REDUAL PCI Real Life Registry

Laborértékek

• A potential subject who meets any of the following criteria will be excluded from participation in this study: • Patients unable or unwilling to comply with the protocol or with life expectancy shorter than the duration of the study • Glomerular filtration rate < 30 ml/min • Prior or planned mechanical heart valve prosthesis. Patients with (planned) Transcatheter Aortic Valve Implantation or Aortic Valve Replacement with bioprosthetic valve, are eligible for participation in this study. • Cardiogenic shock • Contra-indication for Dabigatran, Ticagrelor or Clopidogrel o Liver dysfunction (ALAT, ASAT, Alkaline phosphatase > 3x upper limit of normal) or liver disease (like hepatitis A, B, C) o Lesion or condition with a significant risk of serious bleeding, such as:  current or recent gastrointestinal ulceration;  malignant neoplasms with more bleeding risk;  recent brain / spinal cord injury;  recent surgery on the brain, spinal cord or eyes;  recent or history of intracranial haemorrhage;  oesophageal varices;  arteriovenous malformations;  vascular aneurysms; o severe intraspinal or intracerebral vascular abnormalities. o comedication with cyclosporine, itraconazole, ketoconazole (systemic) and glecaprevir / pibrentasvir, dronedarone, rifampicine, carbamazepine, St. Jan’s wort or phenytoin o Comedication with tacrolimus is not recommended. • Allergy to for Dabigatran, Ticagrelor or Clopidogrel • Pregnancy • Significant thrombocytopenia (platelet count < 50x10 9/L) • Major bleeding according to BARC ≥3 within the past 6 months. • Weight < 50 kg

• In order to be eligible to participate in this study, the investigator should have carefully considered participation of the patient after extensively consideration between high risk of bleeding and risk of thromboembolic events. Furthermore, a subject must meet all of the following criteria: • Age ≥ 18 years • PCI and successful stenting with a Drug Eluting Stent (DES) • Patients having an indication for a NOAC or will start with oral anticoagulation (NOAC). Patients with permanent, persistent or paroxysmal atrial fibrillation are eligible. • Written informed consent. In addition to the inclusion criteria above, all patients should meet one of the following conditions: • Admission to the hospital with ACS (unstable angina, NSTEMI, STEMI) • High risk PCI as defined by the presence of one of the following conditions: o Chronic Total Occlusion o Two-stent bifurcation laesion o Total stent length of >60mm in initial procedure o Venous graft stenting • Or the presence of medically treated type I or II diabetes mellitus