Plaque modification and impact on the microcirculation territory after drug-coated balloon angioplasty. The PLAMI study design.

Introduction and objectives: Although drug-eluting stents are the main treatment in percutaneous coronary interventions (PCI), drug-coated balloons (DCB) represent an appealing alternative as they eliminate the risk of stent thrombosis and avoid leaving any metal structure in the vessel wall. However, limited evidence has been published to date on the vessel wall healing processes, plaque remodeling, plaque composition, and the impact on the coronary microcirculation after percutaneous coronary intervention with DCB (DCB-PCI). Methods: This is investigator-initiated, single-center, single-arm, open-label, pilot study of 30 patients with native vessel disease undergoing DCB-PCI. Intravascular ultrasound and angiography-derived index of microvascular resistance (IMRangio) will be performed before and immediately after PCI, and at 3 months of follow-up. Conclusions: The study aims to provide new evidence on the modification of atherosclerotic plaque in patients with de novo lesions undergoing PCI with DCB. This will be assessed by examining the change in the percentage of atheroma volume and late lumen enlargement using intravascular ultrasound and by evaluating changes in the microcirculation using IMRangio.Registered at Clinicaltrials.gov (NCT06080919).