Written or medically reviewed by a board-certified physician. See About.com's Medical Review Policy.

Updated November 19, 2014.

There’s a new balloon in town; and this one is covered in drugs. In October 2014, the FDA approved Lutonix DCB, a balloon catheter coated with paclitaxal (in a polysorbate/sorbitol carrier) for use in peripheral artery disease (PAD).  Specifically, Lutonix DCB has been approved for the treatment of stenotic lesions in the knee (popliteal arteries) and thigh (superficial femoral arteries).  In other words, the drugs open up clogged arteries which feed oxygen-rich blood to your legs and thus help with PAD symptoms like pain and cramping.


 

 

What is peripheral artery disease?

 

Peripheral artery disease causes gradual occlusion or stenosis of the arteries which supply the limbs.  It’s an insidious disease that occurs when fatty material called plaque clogs up the arteries which deliver oxygen-rich blood to the legs and (less often) arms.  Peripheral artery disease causes intermittent claudication or pain, cramps, and numbness when walking.  The disease can also cause fatigue, cramping or pain while exercising or performing routine physical activities (like climbing the stairs).  Advanced disease results in pain at rest which disrupts sleep.  Symptoms occur in anatomical locations downstream from the occlusion—the hip, thigh or (most typically) calf.  Peripheral artery disease can eventually lead to painful sores and even gangrene.

Here are typical treatments for peripheral artery disease:

• Exercise
• Drug therapy
• Bare-metal stents
• Drug-eluting stents
• Surgical bypass
• Balloon angioplasty

Of note, bare metal stents.are small, mesh tubes that help support arterial walls and keep them open.

  Drug-eluting stents incorporate drugs like paclitaxal into their scaffolding.  By interfering with cellular replication, such drugs help prevent reocclusion of arteries.   Several clinical trials have shown that drug-eluting stents are more effective at preventing reocclusion than bare-metal stents.

 

But what is balloon angioplasty?

 

According to Hurst’s The Heart, the use of a balloon to dilate or expand constricted arteries was popularized by Dr. Andreas R. Gruentzig who, in 1974, developed “a polyvinyl chloride balloon catheter with fixed maximal inflated diameters.”  (To be fair, Dotter and Judkins pioneered the work.)  In 1977, percutaneous transluminal coronary angioplasty (balloon angioplasty) was performed on a 37-year-old German insurance salesman who was pained with angina and high-grade stenonsis of the left anterior descending (LAD) coronary artery.  The procedure was not only successful but in 1987 and 2000 this same coronary artery remained patent or nonocculuded! 

Interest in balloon angioplasty mushroomed with new advances in guidewire and balloon-catheter technology.  Moreover, balloon angioplasty began to be employed with more than just coronary artery disease with vascular surgeons using the technique to revascularize peripheral arteries.  Such potential applications prove how much balloon angioplasty revolutionized not only cardiology but also vascular surgery, where less-invasive surgeries are preferred to more daunting arterial bypass (surgery).

Lutonix DCB is a balloon covered in a solvent laden with paclitaxal.  According to the authors of “The LEVANT 1 Trial for Femoropopliteal Revascularization”: “Drug-coated balloons (DCB) offer a mechanism to deliver antiproliferative drugs directly to the diseased artery wall without the need for a stent scaffold.  Preclinical studies demonstrate even limited exposure of smooth muscle to paclitaxel yields sustained inhibition to proliferation.”

 

What drug-covered balloons mean to you?

 

For optimal revascularization, balloon angioplasty is often used in conjunction with (drug-eluting) stent deployment.  The decrease in long-term reocclusion (measured as late lumen loss or LLL) in patients receiving angioplasty via drug-covered balloons versus standard balloons represents a definite advance in the perpetual war specialists wage against reocclusion.  For you or someone you love with peripheral artery disease, this means that less invasive measures meant to revascularize blocked arteries are now better than ever before. 

Once upon a time, bypass surgery was the only direct means of opening stenotic arteries occluded by fatty plaques; and such surgery carries its own risks and complications.  Today, bypass surgery can be either avoided or delayed thanks to the development of drug-eluting stents and now drug-coated balloons.  These measures come as a great benefit to people with peripheral arterial disease who are often poor surgical candidates.

I leave you with a completely tangential observation:  For decades, smugglers have swallowed balloons filled with illegal drugs in hopes of making it past customs.  Now physicians are covering balloons with drugs aimed at revascularization..

 

Selected sources      

 

Douglas JS, Jr., King SB, III. Chapter 62. Percutaneous Coronary Intervention. In: Fuster V, Walsh RA, Harrington RA. eds. Hurst's The Heart, 13e. New York, NY: McGraw-Hill; 2011.  Accessed October 23, 2014.

Creager MA, Loscalzo J. Chapter 249. Vascular Diseases of the Extremities. In: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson J, Loscalzo J. eds. Harrison's Principles of Internal Medicine, 18e. New York, NY: McGraw-Hill; 2012.  Accessed October 23, 2014.

Lin PH, Poi M, Matos J, Kougias P, Bechara C, Chen C. Arterial Disease. In: Brunicardi F, Andersen DK, Billiar TR, Dunn DL, Hunter JG, Matthews JB, Pollock RE. eds. Schwartz's Principles of Surgery, 10e. New York, NY: McGraw-Hill; 2014. . Accessed October 23, 2014.

http://www.nlm.nih.gov/medlineplus/ency/article/007393.htm

“The LEVANT 1 (Luvonix-Paclitaxal-Coated Balloon for the Prevention of Femoropopliteal Restenosis) Trial for Femoropopliteal Revascularization,”  from JACC: Cardiovascular Interventions (2014) by Dierk Scheinert and colleagues.

http://www.vascularweb.org/vascularhealth/pages/angioplasty-and-stenting.aspx