Abstract
IntroductionPatients (pts) enrolled in CRT trials have a low reported baseline quality of life (QoL); however, these trials have enrolled primarily men. The AdaptResponse trial is the first large CRT trial well represented with women. Accordingly, the present analysis was designed to assess the relationship between gender and other patient characteristics and QoL.MethodsThe AdaptResponse trial enrolled CRT indicated pts with NYHA Class II-IV HF, LBBB (QRS ≥140 ms in men, ≥130 ms in women), and baseline PR interval ≤200ms. Multivariable linear regression was used to assess the relation of baseline Kansas City Cardiomyopathy Questionnare (KCCQ) overall summary score and patient characteristics. Backward selection was used on an initial model with 31 variables and gender interactions. Height and key comorbidities were added back to the model.ResultsThere were 3620 pts randomized in 226 centers worldwide, including 1569 (43.3%) women. Women had a significantly lower score on most KCCQ domains (Figure), such as in the Physical Limitation (62.4 ± 25.1 versus 72.3 ± 24.3, p<0.001) and in the Clinical Summary domain (63.3 ± 23.1 versus 72.4 ± 22.1, p<0.001). Several clinical characteristics were associated with a lower KCCQ overall summary score, especially higher NYHA class, chronic lung disease, depression, previous HF hospitalization and loop diuretic use (Table). Multivariable analysis showed that women have a 4.89 points lower score than men (p<0.0001).ConclusionWomen undergoing CRT have important differences from men with regard to patient characteristics and baseline QoL. The impact of these differences on clinical outcomes will be evaluated in the AdaptResponse trial.