Investigators have announced the launch of a new study, evaluating a strategy of single-antiplatelet therapy (SAPT) following percutaneous coronary intervention (PCI) with latest-generation drug-coated balloons (DCBs) in an elderly and high bleeding risk population.
Fondazione Ricerca e Innovazione Cardiovascolare ETS (Fondazione RIC), an independent non-profit cardiovascular research foundation and Educación en Procedimientos de Intervencionismo en Cardiología (Fundación EPIC), the Spanish interventional cardiology education and research foundation, announced the launch of the clinical trial—PICCOLETO—after the first patient enrolment at Auxologico Research Hospital (Milan, Italy).
PICCOLETO IV is an international multicentre, investigator-driven, open-label, randomised (1:1), clinical investigation designed to observe and evaluate the rate of ischaemic and bleeding adverse events of SAPT after PCI with latest-generation DCBs in an elderly or high-bleeding risk population with stable or unstable coronary syndromes.
The study will enrol approximately 576 patients across 20 centres in four countries—Spain, Italy, Belgium, and Luxembourg—with a planned follow-up period of 12 months.
As per international guidelines, coronary lesions are primarily treated with drug-eluting stents (DESs). While DESs have demonstrated good clinical outcomes, even the latest generations remain associated with restenosis, vessel thrombosis, and myocardial infarction (MI), investigators state in a press release. In addition, DES carry an intrinsic thrombotic risk, requiring dual antiplatelet therapy (DAPT). However, elderly patients and those at high bleeding risk (HBR) have a cumulative increase in adverse events, including a higher thrombotic risk after angioplasty with DES.
Recently DCB have emerged as an attractive alternative for the treatment of coronary de novo lesions. In recent years, a new generation of DCBs have been developed, with the aim of improving the trackability and deliverability of these devices, along with an improvement of drug release and persistence in the vessel wall.
The PICCOLETO IV study evaluates a DCB strategy in native coronary artery disease using the Essential Pro (iVascular) DCB, followed by SAPT instead of DAPT. The study addresses whether SAPT after successful DCB angioplasty is safe and effective compared with standard DAPT in patients aged ≥75 years or those identified as HBR with either stable or unstable coronary syndromes
“This study is very important, because it will find the right spot for DCBs in a very high risk patient population, namely elderly patients or patients at high bleeding risk,” comments Bernardo Cortese (Fondazione RIC and Harrington Heart & Vascular Institute UH, Cleveland, USA). “Stents do not perform well here, either for the necessity of a prolonged double antiplatelets duration, and for a higher pro-thrombotic risk. With this scientifically robust randomised clinical trial we will deeply investigate the role of DCB here.”
“After the publication of the DCB ARC [Drug Coated Balloon Academic Research Consortium] consensus papers in 2025, the time to explore additional indications for DCB has come,” adds Armando Perez de Prado (Fundación EPIC and University Hospital of León, León, Spain).
