Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)

Prior treatment

• 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;
• History of gastrointestinal perforation, ulceration, or bleeding (peptic ulcer bleeding-PUBs) related to previous use of NSAIDs or anticoagulant medications, or intracranial hemorrhage;

Other illness

• 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;
• ST-elevation myocardial infarction;
• History of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines (NSAIDs);
• Hemorrhagic diathesis (including known bleeding disorders or ongoing active bleeding);
• Severe cardiac failure (NYHA grade III or IV);
• Patients with a very high risk of thrombosis.

Lab values

• Left ventricular ejection fraction \<30%;
• 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);
• Patients with baseline neutrophil counts \< 1500 cells/mm³;

Other

• Stent implantation during index or recent (\<6 months) procedure;
• Pregnancy at the time of hospitalization;
• Life expectancy \<12 months;
• 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.
• Acute gastrointestinal ulcers;
• Combination with methotrexate at doses of 15 mg/week or more;
• Breastfeeding women;
• Full-blown thyrotoxicosis;

• 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.