Drug-eluting balloons (DEBs) were developed as an alternative to drug-eluting stents for the treatment of coronary artery disease. DEBs work by temporarily delivering an anti-proliferative drug, such as paclitaxel, during balloon angioplasty to prevent restenosis. This localized drug delivery allows for higher drug concentrations at the site of injury while avoiding systemic drug exposure.

How Drug Eluting Balloon Work

Standard balloon angioplasty involves inflating an uncoated balloon inside the coronary artery to widen the blood vessel and improve blood flow. However, the procedure often leads to renarrowing of the artery, known as restenosis, in around 20-30% of patients within 6 months. Drug Eluting Balloon were designed to overcome this limitation. The balloon of a DEB is coated with an anti-proliferative drug, usually paclitaxel. When inflated at the site of narrowing, the drug is transferred to the arterial wall. This drug inhibits smooth muscle cell proliferation and migration, reducing the rate of restenosis. Without a permanent metallic implant, DEBs avoid drawbacks like late stent thrombosis seen with drug-eluting stents.

Short-Term Clinical Trial Results

Several randomized clinical trials have shown DEBs to be non-inferior to drug-eluting stents for treating in-stent restenosis. The PEPCAD II trial randomized 363 patients and found equivalence between paclitaxel-eluting balloons and paclitaxel-eluting stents at 9 months. The DIOR trial also found paclitaxel DEBs to perform similarly to a paclitaxel stent at 6 months with a lower rate of major adverse cardiac events. The DEBATE-NIH trial randomized 210 patients and demonstrated similar target vessel revascularization rates between DEBs and stents at 1 year. These trials established DEBs as a viable option for many lesion subsets.

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