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MedStar Health Research Institute is leading a worldwide study to explore the safety and effectiveness of a technology that could offer patients and providers a new option when treating coronary artery disease.
When plaque builds up inside blood vessels, it can restrict blood flow in the tiny arteries that supply blood to the heart. This is called atherosclerosis, which over time can lead to coronary artery disease (CAD) with narrowing or obstruction of the coronary artery that can cause chest pain, a heart attack, and result in heart failure.
A minimally invasive procedure called percutaneous coronary intervention (PCI), also known as angioplasty, is a common and effective method for improving symptoms and blood flow. Over one million PCIs are performed each year in the U.S. The non-surgical procedure can be a simple alternative to coronary artery bypass surgery. Most PCIs involve the placement of a stent, a mesh scaffold to hold open the artery. While stents are highly effective, some patients don’t want a permanent implant, and a small percentage of people are allergic or sensitive to metals used in stents.
MedStar Health Research Institute is leading a worldwide research effort called the Prevail Global Study to explore the safety and effectiveness of a new twist on PCI.
For the first time in the U.S., our research examines the Prevail drug-coated balloon, which could be a suitable, temporary alternative to stenting, leaving no metal behind for some patients.
A temporary stent alternative.
During PCI, patients receive a sedative to help them relax and a local anesthetic to numb the wrist or leg. At one of these sites, interventional cardiologists make a small incision in the skin and pass a tiny, flexible tube called a catheter into the artery.
Guided by X-ray images, the doctor threads the catheter through the arteries to the location of the blockage. There, they inflate a balloon, which compresses the plaque against the wall of the artery. This action reopens the passage, allowing blood to flow more freely.
Currently, to help keep the artery open, the doctor places a stent. The stent is made of metal and coated with a polymer that slowly releases a medication to prevent future narrowing, also restenosis, of the artery. This represents the standard of care in the U.S.
Our study is examining an alternative. Instead of a permanent stent, we propose inflating a balloon coated with the same medication in the artery after successful PCI. After 30 seconds, the balloon is deflated and removed, leaving the medication behind. Over the next 60 days, the drug is slowly absorbed into the artery wall to prevent reblockage of the artery.
Related reading: Research Aims for Definitive Answers on Coronary Imaging Guidance.
Global research leadership in CAD treatment.
To test this drug-coated balloon technology, Medstar Health was selected to be among 65 sites across the world. One thousand participants will enroll over about 12 months, and we’ll follow their progress for five years to assess the long-term effects of treatment.
Patients undergoing PCI who choose to participate in the study will be divided into two groups, each with a distinct study design.
In-stent restenosis group.
This group will include patients who have already had a stent placed in their coronary artery, but the blood vessel is narrowing again within or near the original stent.
In this randomized controlled trial, participants will be randomly assigned to one of two groups. One group will be treated with the Prevail drug-coated balloon. Another will be treated with a different type of drug-coated balloon known as Agent. We’ll compare the outcomes between the two groups to understand how patient outcomes differ following these treatments.
De novo lesions in small vessel disease group.
This group includes patients who have a new blockage (a de novo lesion) in a small coronary artery (<2.75 mm). This portion of the study will compare the Prevail drug-coated balloon to the standard of care, a drug-eluting stent.
Because this portion of the trial is a single-arm, prospectively enrolled study, all participants will receive the Prevail drug-coated balloon. We’ll compare their outcomes to data from prior studies of the drug-eluting stent.
Related reading: Interventional Cardiologists Perform the Southern Maryland Region’s First Drug-Coated Balloon Angioplasty Procedure at MedStar Southern Maryland Hospital Center.
Exploring another option for patients and providers.
When we talk with patients about PCI, it’s common for them to have reservations about leaving a metal stent inside their coronary arteries. Our study examines, for the first time in the U.S., an alternative for the treatment of coronary artery disease.
As our center is the leading research center in the region, our patients at MedStar Washington Hospital Center can get access to this device sooner. The study is approved by the Food and Drug Administration, which will decide, based on the study’s results, whether to approve the Prevail drug-coated balloon for PCI.
There’s no one-size-fits-all treatment for CAD. MedStar Health’s interventional cardiologists work closely with patients to customize a treatment plan that best addresses their unique condition and helps them achieve their goals.
