title: Primary prevention of arterial thromboembolism in nonrheumatic atrial fibrillation: the PATAF trial study design.
abstract: Patients with nonrheumatic atrial fibrillation (NRAF) have a higher risk of thromboembolism than patients in sinus rhythm. Several trials have been conducted to establish the best preventive regimen in patients with NRAF, but not in the primary-care setting. The Primary Prevention of Arterial Thromboembolism in Nonrheumatic Atrial Fibrillation (PATAF) study, a primary-care-based trial, was set up to compare the preventive efficacy of low-intensity anticoagulation (AC), target range International Normalized Ratio (INR) 1.1 < INR < 1.6 and regular-intensity AC (2.5 < INR < 3.5) therapies with that of aspirin 150 mg/d for the occurrence of thromboembolism in NRAF patients. Patients eligible for regular-intensity AC were randomly assigned to aspirin at 150 mg/d, low-intensity AC, or regular AC in group I. In cases of noneligibility for regular AC, the trial randomized patients between aspirin and low-intensity AC (assigned to group II). Primary outcome events were stroke (including intracranial hemorrhage), systemic embolism, major hemorrhage, or vascular death. Analysis of the data was based on Cox regression to compute the hazard ratio (HR) with a 95% confidence interval, using the likelihood ratio test. The trial randomized 729 patients. Patient enrollment and follow-up has been stopped, and the final analysis is now complete. We shall publish the main results as soon as possible.
authors.affiliation: Department of General Practice, University of Maastricht, The Netherlands.
authors.forename: B S
authors.initials: BS
authors.lastname: Hellemons
authors.forename: M
authors.initials: M
authors.lastname: Langenberg
authors.forename: J
authors.initials: J
authors.lastname: Lodder
authors.forename: F
authors.initials: F
authors.lastname: Vermeer
authors.forename: H J
authors.initials: HJ
authors.lastname: Schouten
authors.forename: T G
authors.initials: TG
authors.lastname: Lemmens
authors.forename: J W
authors.initials: JW
authors.lastname: van Ree
authors.forename: J A
authors.initials: JA
authors.lastname: Knottnerus
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D001281:Atrial Fibrillation / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D011320:Primary Health Care; D013923:Thromboembolism / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D001241:Aspirin