Drug-Coated Stents FAQ

Most of us have heard the word "stent" before, but we might not be sure what it is. A stent is a small, lattice-shaped tube, made of metal or plastic, that doctors insert permanently into an artery or blood vessel. Doctors typically use them to treat coronary artery disease. They also use them in conjunction with a balloon catheter.

A stent opens an artery that has become too narrow due to atherosclerosis. This is a condition where plaque builds up on the artery's inner walls, blocking blood flow. Surgeons typically place stents inside a coronary artery after a balloon angioplasty procedure. It helps prevent restenosis. Restenosis is the re-closing or re-blocking of the artery.

Here, we'll discuss the types of stents and how drug-coated stents can be dangerous for patients.

What is a drug-coated stent?

A drug-coated stent is a regular bare-metal stent that slowly releases drugs into your body. These drugs help prevent arterial scarring. They also reduce the possibility of restenosis.

The Food and Drug Administration (FDA) has approved two leading brands of drug-coated stents, among others. These include:

• The Cypher Sirolimus-Eluting Coronary Stent, manufactured by Cordis Corporation
• The Taxus Express Paclitaxel-Eluting Coronary Stent System, manufactured by Boston Scientific Corporation

The FDA lists recently approved medical devices on its website with links to consumer information.

What types of stents do cardiologists use?

Cardiologists and other healthcare professionals use different types of stents. It depends on the nature of your medical issues and desired clinical outcomes. Cardiologists often use stent implantation to address various cardiovascular diseases and problems.

Some of the health issues stents address include:

• Angina
• Heart attack
• Atherosclerosis
• Stroke
• Coronary artery disease
• Inflammation or infection of endothelial (vessel walls)
• Acute myocardial infarction
• Acute coronary syndrome
• Coronary lesions
• Coronary angioplasty
• Neointimal hyperplasia

Doctors treat these health issues in various ways. Surgeons, doctors, and cardiologists perform numerous procedures to help patients live longer and avoid future cardiovascular problems.

The different types of stents available to cardiologists include the following:

• Polymer-coated
• Bare metal stents (BMS)
• Stainless steel stents
• Sirolimus-eluting stents
• Everolimus-eluting stents
• Intracoronary stents
• Coronary artery stents
• Durable polymer stents
• Paclitaxel-eluting stents

If your doctor uses a stent and you get sick, you may have a legal claim. It depends on whether the surgeon was negligent and the medical device was defective. The drug-eluting stent compounds (DES) could also be an issue. If the stents contain an infection, you may develop a severe illness.

What procedures require drug-coated stents?

Medical professionals use stents to improve long-term outcomes for cardiac patients. Whether they move forward with a procedure depends on a patient's risk factors and whether they can handle the potential side effects of a stent implantation.

Some of the procedures that require the use of drug-coated stents include:

• Target vessel revascularization
• Percutaneous coronary intervention (PCI)
• Coronary artery bypass
• Cardiovascular surgery
• Vascular surgery
• Interventional cardiology
• Bypass surgery
• Dual antiplatelet therapy

These procedures and therapies often require the use of cardiac medications. For example, some stents contain clopidogrel or zotarolimus, an immunosuppressant.

Some of the other drugs that doctors administer using heart stents include:

• Proliferation medications
• Antiproliferative drugs
• Monotherapy inhibitors

Before the FDA approves certain drugs and drug-coated stents, they review the results of randomized controlled trials. They need to confirm the benefits of these surgical interventions outweigh any risks.

If you undergo a cardiac procedure using a drug-coated stent and develop health issues, contact your cardiologist immediately. You may also want to get a personal injury lawyer. There's a chance you have a legal claim.

Is the FDA investigating drug-coated stents?

In 2006, the FDA announced that it was closely monitoring drug-coated stents and had been since the devices entered the U.S. market in 2003 and 2004. Reports showed a small but significant risk of stent thrombosis. Stent thrombosis is when blood clots in the stent. However, the FDA lacked sufficient information to decide the severity of the risk.

According to the Mayo Clinic, the FDA believes these stents are safe and effective if doctors use them properly. However, the FDA continues to monitor new designs of these devices to ensure they remain safe.

What are the risks of drug-coated stents?

The FDA was initially concerned with the risks of stents and stent placement. Even if appropriately implanted, patients still face certain risks.

Some of the risks of drug-eluting stents include:

• Infection
• Blood clot
• Late stent thrombosis
• Bleeding
• Rupture of the duct or vessel when the surgeon inserts the stent
• Stent migration
• Allergic reaction to the drug used in a drug-coated stent
• In-stent restenosis, when the inside of the stent becomes clogged and the risk is higher in those with non-drug-coated stents

Other rare complications of coronary stents include chest pain, heart attack, or tearing of the blood vessel.

Drug-coated stents may have additional risks. Ask your healthcare professional about the risks associated with stents and drug-coated stents.

When should people avoid drug-coated stents?

Drug-coated stents can be dangerous for patients who have had recent heart surgery. They can also be harmful to women who are nursing or pregnant. Patients who receive a drug-coated stent may need antiplatelet drugs for at least several months.

Patients who can't tolerate angioplasty or are allergic to the stent materials should avoid these procedures. Doctors shouldn't use these devices in patients who can't take blood-thinning (antiplatelet) medication.

Clinical trials haven't studied the safety and effectiveness of a drug-coated stent in the following patients:

• People with a blockage in a heart bypass graft
• Individuals who are having a heart attack
• Those patients who previously underwent intravascular radiation treatment

Drug-coated stents have additional restrictions. Your healthcare professional can tell you more about whether you're an appropriate candidate for this technology.

Getting Legal Help

Medical device manufacturers must make their products as safe as possible. They must also inform the medical community and the public of any known risks associated with its products.

If a device manufacturer fails to do this, they may be legally responsible for patients' injuries. This is the case when plaintiffs' injuries result from inadequate warnings or the unreasonably dangerous nature of the medical device.

These cases fall under product liability law. If you or a loved one had a drug-coated stent implanted and are experiencing unusual health problems, contact your doctor immediately. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy.