Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease: Phase IV: Multicenter trial

Not Applicable

Terminated

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0002895
• Lead Sponsor: Asan Medical Center

Brief Summary

Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 May 2019

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: 888

Inclusion Criteria

Age 18 years of older
Angiographically confirmed multivessel CAD [critical (>70%) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA)] and amenable to either PCI or CABG.
Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
Geographically accessible and willing to come in for required study visits
Signed informed consent.

Exclusion Criteria

1.    The patient has a known hypersensitivity or contraindication to any of the following medications:
·         Heparin
·         Aspirin
·         Both Clopidogrel and TIclopidine
·         Sirolimus, paclitaxel, ABT 578
·         Stainless steel and/or
·         Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
2.    Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment. The deree of left ventricular ejection fraction is not considered as an index of exclusion.
3.    Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent).
4.    Prior CABG surgery
5.    Prior PCI with DES implantation within 1 year
6.    Two or more chronic total occlusions in major coronary territories
7.    Acute ST-elevation MI(Q-wave) within 72 hours prior to enrollment requiring revascularization.
8.    Abnormal creatine kinase (CK > 2x normal) and/or abnormal CK-MB levels and/or elevated Troponin levels at time of randomization. When the cardiac enzyme is returned to normal, those can be enrolled.
9.    Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement.
10. Dementia with MMSE score 20 and less.
11.  Extra-cardiac illness that is expected to limit survival to less than 2 years; e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease.
12.  Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during CABG or PCI/DES related anticoagulation.
13.  Contraindication either CABG or PCI/DES because of a coexisting clinical condition
14. Severe leukopenia, monocytopenia, thrombocytopenia, anemia, bleeding tendency.
15.  Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
16.  Suspected pregnancy.
17.  Concurrent enrollment in another clinical trial
18. Left main stenosis (at least 50% diameter stenosis)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the composite of death, nonfatal myocardial infarction, and ischemia-driven target vessel revascularization (TVR)