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STREAM Trial: Stopping Statins in Adults Over 70 Met Noninferiority but Brought More Heart Attacks, Strokes and Deaths

In a peer-reviewed NEJM trial of 1,880 older adults on statins for primary prevention, the primary outcome occurred in 12.7% of those who stopped versus 9.2% of those who continued.

By THE COLDAI TIMES desk (AI-assisted)Editor: Dr. Shayan Salehi H.C.Published 5 min read1,056 words
Contextual file photo of rosuvastatin tablets, a statin; the STREAM trial report does not name the statins its participants took.
Contextual file photo of rosuvastatin tablets, a statin; the STREAM trial report does not name the statins its participants took. — Mk2010 · Crestor Tablets (rosuvastatin).jpg · Wikimedia Commons · CC BY-SA 4.0

Key facts

  • The STREAM trial randomised 1,880 adults aged 70 or older who took statins for primary prevention, with 938 assigned to stop and 942 to continue, at 24 centres in Switzerland, the Netherlands and France.[1][2]
  • Over a median follow-up of 103 weeks, the STREAM primary outcome of non-fatal heart attack, non-fatal ischaemic stroke or death occurred in 12.7% of participants who stopped statins and 9.2% of those who continued.[2][3]
  • The STREAM investigators reported a 2.0-week difference in two-year event-free survival, inside a prespecified noninferiority margin of 5.2 weeks, and a hazard ratio of 1.38 (95% CI 1.05 to 1.81).[2]
  • STREAM was an open-label trial published in the New England Journal of Medicine on 7 November 2026 at the American Heart Association Scientific Sessions, while the AHA says the conference abstract itself is not peer-reviewed.[1][2]
  • The STREAM data and safety monitoring board recommended that participants who stopped statins discuss restarting them with their physicians.[2]

Stopping statins in people aged 70 and older who take them for primary prevention was statistically noninferior to continuing them over two years, but it came with more heart attacks, strokes and deaths, according to the STREAM trial presented at the American Heart Association (AHA) Scientific Sessions in Chicago on 7 November 2026. The randomised trial of 1,880 adults, published the same day in the New England Journal of Medicine, found the primary outcome in 12.7% of those who stopped versus 9.2% of those who continued, according to HCPLive's report on the paper.

The result is a peer-reviewed full paper, not a preprint or a company announcement, although the AHA's own release notes that the conference abstract itself is not peer-reviewed and calls the findings preliminary.

What did the STREAM trial test?

STREAM enrolled adults aged 70 or older, with a mean age of about 77, who had been on a statin for at least a year for primary prevention. Every participant had at least two chronic conditions and no known atherosclerotic cardiovascular disease, according to the AHA's news release. Of the 1,880 participants, 938 were assigned to stop and 942 to continue. Recruitment ran from November 2021 across 24 centres in Switzerland, the Netherlands and France.

The design was open-label, meaning patients and doctors knew the assignment, with blinded adjudication of outcomes. The primary outcome was a composite of non-fatal heart attack, non-fatal ischaemic stroke or death from any cause. As HCPLive reports, noninferiority was judged on restricted mean event-free survival at two years rather than on a simple event count.

What did the numbers show?

At two years, event-free survival averaged 96.5 weeks in the discontinuation group and 98.5 weeks in the continuation group, a difference of 2.0 weeks. HCPLive reports that the 95% confidence interval ran from minus 3.7 to minus 0.3 weeks, inside a prespecified margin of minus 5.2 weeks, which is why the trial met its noninferiority test.

Over a median follow-up of 103 weeks, the primary outcome occurred in 119 of 938 participants who stopped statins (12.7%) and 87 of 942 who continued (9.2%). The hazard ratio was 1.38, with a 95% confidence interval of 1.05 to 1.81, per HCPLive. Investigators estimated one additional major cardiovascular event or death over two years for every 40 people who stopped.

Component events within two years, as reported by HCPLive, favoured continuing: heart attack in 1.4% versus 0.6%, ischaemic stroke in 1.9% versus 0.8%, and death from any cause in 8.2% versus 6.9%.

So the trial met its prespecified noninferiority definition while also showing a statistically higher hazard of events in the discontinuation arm.

What did not differ?

The AHA release says there were no differences between the groups in quality of life, muscle pain, falls or sarcopenia. HCPLive gives the time points: quality of life at 24 months, pain at three months, falls at 12 months and sarcopenia risk at 24 months. At least one serious adverse event occurred in 43.0% of the discontinuation group and 39.8% of the continuation group.

How do the authors interpret it?

Rita F. Redberg, a professor of cardiology at the University of California, San Francisco, and a study author, said in the AHA release that "discontinuation is safe for most people who are in this age group." The same release quotes her saying that "one cannot make a general recommendation about stopping statins in this patient population" and that "there should be shared decision-making between the patient and the healthcare professional."

The release adds that about 14% of participants crossed over to the other arm, and that additional analyses did not change the results. HCPLive reports 131 crossovers in the discontinuation group and 112 in the continuation group, and says a tipping-point analysis suggested they were unlikely to alter the conclusions. The AHA release also notes a rise in risk among a small number of people at up to four years of follow-up, which Redberg suggested may be visible because of the trial's size and length.

The American College of Cardiology's coverage of the session likewise reports the 2.0-week difference in event-free survival and the 103-week median follow-up. HCPLive adds that Nicolas Rodondi, who presented the findings, reinforced the need for shared decision-making given the rise in events after discontinuation, and that the trial's data and safety monitoring board recommended that participants in the discontinuation group discuss restarting statins with their physicians once the trial ended.

Why does it matter beyond this trial?

Statins are among the most widely prescribed drugs in the world, and older adults on them for primary prevention are a large group whose benefit from continuing has been contested. HCPLive notes that an earlier French trial of 1,160 adults aged 75 or older found stopping noninferior for death at three years, but its participants were healthier, with three-year mortality of 7.5% against 15.1% in STREAM. The comparison suggests the answer depends on how sick the patient already is.

HCPLive also points to the STAREE trial, in which starting atorvastatin in older adults reduced major cardiovascular events without improving disability-free survival, and says the STREAM investigators indicated that finding should not guide decisions about stopping. For longevity-minded readers, the distinction is useful: preventing a cardiac event and extending healthy, disability-free life are separate endpoints, and different trials have measured different ones.

What we don't know yet

Several points are unresolved from the coverage reviewed. The AHA release and HCPLive do not report funding sources or author disclosures. The trial was open-label without a placebo, which HCPLive cites as a limitation, and the release says the results apply only to older adults without established cardiovascular disease. Sources differ on the enrolment end date, with one citing April 2025 and another April 2026, so it is left unstated here. The reports do not say which statins participants took or at what doses.

It is also unclear whether guideline bodies will change advice. None of the coverage reviewed reports a guideline response, and the AHA's own framing remains cautious. For now the practical message from the trial's authors is conditional: for most older adults without prior cardiovascular disease, stopping did not produce excess harm in the first two years on the measures tracked, yet the event rate was higher, and the choice belongs in a conversation between patient and clinician.

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