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Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy
M. Valgimigli, E. Frigoli, P. Vranckx, Y. Ozaki, MC. Morice, B. Chevalier, Y. Onuma, S. Windecker, L. Delorme, P. Kala, S. Kedev, RK. Abhaichand, V. Velchev, W. Dewilde, J. Podolec, G. Leibundgut, D. Topic, C. Schultz, G. Stankovic, A. Lee, T....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, randomizované kontrolované studie, práce podpořená grantem
NLK
Free Medical Journals
od 1983 do Před 1 rokem
Open Access Digital Library
od 1998-01-01
- MeSH
- adherence k farmakoterapii MeSH
- inhibitory agregace trombocytů terapeutické užití MeSH
- kombinovaná farmakoterapie MeSH
- koronární angioplastika * metody MeSH
- krvácení chemicky indukované farmakoterapie epidemiologie MeSH
- lidé MeSH
- polymery MeSH
- stenty uvolňující léky * škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: Nonadherence to antiplatelet therapy after percutaneous coronary intervention (PCI) is common, even in clinical trials. OBJECTIVES: The purpose of this study was to investigate the impact of nonadherence to study protocol regimens in the MASTER DAPT (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen) trial. METHODS: At 1-month after PCI, 4,579 high bleeding risk patients were randomized to single antiplatelet therapy (SAPT) for 11 months (or 5 months in patients on oral anticoagulation [OAC]) or dual antiplatelet therapy (DAPT) for ≥2 months followed by SAPT. Coprimary outcomes included net adverse clinical events (NACE), major adverse cardiac and cerebral events (MACE), and major or clinically relevant nonmajor bleeding (MCB) at 335 days. Inverse probability-of-censoring weights were used to correct for nonadherence Academic Research Consortium type 2 or 3. RESULTS: In total, 464 (20.2%) patients in the abbreviated-treatment and 214 (9.4%) in the standard-treatment groups incurred nonadherence Academic Research Consortium type 2 or 3. At inverse probability-of-censoring weights analyses, NACE (HR: 1.01; 95% CI: 0.88-1.27) or MACE (HR: 1.07; 95% CI: 0.83-1.40) did not differ, and MCB was lower with abbreviated compared with standard treatment (HR: 0.51; 95% CI: 0.60-0.73) consistently across OAC subgroups; among OAC patients, SAPT discontinuation 6 months after PCI was associated with similar MACE and lower MCB (HR: 0.47; 95% CI: 0.22-0.99) compared with SAPT continuation. CONCLUSIONS: In the MASTER DAPT adherent population, 1-month compared with ≥3-month DAPT was associated with similar NACE or MACE and lower MCB. Among OAC patients, SAPT discontinuation after 6 months was associated with similar MACE and lower MCB than SAPT continuation (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).
1st Department of Cardiology University of Medical Sciences Poznan Poland
Cardiologie et Maladies Vasculaires AIHP ACCAHP Clinique du Pont De Chaume Montauban Cedex France
Cardiology Cantonal Hospital Baselland Liestal Switzerland
Cardiology Clinic St Anna University Hospital Sofia Sofia Medical University Sofia Bulgaria
Cardiovascular European Research Center and ICPS Ramsay General de santé Massy France
CTU Bern University of Bern Bern Switzerland
Department of Cardiology Bern University Hospital Bern Switzerland
Department of Cardiology Catharina Hospital Eindhoven the Netherlands
Department of Cardiology Maasstad Hospital Rotterdam the Netherlands
Department of Cardiology The Wollongong Hospital Wollongong New South Wales Australia
Duke Clinical Research Institute Duke University School of Medicine Durham North Carolina USA
G Kuppuswamy Naidu Memorial Hospital Coimbatore India
Imelda Hospital Bonheiden Belgium
National University of Ireland Galway Ireland
University Clinic of Cardiology Medical Faculty University St Cyril and Methodius Skopje Macedonia
University Hospital Brno and Medical Faculty of Masaryk University Brno Czech Republic
University Hospitals Bristol and Weston NHS Foundation Trust Bristol United Kingdom
Citace poskytuje Crossref.org
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