Innovations in Drug-Coated Balloons and Stentless Coronary Interventions: Evaluating the Evidence, Limitations, and Future Prospects in De-Novo Lesion Management
George Davidson *
RWJ Barnabas Health, New Jersey, United States.
Nwachukwu O. Nwachukwu
Darlington Memorial Hospital, Darlington, United Kingdom.
Chimaobi Nwevo
NYC Health + Hospital/ South Brooklyn Health, 11235, Brooklyn NY, United States.
Ahmed Ismail Ali
Medical Academy named after S.I. Georgievsky of Vernadsky, Simferopol, Russia.
Nwamaka C. Bob-Ume
All Saints University School of Medicine, Belair Kingstown, St Vincent & The Grenadines.
Abduljabbar A. Abdulaziz
University of Ilorin, Ilorin, Nigeria.
Adu Agyen Kwame
Kwame Nkrumah University of Science amd Technology, Kumasi, Ghana.
Muhiyadin S. Ali
Garissa County Referral and Teaching Hospital, Garissa, Kenya.
Alexander C. Ogbodo
Southtynside and Sunderland NHS Foundation Trust, United Kingdom.
Obinna D. Nwaizuzu
University of Nigeria, Nsukka, Nigeria.
*Author to whom correspondence should be addressed.
Abstract
Coronary artery disease (CAD) remains a major cause of morbidity and mortality, and percutaneous coronary intervention (PCI) is central to the management of obstructive coronary disease. Although drug-eluting stents (DESs) have reduced restenosis and repeat revascularisation, their permanent metallic structure is associated with persistent concerns, including chronic vascular inflammation, impaired vasomotion, delayed healing, neoatherosclerosis, stent thrombosis and difficulties during future revascularisation. Drug-coated balloons (DCBs) provide a stentless approach by delivering an antiproliferative agent to the vessel wall during balloon inflation without leaving a permanent scaffold. This narrative review evaluates the evidence, limitations and future prospects of DCB-based coronary intervention for de novo coronary artery lesions. Contemporary randomised trials, systematic reviews, meta-analyses, pooled analyses and expert reviews were examined, with emphasis on clinical outcomes, angiographic findings, lesion preparation, device-related considerations and long-term safety. The reviewed evidence indicates that DCBs can achieve clinical and angiographic outcomes broadly comparable to those of DESs in appropriately selected patients, particularly in small-vessel coronary artery disease. Three-year and longer-term analyses also suggest similar rates of major adverse cardiovascular events, target lesion revascularisation and cardiac mortality in selected populations. Emerging evidence supports possible use in selected large-vessel lesions, although this indication is less established. The principal advantage of DCB therapy is its leave-nothing-behind strategy, which preserves native vessel architecture and avoids complications related to permanent implants. However, outcomes depend strongly on adequate lesion preparation, careful patient selection and device-specific performance. Current evidence supports DCB-based stentless intervention as a maturing revascularisation strategy for selected de novo lesions, while further standardised trials are required to define its role in complex anatomy and acute coronary syndromes.
Keywords: Drug-coated balloon, stentless coronary intervention, De novo coronary lesions, percutaneous coronary intervention, drug-eluting stent, coronary artery disease, small-vessel disease, lesion preparation, leave-nothing-behind strategy, target lesion revascularization.