Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI

Korábbi kezelés

• PCI without drug-eluting stent implantation or with a bioresorbable scaffold
• Any planned surgery within 12 months unless intended antiplatelet therapy could be maintained throughout the peri-surgical period
• Need for oral anticoagulation therapy
• Use of fibrinolytic therapy within 24 hours of PCI
• increased thrombotic risk related to the patient (previous stent thrombosis, ≥ 2 previous myocardial infarction, symptomatic peripheral artery disease, chronic systemic inflammatory disease treated with corticoids or immunosuppressive drug) or the index clinical event (left main treated, ≥3 stents/treated lesions, total length of stents>60mm, bifurcation lesion with stents in each branch, stenting of the last patent vessel)

Más betegség

• Planned coronary artery bypass grafting or cardiac surgery
• Index clinical event PCI for stent thrombosis, in-stent restenosis or chronic total occlusion
• Known hypersensitivity or allergy to aspirin, clopidogrel, ticagrelor or prasugrel
• Patients considered as vulnerable by the investigators because of medical, psychological or social conditions:
  • Patients with known or discovered severe cognitive impairment
  • Patients with treated or untreated severe psychological or psychiatric conditions
  • Patients with uncorrected severe hearing or visual handicap
  • Patients with addictive alcohol, drug or substance abuse
  • Patients with protective measures (guardianship, tutorship, curatorship)
  • Any other condition considered by the investigators as not warranting informed consent
• patients with poor quality of the downstream territory with diffuse distal coronary disease

Laborértékek

• Severe renal insufficiency (MDRD creatinine clearance < 30 ml/min/m2) and/or dialysis
• Increased bleeding risk (prior hemorrhagic stroke; stroke < 30 days; brain injury<6 months; history of intracranial tumor or intracranial hemorrhage; internal bleeding<6 weeks; active bleeding; anemia (hemoglobin ≤ 8 g/dl) or thrombocytopenia (platelets < 100 000 G/L); major surgery<3 weeks)

Egyéb

• Life expectancy less than 1 year
• Participation in another interventional trial
• women of childbearing potential: non menopaused -with no menses for 12 months without an alternative medical cause- and not permanently sterilized -hysterectomy, bilateral salpingectomy or bilateral oophorectomy-

• Patients ≥ 65 years
• Successfully treated with percutaneous coronary intervention (PCI) with ≥ 1 drug-eluting stent (final TIMI 3 flow and visually estimated residual diameter stenosis <30%) for acute coronary syndrome (including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction and unstable angina) or chronic coronary syndrome (elective PCI). Inclusion is possible after the last PCI procedure in staged procedure.
• Randomization must be performed before the discharge from the study site.
• Written informed consent
• Social security affiliated