The FRAGILE clinical trial: the impact of the coronary artery bypass graft in frailty
Authors: Mejia O A V , Meneghini B , Freitas F L , Hoeflinger L C F , Guerrieri M L J , Hueb A C , Cosentino F , Segalote R , Ribas F F , Oliveira M A P , Deininger M O , Dallan L R , Lisboa L A F , Dallan L A O , Jatene F B 
Published: November 2023

Abstract

Background
The exponential increase in the elderly population has been observed worldwide, and it implies a higher incidence of coronary artery disease and, consequently the need for coronary artery bypass graft (CABG). The growing number of elderlies is also related to frailty, a syndrome that affects at least 10% of the elderly population and is an exceedingly effective parameter for correlating with the adverse effects of aging. The impact of frailty concerning mortality and morbidity is well established however, there are no studies regarding the outcomes of CABG and its techniques in frail patients.

Purpose
To evaluate the impact of coronary artery bypass graft surgery in patient's frailty and compare the differences in the frailty index after a 6-month follow-up between the groups off-pump and on-pump.

Methods
This was a subanalysis of the FRAGILE trial, a brazilian multicenter, randomized, controlled clinical trial that analyzed 169 patients aged 60 years or older undergoing coronary artery bypass graft surgery with (on-pump) and without (off-pump) cardiopulmonary bypass. Using the Fried's Frailty Criteria, we classifed the patients into frail, pre-frail, and non-frail and also evaluated the five paramenters of this criteria. The patients were divided into two groups: the off-pump CABG group (n=87) and the on-pump CABG group (n=82), and compared unintentional weight loss, self-reported fatigue, physical activity level, grip strength, and gait speed before and after surgery, and between groups. The study was approved by the local Ethics Committee and all patients signed the informed consent.

Results
We observed an improvement in the frailty of patients undergoing CABG. Overall, over 50% of frail patients became pre-frail after CABG, and only 3% of the total patients were classified as frail after 6 months of surgery (Fig 1A). No patient was classified as non-frail preoperatively in both groups because it was one of the exclusion criteria. There is no difference between the groups off-pump and on-pump (Fig 1B). The total time of physical activity, the gait speed, and the self-reported fatigue were positively impacted regardless of surgical technique. However, grip strength and unintentional weight loss were improved only in the group that underwent off-pump CABG surgery. Patients reported practicing an average more time of exercises, improved gait speed, and claimed to be less fatigated compared to the before-surgery measurements. However, grip strength and unintentional weight loss were improved only in the group that underwent off-pump CABG surgery (Table 1).

Conclusion
CABG positively impacts patients' frailty after six months of surgery. Both techniques, on-pump and off-pump, showed positive results when comparing frailty features before and after CABG surgery. Nevertheless, the off-pump CABG was the only technique that played a role in improving grip strength and unintentional weight loss of patients after 6 months of surgery.Frailty classificationFrailty's parameters