Efficacy and safety of thromboprophylaxis with low-molecular-weight heparin or rivaroxaban in hip and knee replacement surgery

Abstract

Prospective trials have shown that rivaroxaban thromboprophylaxis is superior over low-molecular-weight heparin (LMWH) in patients undergoing hip and knee replacement surgery. However, patients treated under trial conditions are different from unselected routine patients, which may affect efficacy and safety of thromboprophylaxis. The objective was to evaluate the efficacy and safety of rivaroxaban or LMWH thromboprophylaxis in unselected patients undergoing hip and knee replacement surgery in daily care. In a monocentric, retrospective cohort study in 5,061 consecutive patients undergoing hip and knee replacement surgery a comparison of LMWH (hospital standard in 2006-2007) and rivaroxaban (since 2009) was made with regard to rates of symptomatic VTE, bleeding and surgical complications and length of hospital stay. Rates of symptomatic VTE were 4.1 % (LMWH) and 2.1 % (rivaroxaban; p=0.005) with rates for distal DVT 2.5 vs. 1.1 % (p<0.001). Rates of major VTE were numerically higher with LMWH (1.7 vs. 1.1%, not statistically significant). Rates of major bleeding (overt bleeding leading to surgical revision or death, occurring in a critical site, or transfusion of at least two units of packed red blood cells) were statistically lower with rivaroxaban (2.9 vs. 7.0%; p<0.001). Rivaroxaban patients had fewer surgical complications (1.1 vs. 3.7%; p<0.001) and a shorter length of hospitalisation (8.3 days; 95% CI 8.1- 8.5 vs. 11.1 days; 10.7- 11.5; p< 0.001). We conclude that rivaroxaban thromboprophylaxis is more effective than LMWH in unselected patients undergoing hip and knee replacement surgery in daily care and that switching from LMWH to rivaroxaban could be beneficial. Prospective comparisons are warranted to confirm our findings.

Do We Know All About Prevention of Venous Thromboembolism After Major Orthopedic Surgery?

“…нМг получали 11 471 пациент и ривароксабан -12 850 пациентов. Всего было зарегистрировано 154 венозных тромбоэмболических события (61 в группе ривароксабана и 93 в группе нМг) и 46 крупных кровотечений (23 в группе ривароксабана и 23 в группе нМг [27].…”

Evolving Treatments for Arterial and Venous Thrombosis

“…Postmarketing data from prospective observational studies, registries, insurance claim databases, and pharmacovigilance networks suggest that the effectiveness and safety of the DOACs in practice are consistent with the findings of the clinical trials (Table 5). [111][112][113][114][115][116][117][118][119][120][121][122][123][124] Additional studies are ongoing, but the results observed to date have encouraged the uptake of the DOACs for the licensed indications. 125 …”

Comparison of Anti-Xa and Dilute Russell Viper Venom Time Assays in Quantifying Drug Levels in Patients on Therapeutic Doses of Rivaroxaban

“…The drug has been used for stroke prevention in nonvalvular atrial fibrillation, 1 as treatment for pulmonary embolism 2 and symptomatic deep vein thrombosis, 3 for anticoagulation in recent ST-segment elevation myocardial infarction, 4 as thromboprophylaxis in patients after knee or hip replacement, 5 and in medically ill patients. 6 Rivaroxaban has predictable pharmacokinetics, is not affected by diet, is given at fixed doses, and does not require routine coagulation monitoring.…”