Heart attacks and strokes can appear to happen without warning, but the disease behind them often develops over decades.
Fatty deposits slowly collect inside arteries, and a person may feel completely well until blood flow suddenly becomes blocked.
A major study from Mass General Brigham suggests that treating very high cardiovascular risk earlier could prevent some of these first major events.
The research was published in JAMA and presented at the American College of Cardiology’s Annual Scientific Session.
The study focused on evolocumab, a powerful cholesterol-lowering medicine. Researchers wanted to know whether it could protect people with diabetes who were at high risk of heart disease but had not yet developed major known artery disease.
Diabetes is an important risk factor for cardiovascular disease. Over time, high blood sugar and other metabolic changes can damage blood vessels and make fatty plaque more likely to develop.
Cholesterol also plays a central role. The body needs cholesterol for normal functions, but high levels of LDL cholesterol can contribute to plaque building up inside artery walls.
LDL is commonly called “bad” cholesterol because high levels are strongly linked with heart attacks and strokes. Lowering LDL is therefore one of the main ways doctors try to prevent cardiovascular disease.
Statins are usually the first medicines used for this purpose. They reduce the liver’s production of cholesterol and have been shown in many large trials to lower the risk of heart attack, stroke and cardiovascular death.
But some people remain at high risk even when they take statins. Others may need a much larger reduction in LDL than statins alone can provide.
Evolocumab belongs to a newer class of medicines known as PCSK9 inhibitors. Rather than working in the same way as statins, it helps the liver remove more LDL cholesterol from the bloodstream.
The medicine is given by injection. PCSK9 inhibitors have already been used extensively in people with established cardiovascular disease or very high cholesterol, but researchers have also been interested in whether these drugs can prevent a first major cardiovascular event in selected high-risk patients.
The new study included 3,655 people with diabetes who were considered at high cardiovascular risk but did not have significant known blocked arteries. Participants continued appropriate standard treatment, including cholesterol-lowering therapy such as statins.
They were randomly assigned to receive either evolocumab or a placebo injection every two weeks. Random assignment is important because it helps make the groups similar and reduces the chance that differences in health or behavior explain the results.
After 48 weeks, people receiving evolocumab had substantially lower LDL cholesterol than those receiving placebo. This confirmed that the drug was producing the strong cholesterol-lowering effect researchers expected.
The more important question was whether lower cholesterol translated into fewer serious health problems. Participants were followed for nearly five years so the researchers could record major cardiovascular events.
During follow-up, people receiving evolocumab had a 31% lower risk of experiencing a first major cardiovascular event. The events included heart attack, stroke and death related to cardiovascular disease.
This result suggests that aggressively lowering LDL before obvious artery disease develops may benefit some people whose underlying risk is already very high. In this study, diabetes was a major reason participants were considered vulnerable.
The treatment also appeared generally well tolerated. Rates of serious adverse events were similar between the evolocumab and placebo groups, an important finding for a medicine that could potentially be taken for years.
The research fits with a broader change in cardiovascular medicine toward earlier prevention. Doctors increasingly try to estimate a person’s future risk and control major risk factors before a heart attack or stroke occurs rather than waiting until after the first event.
Still, the study does not mean everyone with diabetes should begin taking evolocumab. PCSK9 inhibitors are powerful prescription medicines, and treatment decisions depend on LDL levels, overall cardiovascular risk, existing medicines, side effects, cost and other individual factors.
The 31% figure also describes a relative reduction in risk between the study groups. A person’s actual, or absolute, benefit depends on how likely that individual was to experience a cardiovascular event in the first place.
The trial has important strengths. It included thousands of patients, used random assignment and placebo comparison, and followed participants for several years, making it much stronger evidence than a simple observational study.
However, its results apply most directly to people resembling those enrolled in the trial: patients with diabetes who had high cardiovascular risk but no significant established artery disease. More research may be needed before extending the same strategy to people at lower risk or without diabetes.
The study also reinforces that cholesterol is only one part of cardiovascular prevention. Blood pressure, blood sugar, smoking, physical activity, diet and body weight can all influence long-term heart and stroke risk.
Overall, the JAMA study provides strong evidence that very intensive LDL lowering can prevent first cardiovascular events in a carefully selected high-risk population. Its larger message is that waiting for visible artery disease may not always be necessary before using powerful prevention strategies.
If these findings influence future guidelines, doctors may have more reason to consider PCSK9 treatment earlier for some people with diabetes and very high cardiovascular risk. For patients, the decision will still require an individual discussion about expected benefit, risks, existing treatment and cost.
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