Acute Coronary Syndrome, Antineoplastic Agents, Arterial Occlusive Diseases, Aspirin, Atherosclerosis, Cardiovascular Diseases, Clopidogrel, Coronary Artery Disease, Coronary Disease, Coronary Stenosis, Cyclooxygenase Inhibitors, Dual Antiplatelet Therapy, Enzyme Inhibitors, Heart Diseases, High Bleeding Risk, Immunosuppressive Agents, Molecular Mechanisms of Pharmacological Action, MTOR Inhibitors, Myocardial Ischemia, P2Y12 Inhibitor, Physiological Effects of Drugs, Platelet Aggregation Inhibitors, Protein Kinase Inhibitors, Single Antiplatelet Therapy, Vascular Diseases
Conditions
Keywords
DCB, Angioplasty, Paclitaxel, Antiplatelet treatment, Single antiplatelet therapy (SAPT), Dual antiplatelet therapy (DAPT), High bleeding risk (HBR), MACE, Native CAD, stable or unstable coronary syndromes
Brief summary
This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients undergoing percutaneous coronary intervention (PCI) with the latest generation drug-coated balloon (DCB). The study includes patients with stable or unstable coronary syndromes and aims to assess rates of ischemic and bleeding adverse events.
Detailed description
The purpose of the PICCOLETO IV-EPIC 38 study is to observe and evaluate the efficacy and safety of single antiplatelet therapy (SAPT) after successful PCI with the Essential Pro drug-coated balloon in native coronary artery disease in vessels with a diameter between 2.0 and 4.0 mm, compared to routine dual antiplatelet therapy (DAPT). Patients aged 75 years or older, or those at high bleeding risk, with stable or unstable coronary syndromes will be enrolled and randomized in this study.
Interventions
DEVICEDrug-coated balloon
Essential Pro paclitaxel eluting coronary balloon dilatation catheter is a rapid exchange catheter, also known as RX because it has a proximal simple lumen configuration and a distal coaxial dual lumen, intended for coronary arteries percutaneous transluminal angioplasties. Patients assigned to this Arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.
The antithrombotic regimen is single antiplatelet therapy (SAPT). The Investigator will decide if to use aspirin or clopidogrel, whereas ticagrelor or prasugrel are not recommended in our study population since no benefit (or even harm) has been shown by these drugs in head-to-head trials versus clopidogrel in elderly PCI populations. The type of agent and treatment duration will be selected according to the clinical characteristics of the patient.
The antithrombotic regimen will follow the standard of care with a dual antiplatelet regimen (DAPT) per local preferences and international guidelines/ARC consensus paper. The type of agent and treatment duration will be selected according to the patient's clinical characteristics.
Sponsors
Fondazione Ricerca e Innovazione Cardiovascolare ETS
Fundación EPIC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Male and female patients who meet the following criteria: * Age ≥ 75 years or age ≥ 18 years at high bleeding risk; * Successful PCI with Essential Pro 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 given by the patient or impartial witness.
Exclusion criteria
* Stent implantation during index or recent (\<6 months) procedure; * Known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel or contrast media, or any of their excipient which cannot be adequately pre-medicated; * Pregnancy at the time of hospitalization; * Patients participating in another clinical study in which an investigational drug or device was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer; * 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. * History of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines (NSAIDs); * History of gastrointestinal perforation, ulceration, or bleeding (peptic ulcer bleeding-PUBs) related to previous use of NSAIDs or anticoagulant medications, or intracranial hemorrhage; * Acute gastrointestinal ulcers; * Hemorrhagic diathesis (including known bleeding disorders or ongoing active bleeding); * Severe renal impairment (eGFR \< 30 mL/min); * Severe hepatic impairment (Child-Pugh C), with elevated liver enzymes (ALT/AST \> 2 x ULN or total bilirubin \>1.5 x ULN); * Severe cardiac failure (NYHA grade III or IV); * Combination with methotrexate at doses of 15 mg/week or more; * Patients with baseline neutrophil counts \< 1500 cells/mm³; * Breastfeeding women; * Full-blown thyrotoxicosis; * Patients with a very high risk of thrombosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Net Adverse Clinical Events (NACE) at 12 months | 12 months | Superiority of single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB), assessed by the rate of Net Adverse Clinical Events (NACE). NACE is defined as the composite of major adverse cardiovascular events (MACE) plus clinically relevant bleeding events classified as BARC 2, 3, or 5, evaluated at 12 months following successful PCI with DCB. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Clinically Relevant Bleeding Events (Bleeding Academic Research Consortium [BARC] Scale, Grades 2-5; range 0-5, where higher grades indicate more severe bleeding and worse clinical outcome) | 12 months | Incidence of clinically relevant bleeding events classified as BARC grades 2, 3, or 5 according to the Bleeding Academic Research Consortium (BARC) bleeding definition (scale range 0-5; higher scores indicate worse outcome) in elderly or high bleeding risk patients treated with single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) with drug-coated balloon (DCB). |
| Procedural success rate immediately post-PCI | Post-PCI | Defined as final stenosis \<30%, distal TIMI 3 flow, and no major in-hospital adverse events. |
| Patient-oriented composite endpoint (PoCE) | 12 months | Composite of all-cause death, all myocardial infarctions (MIs), or any repeat revascularization. |
Countries
Italy
Contacts
CONTACTBernardo Cortese, MD MSc
CONTACTBeatrice Barbano
Outcome results
None listed