News | Cardiovascular Clinical Studies | September 02, 2026

Study: Evolocumab Reduces Risk for Patients at High Risk for First Heart Attack, Stroke

Amgen's Repatha is the first  PCSK9 Inhibitor shown to lower the risk of dying from all causes, including cardiovascular events, in high-risk primary prevention patients in a Phase 3 Trial.

Study: Evolocumab Reduces Risk for Patients at High Risk for First Heart Attack, Stroke

Aug. 31, 2026 — Amgen has announced new findings showing Repatha (evolocumab) reduced the risk of death in high-risk adults without a prior heart attack or stroke when added to statins or other low-density lipoprotein cholesterol (LDL-C)-lowering treatments.

The results are from a pre-specified analysis of the Phase 3 VESALIUS-CV trial and were presented in a late-breaking science session at the European Society of Cardiology Congress 2026 in Munich. They were also simultaneously published in Circulation.

Benefits of Evolocumab

In a study of more than 12,000 high-risk patients, Repatha helped reduce the risk of dying by 20%. Treatment with Repatha led to meaningful reductions both in overall deaths and cardiovascular deaths in this pre-specified secondary analysis of VESALIUS-CV. By helping prevent major cardiovascular events, such as heart attacks and strokes, Repatha may extend life by helping patients avoid the serious health decline that can follow, contributing to fewer deaths overall. The reduction in deaths began to appear after approximately 1.5 years of treatment and continued through a median follow-up of 4.6 years.

"For people at high risk of a heart attack or stroke, lowering LDL-C or 'bad' cholesterol with Repatha may do more than help prevent these events; it may also reduce the risk of dying from heart disease and its serious consequences," said Jay Bradner, M.D., executive vice president, Research and Development, Artificial Intelligence and Data at Amgen. "This is especially significant given cardiovascular disease remains the leading cause of death worldwide. The totality of these data is practice-changing and reinforces the importance of identifying high-risk patients early and lowering LDL-C aggressively and consistently with Repatha."

Additional VESALIUS-CV and Real-World Analyses 

The mortality findings were accompanied by two additional VESALIUS-CV analyses. One analysis showed that Repatha reduced the risk of first, subsequent and total CV events. The other analysis showed that the reduced risk of heart attack with Repatha was seen as early as six months after initiating treatment. The reduction in risk was primarily driven by a decrease in heart attacks caused by a rupture of atherosclerotic plaque (type 1) and larger infarctions. In both analyses, benefits were consistent across key patient subgroups, adding to the growing body of evidence supporting the importance of earlier LDL-C lowering with Repatha in high-risk patients.

"These analyses reinforce that a patient's first major cardiovascular event is not merely an isolated occurrence, but often a transition to a higher risk state," said Marc S. Sabatine, M.D., M.P.H., Chair of the TIMI Study Group and the Lewis Dexter, MD, Endowed Chair in Cardiovascular Medicine at Mass General Brigham Heart & Vascular Institute. "Evolocumab reduced not only first cardiovascular events, but also subsequent events during the course of the study, the latter of which almost doubled the number of events prevented. By preventing these events, evolocumab can alter the patient's trajectory, with lower rates of all-cause mortality and consistent effects for both cardiovascular and non-cardiovascular mortality. Together, these data support the large clinical benefit of intensive LDL-C lowering with evolocumab down to ~40 mg/dL to help prevent cardiovascular morbidity and mortality."

 

 

 

 

Amgen Repatha evolocumab

 


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