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In the STREAM trial, stopping primary-prevention statins in adults aged 70 or older met the study’s non-inferiority criterion for event-free survival over two years. However, cardiovascular events were numerically more frequent after discontinuation, and stopping treatment did not improve measured quality-of-life outcomes.
The STREAM randomized trial found that adults aged 70 or older who stopped statins taken to prevent a first cardiovascular event did not have a statistically significant reduction in mean event-free survival over two years compared with adults who continued treatment. But cardiovascular events were numerically more frequent after discontinuation, and researchers found no improvement in measured patient-centered outcomes such as pain, falls or muscle loss.
STREAM enrolled 1,880 people aged 70 or older who had at least two chronic conditions, no known cardiovascular disease and were taking statins for primary prevention. Participants were randomly assigned to stop or continue treatment. Their average age was 77.5, 46.9% were women and nearly one-third had diabetes. More than half were recruited through primary care rather than hospitals.
Over two years, mean event-free survival for the 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 criterion, with P<0.001 for non-inferiority. That result does not mean stopping treatment was shown to be equally safe in every respect: the primary endpoint occurred in 10.7% after discontinuation versus 8.2% with continuation. Across the available follow-up, with a median of 103 weeks, event rates were 12.7% and 9.2%, respectively.
The report described the difference in the primary endpoint as one additional cardiovascular event for every 40 people who stopped statins over two years. The trial also found no difference between groups in patient-centered secondary outcomes, including pain, falls and sarcopenia. Among a subset of 235 participants whose cholesterol was checked at 12 months, average LDL cholesterol was 176.0 mg/dL in the discontinuation group and 99.4 mg/dL in the continuation group.
Balancing Treatment Burden and Risk
The results bear on a common question for older adults taking statins to prevent a first heart attack or stroke: whether continuing treatment remains worthwhile as health conditions, priorities and life expectancy change. STREAM offers randomized evidence that stopping did not cross the trial’s statistical threshold for worse average event-free survival during its follow-up. At the same time, the higher numerical event rate after stopping and lack of quality-of-life gains mean the result should not be read as proof that discontinuation carries no downside.
For patients and clinicians, the findings support a case-by-case discussion rather than a blanket rule to stop or continue. The balance may differ for someone with severe illnesses and limited life expectancy compared with a relatively healthy older adult. The trial’s findings apply to its enrolled population and study period; they do not settle the risks for all older people or establish what happens over longer periods.
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Who STREAM Studied and When
The open-label European trial was conducted from 2021 to 2025 and was presented at the American Heart Association annual meeting in Chicago. It was also published simultaneously in the New England Journal of Medicine. Participants were taking statins for primary prevention, meaning they had no established cardiovascular disease when enrolled. Their existing treatment varied: 7.5% used low-intensity statins, 72.9% moderate-intensity and 19.6% high-intensity therapy.
STREAM follows the SITE/SAGA randomized study, which, according to the report, did not find a significant increase in mortality after statin discontinuation but also found no improvement in quality of life. SITE/SAGA had not reached its planned enrollment. The STREAM investigators said interpretation of discontinuation trials can be affected by treatment crossovers and by other preventive medicines used during follow-up.
“Generally safe”
— Nicolas Rodondi, MD, MAS, of Inselspital, University of Bern
Long-Term Risk and Trial Limits
STREAM followed participants for a median of 103 weeks, so it does not establish the cardiovascular consequences of stopping statins over a longer period. The trial was open-label, meaning participants and researchers knew treatment assignments, and the investigators reported substantial crossovers. These features can complicate interpretation of the results. The report also does not establish which individual patients can stop without added risk.
Some subgroup findings were described as suggesting more favorable outcomes after discontinuation among people with diabetes and relatively healthy participants recruited outside hospital settings. The material does not provide enough detail to determine how reliable or definitive those subgroup results are. The higher LDL cholesterol reported at 12 months came from a subset of 235 participants, not the full trial population. Longer-term outcomes and the effects of other preventive medicines remain unresolved.
Further Trials and Individual Decisions
The investigators called for additional randomized trials examining discontinuation of specific medicines and for better assessment of other cardiovascular preventive treatments during follow-up. In clinical practice, the immediate next step described by the researchers is discussion between patients and clinicians, weighing cardiovascular risk, other illnesses, treatment burden and the patient’s priorities. STREAM does not supply a universal stopping rule, and its two-year findings should not be treated as a personal treatment recommendation.
Key Questions
What did the STREAM trial find about stopping statins?
Among adults aged 70 or older taking statins to prevent a first cardiovascular event, stopping treatment met the trial’s non-inferiority criterion for mean event-free survival over two years. However, the composite event rate was numerically higher after discontinuation: 10.7% versus 8.2%.
Did participants feel better after stopping statins?
The trial found no difference between the groups in measured patient-centered outcomes such as pain, falls and sarcopenia. It did not show a quality-of-life benefit from stopping.
Does the trial prove that stopping statins is safe for every older adult?
No. The findings apply to the people enrolled and the study’s follow-up period. The numerical event rates were higher after discontinuation, and the trial had crossovers and an open-label design. The results do not establish that stopping is risk-free or appropriate for every patient.
What does primary prevention mean in this study?
It means participants were taking statins to prevent a first cardiovascular event and did not have established cardiovascular disease when they entered the trial.
What remains unknown?
The trial does not settle the effects of discontinuation over longer periods or identify with certainty which older adults can stop without increased risk. The authors called for further randomized research, including closer assessment of other preventive medicines used during follow-up.
Source: medpagetoday.com
