Un-fractionated Heparin Versus Bivalirudin During Percutaneous Coronary Interventions (PCI) (ISAR-REACT-3)

Inclusion Criteria: Patients older than 18 years of age to undergo PCI Clopidogrel loading at least 2 hrs prior to PCI according to the PCI guidelines Informed, written consent Exclusion Criteria: Recent ST-elevation myocardial infarction within the last 48 hours Cardiogenic shock ACS and positive biomarkers (Troponin T > 0.03 µg/L) Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than one year or that may result in protocol non-compliance Active bleeding; bleeding diathesis History of gastrointestinal or genitourinary bleeding within the last 6 weeks Presence of diseases which have a high probability of vascular lesions and subsequent bleeding such as active gastric ulcer or active ulcerous colitis Recent trauma or major surgery in the last month Ophthalmic surgery or brain surgery in the last month Retinopathies or vitreous body bleeding in the last month History of intracranial bleeding or structural abnormalities (for example aneurysm of cerebral arteries) Suspected aortic dissection; pericarditis and subacute bacterial endocarditis Patient's refusal to blood transfusion Oral anticoagulation therapy with coumarin derivative within the last 7 days Treatment with UFH within 6 hours or low-molecular weight heparin within 8 hours before randomization Treatment with bivalirudin within 24 hours before randomization Severe uncontrolled hypertension >180/110 mmHg unresponsive to therapy Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days Relevant hematologic deviations:hemoglobin < 100 g/L; platelet count < 100 x 109 /L Glomerular filtration rate (GFR) < 30 ml/min or serum creatinine > 30 mg/L or dependence on renal dialysis Known allergy to the study medications: aspirin, clopidogrel, UFH, bivalirudin; stainless steel; true anaphylaxis after prior exposure to contrast media Known heparin-induced thrombocytopenia (Typ II) Previous enrollment in this trial Pregnancy (present, suspected or planned) or positive pregnancy test Spinal, peridural and epidural anesthesia Patient's inability to fully cooperate with the study protocol