Study design

We conducted a secondary analysis of the ACCORD study, a double 2-by-2 randomized factorial trial that enrolled 10,251 participants from January 2001 to October 2005 from 77 centers in the United States and Canada. Participants were aged 40 to 79 years (with a history of cardiovascular disease [CVD]) or 55 to 79 years (with significant albuminuria, atherosclerosis, left ventricular hypertrophy, or a minimum of 2 CVD risk factors). They were randomly allocated to receive either an intensive glucose-lowering intervention with a glycated hemoglobin (HbA_1C) goal <6% or standard glycemic treatment aiming for an HbA_1C of 7.0% to 7.9%. Additionally, 5,518 participants were randomly assigned to either simvastatin plus fenofibrate or simvastatin plus placebo (ACCORD lipid trial), and the remaining 4,733 were randomized to either an intensive BP arm with a systolic BP (SBP) goal of <120 mm Hg or a standard BP arm with a SBP goal of <140 mm Hg (ACCORD BP trial). The full details about the rationale and design of ACCORD have been published elsewhere.¹⁷

We excluded participants with a history of AF/missing AF status at baseline (n = 171), missing AF status at follow-up (n = 769), or <5 BP measurements (n = 912) during the initial 24 months (BP variability assessment period). We included participants with ≥5 BP visits due to evidence showing the visit-to-visit variability of BP increases with the number of visits used for its calculation.¹⁸

The research protocol was approved by the institutional review board at all the participating centers, and each participant gave an informed consent.¹⁷