This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) for very long coronary lesions.
Following angiography, patients with significant diameter stenosis \> 50% and lesion length (\> 50mm) requiring at least 2 multiple long-stent placement by visual estimation and eligible for LONG-DES VI trial inclusion and exclusion criteria will be randomized 1:1 to zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) by the stratified randomization method.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
302
drug eluting stent implantation
Gangwon National Univ. Hospital
Chuncheon, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Kyungpook National university hospital
Daegu, South Korea
In-segment late luminal loss at 13 month follow-up
Time frame: 13 month post stenting
1. All Death
Time frame: 12 month clinical follow-up
2. Cardiac death
Time frame: 12 month clinical follow-up
3. Myocardial infarction (MI)
Time frame: 12 month clinical follow-up
4. Composite of death or MI
Time frame: 12 month clinical follow-up
5. Composite of cardiac death or MI
Time frame: 12 month clinical follow-up
6. Target vessel revascularization (ischemia-driven and clinically-driven)
Time frame: 12 month clinical follow-up
7. Target lesion revascularization (ischemia-driven and clinically-driven)
Time frame: 12 month clinical follow-up
8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)
Time frame: 12 month clinical follow-up
9. Stent thrombosis (ARC criteria)
Time frame: 12 month clinical follow-up
10. In-stent late loss
Time frame: 13 month angiographic follow-up
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The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea
Chonnam National University Hospital
Gwangju, South Korea
National Health Insurance Service Ilsan Hospital
Ilsan, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyunghee University Medical Center
Seoul, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, South Korea
St.carollo Hospital
Suncheon, South Korea
...and 1 more locations
11. In-stent and in-segment restenosis
Time frame: 13 month angiographic follow-up
12. Angiographic pattern of restenosis
Time frame: 13 month angiographic follow-up
13. Volume of intimal hyperplasia
sub-study
Time frame: 13 month IVUS follow-up
14. Incidence of late stent malapposition
sub-study
Time frame: 13 month IVUS follow-up
15. Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay
Time frame: 2-3 days post stenting