Drug Eluting Balloon - A Breakthrough in Treating Peripheral Artery Disease

 

Drug Eluting Balloon
Drug Eluting Balloon

What are Drug Eluting Balloons?

Drug-eluting balloons (DEBs) are angioplasty balloons coated with an anti-proliferative drug, typically paclitaxel, dexamethasone, or sirolimus. During angioplasty to open blocked arteries, the drug-coated balloon is inflated at the site of stenosis to deliver the drug directly to the vessel wall. This helps prevent restenosis or re-narrowing of the artery which commonly occurs with conventional balloon angioplasty and bare metal stenting.

Drugs used in DEBs

The most commonly used drug is paclitaxel, a chemotherapy drug that works by preventing cell division and proliferation. When delivered locally via a Drug Eluting Balloon, it inhibits neointimal hyperplasia which is the narrowing of the artery that occurs after conventional angioplasty as the body tries to repair the damaged vessel wall. This helps maintain vessel patency for a longer period.

Dexamethasone, a corticosteroid, works by modulating the body's immune response and reducing inflammation at the treatment site. Sirolimus, also called rapamycin, is an immunosuppressive drug that prevents proliferation of smooth muscle cells in the vessel wall. All three drugs help address restenosis by limiting cell overgrowth post angioplasty.

Advantages over Other Treatments

Compared to plain old balloon angioplasty (POBA) which has high restenosis rates of 30-50%, drug-eluting balloons significantly reduce the risk of re-narrowing when used for indications like superficial femoral artery disease. They also appear superior to drug-eluting stents in preventing instent restenosis for below-the-knee interventions.

Unlike stents, DEBs do not introduce a permanent foreign body into the vessel. This eliminates issues like late stent thrombosis seen with drug-eluting stents. DEBs also have advantages over uncoated balloons like betterlesion crossing ability and pushability.

Areas of Application

Given their proven benefits, drug-eluting balloons are increasingly being used for endovascular treatment of peripheral artery disease (PAD) involving the superficial femoral artery (SFA), popliteal artery and below-the-knee vessels like tibial and peroneal arteries. Restenosis following angioplasty remains a challenge in smaller vessels below the knee. DEBs overcome this limitation and offer patients an alternative to repeat revascularization procedures or amputation.

Drug-eluting balloons are also used for in-stent restenosis where a previously placed stent gets blocked again. By delivering high drug doses locally, DEBs can re-treat such lesions more effectively than plain balloon angioplasty.

Overall, DEBs expand the scope of endovascular therapy to more complex PAD cases including complex long lesions, chronic total occlusions, small vessel and instent restenosis scenarios.

Clinical Evidence

Several randomized controlled trials have validated the benefits of DEBs. The landmark IN.PACT SFA trial compared standard angioplasty to treatment with a paclitaxel-coated balloon (IN.PACT Admiral) for SFA disease. It found that DEB angioplasty significantly reduced rates ofrestenosis and target lesion revascularization over 12 months.

The FEMPac trial also looked at outcomes with DEBs in SFA. At 24 months follow-up, patients who received a paclitaxel balloon had much lower rates of re-intervention compared to those treated with an uncoated balloon.

Other studies like the THUNDER trial proved the safety and efficacy of DEBs for treating small vessel PAD like below-the-knee arteries with good mid-term patency outcomes. In stent restenosis was effectively addressed in trials like IN.PACT SFA drug-coated balloon versus standard angioplasty for the treatment of SFA In-Stent restenosis.

Overall, there is a robust body of Level 1 evidence from randomized studies establishing drug-eluting balloons as a primary option for endovascular revasvularization in suitable patients with PAD. They deliver significant advantages over uncoated balloons or drug-eluting stents.

Safety Considerations

While they are generally safe and well-tolerated, there are some potential concerns due to the drug coatings:

- Allergic reactions to the drugs used, especially paclitaxel, are possible in sensitive patients. Skin testing may be done prior to treatment.

- Systemic drug absorption into bloodstream with toxic effects cannot be entirely ruled out. However levels are expected to be very low.

- Long term safety profile is still under evaluation as DEBs are a relatively new technology. Large registry data will provide more definitive answers.

- Cost is currently higher than uncoated balloons but may reduce with wider adoption.

When handled properly as per manufacturer instructions by experienced endovascular teams, they have an excellent safety profile. But like all new devices, long term follow up is important to establish lifetime performance and safety.

Advancements continue in this technology. Researchers are working on improving drug coatings for enhanced drug transfer and modulated drug release properties.

Biodegradable polymer coatings that do not require drug diffusion are being evaluated. Combination drug regimens may further reduce restenosis. Device modifications such as drug-coated balloons with nanocoating technology hold promise.

Developing patient-specific solutions based on individual lesion characteristics will optimize outcomes. Extending the benefits of DEB angioplasty to coronary interventions is another active area of research.

Overall, drug-eluting balloons represent a major breakthrough in interventional cardiology and vascular medicine. With continued developments, they have the potential to transform endovascular therapy for PAD and other vascular conditions globally.

 Gets More Insights, Drug Eluting Balloon

 

About Author:

Vaagisha brings over three years of expertise as a content editor in the market research domain. Originally a creative writer, she discovered her passion for editing, combining her flair for writing with a meticulous eye for detail. Her ability to craft and refine compelling content makes her an invaluable asset in delivering polished and engaging write-ups.

(LinkedIn: https://www.linkedin.com/in/vaagisha-singh-8080b91)

 

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