The newer generation ZES (Medtronic, Minneapolis, MN, Resolute Integrity) and EES (Abbott Vascular, Abbott Park, Illinois, Xience Prime) were introduced to South Korea. Although these are thought to be superior in effect and stability compared to ZES and EES of previous generation, there are few clinical data regarding the high risk groups of diabetes patients or small vessels lesion. Moreover, looking at the 8.3% of restenosis in Resolute All Comer study (23% diabetes), the investigators could not know the outcome in high risk patients such as diabetes or small vessels lesion. Therefore, the aim of this study is to investigate the effectiveness and safety of Resolute Integrity or Xience Prime in diabetes or small vessels lesion patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
600
1\. Intracoronary stenting 1. The procedure could be conducted via brachial, radial or femoral approaches. 2. There are no restrictions regarding lesion's length or diameter. For long lesions, overlapping of several stents would be allowed but only allocated type of stents should be used. 3. When several lesions are included in the study of a patient, each lesion may be allocated in different groups. Only if deployment of the allocated stent is not possible, crossing to other stent would be allowed. 4. Direct stenting or bifurcation stenting is allowed. 5. Predilation before stenting, IVUS examination, and administration of glycoprotein IIb/IIIa inhibitor would be determined by investigator.
Devision of cardiology, Chonbuk national university hospital
Jeonju, Chon-buk, South Korea
RECRUITINGin-segment late lumen loss (mm)at 12month
Time frame: 12month
major adverse cardiac events(MACE) at 12month
1\) Occurrence of major adverse cardiac events (MACE) during 12 months * Cardiac death * Target vessel related myocardial infarction * Ischemia driven Target Vessel Revascularization (TVR) * Ischemia driven Target Lesion Revascularization (TLR) * Definite / probable stent thrombosis by ARC definition
Time frame: 12month
MACE at 24month
2\) Occurrence of major adverse cardiac events (MACE) during 24 months * Cardiac death * Target vessel related myocardial infarction * Ischemia driven Target Vessel Revascularization (TVR) * Ischemia driven Target Lesion Revascularization (TLR) * Definite / probable stent thrombosis by ARC definition
Time frame: 24month
procedure success rate
Procedure success rate proportion of investigational stent deployed successfully without chage to other stent
Time frame: 1 day (after procedure)
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