The primary objective of the PRE-COMBAT trial is: To establish the safety and effectiveness of coronary stenting with the sirolimus-eluting balloon expandable stent (Cordis Johnson \& Johnson, Warren, New Jersey) compared with bypass surgery for the treatment of an unprotected LMCA stenosis. The alternative hypothesis is that the experimental strategy (coronary stenting with the sirolimus-eluting stents) is not inferior to the standard strategy (bypass surgery).
Despite bypass surgery has been considered as the standard strategy for the treatment of unprotected left main coronary artery (LMCA) lesions, several studies have demonstrated that percutaneous coronary intervention (PCI) of the unprotected LMCA is feasible and appears to be an alternative strategy in selected patients. However, the safety and efficacy of PCI in patients with unprotected LMCA stenosis are still a matter of debate. Previous studies have demonstrated the safety and feasibility of unprotected LMCA intervention using bare metal stents (BMS). There was a favorable initial outcome after LMCA intervention using BMS in low-risk patients. However, in-stent restenosis after BMS implantation has emerged as the interference to widely perform PCI for unprotected LMCA lesions and the most important reason for selection of bypass surgery as the first choice for treating LMCA stenosis. In-stent restenosis in these patients not only influences long-term survival, but also make repeat intervention more complex. Despite endeavors to decrease in-stent restenosis after LMCA intervention using BMS, such as aggressive debulking atherectomy, the restenosis rate still remains at 20-30%. The sirolimus-eluting stent (SES) (Cypher, Cordis, Johnson \& Johnson Corp, Miami, Florida) markedly decreases in-stent restenosis in elective patients with relatively simple coronary lesions. In real-world practice using SES, patients undergoing SES implantation were treated with a less restrictive interventional approach. However, the results are very promising similar to the randomized controlled trials. These findings warrant new studies to compare the efficacy of SES for more complex lesion subsets including LMCA disease with coronary artery bypass graft (CABG).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Using silorimus eluting stent
coronary artery bypass graft
Daegu Catholic University Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Major cardiac and cerebrovascular event (MACCE): the composite of death, myocardial infarction, stroke, and ischemica-driven target vessel revascularization
Time frame: one-year after treatment
All-cause mortality
Time frame: at 30 days, 6 months, 1 year, and yearly to 5 years
Cardiac death
Time frame: at 30 days, 6 months, 1 year, and yearly to 5 years
Myocardial infarction
Time frame: at 30 days, 6 months, 1 year, and yearly to 5 years
Cerebrovascular accident
Time frame: at 30 days, 6 months, 1 year, and yearly to 5 years
Target vessel revascularization (all and ischemia-driven)
Time frame: at 30 days, 6 months, 1 year, and yearly to 5 years
Target lesion revascularization (all and ischemia-driven)
Time frame: at 30 days, 6 months, 1 year, and yearly to 5 years
Stent thrombosis in the PCI group
Time frame: at 30 days, 6 months, 1 year, and yearly to 5 years
Binary restenosis in both in-stent and in-segment
Time frame: at 9 month angiographic follow-up
Graft patency and reocclusion rate
Time frame: at 9 months angiographic follow-up
Late luminal loss in both in-stent and in-segment
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Masking
NONE
Enrollment
1,454
Seoul National University Bundang Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
St.Mary's Catholic Medical Center
Seoul, South Korea
...and 3 more locations
Time frame: at 9 month angiographic follow-up