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The FRAGILE Clinical Trial: The Impact of the Coronary Artery Bypass Graft in Frailty
The elderly population is exponentially increasing worldwide, leading to a higher incidence of coronary artery disease. The growing number of elderly patients is closely related to a higher incidence of frailty. Despite frailty being a known predictor of increased mortality and morbidity, there is a lack of evidence regarding the outcomes of coronary artery bypass grafting (CABG) in frail patients.
The FRAGILE trial is a Brazilian multicenter, randomized, controlled clinical trial that analyzed 169 patients aged over sixty years who underwent on-pump and off-pump CABG. In this subanalysis of the FRAGILE trial, patients were divided into two groups for statistical comparisons: off-pump (n= 87) and on-pump CABG (n= 82). Based on the Fried's frailty criteria, patients were classified as frail, pre-frail, and non-frail. Unintentional weight loss, self-reported fatigue, physical activity level, grip strength, and gait speed before and after surgery were compared between the off-pump and on-pump study groups. Patients who were non-frail before surgery were excluded from the analysis.
Patients' frailty was positively impacted by CABG six months following surgery. Overall, more than 50 percent of frail patients became pre-frail after CABG, and only 3 percent of the total patients were classified as frail six months following surgery. Patients reported more total time of physical activity, less fatigue, and an improved gait speed after surgery. Moreover, patients from the off-pump CABG group improved their grip strength and presented with less unintentional weight loss.