Drug-Coated Balloons Can Replace Stents Even in Larger Coronary Arteries

Narrowed or blocked arteries pose a major global health burden, often leading to heart attacks, heart failure, or stroke when blood flow becomes compromised. Traditional balloon angioplasty can reopen vessels but often results in restenosis, while stents leave permanent metal implants that carry long-term risks. A minimally invasive alternative has now shown a strong performance in larger vessels, offering clinicians an additional option for treating coronary artery disease.

Researchers from Saarland University (Saarland, Germany) led a large international study validating the use of drug-coated balloons (DCBs) in arteries wider than 2.75 mm. DCB technology, originally developed two decades ago, delivers an antiproliferative drug deep into the vessel wall during balloon inflation, reducing the chance of tissue regrowth that causes re-narrowing. Unlike stents, DCBs leave no permanent implant behind.

In this multicenter SELUTION DeNovo study of more than 3,300 patients, the researchers found that DCBs produced one-year outcomes comparable to modern drug-eluting stents in larger coronary arteries. Serious clinical events such as heart attack, sudden cardiac death, or repeat intervention occurred at similar rates in both groups. Published evidence from The Lancet and the European Heart Journal had already demonstrated strong performance of DCBs in smaller coronary vessels, and the new study significantly extends their applicability.

The data also offer important context for the earlier Chinese Rec-Cagefree I study, which suggested inferior performance of DCBs in large-vessel stenosis. The updated three-year results indicate that differences in drug coating chemistry and drug-retention profiles likely explain inconsistent outcomes. According to researchers, the coating used in the Rec-Cagefree I trial did not maintain drug presence in the vessel wall long enough to prevent restenosis reliably.

The findings reinforce global movement toward interventional strategies that minimize permanent implants, reducing medium- and long-term risks associated with stents. For some patients, combining short-length stents with targeted DCB therapy may remain the optimal approach, especially in complex coronary disease. Ongoing international trials continue to evaluate DCB therapy across diverse patient groups and lesion types.

“In addition to comparing different technologies for treating coronary artery disease, my team and I are focused on developing new strategies tailored to individual patient needs,” said Professor Bruno Scheller of Saarland University. “For many patients, a combination of drug-eluting stents and drug-coated balloons DCBs will remain the best option. DCBs allows us to avoid long stent lengths, which can pose significant risks to patients over the medium to long term.”

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