- Design
- Post hoc analysis of a randomised trial by FRAIL scale category
- Population
- 1222 patients after transcatheter aortic valve implantation (47.2% frail)
- Primary outcome
- All-cause death or worsening heart failure at one year
- Effect
- Frail HR 0.53 (0.36 to 0.77); prefrail 1.01; robust 1.26; interaction P = 0.021
DapaTAVI randomised patients after transcatheter aortic valve implantation to dapagliflozin or standard care. This post hoc analysis grouped 1222 patients by the FRAIL scale: 47.2% were frail, 40.3% prefrail and 12.4% robust. Over a year, 17.6% died or had worsening heart failure.
Frailty predicted the outcome: compared with robust patients, the adjusted hazard was 1.88 for prefrail and 2.29 for frail. Dapagliflozin was associated with a lower hazard in frail patients (HR 0.53, 95% CI 0.36 to 0.77), but not in prefrail (1.01) or robust patients (1.26), with a significant interaction (P = 0.021). Safety did not differ by frailty.
This is a post hoc subgroup analysis and needs confirmation. But it runs against the instinct to withhold additional drugs from frail older patients: the group most at risk appeared to gain most. The FRAIL scale takes a minute and is worth recording before and after valve intervention.
- Score frailty with the FRAIL scale in older patients before and after TAVI.
- Do not withhold dapagliflozin after TAVI solely because a patient is frail; the frail group appeared to benefit most.
- Check renal function, volume status and genital hygiene when starting an SGLT2 inhibitor in frail older adults.
- Review the whole drug list when adding a medicine, to keep the total burden manageable.
Why it matters
It challenges the assumption that frail patients gain least from added cardiovascular therapy.
Don't overread it
A post hoc subgroup analysis; the benefit in frail patients needs confirmation in a prospective trial.
The statistics, in plain English
A hazard ratio of 0.53 means the event rate was roughly halved in frail patients on dapagliflozin. An interaction P of 0.021 suggests the effect differed by frailty, but subgroup findings that were not the trial's main question are more often due to chance.
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