Multicenter Prospective Observational Double Cohort Study to Evaluate the Associations between Clinical Characteristics and Use of ORAL Anticoagulants in Italian Elderly Patients Suffering from NVAF. Presbus Study Design
Author(s)
Tommasi C1, Toma C1, Vetta F2, Marchionni N3, Antonelli Incalzi R4, Fimognari FL5, Boccanelli A6, Bo M7
1Bristol Myers Squibb Company, Rome, Italy, 2Italian Society Of Hospital And Community Geriatrics (SIGOT), Rome, Italy, 3Careggi Hospital, Florence, Italy, 4Italian Society of Gerontology and Geriatric (SIGG), Florence, Italy, 5Italian Society Of Hospital Geriatrician (SIGOT), Rome, Italy, 6Italian Society of Geriatric Cardiology (SICGe), Florence, Italy, 7Molinette Hospital, Turin, Italy
Background: To provide real-world data useful to address the question: “What factors are associated with the use of oral anticoagulants in elderly patients affected by Non Valvular Atrial Fibrillation (NVAF) in Italy, and what is the persistence rate over one year?” OBJECTIVES: Primary objectives Cross-sectional Phase: to evaluate the possible association between clinical characteristics and use or non-use of oral anticoagulants at enrollment in patients suffering from NVAF in Italian geriatric centers in a real-world setting. Longitudinal Phase: to describe persistence to treatment during a 12-month follow-up period in patients receiving and not receiving oral anticoagulants at enrollment. Secondary objectives Cross-sectional Phase: evaluation of the factors associated to the type of oral anticoagulant treatment administered to the patients enrolled in the study. Longitudinal Phase: (1) description of the pattern of use of DOACs during a 12-month follow-up period; (2) description of hospitalizations occurred during a 12-month follow-up period, in terms of number, type, duration, causes/diagnosis; (3) description of safety events during a 12-month follow-up period, especially in terms of net clinical outcomes intended as occurrence of stroke, systemic embolism, major bleeding, or death from any cause. METHODS: Observational, multi-center, prospective cohort study, on elderly patients with NVAF and indication to oral anticoagulation. Two cohorts of patients will be identified: patients receiving oral anticoagulants (OA) at enrollment and patients who are not (Not-OA) without any predetermined proportion between the two groups. STUDY POPULATION: 720 patients aged ≥75 years managed in Italian geriatric departments, with diagnosis of NVAF, naïve to anticoagulant treatments or not having received anticoagulantion during the 6 months prior to enrollment. Exclusion criteria: valvular AF due to artificial heart valve; other medical conditions requiring anticoagulantion (such as deep vein thrombosis or pulmonary embolism); inclusion in any clinical trial; inappropriate DOAC dosage based on the current SmPC for any drugs.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Value in Health, Volume 23, Issue S2 (December 2020)
Code
PDG7
Disease
Cardiovascular Disorders, Drugs, Geriatrics