Key result
Major bleeding during extended thromboprophylaxis was associated with a higher incidence of all-cause mortality, whereas nonmajor clinically relevant bleeding was not consistently associated.
Why the study?
Extended thromboprophylaxis has not been widely implemented in acutely ill medical patients due to bleeding concerns, prompting an evaluation of how bleeding severity associates with all-cause mortality.
Does bleeding severity affect all-cause mortality in medically ill patients receiving extended thromboprophylaxis?
RCT
Parallel Group
Yes
Does bleeding severity affect all-cause mortality in medically ill patients receiving extended thromboprophylaxis?
In medically ill patients receiving extended thromboprophylaxis, major bleeding is associated with increased all-cause mortality, whereas nonmajor clinically relevant bleeding is not consistently associated with death.
Answers are grounded in this paper and cite their sources.
Major bleeding signals higher mortality during extended thromboprophylaxis; leaves open whether mitigation improves survival in randomized trials.
BACKGROUND: Extended thromboprophylaxis has not been widely implemented in acutely ill medical patients because of bleeding concerns. 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 evaluated whether rivaroxaban compared with enoxaparin or placebo could prevent venous thromboembolism without increased bleeding. We hypothesized that patients with major bleeding but not those with nonmajor clinically relevant bleeding would be at an increased risk of all-cause mortality (ACM). METHODS: We evaluated all bleeding events in patients taking at least 1 dose of study drug and their association with ACM in 4 mutually exclusive groups: (1) no bleeding, or first event was (2) nonmajor clinically relevant bleeding, (3) major bleeding, or (4) trivial bleeding. Using a Cox proportional hazards model adjusted for differences in baseline characteristics associated with ACM, we assessed the risk of ACM after such events. Major bleeding was associated with a higher incidence of ACM in both studies, whereas trivial bleeding was not associated with ACM in either study. CONCLUSIONS: Patients with major bleeding had an increased risk of ACM, whereas nonmajor clinically relevant bleeding was not consistently associated with an increased risk of death. These results inform the risk-benefit calculus of extended thromboprophylaxis in medically ill patients. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: MAGELLAN, NCT00571649. URL: https://www. CLINICALTRIALS: gov; Unique identifier: MARINER, NCT02111564.
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Spyropoulos et al. (2022) conducted an RCT in Acutely ill medical patients. Rivaroxaban vs. Enoxaparin or placebo was evaluated on All-cause mortality (p==0.021). Major bleeding during extended thromboprophylaxis was associated with a higher incidence of all-cause mortality, whereas nonmajor clinically relevant bleeding was not consistently associated.
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