[Background]
Resolute Onyx DES was proposed to be built on the Integrity platform for even greater flexibility and conformability. Featured Core wire technology, having a denser core metal wrapped in a cobalt alloy outer layer, enhances deliverability in challenging coronary anatomies, and improves conformability against the vessel wall and increases radiopacity, i.e. visibility during coronary intervention with no compromise to radial and longitudinal strength, despite being composed of thinner stent struts as compared with Resolute Integrity ZES (81 μm vs. 91 μm, respectively). Recent result showed Resolute Onyx have a lower crossing profile and improved trackability about 20% more than RI-ZES. Furthermore, Resolute Onyx DES with increased strut width to thickness ratio showed higher radial strength compared to RI-DES. Regarding these features, Resolute Onyx DES will be anticipated in improved clinical outcomes regard to better vessel conformability especially in complex lesions such as long, calcified and tortuous lesions. 

However, there is a paucity of data on clinical outcome in patients with CAC receiving zotarolimus-eluting stents. The present study would be prospective, multicenter, post-approval study to examine the 12-month and 24-month effectiveness of Resolute Onyx® stents in all comer CAD patients who have CAC. 

[Study hypothesis] 
The 12- and 24-month effectiveness of Resolute Onyx® stents in patients with angiographically moderate or severe coronary artery calcification (group I) would be comparable with mild or no calcification lesions (group II). Resolute Onyx® stents will show similar procedure success rate even in moderate or severe calcification patients. 

[Study design]
Prospective, multicenter, post-approval study designed to examine the 12-month and 24-month effectiveness of Resolute Onyx® stents in moderate or severe CAC.

Cohort/Group Label

Group I (Moderate Calcification, n=100)

Cohort/Group Description

Categorized as three groups according to the degree of calcification in coronary angiography.
Moderate (Score 2, Group I): CAC is easily observed(if there is only radiation shade observed during cardiac movement before contrast medium is administered)

Cohort/Group Label

Group II (Severe Calcification, n=100)

Cohort/Group Description

Categorized as three groups according to the degree of calcification in coronary angiography.
Severe (High, Score 3, Group II): severe CAC (when prominent shading invading both sides of the coronary artery is observed regardless of heart movement prior to the administration of the contrast medium)

Cohort/Group Label

Group III (No or Mild Calcification, n=100)

Cohort/Group Description

Categorized as three groups according to the degree of calcification in coronary angiography.
Zero (Score 0, Group III): No CAC
mild (Score 1, Group III): CAC observed only after close observation (radio-shading observed in part of the heart cycle)

Not collect nor Archive

Patients who have CAD and amendable for implantation of Resolute Onyx® stents during the index PCI would be enrolled.

Patients who visited the hospital during the period and inserted Resolute Onyx stent due to coronary disease.

Gender

Age

Description

The patient must be ≥18 years of age. 

The patient has CAD and needs to be treated with stenting. CAD includes stable angina pectoris and acute coronary syndrome (unstable angina pectoris, non-ST-elevation myocardial infarction (MI), or ST-elevation MI). Patients with chronic total occlusion are also deemed eligible. 

The patient has consented to participate and has authorized the collection and release of his medical information by signing the “Patient Informed Consent Form” 

The patient or guardian is willing and able to cooperate with study procedures and required follow up visits.

Patients with left main disease 

Patients with cardiogenic shock 

Patients who have contraindication for 12-month dual anti-platelet therapy (DAPT). 

Female of childbearing potential, who possibly plans to become pregnant any time after enrollment into this study.  

Patients with hypersensitivity or allergies to the drug or components indicated in the Instructions for Use of the stent.  

History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions. 

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

Current known platelet count <50,000 cells/mm3 or Hgb <8 g/dL. 

Patients with cardiogenic shock 

Patients with a life expectancy shorter than 12 months

MACE(Major adverse cardiac events) is defined as the composite of cardiac death, new MI, ischemia-driven target vessel revascularization (TVR) by either PCI or CABG.

12Month

Major adverse cardiac events

24 months

Composite of all cause death, new myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization

12 months and 24 months

Acute procedure success rate during the index PCI

N/A

MACE according to calcium index of IVUS

12 months and 24 months