OBJECTIVE: The objective of this prespecified substudy of the AFFIRM study, in which no differences in survival or event rates were found in patients with atrial fibrillation (AF) randomized to either rate control or rhythm control, was to test the null hypothesis that quality of life (QoL) is equal with rate- versus rhythm-control treatment strategies in AF. METHODS:Fifty-six (25%) of AFFIRM sites were randomly selected to recruit AFFIRM patients for the QoL substudy. Instruments used in the QoL assessment were (1) Perceived Health; (2) the Cantril Ladder of Life; (3) the Short Form 36 survey; (4) the QoL Index; and (5) the Symptom Checklist: Frequency and Severity. Data were collected at baseline, 2 months, 12 months, and annually; data are reported through 4 years of follow-up. RESULTS: Baseline characteristics of the AFFIRM QoL patients (n = 716) were generally similar to those of the rest of AFFIRM patients. Quality-of-life scores were similar in rate- and rhythm-control assignment groups at all time points. Quality-of-life scores were similar whether the actual rhythm was sinus or AF. Scores increased from baseline to subsequent time points similarly for both groups; these improvements were not additive over time. CONCLUSIONS:Quality of life was comparable between rate- and rhythm-control treatment strategies. In addition, QoL was similar with sinus rhythm versus AF. Attempts to improve QoL by restoring sinus rhythm will usually be unsuccessful.
RCT Entities:
OBJECTIVE: The objective of this prespecified substudy of the AFFIRM study, in which no differences in survival or event rates were found in patients with atrial fibrillation (AF) randomized to either rate control or rhythm control, was to test the null hypothesis that quality of life (QoL) is equal with rate- versus rhythm-control treatment strategies in AF. METHODS: Fifty-six (25%) of AFFIRM sites were randomly selected to recruit AFFIRM patients for the QoL substudy. Instruments used in the QoL assessment were (1) Perceived Health; (2) the Cantril Ladder of Life; (3) the Short Form 36 survey; (4) the QoL Index; and (5) the Symptom Checklist: Frequency and Severity. Data were collected at baseline, 2 months, 12 months, and annually; data are reported through 4 years of follow-up. RESULTS: Baseline characteristics of the AFFIRM QoL patients (n = 716) were generally similar to those of the rest of AFFIRM patients. Quality-of-life scores were similar in rate- and rhythm-control assignment groups at all time points. Quality-of-life scores were similar whether the actual rhythm was sinus or AF. Scores increased from baseline to subsequent time points similarly for both groups; these improvements were not additive over time. CONCLUSIONS: Quality of life was comparable between rate- and rhythm-control treatment strategies. In addition, QoL was similar with sinus rhythm versus AF. Attempts to improve QoL by restoring sinus rhythm will usually be unsuccessful.
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