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A long-term observational study of 52,330 women in Israel found no higher rates of heart attack, stroke, blood clots or death among women who started contemporary hormone replacement therapy than among women who did not. The preliminary findings are due to be presented at the American Heart Association’s Scientific Sessions 2026 and do not establish that HRT causes no cardiovascular harm.
A study tracking 52,330 women in Israel found no higher rates of heart attack, stroke, blood clots or death among women who started contemporary hormone replacement therapy (HRT) than among women who did not, according to preliminary findings scheduled for presentation at the American Heart Association Scientific Sessions 2026. The results add long-term observational evidence about the cardiovascular safety of current HRT options, but cannot prove that treatment itself caused the similar outcomes.
The researchers used records from Clalit Health Services to compare women ages 45 to 59 with no prior heart disease, blood clots or cancer. About half had started HRT; the comparison group had recently visited a gynecologist but did not begin HRT and, according to the study description, did not use it during the study period. Researchers matched the groups for age, body mass index, cardiometabolic risk factors, smoking and socioeconomic status.
After an average of 12 years of follow-up, 2,311 women in the HRT group, or 4.4%, had a heart attack, stroke or related heart disease, compared with 2,383 women, or 4.6%, in the non-HRT group. Blood clots were reported in 0.33% of each group: 174 women who took HRT and 175 who did not. Death before age 80 occurred in 659 HRT users, or 1.3%, and 653 non-users, or 1.2%.
Follow-up extended as long as 23 years for some participants. The researchers reported similar results across the HRT formulations and delivery routes studied, including oral medicines, patches and gels. The study assessed outcomes in women without a previous cardiovascular diagnosis; its findings do not directly address safety for women with established heart disease or a history of blood clots.
What the Results Mean for Menopause Care
Heart and clotting concerns can affect whether patients and clinicians consider hormone therapy for menopause symptoms. These findings may inform those conversations by providing long-term outcome data for women who began treatment in midlife, a group that is more closely aligned with current guidance than populations in some earlier research.
Lead researcher Ronen Arbel said the results suggest currently available therapies do not appear to raise the measured risks for women in their mid-forties to late fifties without a history of heart disease or clots. That interpretation should be weighed against the study’s observational design: similar rates between groups are reassuring evidence, not proof that HRT carries no risk or that every patient has the same risk profile.
Stacey E. Rosen, an American Heart Association women’s heart health expert who was not involved in the research, said the findings could support more informed discussions about treatment benefits and risks. Decisions about HRT still depend on an individual’s health history and treatment needs; the study does not replace clinical guidance or individualized medical advice.
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How Current HRT Evidence Has Shifted
Earlier randomized trials reported associations between HRT and cardiovascular harm, but results were mixed. The study report says much of that evidence involved older formulations, higher doses or women who began treatment long after menopause. The new analysis instead focused on women ages 45 to 59 receiving therapies described as contemporary.
Current guidance from the American College of Obstetricians and Gynecologists recommends starting HRT within 10 years of menopause onset and before age 60. The report also notes that in November 2025 the U.S. Food and Drug Administration removed black-box warnings from HRT products after reviewing available scientific evidence. That regulatory action and the new study are separate developments; neither establishes that treatment is appropriate for every woman.
The findings will be presented at the American Heart Association meeting in Chicago, scheduled for Nov. 6-9, 2026. The report characterizes the research as independent and preliminary. A conference presentation is not the same as a full peer-reviewed publication, and readers should look to the detailed study report for methods and limitations.
“Our results indicate that, for women in their mid-forties to late fifties with no history of heart disease or blood clots, the currently available hormone therapies prescribed to manage menopause symptoms do not appear to raise the risk of heart attack, stroke, clots or early death, even after long-term use.”
— Ronen Arbel, Ph.D., lead researcher
Limits of the Observational Evidence
The study was observational, so it cannot establish that HRT caused—or did not cause—the outcomes. Matching the groups for recorded characteristics reduces some differences but does not rule out other factors. The researchers noted that health records may not capture all relevant distinctions between women who chose HRT and those who did not.
The available report does not provide detailed results for every formulation, dose, duration of use or participant subgroup, nor does it establish how findings apply to women with prior cardiovascular disease, blood clots or other conditions excluded from the analysis. The findings are preliminary ahead of the conference presentation, and the report does not describe a full peer-reviewed publication. Those details may affect how clinicians interpret the results.
Conference Presentation and Further Review
The research is scheduled for presentation at the American Heart Association Scientific Sessions in Chicago from Nov. 6 to 9, 2026. The presentation and any subsequent publication may provide fuller information about the analysis, including how treatment exposure and outcomes were defined and how the researchers addressed missing or unmeasured factors.
Until more detail is available, the study supports a cautious conclusion: no increased rate of the measured outcomes was observed in this matched comparison, but the research does not settle every question about HRT’s cardiovascular effects. Women considering treatment can discuss their own symptoms, medical history and risk factors with a qualified health professional.
Key Questions
What did the study find about HRT and cardiovascular events?
Among women ages 45 to 59 without prior heart disease or blood clots, researchers found similar recorded rates of heart attack, stroke or related heart disease, blood clots and death before age 80 in HRT users and non-users over an average of 12 years.
How many women were included?
The study included 52,330 women whose health records were drawn from Clalit Health Services in Israel.
Does the study prove that HRT is safe for everyone?
No. It was observational and cannot prove cause and effect. Participants with a history of heart disease or blood clots were excluded, so the findings do not establish safety for those groups or for every individual.
When will the findings be presented?
The findings are scheduled for presentation at the American Heart Association Scientific Sessions in Chicago, Nov. 6-9, 2026.
Source: news-medical.net
