Rossella Baggetta a, n , Davide Bolignano a, n , Claudia Torino a , Fabio Manfredini b , Filippo Aucella c , Antonio Barillà d , Yuri Battaglia d , Silvio Bertoli e , Graziella Bonanno f , Pietro Castellino g , Daniele Ciurlino e , Adamasco Cupisti h , Graziella D'Arrigo a , Luciano De Paola i , Fabrizio Fabrizi j , Pasquale Fatuzzo f , Giorgio Fuiano l , Luigi Lombardi i , Gaetano Lucisano l , Piergiorgio Messa j , Renato Rapanà k , Francesco Rapisarda f , Stefania Rastelli g , Lisa Rocca-Rey e , Chiara Summaria l , Alessandro Zuccalà k , Samar Abd ElHafeez m , Giovanni Tripepi a , Luigi Catizone d , Francesca Mallamaci a , Carmine Zoccali a
29 July 2014
Background/Aims: In this corollary analysis of the EXCITE study, we looked at possible differences in baseline risk factors and mortality between subjects excluded from the trial because non-eligible (n=216) or because eligible but refusing to participate (n=116). Methods: Baseline characteristics and mortality data were recorded. Survival and independent predictors of mortality were assessed by Kaplan-Meier and Cox regression analyses. Results: The incidence rate of mortality was higher in non-eligible vs. eligible non-randomized patients (21.0 vs. 10.9 deaths/100 persons-year; P<0.001). The crude excess risk of death in non-eligible patients (HR 1.96; 95% CI 1.36 to 2.77; P<0.001) was reduced after adjustment for risk factors which differed in the two cohorts including age, blood pressure, phosphate, CRP, smoking, diabetes, triglycerides, cardiovascular comorbidities and history of neoplasia (HR 1.60; 95% CI 1.10 to 2.35; P=0.017) and almost nullified after including in the same model also information on deambulation impairment (HR 1.16; 95% CI 0.75 to 1.80; P=0.513). Conclusions: Deambulation ability mostly explains the difference in survival rate in non-eligible and eligible non-randomized patients in the EXCITE trial. Extending data analyses and outcome reporting also to subjects not taking part in a trial may be helpful to assess the representability of the study population.