Due to bleeding concerns, extended thromboprophylaxis was not commonly used in critically sick medical patients. The MAGELLAN (Multicenter, Randomized, Parallel-Group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin) and MARINER (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk) trials compared rivaroxaban to enoxa. Researchers expected that patients with substantial bleeding, but not those with little but clinically significant bleeding, would have a higher risk of all-cause death (ACM).
All bleeding episodes in patients who received at least one dosage of the study medicine were categorized into four groups: no bleeding, nonmajor clinically significant bleeding, major bleeding, or trivial hemorrhage. Investigators examined the probability of ACM following such incidents using a Cox proportional hazards model that was adjusted for baseline factors associated with ACM.
Patients with nonmajor clinically significant bleeding had a lower risk of ACM in MARINER (hazard ratio, 0.43; P=0.235) but a higher risk of ACM in MAGELLAN (hazard ratio, 1.74; P=0.021). Both investigations found that major bleeding was linked to an increased risk of ACM, but minor bleeding was not. Major bleeding was related to a higher risk of ACM, while nonmajor clinically significant bleeding was not consistently linked to an increased risk of mortality. The findings helped doctors weigh the risks and benefits of prolonged thromboprophylaxis in medically sick patients.
Reference:www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.057847
