tailored versus conventional antithrombotic strategy intended for complex high-risk pci

Conditions: Coronary Stenoses

Summary: this study evaluates the efficacy and safety of tailored antithrombotic therapy with early (\ 6-month post-pci) deescalated (clopidogrel alone) strategy in patients undergoing high-risk complex pci as compared with standard dual antiplatelet therapy(aspirin and clopidogrel for 12 months).


Eligibility criteria:
inclusion criteria: 1. age 19 and more 2. subjects who scheduled for percutaneous coronary intervention(pci) with contemporary drug-eluting stent 3. 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 4. 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. exclusion criteria: 1. enzyme-positive acute myocardial infarction (non-st-elevation myocardial infarction (nstemi) or st elevation myocardial infarction (stemi)) 2. contraindication to aspirin or p2y12 inhibitors (ticagrelor or clopidogrel) 3. use of gp iib/iiia inhibitors at randomization 4. cardiogenic shock 5. treatment with only bare-metal stent (bms) or balloon angioplasty during the index procedure. 6. requirements for chronic oral anticoagulation (warfarin or non-vitamin k antagonist oral anticoagulant (noacs)) 7. 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) 8. history of intracranial hemorrhage or intracranial aneurysm 9. planned surgery within 180 days 10. severe liver disease (ascites and/or coagulopathy) or dialysis-dependent renal failure at screening 11. platelet count \<80,000 cells/mm3 or hemoglobin level \<10 g/dl 12. at risk of bradycardia (subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but without a permanent pacemaker) 13. 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 14. pregnant and/or lactating women. 15. concurrent medical condition with a life expectancy of less than 1 years 16. active participation in another investigational study of a drug or device that has not completed the primary endpoint or follow-up period 17. inability to provide written informed consent or participate in long-term follow-up

Keywords: antithrombotic strategy dual antiplatelet therapy