Drug-eluting Balloons Equivalent to Drug-Eluting Stents in Terms of Safety for Managing Coronary Artery Disease

 


Drug-elutingBalloon (DEB), also referred to as drug-coated balloon (DCB), is used to release anti-proliferative drugs into the vessel wall during inflation of the balloon, usually at nominal pressures with a specific minimal inflation time. These semi-compliant angioplasty balloons are typically used in re-stenotic lesions, which are previously stented segments that have developed neointimal hyperplasia and luminal loss. There are four key components to a DEB. These include, the balloon platform, the drug, an excipient to hold the drug on the balloon and control its release, and the balloon coating process.

The transcatheter technology in drug-eluting balloons helps to reduce high restenosis rates in peripheral artery disease (PAD). The global prevalence of PAD in people aged 25 years and older was 5·56%, according to a study, published in The Lancet in August 2019. The study took into account national prevalence data of PAD from Bangladesh, Brazil, China, France, Germany, India, Indonesia, Italy, Japan, Mexico, Pakistan, Russia, Spain, the UK, and the USA. In the U.S., the Food and Drug Administration has cleared C. R. Bard’s Lutonix 035 DEB and Medtronic’s In.Pact Admiral DEB for use in the superficial femoral and popliteal arteries in the upper leg. Other companies that are focused on development and launch of DEBs are Covidien, Biotronik, Cook Medical, Boston Scientific, EuroCor, Cardionovum and Aachen Resonance.

Drug-eluting balloons are similar to conventional angioplasty balloons. But unlike to conventional angioplasty balloons, DEBs elute the antiproliferative drug paclitaxel into the vessel wall once expanded. However, use of DEBs is associated with drug loss. Majority of the drug, with the use of DEBs, ends up in the bloodstream. Moreover, availability of new generation drug-eluting stents is expected to limit demand for DEBs. Several studies have highlighted the effectiveness of new generation drug-eluting stents in the treatment of in-stent restenosis compared with the first-generation DEBs. Some studies have also confirmed that DEBs are equivalent to DES in terms of safety for managing coronary artery disease.


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