Rivaroxaban has no net clinical benefit over enoxaparin for thromboprophylaxis in acutely ill patients

Feb 6th – NEJM – Extended-duration rivaroxaban was superior to standard-duration enoxaparin for thromboprophylaxis, but was associated with increased bleeding risk.

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1. Standard-duration rivaroxaban had no net clinical benefit over standard-duration enoxaparin for thromboprophylaxis in acutely ill hospitalized patients.

2. Extended-duration rivaroxaban was superior to standard-duration enoxaparin for thromboprophylaxis, but was associated with increased bleeding risk.

Preventing thromboembolism in acutely ill hospitalized patients is a balancing act between reducing clot formation and the increasing bleeding risk. As some studies have shown the risk of thromboembolism persists after discharge from the hospital, this study compared thromboprophylaxis with standard-duration enoxaparin vs. extended-duration rivaroxaban

For preventing thromboembolism, rivaroxaban was non-inferior to enoxaparin over the standard-duration, and superior to enoxaparin over the extended-duration. However, rivaroxaban was also associated a higher risk of clinically relevant bleeding compared to enoxaparin. The study did not establish a net clinical benefit of choosing rivaroxaban over enoxaparin after accounting for both efficacy and safety.

This study affirms that an optimal treatment for thromboprophylaxis has yet to emerge. Better patient stratification based on bleeding risks is needed in order to maximize the clinical benefit of rivaroxaban.

Click to read the study in NEJM

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1. Rivaroxaban had no net clinical benefit over enoxaparin for short-term thromboprophylaxis in acutely ill hospitalized patients.

2. Extended-duration rivaroxaban was superior to standard-duration enoxaparin for thromboprophylaxis, but was associated with increased bleeding risk.

This [randomized, double-blind] trial compared rivaroxaban to enoxaparin for thromboprophylaxis in hospitalized patients.

Patients were randomly assigned one of two treatment regimens – the enoxaparin group received enoxaparin sub-Q 40 mg qd for 10±4 days (and PO placebo for 35±4 days); the rivaroxaban group received rivaroxaban PO 10 mg qd for 35±4 days (and subQ placebo for 10±4 days).

In efficacy outcome analyses, at 10±4 days, rivaroxaban was non-inferior to enoxaparin (RR 0.97; 95% CI, 0.71 to 1.31, P=0.003 for non-inferiority). Over the extended duration of 35±4 days, rivaroxaban was superior to enoxaparin (RR 0.77; 95% CI, 0.62 to 0.96, P=0.02).

In safety outcome analyses, the rivaroxaban cohort had an increased bleeding risk during both day 1 to 10 (RR 2.3; 95% CI, 1.63 to 3.17, P<0.001) and day 1 to 35 (RR 2.5; 95% CI, 1.85 to 3.25, P<0.001).

Combining efficacy and safety, the study found no net clinical benefit of rivaroxaban over enoxaparin.

In sum: Preventing thromboembolism in acutely ill hospitalized patients is a balancing act between reducing clot formation and the increasing bleeding risk. As some studies have shown the risk of thromboembolism persists after discharge from the hospital, this study compared thromboprophylaxis with standard-duration enoxaparin vs. extended-duration rivaroxaban

For preventing thromboembolism, rivaroxaban was non-inferior to enoxaparin over the standard-duration, and superior to enoxaparin over the extended-duration. However, rivaroxaban was also associated a higher risk of clinically relevant bleeding compared to enoxaparin. The study did not establish a net clinical benefit of choosing rivaroxaban over enoxaparin after accounting for both efficacy and safety.

This study affirms that an optimal treatment for thromboprophylaxis has yet to emerge. Better patient stratification based on bleeding risks is needed in order to maximize the clinical benefit of rivaroxaban.

Click to read the study in NEJM

By Xiaozhou Liu and Mitalee Patil

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