 | 0.440 | |
Drainage (mL) | ||||||
POD1 | 181.41±123.23 | 107.51±88.65 | 107.68±85.89 | 0.000 | 0.984 | |
POD2 | 93.41±92.54 | 64.17±76.67 | 66.27±80.03 | 0.000 | 0.782 | |
Obvious total blood loss (mL) | 687.60±296.09 | 469.33±224.72 | 481.01±205.16 | 0.000 | 0.573 | |
HCT (%) | ||||||
POD1 | 32.09±1.74 | 34.37±3.82 | 34.56±2.66 | 0.000 | 0.564 | |
POD3 | 33.92±3.32 | 35.78±3.17 | 35.69±1.71 | 0.000 | 0.730 | |
POD5 | 37.00±1.12 | 38.13±1.68 | 38.09±1.74 | 0.000 | 0.794 | |
Hb (g/L) | ||||||
POD1 | 112.75±15.65 | 116.15±16.14 | 117.84±7.48 | 0.025 | 0.166 | |
POD3 | 113.49±10.61 | 118.92±9.96 | 119.67±2.25 | 0.000 | 0.282 | |
POD5 | 118.34±6.62 | 122.10±4.33 | 121.84±2.95 | 0.000 | 0.469 | |
Abbreviations: Hb, hemoglobin; HCT, hematocrit; POD, postoperative day; SD, standard deviation. a bP values were calculated using Welch’s two-sample t-test. |
Events, n | Group A | Group B | Group C | P Valueb | ||
---|---|---|---|---|---|---|
A vs B | B vs C | |||||
Blood transfusion | 100 | 37 | 33 | 0.000 | 0.516 | |
Autologous blood transfusion | 98 | 34 | 31 | 0.000 | 0.599 | |
Allogeneic blood transfusion | 2 | 3 | 2 | 0.676 | 0.682 | |
Intermuscular vein thrombosisc | 36 | 34 | 8 | 0.959 | 0.000 | |
aStatistical analysis for comparison between groups: P<0.05, statistical significance. bP values were calculated using Pearson chi-square test with Yates’ continuity correction or Fisher test. cIdentified via postoperative ultrasound examination. |
Zhou et al (2023)35
Mean±SD | Group 1 (n=60) | Group 2 (n=60) | Group 3 (n=60) | F Value | P Value |
---|---|---|---|---|---|
Intraoperative blood loss, mL | 269.7±88.0 | 274.1±87.3 | 256.4±83.5 | 0.6 | 0.5 |
Drainage volume after treatment, mL | 243.4±72.5 | 295.4±72.5a | 205.2±69.0a,b | 24.1 | <0.001 |
TBL, mL | 902.1±129.5 | 959.0±131.9a | 833.2±115.0a,b | 15.0 | <0.001 |
Abbreviations: SD, standard deviation; TBL, total blood loss. aCompared with group 1, P<0.001. bCompared with group 2, P<0.001. |
n (%) | Group 1 (n=60) | Group 2 (n=60) | Group 3 (n=60) | χ2 a | P Value |
---|---|---|---|---|---|
VTE between the muscles of lower limbs | 4 (6.7) | 4 (6.7) | 7 (11.7) | - | - |
VTE in the left common femoral vein and superficial femoral vein | 0 (0.0) | 1 (1.7) | 0 (0.0) | - | - |
Total incidence | 4 (6.7) | 5 (8.3) | 7 (11.7) | 0.9 | 0.6 |
Abbreviation: VTE, venous thromboembolism. aComparison between groups was expressed as χ2 inspection at the inspection level of α=0.05 (two-sided). |
Douketis et al (2024)18 conducted a post hoc subanalysis of the COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial to evaluate the perioperative management and clinical outcomes in patients who required a surgery or invasive procedure during the trial and were receiving low-dose XARELTO and/or ASA.
Clinical Outcome | Group 1 n (%) | Group 2 n (%) | Group 3 n (%) | P Value |
---|---|---|---|---|
MI/ischemic stroke/acute limb ischemia | 126 (14.4) | 156 (18.2) | 157 (17.4) | 0.075 |
MI/ischemic stroke/acute limb ischemia/CV death | 132 (15.1) | 164 (19.1) | 162 (18.0) | 0.069 |
Any bleeding: minor/major bleeding | 37 (4.2) | 27 (3.1) | 35 (3.9) | 0.47 |
Stroke | 7 (0.80) | 9 (1.1) | 11 (1.2) | 0.69 |
MI or angina | 111 (12.7) | 131 (15.3) | 130 (14.4) | 0.28 |
VTE | 2 (0.23) | 2 (0.23) | 1 (0.11) | 0.75 |
Major bleeding | 10 (1.1) | 10 (1.2) | 11 (1.2) | 1.00 |
Minor bleeding | 27 (3.1) | 17 (2.0) | 25 (2.8) | 0.33 |
Death | 12 (1.4) | 13 (1.5) | 15 (1.7) | 0.88 |
Abbreviations: CV, cardiovascular; MI, myocardial infarction; VTE, venous thromboembolism. |
A literature search of MEDLINE®
1 | XARELTO (rivaroxaban) [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/XARELTO-pi.pdf. |
2 | |
3 | |
4 | |
5 | |
6 | |
7 | |
8 | |
9 | |
10 | |
11 | |
12 | |
13 | |
14 | |
15 | |
16 | |
17 | |
18 | |
19 | |
20 | |
21 | |
22 | |
23 | |
24 | |
25 | |
26 | |
27 | |
28 | |
29 | |
30 | |
31 | |
32 | |
33 | |
34 | |
35 |