Study findings raise questions about the inclusion of sepsis bundle in the CMS value program

Embargoed for release until 5:00 p.m. ET on Monday 17 February 2025   

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Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.         
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1. Study findings raise questions about the inclusion of sepsis bundle in the CMS value program

CMS-implemented sepsis bundle not associated with overall mortality in patients

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-24-02426

URL goes live when the embargo lifts          

A systematic review assessed compliance or implementation of the Centers for Medicare & Medicaid Services (CMS) Severe Sepsis and Septic Shock Management Bundle (SEP-1) and its association with sepsis mortality. The study found no moderate-to-high evidence that SEP-1 compliance or implementation was associated with improved mortality. The results suggest the inclusion of SEP-1 in the Hospital Value-Based Purchasing (VBP) Program should be reconsidered. The review is published in Annals of Internal Medicine.

Researchers from the University of California San Diego and colleagues studied data from 17 observational studies of adults with sepsis, severe sepsis or septic shock that included three- or six-hour sepsis bundles defined by SEP-1 specifications. The two principal questions the review aimed to answer were: Is there evidence that SEP-1 compliance (patient level) is associated with improvement in sepsis mortality, and 2/ is there evidence that SEP-1 implementation (system level) is associated with improvement in sepsis mortality? Of the 17 studies reviewed, 12 assessed the effect of SEP-1 compliance on mortality. Five of these studies showed a mortality benefit in at least one subgroup and six found no association between compliance and mortality. Five studies assessed the effect of SEP-1 implementation on mortality, with one study showing a survival benefit and four showing no association between mortality and implementation. To the authors’ knowledge, this is the first review to evaluate the level of evidence for the effect of both SEP-1 compliance and implementation on mortality. Overall, the researchers found no moderate-to-high level evidence that SEP-1 compliance or implementation is associated with sepsis mortality. They also note that some population subgroups, like Medicare beneficiaries and septic shock patients, could see a mortality benefit. However, until higher quality evidence supporting SEP-1 is available, the researchers recommend that the addition of SEP-1 into the Hospital VBP program should be reconsidered.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author James S. Ford, MD, MAS, please email Stephanie Healey at s2healey@ucsd.edu.

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2. Ticagrelor monotherapy associated with lower risk of bleeding, without increase in ischemic events than standard dual antiplatelet therapy in patients with acute coronary syndrome

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-24-03102

URL goes live when the embargo lifts           

A systematic review and meta-analysis compared the efficacy and safety of de-escalating dual antiplatelet therapy (DAPT) to ticagrelor monotherapy versus standard DAPT in patients with acute coronary syndrome (ACS) undergoing drug-eluting stint (DES). The results found that de-escalating DAPT to ticagrelor monotherapy was associated with a lower risk for major bleeding, with no increase in ischemic events. The review is published in Annals of Internal Medicine. 

Researchers from Yonsei University College of Medicine, Nanjing Medical University and colleagues studied data from three randomized controlled trials comprising of 9,130 patients with ACS undergoing DES implantation. Current guidelines recommend ACS patients undergoing DES implementation receive 12 months of DAPT with aspirin and a P2Y12 inhibitor, however, prolonged use of DAPT carries an increased risk of bleeding complications. The researchers aimed to demonstrate the efficacy and safety of de-escalating DAPT to ticagrelor monotherapy on bleeding ischemic events. Of the ACS patients included in the analysis, 3,132 had ST-segment elevation myocardial infarction (STEMI), 2,023 had non-STEMI (NSTEMI) and 2,975 had unstable angina. About half of the patients were randomly assigned to de-escalating DAPT to ticagrelor monotherapy, and the remaining half were assigned to standard DAPT. The researchers found that compared with standard DAPT, de-escalating DAPT to ticagrelor monotherapy was associated with a lower risk for major bleeding without increasing the risk for ischemic events. These effects were consistent across various subgroups, including different ACS types. The findings suggest that de-escalating DAPT to ticagrelor monotherapy in patients with ACS undergoing DES implantation could be a feasible treatment option to avoid aspirin-associated major bleeding. 

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding authors Myeong-Ki Hong, MD and Shao-Liang Chen, please email Yong-Joon Lee, MD, PhD at alpha10000@yuhs.ac.  

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Also new in this issue:

The Target Trial Framework for Causal Inference From Observational Data: Why and When Is It Helpful?

Miguel A. Hernán, MD, DrPH; Issa J. Dahabreh, MD, ScD; Barbra A. Dickerman, PhD; and Sonja A. Swanson, ScD

Research and Reporting Methods

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-24-01871