TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI

Korábbi kezelés

• Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
• Use of Gp IIb/IIIa inhibitors at randomization
• Treatment with only bare-metal stent (BMS) or balloon angioplasty during the index procedure.
• Planned surgery within 180 days
• Use of strong cytochrome P-450 3A inhibitor or inducers within 2 week of the date of enrollment
  • : ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir, rifampin/rifampicin, rifabutin, dexamethasone, phenytoin, carbamazepine, phenobarbital
• Concurrent medical condition with a life expectancy of less than 1 years
• Active participation in another investigational study of a drug or device that has not completed the primary endpoint or follow-up period

Más betegség

• Enzyme-positive Acute myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST Elevation Myocardial Infarction (STEMI))
• Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding)
• History of intracranial hemorrhage or intracranial aneurysm
• Severe liver disease (ascites and/or coagulopathy) or Dialysis-dependent renal failure at screening

Laborértékek

• Platelet count \<80,000 cells/mm3 or hemoglobin level \<10 g/dL

Egyéb

• Cardiogenic shock
• Requirements for chronic oral anticoagulation (warfarin or Non-vitamin K antagonist oral anticoagulant (NOACs))
• At risk of bradycardia (subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but without a permanent pacemaker)
• Pregnant and/or lactating women.
• Inability to provide written informed consent or participate in long-term follow-up

• Age 19 and more
• Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent
• Patients must have at least one of any features of complex high-risk anatomic, procedural, or clinical-related factors;
  • Clinical factors: diabetes, chronic kidney disease (i.e. creatinine clearance \<60 mL/min), or low left ventricular ejection fraction (\<40%) or
  • Lesion- or procedure-related factors: left main PCI, chronic total occlusion, bifurcation lesion requiring two-stent technique, severe calcification, diffuse long lesion (lesion length ≥ at least 30 mm), multi-vessel PCI (≥ 2 vessels requiring stent implantation), ≥3 requiring stent implantation, ≥ 3 lesions will be treated, or predicted total stent length for revascularization \> 60 mm
• The patient or guardian agreed to the study protocol and the schedule of clinical follow-up and provided informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site.