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  3. New treatment for Coronary Artery Disease- FDA Approved 2022
  • Heart

New treatment for Coronary Artery Disease- FDA Approved 2022

By Rahul Chauhan| Last Updated at: 27th Mar '24| 16 Min Read

The coronary arteries are our body's most important blood vessels. They supply blood, oxygen, and nutrients to the heart. When the coronary arteries cannot function properly, cholesterol builds up in them. After a certain amount of cholesterol build-up, the arteries start narrowing. This causes Coronary Artery Disease (CAD).


 

Coronary Artery Disease (CAD) is the most common heart disease. It is also the leading cause of death from cardiovascular diseases worldwide. Each year, more than 7 million people die from CAD worldwide. The number is expected to increase to 11 million in the coming years. Every 26 seconds, a person suffers from a heart condition, and every minute, a person dies from CAD in the USA.


 

In Europe, approximately 1 in 6 women dies because of CAD. It is also responsible for the deaths of around 20% of men in Europe. The above-given figures show the severity of coronary artery disease. This proves why continuous advancements in treating CAD are necessary. On 13th May 2022, the U.S. Food and Drug Administration (FDA) approved the Onyx Frontier drug-eluting stent (DES).


We have discussed this new treatment for coronary heart disease in detail. Continue reading further to learn more!


More details about the new CAD treatment

The Onyx Frontier DES is the newest of Medtronic's heart stents. The Onyx Frontier DES is used to treat patients with coronary artery disease (CAD) caused by plaque build-up inside the coronary arteries.


A surgeon places the stent in the artery through minor surgery to unblock the artery. It has an advanced drug-delivering system, leading to more efficient CAD treatment. 

In a press release, Azeem Latib, MD, section head of interventional cardiology and medical director of structural heart interventions at Montefiore Medical Center in New York City, said that,

"Delivering safe and effective outcomes to our patients is our number one priority. It's important that physicians have access to tools like the Onyx Frontier DES that can allow them to efficiently achieve those outcomes."


There are many factors one should keep in mind before considering Onyx Frontier. We have curated them for you. 


So please read them carefully!


 

What Should Patients Know Before Treatment?

  • Only experienced physicians should perform the implantation of the stent.  
  • Do not expose the product to alcohol or other organic solvents.
  • The use of drug-eluting stent (DES) outside of the given indications, including use in patients with tortuous anatomy, may more the risk of side effects, including stent thrombosis and embolization, and myocardial infarction (MI).
     

The safety and effectiveness of the Onyx Frontier - DES is not yet been established in the following patient populations: 

  • Women who are pregnant or lactating 
  • Patients with blood clots at the lesion site.
  • Patients with a history of brachytherapy.
  • Patients below the age of 18 years
  • Patients with abnormal tissues in the left main coronary artery, saphenous vein graft, or ostial lesions. 
  • Patients with poor flow distal or diffuse disease to identified lesions.
  • Using stent along with atherectomy devices.
     

This new treatment for coronary artery disease is very promising! However, it comes with a few setbacks. 


 

Due to certain reasons, not all patients can opt for Onyx Frontier. We have discussed them below.


 

Who is Not Eligible for this New Treatment? 

  • Patients with hypersensitivity or allergies to aspirin, bivalirudin, clopidogrel, heparin, prasugrel, ticagrelor, ticlopidine, zotarolimus, tacrolimus, sirolimus, everolimus, or similar medicines or any other analog or derivative.
  • Patients with known hypersensitivity to the BioLinxTM polymer or its components. 
  •  Patients with known hypersensitivity to the cobalt-based alloy or platinum-iridium alloy. 
  • Patients in whom antiplatelet or anticoagulation therapy is not suitable.
  • Patients judged to have a lesion that complicates angioplasty or stent procedure.


Like any other treatment, this new treatment for coronary artery disease has adverse effects. No matter how minimal, you should know them!


 

We have presented the potential risks of Onyx Frontier below. So pay attention!

 

What are its side effects?

Below are the known adverse effects of the Onyx Frontier - DES. However, there might be more effects that are yet to be identified.

  • Access site pain, hematoma, or hemorrhage 
  • Aneurysm, pseudoaneurysm, or arteriovenous fistula (AVF)
  • Arrhythmias, including ventricular fibrillation 
  •  Bleeding
  •  Cardiac tamponade
  • Allergic reactions
  • Coronary artery occlusion, perforation, rupture, or dissection 
  • Coronary artery spasm 
  • Embolism (air, tissue, device, or thrombus) 
  • Infection or fever 
  • Myocardial Infarction (MI)
  • Pericarditis
  • Abrupt vessel closure 
  • Peripheral ischemia/peripheral nerve injury
  • Renal failure
  • Restenosis of the stented artery
  • Shock/pulmonary edema 
  • Stable or unstable angina 
  • Stent deformation, collapse, or fracture 
  • Stent migration or embolization 
  • Stroke/transient ischemic attack
  • Thrombosis (acute, subacute, or late)

References:

https://www.practicalcardiology.com/

https://www.nsmedicaldevices.com/news

https://cardiovascularnews.com/

https://www.medscape.com/

https://citoday.com/news

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