OCTOCAB is a prospective, randomized (1:1), single-center trial. The purpose of this study is to determine whether intravascular optical coherence tomography (OCT) guided saphenous vein grafting in coronary artery bypass surgery will reduce the rate of early vein graft failure (VGF).
Within the first year of coronary artery bypass grafting (CABG) surgery, the saphenous vein grafts have a failure rate of 10 to 25%. Visual inspection of the vein graft conduit is the current standard in determining the quality of the vein segment. However, there may be intraluminal abnormalities that are undetectable via a visual inspection. OCT examination, using the ILUMIEN OPTIS NEXT OCT Imaging system, of endoscopically harvested saphenous vein conduits will indicate such pathology and enable the surgeon to assess the quality of the harvested vein at the intravascular level. This study is designed to demonstrate the superiority of OCT-guided saphenous vein CABG in improving the rates of early VGF and the overall outcome of CABG. The study will follow two randomization arms: OCT-guided saphenous vein CABG (interventional arm) vs. visual inspection-guided saphenous vein CABG (standard of care arm). The analysis of subjects will be with respect to their analyzed group. Following enrollment, participants will be followed for up to 10 years. The primary endpoint is per graft incidence of vein graft failure. The assessment of the vein graft will be conducted via coronary CT angiogram (CCTA) at 12 months. In the case where the participant has unplanned angiogram due to clinical reasons, prior to the 12 months, the condition of the graft will be determined via the angiogram. Unless all target grafts have reached the endpoint prior to the 12 month time point, a CCTA will be required. To achieve the power level of 85% at the significance level of 0.025, 760 patients is the anticipated sample size. Analysis will be conducted at the graft level with a Linear Mixed model to account for any potential patient effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
760
OCT examination of harvested saphenous vein conduits will indicate pathology. Under the surgeon's discretion the conduit segments with pathology will not be grafted.
St Francis Hospital
Roslyn, New York, United States
RECRUITINGVein graft failure (VGF)
Per graft incidence of VGF defined as greater than or equal to 70% in the body of the graft on coronary CT angiography (CCTA)
Time frame: 12 months
Target graft failure (TGF)
Composite time-to-first event rate of cardiac death, target graft myocardial infarction (TG-MI), or ischemia-driven target graft revascularization (ID-TGR)
Time frame: 12 months
Per graft incidence of ischemic vein graft failure
Greater than or equal to 70% stenosis
Time frame: 12 months
Per graft incidence anatomic vein graft failure
Greater than or equal to 50% stenosis
Time frame: 12 months
Per patient incidence of vein graft patency
Vein graft having less than 50% stenosis
Time frame: 12 months
Per patient incidence of ischemic vein graft failure
Greater than or equal to 70% stenosis
Time frame: 12 months
Per patient incidence of anatomic vein graft failure
Greater than or equal to 50% stenosis
Time frame: 12 months
Mean vein graft diameter stenosis
Time frame: 12 months
Mean vein graft area stenosis
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Time frame: 12 months
All-cause mortality
Time frame: 12 months
Cardiac and non-cardiac mortality
Time frame: 12 months
All Myocardial Infarction (MI)
Time frame: 12 months
Target graft myocardial infarction (TG-MI) and Non-Target graft myocardial infarction (non-TG-MI)
Time frame: 12 months
All revascularization
Time frame: 12 months
Ischemia driven (ID)-revascularization and Non-ischemia driven (ID)-revascularization
Time frame: 12 months
Ischemia driven-target graft failure (ID-TGR)
Time frame: 12 months
Ischemia driven (ID)-revascularization of target native coronary artery subtended by the graft
Time frame: 12 months