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. 2023 Jan 6;9:1050744. doi: 10.3389/fcvm.2022.1050744

TABLE 1.

Summary of strategies for emulating target trial.

Components Target trial (EAST-AFNET4) This study
Inclusion period 28 July 2011 – 30 December 2016 1 January 2005 – 31 December 2015
Eligibility criteria 1) Adults (≥18 years of age) who were older than 75 years of age, had had a previous transient ischemic attack or stroke, or met two of the following criteria: age greater than 65 years, female sex, heart failure, hypertension, diabetes mellitus, severe coronary artery disease, chronic kidney disease, and left ventricular hypertrophy
2) Early AF (diagnosed ≤12 months before enrollment)
1) Selected older adults (≥65 years of age) that received a rhythm-control or rate-control treatments and have no prior history of prescriptions and no records of ablation in the database who were older than 75 years of age, had a previous transient ischemic attack or stroke, or met two of the following criteria: age greater than 65 years, female sex, heart failure, hypertension, diabetes mellitus, myocardial infarction, and chronic kidney disease
2) Early AF (defined as AF diagnosed ≤12 months before enrollment)
3) Undergoing oral anticoagulation (>90 days of supply within 180 days after their first recorded prescription of rhythm- or rate-control medications or ablation procedure)
Exposed group Rhythm control: antiarrhythmic drugs, AF ablation, cardioversion of persistent AF, to be initiated early after randomization Rhythm control: a prescription of more than a 90-day supply of any antiarrhythmic drugs in the 180-day period since the first prescription or the performance of an ablation procedure for AF.
Unexposed group Usual care: initially treated with rate-control therapy without rhythm-control therapy Rate control: a prescription of more than a 90-day supply of any rate-control drugs in the 180-day period since the first prescription and with no prescription of rhythm-control drug and no ablation within this period. Patients prescribed rhythm-control drugs for more than 90 days or who underwent ablation within the 180-day period since the initiation of rate-control drugs were classified as intention-to-treat with rhythm control.
Primary outcome 1) A composite of death from cardiovascular causes, stroke, or hospitalization with worsening of heart failure or acute coronary syndrome
2) The number of nights spent in the hospital per year.
1) A composite of death from cardiovascular causes, ischemic stroke, hospitalization for heart failure, or acute myocardial infarction
2) The number of nights spent in the hospital per year.
Secondary outcome Each component of the primary outcome, rhythm, left ventricular function, quality of life, AF-related symptom Each component of the primary outcome
Safety outcome A composite of death from any cause, stroke, or pre-specified serious adverse events of special interest capturing complications of rhythm-control therapy A composite of death from any cause, intracranial or gastrointestinal bleeding requiring hospitalization, or pre-specified serious adverse events of special interest capturing complications of rhythm control
Follow-up From randomization until the end of the trial, death, or withdrawal from the trial. From 180 days after their first recorded prescription or procedure to avoid immortal time bias until the end of follow-up of the database (31 December 2016) or death.