Landi, Antonio; Alasnag, Mirvat; Heg, Dik; Frigoli, Enrico; Malik, Fazila Tun Nesa; Gomez-Blazquez, Ivan; Pourbaix, Suzanne; Chieffo, Alaide; Spaulding, Christian; Sainz, Fermin; Routledge, Helen; Andò, Giuseppe; Testa, Luca; Sciahbasi, Alessandro; Contractor, Hussain; Jepson, Nigel; Mieres, Juan; Imran, Syed Saqib; Noor, Husam; Smits, Pieter C; ... (2024). Abbreviated or Standard Dual Antiplatelet Therapy by Sex in Patients at High Bleeding Risk: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA cardiology, 9(1), pp. 35-44. American Medical Association 10.1001/jamacardio.2023.4316
Full text not available from this repository.IMPORTANCE
Abbreviated dual antiplatelet therapy (DAPT) reduces bleeding with no increase in ischemic events in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI).
OBJECTIVES
To evaluate the association of sex with the comparative effectiveness of abbreviated vs standard DAPT in patients with HBR.
DESIGN, SETTING, AND PATIENTS
This prespecified subgroup comparative effectiveness analysis followed the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs Standard DAPT Regimen (MASTER DAPT) trial, a multicenter, randomized, open-label clinical trial conducted at 140 sites in 30 countries and performed from February 28, 2017, to December 5, 2019. A total of 4579 patients with HBR were randomized at 1 month after PCI to abbreviated or standard DAPT. Data were analyzed from July 1 to October 31, 2022.
INTERVENTIONS
Abbreviated (immediate DAPT discontinuation, followed by single APT for ≥6 months) or standard (DAPT for ≥2 additional months, followed by single APT for 11 months) treatment groups.
MAIN OUTCOMES AND MEASURES
One-year net adverse clinical events (NACEs) (a composite of death due to any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCEs) (a composite of death due to any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding (MCB).
RESULTS
Of the 4579 patients included in the analysis, 1408 (30.7%) were women and 3171 (69.3%) were men (mean [SD] age, 76.0 [8.7] years). Ischemic and bleeding events were similar between sexes. Abbreviated DAPT was associated with comparable NACE rates in men (hazard ratio [HR], 0.97 [95% CI, 0.75-1.24]) and women (HR, 0.87 [95% CI, 0.60-1.26]; P = .65 for interaction). There was evidence of heterogeneity of treatment effect by sex for MACCEs, with a trend toward benefit in women (HR, 0.68 [95% CI, 0.44-1.05]) but not in men (HR, 1.17 [95% CI, 0.88-1.55]; P = .04 for interaction). There was no significant interaction for MCB across sex, although the benefit with abbreviated DAPT was relatively greater in men (HR, 0.65 [95% CI, 0.50-0.84]) than in women (HR, 0.77 [95% CI, 0.53-1.12]; P = .46 for interaction). Results remained consistent in patients with acute coronary syndrome and/or complex PCI.
CONCLUSIONS AND RELEVANCE
These findings suggest that women with HBR did not experience higher rates of ischemic or bleeding events compared with men and may derive particular benefit from abbreviated compared with standard DAPT owing to these numerically lower rates of events.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03023020.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology 04 Faculty of Medicine > Pre-clinic Human Medicine > Department of Clinical Research (DCR) |
UniBE Contributor: |
Heg, Dierik Hans, Valgimigli, Marco |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
2380-6583 |
Publisher: |
American Medical Association |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
23 Nov 2023 12:40 |
Last Modified: |
20 Feb 2024 14:15 |
Publisher DOI: |
10.1001/jamacardio.2023.4316 |
PubMed ID: |
37991745 |
URI: |
https://boris.unibe.ch/id/eprint/189295 |
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