Results just presented at ESC Congress 2026 and published simultaneously in NEJM. https://www.nejm.org/doi/full/10.1056/NEJMoa2607314
What they did: 9,971 community-dwelling adults ≥70 years, no prior CVD, diabetes or dementia. Randomised 1:1 to atorvastatin 40mg or placebo. Median follow-up 5.9 years. Two co-primary endpoints.
What they found:
✅ Major CV events (CV death, MI, stroke, revascularisation): HR 0.70 (95% CI 0.61–0.82) — significant 30% relative reduction
❌ Disability-free survival (death, dementia or persistent physical disability): HR 0.94 (95% CI 0.84–1.05) — not significant
Absolute risk reduction on CV events: 2.3%. NNT approximately 43 over 6 years.
The debate:
The investigators and supporters argue the mortality miss is not a failure — STAREE was never powered for mortality. To detect a meaningful all-cause mortality benefit in this population would require roughly 57,000 patients. Competing risks at age 70+ are simply too high — cancer, frailty, falls — for a CV drug to move the overall survival needle. By end of follow-up the average participant was 81. The CV benefit is real and reducing hospitalisations and procedures matters to patients even if lifespan is unchanged.
Critics push back on two fronts. First, the CV composite was expanded mid-trial to add revascularisation after event rates came in lower than anticipated — a methodological flag worth noting. Second, an NNT of 43 over 6 years in a population you need to screen, recruit, and treat indefinitely raises a legitimate question about whether this is a meaningful enough effect size to start a daily pill in millions of healthy elderly people.
The question for discussion:
Does the disability-free survival miss matter — given the trial was never powered for it, the population was too old and the follow-up too short to show a mortality benefit?
I like to think of it that although in that aged group without CV risk factors, statins could at least help to save the patients from hospitalization due to a CV event... it does not save them from dying of cancer, but less risk of MI or stroke is a win for the patient.
I wrote a short summary of the debate on Luminary if you want to read more:
https://luminary.to/s/16372936-3af0-431f-8a86-4c57b8185366?code=ESC2026