| Number of patients | 3555 vs. 3564 | 1500 vs. 1509 | 1495 vs. 1498 | 7980 vs. 7988 |
| Location | Austria, Canada, China, Germany, India, Israel, Italy, Poland, Spain, UK, USA | Japan | Korea | Canada, Netherlands, Belgium, France, Spain, Portugal, Hungary, Italy, Switzerland, Austria, UK, Denmark, Poland, Germany, Brazil, Australia, Singapore, Bulgaria |
| Study design | Randomized, multicentre, double-blind, placebo-controlled trial | Randomized, multicentre, open label, adjudicator-blinded clinical trial | Randomized, investigator-initiated, multicentre, open label, non-inferiority | Randomized, open label, superiority trial, multicentre, multinational |
| Funding | Sponsored by Icahn School of Medicine, investigator-initiated grant from AstraZeneca | Abbott Vascular funded the study but did not provide medications or coronary devices | Unrestricted grants from the Korean Society of Interventional Cardiology (grant 2013-3), Abbott Vascular, Biotronik, and Boston Scientific | Sponsored by European Clinical Research Institute, which received funding from Biosensors International, AstraZeneca, and the Medicines Company. In part, with funding from the Canada Research Chairs Programme.
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| Follow-up (months) | 15 (monthly from 3rd month) | 12 | 12 | 24 (landmark analysis at 1 and 12 months) |
| S-DAPT | 3 months DAPT regimen with aspirin 81–100 mg daily and ticagrelor 90 mg twice daily, followed by ticagrelor monotherapy | 1-month DAPT regimens, either aspirin 81–200 mg daily and clopidogrel 75 mg daily or prasugrel 3.75 mg daily, followed by clopidogrel monotherapy | 3 months DAPT regimens, either aspirin 100 mg daily and clopidogrel 175 mg daily or prasugrel 10 mg daily or ticagrelor 90 mg twice daily followed by clopidogrel or prasugrel or ticagrelor monotherapy | 1-month DAPT regimen with aspirin 75–100 mg daily and ticagrelor 90 mg twice daily followed by 23 months of ticagrelor monotherapy |
| DAPT | 15 months DAPT regimen with aspirin and ticagrelor | 12 months DAPT regimen with aspirin and clopidogrel | 12 months DAPT regimen with aspirin and clopidogrel or prasugrel or ticagrelor | 12 months DAPT regimens with aspirin 75–100 mg daily and clopidogrel 75 mg daily or ticagrelor 90 mg twice daily, followed by aspirin monotherapy for 12 months |
| Inclusion criteria | Must meet one of the following: ≥65 years of age Female gender Troponin positive ACS Established vascular disease defined as previous MI, documented PAD or CAD/PAD revascularization DM treated with medications (oral hypoglycaemic therapy or subcutaneous insulin) CKD defined as estimated GFR <60 mL/min per 1.73 m2 or creatinine clearance <60 mL/min
| Patients who underwent successful PCI with CoCr-EES (DES) | Age ≥20 years Patients are able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure Patients should have undergone successful PCI with DES for stable ischaemic heart disease or ACS Patients must have one or more coronary stenosis of 50% or more in a native coronary artery with visually estimated diameter of ≥2.25 mm and ≤4.25 mm eligible for stent implantation Target lesion(s) must be amendable for PCI with a DES
| Age ≥18 years Any clinical indication for PCI Presence of one or more coronary stenosis of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation in a vessel with a reference vessel diameter of at least 2.25 mm PCI with a biolimus A9-eluting stent (DES)
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Must meet one of the following: Multivessel CAD Target lesion requiring total stent length >30 mm Thrombotic target lesion Bifurcation lesions with Medina X, 1,1 classification requiring at least two stents Left main (≥50%) or proximal LAD (≥70%) lesion Calcified target lesion(s) requiring atherectomy
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| Exclusion criteria | <18 years old Contraindication to aspirin and/or ticagrelor Planned surgery and/or coronary revascularization (surgical or percutaneous) within 90 days Need for chronic OAC Prior stroke Dialysis-dependent renal failure Active bleeding or extreme-risk for MB Salvage PCI or STEMI presentation Liver cirrhosis Life expectancy <1 year Unable or unwilling to provide informed consent Women of child bearing potential Fibrinolytic therapy within 24 h of index PCI Concomitant therapy with a strong CYP4503A inhibitor or inducer PLTs <100 000 mm3 Requiring ongoing treatment with aspirin ≥325 mg daily
| Need for OAC Need for antiplatelet therapy other than aspirin and P2Y12-i History of intracranial bleeding Known intolerance to clopidogrel No concomitant use of other types of DES No other types of complication other than periprocedural MI
| Patients with a known hypersensitivity or contraindication to any of the following medications: aspirin, clopidogrel, prasugrel, ticagrelor, everolimus or sirolimus Haemodynamic instability or cardiogenic shock Patients with active pathologic bleeding including gastrointestinal or genitourinary bleeding DES implantation within 12 months before index procedure Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study Non-cardiac co-morbid conditions are present with life expectancy <2 years or that may result in protocol non-compliance (per site investigator’s medical judgment) Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
| Known intolerance to aspirin, P2Y12-i, bivalirudin, stainless steel or biolimus Known intake of a strong CYP3A4 inhibitor Fibrinolytic therapy within 24 h of PCI Known severe hepatic impairment Planned CABG as a staged procedure (hybrid) within 12 months of the index procedure Planned surgery within 12 months of PCI unless DAPT is maintained throughout the perisurgucal period Need for OAC PCI for a prior known stent thrombosis Known overt MB Known history of intracranial haemorrhage Known stroke from ischaemic or unknown cause within last 30 days Known pregnancy at time of randomization Inability to provide informed consent Current participating in another trial before reaching primary endpoint
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