Evolocumab Cuts Heart Attack and Stroke Risks in High-Risk Patients

Researchers at Mass General Brigham have released findings from a significant clinical trial demonstrating that the drug evolocumab can notably lower the risk of major cardiovascular events in high-risk adults. The results were presented at the American Heart Association Scientific Sessions and published in The New England Journal of Medicine.

According to Erin Bohula, MD, a cardiologist at the Mass General Brigham Heart and Vascular Institute, “The results of this trial offer hope for preventing a first heart attack, stroke, or other cardiovascular event in patients who are at high risk.” This study highlights the potential for evolving prevention strategies in heart health.

PCSK9 inhibitors, including evolocumab, are designed to lower LDL cholesterol, a significant contributor to cardiovascular incidents. While previous research indicated these inhibitors prevent further events in individuals with a history of heart issues, the current study, known as the VESALIUS-CV trial, is groundbreaking as it focuses on patients who have not previously experienced a heart attack or stroke.

Trial Details and Findings

The phase 3 trial, orchestrated by the TIMI Study Group at Mass General Brigham in collaboration with the trial sponsor, Amgen, Inc., involved 12,257 participants from around the globe. Candidates were required to have atherosclerosis or diabetes, along with LDL cholesterol levels exceeding 90 mg/dL. Importantly, individuals with prior heart attacks or strokes were excluded from the study.

Participants were randomly assigned to receive evolocumab (140 mg biweekly) or a placebo in addition to their standard treatment. They were monitored for a median of 4.6 years. The results revealed that 336 patients (6.2%) in the evolocumab group and 443 patients (8.0%) in the placebo group experienced serious cardiovascular issues, including coronary heart disease deaths, myocardial infarctions, or ischemic strokes. This translates to a 25% reduction in the risk of these events for those taking evolocumab.

Moreover, the trial indicated a 36% reduction in heart attacks among participants receiving evolocumab. There was also a nominal decrease in mortality rates, with 7.9% of evolocumab patients dying compared to 9.7% in the placebo group. The outcomes remained consistent across various cholesterol-lowering treatments utilized by the participants.

Implications for Future Treatments

Most participants in the trial were white, which could limit the generalizability of the results to diverse populations. However, the findings underscore the effectiveness of evolocumab in managing LDL cholesterol levels, which reached an average of 40 mg/dL in the evolocumab group.

Marc S. Sabatine, MD, MPH, Chair of the TIMI Study Group, emphasized the importance of targeting low LDL cholesterol levels to enhance patient outcomes. “I believe that is what we should be targeting in these patients,” he stated.

The implications of the VESALIUS-CV trial extend beyond the individual benefits of evolocumab. They highlight a pivotal shift in the approach to cardiovascular disease prevention, suggesting that proactive treatment could significantly reduce the incidence of heart-related events in high-risk populations.

For further details, refer to the study by Erin A. Bohula et al., titled “Evolocumab in Patients without a Previous Myocardial Infarction or Stroke,” in The New England Journal of Medicine (2025). DOI: 10.1056/nejmoa2514428.