Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB

Launched by FONDAZIONE RICERCA E INNOVAZIONE CARDIOVASCOLARE ETS · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different types of antiplatelet therapy—single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT)—in older patients or those at high risk of bleeding who have undergone a specific heart procedure called percutaneous intervention (PCI) using a drug-coated balloon (DCB). The goal is to see which therapy results in fewer serious heart-related problems or bleeding events after the procedure.

To be eligible for this study, participants must be at least 75 years old or have a high risk of bleeding and have just had a successful PCI involving one to three coronary arteries. They should also have stable or unstable coronary syndromes, which means they have issues with their heart's blood flow. Patients who have recently had certain types of heart issues, are pregnant, or have specific serious conditions may not be able to participate. Those who join the study will be randomly assigned to receive either single or dual therapy and will be monitored for any complications over time. This research is important because it aims to find the safest and most effective treatment for a vulnerable group of patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • successful PCI with solo-DCB just performed, in 1, 2 or 3 coronary vessels;
• • stable or unstable coronary syndromes;
• • de novo coronary lesions in vessels with diameter \>=2.0 and \<=4.0 mm (visual estimation);
• • informed consent to participate in the study;
• • at least one of the following criteria: \>=75 y.o.; high bleeding risk (ARC criteria)
• Exclusion Criteria:
• • stent implantation during index or recent (\<6 months) procedure;
• • patients with known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, contrast media, which cannot be adequately pre-medicated;
• • patients participating in another clinical study; - pregnancy at the time of hospitalization;
• • ST-elevation myocardial infarction;
• • life expectancy \<12 months;
• • left ventricular ejection fraction \<30%;
• • visible thrombus at lesion site;
• * target lesion/vessel with any of the following characteristics:
• • severe and/or \>270° calcification of the target vessel, also proximal to the lesion (intravascular imaging not mandatory);
• • left main stem stenosis \>50%;
• • target lesion is in the left main stem;
• • chronic total occlusion with anticipated necessity of retrograde approach;
• • lesion is in a bypass graft.