Table 1 Eligibility criteria for the ORIENT trial

Inclusion criteria

● Patient age ≥18 years

● Ability to acknowledge verbally the risks, benefits and treatment ramifications in receiving the Orsiro Hybrid® or Resolute Integrity® stent

● Written informed consent given by legally authorized agent prior to any study-related procedure

● Indication for use of drug-eluting stent based on ACC/AHA/SCAI and ESC/EACTS guidelines and/or clinical judgment of interventional cardiologist.

● Target lesion(s) in coronary artery or graft vessel with estimated reference diameter ≥2.5 mm and ≤5.0 mm

● Target lesion(s) amenable to percutaneous coronary intervention

Exclusion criteria

● Known hypersensitivity or contraindication to any of the following agents: heparin, aspirin, clopidogrel, sirolimus, zotarolimus, cobalt chromium or contrast media^a

● Inability to tolerate aspirin or clopidogrel for 1-year duration of study

● Systemic (intravenous) use of sirolimus or zotarolimus within 12 months

● Females with childbearing potential (unless negative by a recent pregnancy test) or anticipating pregnancy following study enrollment

● History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia), or refusal of blood transfusions

● Gastrointestinal or genitourinary bleeding within prior 3 months, or major surgery within 2 months

● Planned major non-cardiac surgery within designated study period

● Cardiogenic shock (Killip class IV)

● Symptomatic heart failure, precluding coronary angiography in a supine position

● Non-cardiac co-morbid conditions limiting life expectancy (to <1 year) or potentially undermining protocol compliance (as judged by the site investigator)

● Active participation in another drug- or device-related investigational study where the primary endpoint follow-up is ongoing

● Unwillingness or inability to comply with protocol procedures