What is coronary artery disease and how is it treated

With an average diameter of about three millimeters - about the thickness of a coffee stirrer - the coronary arteries are the main vessels that keep the heart continuously fed with oxygen-rich blood which is then pumped to the rest of the body. For people who have a condition called coronary artery disease (CAD), the inner walls of the arteries become dangerously coated with plaque, a sticky combination of fats, cholesterol and other substances. Over time, that plaque buildup gradually narrows the space inside the artery, reducing blood flow to the heart. This can cause symptoms including:

• Chest pain, pressure or tightness (angina)
• Shortness of breath
• Fatigue

Coronary artery disease is the most common form of heart disease, and its prevalence continues to rise around the world. It can ultimately lead to heart failure, abnormal heart rhythms (arrhythmia), stroke or, if the artery becomes blocked, heart attack - all of which contributes to CAD's status as the leading cause of death worldwide, claiming about 9 million lives globally each year, including about 370,000 U.S. deaths.

Boston Scientific has a long history of developing innovative, minimally invasive treatments for reopening the arteries, including more than 25 years of pioneering stents and balloons, both with and without drug eluting technologies. Today, we continue to invest in new solutions for addressing CAD, including the recent acquisition of Bolt Medical, Inc. and its next-generation therapy for treating both coronary and peripheral artery disease (PAD).

Enabling more accurate procedures with AI

To date, one of the most common procedures to reopen clogged arteries has been angioplasty, also known as percutaneous coronary intervention (PCI). It involves a doctor clearing out plaque and then, typically, placing a metal stent inside the artery to prop it open. Nevertheless, the artery can become blocked or narrowed again, requiring it to be reopened once more; indeed, about 1 in 10 cases are repeated within a year. A contributing factor is that doctors have historically relied on X-ray images to guide them, even though they provide an incomplete view.

But highly detailed imaging tools called intravascular ultrasound systems (IVUS)can improve patient outcomes, reducing the need for repeat procedures as well as the rates of heart attack and death. And yet these tools are only being used in fewer than 15% of U.S. cases, since they generate an enormous volume of data that can be difficult to interpret in the midst of an angioplasty.

Enter the AVVIGO™+ Multi-Modality Guidance System. The first AI-enabled intravascular ultrasound system, its algorithm streamlines data to precisely locate and measure the blockages within an artery, which helps doctors swiftly determine the best courses of action. By using AI to interpret the data, AVVIGO enables more confident treatment decisions, greater accuracy in reopening vessels and better PCI outcomes.

A metal-free option for treating restenosis

What happens in the one out of ten cases where a patient's stented artery narrows once again? This condition is known as in-stent restenosis (ISR) and until recently, it was usually treated in the U.S. by repeating the procedure, sliding a second stent inside the first one - even though adding another layer of metal inside an artery has risks, including a higher chance the artery will narrow once again, requiring yet another intervention.

For years, however, physicians in Europe, Latin America and Asia have been successfully treating ISR with an alternative called a drug-coated balloon (DCB). Unlike stenting, the procedure leaves no additional metal behind. Rather, after the artery is cleared of its blockage, a narrow balloon is guided through the vessel, gradually inflated until it presses against the trouble spots along the vessel's inner walls, then withdrawn. The balloon is coated in a restenosis-inhibiting medication that transfers to the artery walls.

Our AGENT™ Drug-Coated Balloon is the first device of its kind available in the U.S. Approved by the U.S. Food and Drug Association (FDA) in 2024, it has been shown to be not only safe and effective, but also superior to using an uncoated balloon, with significantly lower rates of heart attack or the need for a repeat revascularization procedure.

"The AGENT DCB addresses a critical unmet need by providing a dedicated treatment option for the challenging condition of ISR, with more than 100,000 patients treated globally to date in both clinical and commercial settings," says Janar Sathananthan, M.D., chief medical officer, Interventional Cardiology Therapies.

A new clinical trial will study AGENT's use within smaller vessels and ones with complex trouble spots. It will also evaluate whether the device could be the first line of defense to address coronary artery disease - meaning that many patients with coronary artery disease getting an angioplasty for the first time could be treated with a drug-coated balloon, leaving them metal-free.

A new therapy for clearing calcium blockages

After years of plaque buildup, the arteries can become clogged by calcium deposits. This calcification can make it far more challenging to place stents in patients who have CAD. A new therapy called intravascular lithotripsy (IVL), though, stands to change that. The technique fractures calcium within clogged arteries using pressure waves - similar to technology that's used to break up kidney stones - and addresses a significant unmet need for patients with complex calcified arterial disease.

That's why, this year, Boston Scientific completed the acquisition of a company called Bolt Medical. Bolt's IVL system, SEISMIQ, uses acoustic pressure waves delivered via a balloon catheter. It has been evaluated in two clinical trials for the treatment of PAD and has begun a clinical trial investigating a coronary application.

Says Dr. Sathananthan: "The addition of this next-generation technology to our offerings can help us better serve physicians and their patients and provides a platform for future innovation" - for treating CAD, PAD and other cardiovascular diseases in patients around the globe.

Learn more about coronary artery disease and its treatment .