TL;DR
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The STREAM trial found that stopping statins in adults aged 70 and older met its two-year non-inferiority criterion for event-free survival. However, cardiovascular events were numerically more frequent after discontinuation, and stopping treatment did not improve reported quality-of-life outcomes. The findings support individualized decisions, not a blanket recommendation to stop.
The STREAM randomized trial found that adults aged 70 and older who stopped statins taken to prevent a first cardiovascular event met the study’s two-year non-inferiority criterion for event-free survival, but cardiovascular events were numerically more frequent than among those who continued treatment. The results, presented at the American Heart Association’s annual meeting and published in the New England Journal of Medicine, do not show that stopping is risk-free or that it improves quality of life.
Researchers randomized 1,880 participants in Europe to discontinue or continue their statin. Participants were at least 70, had two or more chronic conditions, and were taking statins for primary prevention, meaning they had no known cardiovascular disease at enrollment. Their average age was 77.5, 46.9% were women, and nearly one-third had diabetes.
Over two years, the average time without a primary-endpoint event—a composite of heart attack, ischemic stroke or death—was 96.5 weeks in the discontinuation group and 98.5 weeks in the continuation group. The trial met its prespecified non-inferiority test, with P<0.001. That statistical result means discontinuation met the trial’s defined threshold; it does not establish that the two approaches have identical risks.
Primary-endpoint events occurred in 10.7% of participants who stopped and 8.2% of those who continued. The report described this as one additional cardiovascular event for every 40 people who discontinued over two years. Across the full available follow-up, with a median of 103 weeks, event rates were 12.7% and 9.2%, respectively. These differences were numerical; the source does not report them as statistically significant. Measures including pain, falls and sarcopenia did not improve after stopping.
The Trade-Off Behind Statin Withdrawal
The findings speak to a common decision for older adults: whether a preventive medicine still fits a person’s health priorities, other conditions and expected lifespan. The trial offers evidence that discontinuation can meet a statistical non-inferiority threshold in a selected group, but its event-rate pattern leaves a possible cardiovascular cost that patients and clinicians may weigh differently.
There was no measured quality-of-life benefit in the reported patient-centered outcomes. That matters because reducing treatment burden is one reason to consider deprescribing, while the trial did not show that stopping statins relieved the symptoms assessed. The study therefore supports discussion tailored to the individual rather than a general rule for older patients.
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Who Was Studied in STREAM
STREAM was an open-label, non-inferiority trial conducted in Europe from 2021 through 2025. More than half of participants were recruited through primary care rather than hospitals. At baseline, average LDL cholesterol was 88.9 mg/dL in both groups; most participants used moderate-intensity statins, while smaller proportions used low- or high-intensity treatment.
Among a subset of 235 participants whose lipids were measured at 12 months, LDL cholesterol was 176.0 mg/dL after discontinuation and 99.4 mg/dL with continued treatment. Serious adverse events were reported in 43.0% of the discontinuation group and 39.8% of the continuation group. The report also places STREAM alongside the earlier SITE/SAGA trial, which did not find a significant mortality increase after stopping but likewise did not show quality-of-life improvement; that study had not reached its planned enrollment.
“Statin discontinuation is “generally safe.””
— Nicolas Rodondi, MD, MAS, University of Bern
Limits to the Safety Finding
The non-inferiority result does not resolve whether stopping statins carries a meaningful long-term cardiovascular cost. The event rates were numerically higher after discontinuation, and the reported follow-up was about two years; longer-term effects remain uncertain. The trial was open-label, and investigators reported substantial crossovers, both of which complicate interpretation.
Subgroup findings suggested that outcomes after stopping may have differed for participants with diabetes and for relatively healthy people recruited outside hospitals, but the supplied report does not provide enough detail to determine how reliably those results apply to particular patients. The authors also said other cardiovascular preventive medicines used during follow-up could affect results. STREAM does not establish that stopping is appropriate for every older adult or identify a single profile for whom it is clearly preferable.
Individual Decisions and Further Trials
For now, the findings put the focus on shared decision-making between patients and clinicians, weighing potential cardiovascular protection against treatment burden and a person’s other health conditions. Rodondi said the choice should reflect the patient’s circumstances; the report does not announce a change to clinical guidance.
The STREAM investigators called for additional randomized trials focused on discontinuing specific medicines and for closer assessment of other cardiovascular preventive treatments used during follow-up. The available report does not give a date for further STREAM analyses or new trials, so the next evidence milestone is not yet clear.
Key Questions
Did STREAM prove that stopping statins is as safe as continuing them?
No. The trial met its prespecified non-inferiority threshold for average event-free survival over two years, but that does not prove the risks are identical. Cardiovascular event rates were numerically higher after discontinuation.
Who took part in the trial?
The 1,880 participants were aged 70 or older, had at least two chronic conditions, and used statins to prevent a first cardiovascular event. They had no known cardiovascular disease at enrollment.
Did participants feel better after stopping statins?
The study found no difference in the assessed patient-centered outcomes, including pain, falls and sarcopenia, between those who stopped and those who continued.
Should older adults stop taking statins based on STREAM?
The findings do not support a blanket recommendation to stop. They point to an individualized discussion with a clinician about cardiovascular risk, other health conditions, treatment priorities and the limits of the trial evidence.
Source: medpagetoday.com
