instantenous wave-free ratio-guided pci versus fractional flow reserve-guided pci in routine clinical practice, prospective, multicenter registry

Conditions: Stable Angina; Non ST Segment Elevation Myocardial Infarction; ST-segment Elevation Myocardial Infarction; Silent Myocardial Ischemia; Unstable Angina

Summary: the current study sought to evaluate the clinical relevance of ifr-guided strategy in real world clinical practice using unrestricted study population from stable angina to acute coronary syndrome including acute st-segment elevation myocardial infarction. previous abundant historical data of ffr-guided strategy will be also included as historical control to validate the ifr-guided strategy.

in this study, the investigators will validate the clinical relevance of instantaneous wave free ratio (ifr)-guided strategy in real world clinical practice in korea. the 1,200 patients who underwent ifr measurement will be prospectively enrolled at 5 centers in republic of korea. in patients who were indicated revascularization after ifr measurement (ifr\<0.90), ifr pullback system (ifr scout) and post-revascularization ifr measurement will be routinely performed. the primary hypothesis will be tested for non-inferiority of ifr-guided strategy, compared with ffr-guided strategy in terms of 2-year clinical outcomes. for the clinical outcome data following ffr-guided strategy will be used from the pooled data of the defer-des trial, the 3v ffr friends registry (nct01621438), and korean 4-center ffr registry. using those data, 1200 patients will be selected from the pooled data. in addition, routine application of ifr scout and post-revascularization ifr measurement will enable us to validate the clinical relevance of ifr-based prediction of acute procedural results and to compare ffr-pullback methods. primary hypothesis: the ifr-guided strategy will be non-inferior regarding patient-oriented composite outcomes (a composite of any death, any mi, any revascularization) at 2-year, compared with ffr-guided strategy. primary outcome: 1\] patient-oriented composite outcome (poco), defined as a composite of any death, any myocardial infarction (mi) or any revascularization at 2-year after index procedure according to the arc consensus \[2\] difference between predicted post-pci ifr value from ifr scout and actual post-pci ifr measurement sample size 1,200 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non st-segment elevation mi, or st-segment elevation mi with non-culprit stenosis enrolled at 5 centers in republic of korea. 1. inclusion criteria ① subject must be ≥18 years ② patients suspected with ischemic heart disease ③ patients with coronary artery stenosis with intermediate degree of stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery amenable to stent implantation or vessel size≥2.5 mm without definitive previous evidence of myocardial ischemia. ④ subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides 2. exclusion criteria * cardiogenic shock (systolic blood pressure \ 90mmhg) ② patients with a known hypersensitivity or contraindication to any of the following medications: statin, ezetimibe, heparin, aspirin, clopidogrel, prasugrel, ticagrelor * non-cardiac co-morbid conditions are present with life expectancy \<2 year (per site investigator's medical judgment). * history of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia) ⑤ patients with active pathologic bleeding ⑥ gastrointestinal or genitourinary major bleeding within the prior 3 months. ⑦ target lesion located in coronary arterial bypass graft

Eligibility criteria:
inclusion criteria: * subject must be ≥18 years * patients suspected with ischemic heart disease ③ patients with coronary artery stenosis with intermediate degree of stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery amenable to stent implantation or vessel size≥2.5 mm without definitive previous evidence of myocardial ischemia. * subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides exclusion criteria: * cardiogenic shock (systolic blood pressure \ 90mmhg) * patients with a known hypersensitivity or contraindication to any of the following medications: statin, ezetimibe, heparin, aspirin, clopidogrel, prasugrel, ticagrelor ③ non-cardiac co-morbid conditions are present with life expectancy \<2 year (per site investigator's medical judgment). * history of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia) * patients with active pathologic bleeding ⑥ gastrointestinal or genitourinary major bleeding within the prior 3 months. ⑦ target lesion located in coronary arterial bypass graft

Keywords: fractional flow reserve instantaneous wave-free ratio ischemic heart disease