STREAM: Statin Discontinuation Noninferior in Older Adults Without CVD

Discontinuing statin therapy was noninferior to continuation for nonfatal myocardial infarction (MI), nonfatal ischemic stroke, or death at 2 years in adults aged 70 years or older with multiple chronic conditions and no known atherosclerotic cardiovascular disease, according to STREAM trial results presented at the American Heart Association (AHA) Scientific Sessions 2026 and published in the New England Journal of Medicine.¹

The 2-year restricted mean event-free survival time was 96.5 weeks with discontinuation and 98.5 weeks with continuation, a difference of −2.0 weeks (95% CI, −3.7 to −0.3; P < .001 for noninferiority) within the prespecified −5.2-week margin.¹

Over a median follow-up of 103 weeks, the primary outcome occurred in 12.7% (119/938) of the discontinuation group and 9.2% (87/942) of the continuation group (hazard ratio [HR], 1.38; 95% CI, 1.05–1.81). The investigators estimated 1 additional major cardiovascular event or death over 2 years for every 40 people who stopped statins.¹

“This small, increased risk of cardiovascular events means that one cannot make a general recommendation about stopping statins in this patient population,” said Rita F. Redberg, MD, MSc, FAHA, study author and professor of cardiology and the Araxe Vilensky Endowed Chair in Cardiology at the University of California, San Francisco School of Medicine. “There should be shared decision-making between the patient and the healthcare professional to know if it is appropriate for an individual to discontinue the medication. In general, however, discontinuation is safe for most people who are in this age group and without a previous CVD event.”²

STREAM trial design and statin discontinuation outcomes

The open-label, randomized, noninferiority trial with blinded outcome adjudication enrolled 1880 adults at 24 sites in Switzerland, the Netherlands, and France from November 2021 through April 2025. Eligible participants were at least 70 years of age, had taken statins for primary prevention for at least 1 year, and had at least 2 chronic conditions. Participants were randomized 1:1 to discontinue or continue statin and other lipid-lowering therapy.¹

Mean age was 77.5 years, 46.9% of participants were women, 53.5% were recruited by general practitioners, and 32.1% had diabetes. Within the first 2 years, MI occurred in 1.4% vs 0.6% of participants, ischemic stroke in 1.9% vs 0.8%, and death from any cause in 8.2% vs 6.9%. In a subsample of 235 participants, mean LDL cholesterol at 12 months was 176.0 mg/dL with discontinuation and 99.4 mg/dL with continuation.¹

Patient-centered outcomes, safety, and crossover in STREAM

The groups did not differ substantially in quality of life at 24 months, pain at 3 months, falls at 12 months, or sarcopenia risk at 24 months. At least 1 serious adverse event occurred in 43.0% of the discontinuation group and 39.8% of the continuation group.¹

After the trial concluded, the data and safety monitoring board recommended participants in the discontinuation group be advised to discuss restarting statin therapy with their physician.¹

During follow-up, 131 participants in the discontinuation group and 112 in the continuation group crossed over, and a tipping-point analysis indicated crossovers were unlikely to affect conclusions. Participants recruited by general practitioners appeared to be at greater risk after discontinuation, with a 3.4-week shorter event-free survival time vs 1.1 weeks among those recruited in hospitals.¹

The investigators cited the open-label design without placebo as a limitation.¹

“While the Association’s recent joint guideline recommends lifestyle and potentially medication for people with high LDL-C at younger ages to reduce the risk of heart attack and stroke, recent studies question the health benefits of continuing statins in the later decades of life,” said Redberg. “A few previous studies assessed the safety of discontinuing statins for primary prevention at age 70 and later, and they found no difference in mortality. One study suggested quality of life improvements after stopping statins. Whether it is safe to discontinue statins to prevent a first CVD event in the elderly remained unclear and the question we explored in our study.”²

A prior French trial of 1160 adults aged 75 years or older found statin discontinuation noninferior for death at 3 years, though its participants were healthier, with 3-year mortality of 7.5% vs 15.1% in STREAM. In STAREE, starting atorvastatin in older adults reduced major cardiovascular events without improving disability-free survival, findings the STREAM investigators said should not guide discontinuation decisions.^1,3

References

1. Rodondi N, Haller ML, Bardoczi JB, et al. Discontinuing statins in older adults without cardiovascular disease. N Engl J Med. Published online November 7, 2026. doi:10.1056/NEJMoa2606634

2. American Heart Association. Discontinuing statins generally safe for older adults without heart disease. Published November 7, 2026. Accessed November 7, 2026. https://newsroom.heart.org/news/discontinuing-statins-generally-safe-for-older-adults-without-heart-disease

3. HCPLive. STAREE: Statins reduce cardiovascular events but not disability in older adults. https://www.hcplive.com/view/staree-statins-reduce-cardiovascular-events-but-not-disability-in-older-adults. Published August 29, 2026. Accessed November 7, 2026.