Jur Clancy posted an update 11 months, 3 weeks ago
The primary outcome in the main study was a composite of cardiovascular death, hospitalization for heart failure, stroke, systemic embolism, major bleeding, or arrhythmic events, including syncope, sustained ventricular tachycardia, cardiac arrest, life-threatening adverse effects of rate control drugs, and pacemaker or cardioverter-defibrillator implantation. The arrhythmic events were analyzed for the purpose of the present substudy as the occurrence of any composite arrhythmic endpoint. Both strategies were associated with a comparable rate of cardiovascular adverse events. Patients were excluded from the present analyses when they did not complete one of the QOL questionnaires during follow-up (64 patients in the lenient control 3-Methyladenine price group and 78 patients in the strict control arm). Patients who died during the study were also not included in the analysis (17 patients in the lenient control group and 18 in the strict control group). Minimum follow-up was 2 years, and maximal follow-up was 3 years. Median follow-up was 3 years (interquartile range [IQR]: 2.2 to 3.1 years). Results of the questionnaires at baseline, 12 months, and end of study are presented. Importantly, the 12 months of follow-up were the first measurement of QOL after the dose-adjustment phase. Baseline characteristics were comparable between the excluded patients and included patients. Baseline characteristics of the included patients are shown in Table 1. With the exception of a higher prevalence of coronary artery disease and use of statins in the lenient control group, baseline characteristics were comparable between groups. After the dose-adjustment phase, 98% of the patients in the lenient control group met the heart rate target versus 76% in the strict control group. Patients randomized to strict rate control used more and higher dosages of negative dromotropic drugs compared with the rate in the lenient control group (Table 1). During the total follow-up, heart rate was significantly higher in the lenient control group compared with the strict control group (after dose adjustment 93 ± 8 beats/min vs. 76 ± 11 beats/min; at 1 year 84 ± 13 beats/min vs. 74 ± 12 beats/min; at end of study 84 ± 14 beats/min vs. 75 ± 14 beats/min [all p < 0.05]). General health–related QOL was measured by using the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). The SF-36 is a standardized, validated, general health survey that has been used frequently in arrhythmia studies (14). The SF-36 has been translated and validated in the Netherlands (15). It contains items to assess physical health (general health perception, physical functioning, and role limitations due to physical problems and bodily pain) and mental health (social functioning, role limitations due to emotional problems, mental health, and vitality).