rivaroxaban and Fractures--Bone

The management of thromboprophylaxis in patients with pelvic and acetabular fractures remains a highly controversial topic within the trauma community. Despite anticoagulation, venous thromboembolism (VTE) remains the most common cause of surgical morbidity and mortality in this high-risk patient group. Although various thromboprophylactic regimes are employed, evidence relating to the most effective method remains unclear. Controversies surrounding screening, the use of prophylactic inferior vena cava filters (IVCF) and chemothromboprophylaxis in polytraumatised patients, particularly those with pelvic and acetabular fractures, form the basis of considerable debate. With the absence of a well-designed clinical trial and the presence of ongoing controversies within the literature, this review will explore current treatment options available to trauma surgeons and highlight differing scientific opinions, providing an update on the role of screening and current available preventative measures. We cover existing as well as recent advances in chemical thromboprophylactic agents and discuss external mechanical compression devices, the usefulness of serial duplex ultrasonography and the role of extended chemothromboprophylaxis on discharge. The evidence behind prophylactic IVCF is also considered, along with reported complication profiles. We conclude with a proposed protocol for use in major trauma centres, which can form the basis of local policy for the prevention of VTE in trauma patients with pelvic and acetabular fractures.

Topics: Acetabulum; Anticoagulants; Aspirin; Benzimidazoles; beta-Alanine; Coumarins; Dabigatran; Fondaparinux; Fractures, Bone; Heparin; Humans; Mass Screening; Morpholines; Multiple Trauma; Pelvis; Polysaccharides; Pulmonary Embolism; Pyrazoles; Pyridones; Risk Assessment; Rivaroxaban; Thiophenes; Vena Cava Filters; Venous Thromboembolism

The risk of venous thromboembolism is high in patients undergoing fracture-related major orthopedic surgery, but data on pharmacological thromboprophylaxis are limited. This analysis evaluated the effectiveness and safety of rivaroxaban after fracture-related orthopedic surgery in routine care compared with other pharmacological thromboprophylaxis (standard of care [SOC]).. The study population comprised a subset of patients with lower-limb fracture from XArelto in the prophylaxis of post-surgical venous thromboembolism after elective Major Orthopaedic Surgery of hip or knee (XAMOS; a phase IV noninterventional study) and a XAMOS extension study (XAMOS-Extra). The study participants included patients who underwent surgery for hip/femur or lower-leg fractures (below-knee lower-leg fractures, eg, the tibia or foot). All adverse events were recorded, including symptomatic thromboembolic events and bleeding events.. Data from 790 patients were available for analysis (n = 350 for rivaroxaban and n = 440 for SOC). The incidence of symptomatic thromboembolic events 3 months postsurgery was 0.57% (2 of the 350) in the rivaroxaban group and 1.14% (5 of the 440) in the SOC group (odds ratio [OR]: 0.50; 95% confidence interval [CI]: 0.10-2.59). Treatment-emergent major bleeding events occurred in 0.29% (1 of the 350) of patients receiving rivaroxaban and 0.45% (2 of the 440) of patients receiving SOC (OR: 0.63; 95% CI: 0.06-6.95). There were no cases of fatal or critical bleeding in either treatment group. The incidences of wound complications and any other adverse events were numerically lower with rivaroxaban compared with SOC.. These data from routine practice demonstrate that rivaroxaban can provide effective thromboprophylaxis after fracture-related orthopedic surgery of the lower limb with a favorable safety profile.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Female; Fractures, Bone; Humans; Incidence; Male; Middle Aged; Orthopedic Procedures; Postoperative Complications; Rivaroxaban; Thromboembolism

Thromboprophylaxis with rivaroxaban has proved effective and safe in patients undergoing hip and knee replacement surgery. As it is unclear whether it is also effective and safe in fracture patients, the aim of the present study was to evaluate the efficacy and safety of rivaroxaban in patients with lower limb fractures. We performed a retrospective cohort study of 2,050 consecutive patients treated for lower limb fractures at our trauma center, comparing rates of venous thromboembolism (VTE), bleeding and surgical complications, and the length of hospital stay for 608 patients who received rivaroxaban and 717 who received a low-molecular-weight heparin (LMWH). Rates of symptomatic VTE were 4.9 and 8.6% in the rivaroxaban and LMWH groups, respectively (p = 0.008), and distal VTE rates were 1.8 and 5.7%, respectively (p = 0.036). The incidence of major bleeding events in the rivaroxaban group was also lower than in the LMWH group (0.2 vs 0.6%), but the difference between the groups was not statistically significant. The mean length of hospital stay was significantly shorter in the rivaroxaban group (12.2 vs 13.1 days, respectively; p = 0.016). This retrospective cohort study is the first report documenting the efficacy and safety of rivaroxaban in patients with lower extremity fractures. In comparison with LMWH, rivaroxaban reduced the incidence of VTE by 45% without increasing the risk of bleeding. However, prospective, randomized controlled trials comparing rivaroxaban and LMWH are needed to confirm our findings.

Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Factor Xa Inhibitors; Female; Fractures, Bone; Hemorrhage; Heparin, Low-Molecular-Weight; Humans; Incidence; Length of Stay; Lower Extremity; Male; Middle Aged; Morpholines; Postoperative Complications; Retrospective Studies; Rivaroxaban; Thiophenes; Venous Thromboembolism

Warfarin is prescribed to patients with atrial fibrillation (AF) for the prevention of cardioembolic complications. Whether warfarin adversely affects bone health is controversial. The availability of alternate direct oral anticoagulant (DOAC) options now make it possible to evaluate the comparative safety of warfarin in association with fracture risk.. To test the hypothesis that, among patients with nonvalvular AF, use of DOACs vs warfarin is associated with lower risk of incident fracture.. This comparative effectiveness cohort study used the MarketScan administrative claims databases to identify patients with nonvalvular AF and who were prescribed oral anticoagulants from January 1, 2010, through September 30, 2015. To reduce confounding, patients were matched on age, sex, CHA2DS2-VASc (congestive heart failure, hypertension, age [>65 years = 1 point; >75 years = 2 points], diabetes, and previous stroke/transient ischemic attack [2 points], vascular disease) score, and high-dimensional propensity scores. The final analysis included 167 275 patients with AF. Data were analyzed from February 27, 2019 to September 18, 2019.. Warfarin and DOACs (dabigatran etexilate, rivaroxaban, and apixaban).. Incident hip fracture, fracture requiring hospitalization, and all clinical fractures (identified using inpatient or outpatient claims) defined by International Classification of Diseases, Ninth Revision, Clinical Modification codes.. In the study population of 167 275 patients with AF (38.0% women and 62.0% men; mean [SD] age, 68.9 [12.5] years), a total of 817 hip fractures, 2013 hospitalized fractures, and 7294 total fractures occurred during a mean (SD) follow-up of 16.9 (13.7) months. In multivariable-adjusted, propensity score-matched Cox proportional hazards regression models, relative to new users of warfarin, new users of DOACs tended to be at lower risk of fractures requiring hospitalization (hazard ratio [HR], 0.87; 95% CI, 0.79-0.96) and all clinical fractures (HR, 0.93; 95% CI, 0.88-0.98), whereas the association with hip fractures (HR, 0.91; 95% CI, 0.78-1.07) was not statistically significant. When comparing individual DOACs with warfarin, the strongest findings were for apixaban (HR for hip fracture, 0.67 [95% CI, 0.45-0.98]; HR for fractures requiring hospitalization, 0.60 [95% CI, 0.47-0.78]; and HR for all clinical fractures, 0.86 [95% CI, 0.75-0.98]). In subgroup analyses, DOACs appeared more beneficial among patients with AF who also had a diagnosis of osteoporosis than among those without a diagnosis of osteoporosis.. In this real-world population of 167 275 patients with AF, use of DOACs-particularly apixaban-compared with warfarin use was associated with lower fracture risk. These associations were more pronounced among patients with a diagnosis of osteoporosis. Given the potential adverse effects of warfarin on bone health, these findings suggest that caution should be used when prescribing warfarin to patients with AF at high risk of fracture.

Topics: Aged; Aged, 80 and over; Anticoagulants; Atrial Fibrillation; Comorbidity; Comparative Effectiveness Research; Dabigatran; Factor Xa Inhibitors; Female; Fractures, Bone; Hip Fractures; Hospitalization; Humans; Incidence; Male; Middle Aged; Osteoporosis; Proportional Hazards Models; Protective Factors; Pyrazoles; Pyridones; Rivaroxaban; Warfarin

Topics: Aged; Aged, 80 and over; Anticoagulants; Aspirin; Blood Coagulation Factors; Cerebral Hemorrhage, Traumatic; Cerebral Intraventricular Hemorrhage; Clopidogrel; Deamino Arginine Vasopressin; Female; Fractures, Bone; Hematoma; Hematoma, Subdural, Intracranial; Hemostatics; Humans; International Normalized Ratio; Intracranial Hemorrhage, Traumatic; Male; Middle Aged; Pelvic Bones; Platelet Aggregation Inhibitors; Pyrazoles; Pyridones; Retrospective Studies; Rivaroxaban; Subarachnoid Hemorrhage, Traumatic; Thrombosis; Warfarin

This study investigated the effectiveness and the outcomes of rivaroxaban vs the standard of care for venous thromboembolic prophylaxis in patients undergoing fracture-related surgery. A total of 413 patients undergoing fracture-related surgery from 9 Swiss orthopedic and trauma centers were enrolled. The authors selected the type of venous thromboembolic prophylaxis according to standardized medical practice at the participating centers before the inclusion of patients: 208 patients received rivaroxaban and 205 received the standard of care. Data on symptomatic thromboembolic and bleeding events, surgery-related complications, death, adverse events, time to mobilization, and hospital discharge were collected. Symptomatic thromboembolic events were reported in 1 patient (0.5%) and 2 patients (1.0%) and treatment-emergent major bleeding events were reported in 1 patient (0.5%) and 2 patients (1.0%) receiving rivaroxaban and the standard of care, respectively. The durations of hospital stay and venous thromboembolic prophylaxis were similar in the 2 groups. In both groups, adverse events related to venous thromboembolic prophylaxis were reported in 12 patients. The proportion of patients with minor and major fracture surgery was 74.3% and 25.7%, respectively. In patients undergoing minor fracture surgery receiving rivaroxaban (n=167) and the standard of care (n=140), no symptomatic thromboembolic events and no major bleeding events were reported. Outcomes of this study indicate that rivaroxaban might be an appropriate oral alternative for venous thromboembolic prophylaxis in routine medical care after fracture-related major and minor surgery. Reported results were comparable to those from other large-scale, noninterventional and randomized controlled studies. [Orthopedics. 2017; 40(2):109-116.].

Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Factor Xa Inhibitors; Female; Fracture Fixation; Fractures, Bone; Humans; Male; Middle Aged; Perioperative Care; Postoperative Complications; Rivaroxaban; Switzerland; Treatment Outcome; Venous Thromboembolism; Young Adult

Thromboprophylaxis for deep vein thrombosis (DVT) after lower-extremity trauma could include rivaroxaban, an oral medication that does not need laboratory monitoring.. To assess rivaroxaban's efficacy in preventing DVTs after pelvic trauma compared to its historical incidence.. All patients admitted with pelvic fractures in a 12-month period followed a standardized thromboprophylaxis protocol: 1) rivaroxaban 10 mg/day within 24 h of injury or upon hemodynamic stability; 2) pre-operative, post-operative, and 30-day extremity ultrasound; 3) ventilation-perfusion scintigraphy for clinical signs of pulmonary embolus; and 4) a 45-, 90-, and 120-day re-evaluation. Rivaroxaban administration ceased the day of surgery and restarted 12 h post-operatively or upon hemodynamic stability, continuing for 30 days. Excluded patients had severe neurological or hepatosplenic injuries, heparin hypersensitivity, or hemodynamic instability.. Of 113 patients assessed, 84 patients (66 males), average age 46.6 years (range 19-69 years), were included. They had isolated pelvic trauma (n = 37), associated lower limb injuries (n = 47), average Injury Severity Score 21.4 (range 16-50), and average Glasgow Coma Scale score 13.6 (range 9-15). Patients receiving thromboprophylaxis soon after their fracture (n = 64) had a lower incidence of DVT than those receiving delayed thromboprophylaxis (n = 20) (p = 0.02). One patient (1.2%) died from a pulmonary embolus; 13 had asymptomatic below-the-knee DVTs. Rivaroxaban did not increase intra- or post-operative bleeding in surgical wounds.. DVT incidence after pelvic fractures is reduced by administering antithrombotics within 24 h of injury or, if the patient is hemodynamically unstable, 24 h after stabilization. Rivaroxaban is a safe and effective method of providing this thromboprophylaxis.

Topics: Adult; Aged; Anticoagulants; Drug Administration Schedule; Female; Fractures, Bone; Glasgow Coma Scale; Humans; Injury Severity Score; Lower Extremity; Male; Middle Aged; Morpholines; Pelvic Bones; Pulmonary Embolism; Radionuclide Imaging; Rivaroxaban; Thiophenes; Time Factors; Ultrasonography; Venous Thrombosis; Young Adult