Clinical Trial Shows Evolocumab Reduces Heart Attack Risk by 25%

A significant clinical trial conducted by researchers from Mass General Brigham has revealed that the drug evolocumab can substantially decrease the risk of first heart attacks and strokes in high-risk adults. Results were presented at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine on March 15, 2025.

According to Dr. Erin Bohula, 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 trial emphasizes the importance of preventive strategies in healthcare, showcasing a commitment to advancing patient care through rigorous clinical research.

The VESALIUS-CV trial, officially known as The Effect of EVolocumab in PatiEntS at High CArdiovascuLar RIsk WithoUt Prior Myocardial Infarction or Stroke, is a phase 3 study focusing on individuals with high cardiovascular risk. This trial is particularly noteworthy as it is the first to investigate the preventive effects of evolocumab in patients who have not previously experienced a heart attack or stroke.

Participants in the trial included 12,257 adults enrolled worldwide, all of whom had atherosclerosis or diabetes and LDL cholesterol levels above 90 mg/dL. Importantly, candidates with a history of heart attack or stroke were excluded. Participants were randomly assigned to receive either evolocumab (140 mg administered biweekly) or a placebo, alongside their standard care regimen, and were monitored for a median of 4.6 years.

During the study, the results indicated that 336 patients (6.2%) in the evolocumab group experienced major adverse cardiovascular events, compared to 443 patients (8.0%) in the placebo group. This translates to a 25% reduction in risk for events such as coronary heart disease death, myocardial infarction, or ischemic stroke. Furthermore, those receiving evolocumab experienced a 36% reduction in heart attacks compared to their counterparts receiving the placebo.

While there was a nominally lower rate of death among those taking evolocumab (7.9% versus 9.7% in the placebo group), the authors noted that the majority of participants were on high-intensity statins or other cholesterol-lowering medications, although some were on less intensive treatments or none at all. The findings were consistent across varying treatment backgrounds.

Despite the promising outcomes, the trial’s demographic makeup, predominantly white participants, raises questions about the generalizability of the results to diverse populations.

Dr. Marc S. Sabatine, Chair of the TIMI Study Group, remarked on the results, stating, “In VESALIUS-CV, patients in the evolocumab arm achieved LDL-C levels of around 40 mg/dL. I believe that is what we should be targeting in these patients.”

The implications of this trial are significant, highlighting the potential of evolocumab as a vital tool in preventing cardiovascular events in high-risk individuals. As researchers continue to explore the nuances of these findings, the hope is to further improve patient outcomes and quality of life through advanced therapeutic strategies.