This study is a multicenter, open label, prospective, single arm trial Single arm group; following angiography, eligible patients with unprotected LMCA stenosis \>50% by visual estimation, which is equally treatable by the both treatment strategy (EES stenting or CABG), will be treated with EES
The primary objective of the PRECOMBAT-2 trial is to establish the safety and effectiveness of coronary stenting with the everolimus-eluting Xience V stent (EES) compared with the historical control (PRE-COMBAT-1) of bypass surgery and sirolimus-eluting stent (SES) for the treatment of an unprotected LMCA stenosis. The primary alternative hypothesis is that the experimental starategy (coronary stenting with the everolimus-eluting stents) is not inferior to the standard strategy (CABG) or SES. All consecutive patients with unprotected LMCA diseases at participating centers, who are treated with Xience V stent, will be evaluated for the entry into the study.
Study Type
OBSERVATIONAL
Enrollment
397
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
MACCE free survival
Death (all-cause mortality) Cerebrovascular accident Non-fatal myocardial infarction (Q wave and non-Q wave) Ischemia-driven target vessel revascularization either percutaneous or surgical treatment
Time frame: at 2 year
Death(all cause and cardiac)
Time frame: 5 years
Myocardial Infarction
Time frame: 5 years
Cerebrovascular accident
Time frame: 5 years
Target vessel revascularization
Time frame: 5 years
Target lesion revascularization
Time frame: 5 years
Stent thrombosis
Time frame: 5 years
Binary restenosis in both in-stent and in-segment
angiographic follow-up
Time frame: 9 months
Late luminal loss in both in-stent and in-segment
angiographic follow-up
Time frame: 9 months
pattern of restenosis
angiographic follow-up
Time frame: 9 months
Angina status
Time frame: 5 years
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Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Kwangju Christian Hospital
Kwangju, South Korea
...and 11 more locations
Re-hospitalization with a cardiac cause
Time frame: 5 years