About this trial
This is a multi-center, observational cohort study including patients with prior coronary artery bypass grafting (CABG) and ≥1 saphenous vein grafts (SVG) presenting with recurrent ischemic symptoms. Objective: to investigate the clinical outcomes in patients with prior CABG evaluated for bypass graft failure and progression of native coronary artery disease (CAD). Follow-up will be collected through national registry databases, electronic medical patient records and standardized telephonic assessment at 3 and 5 years follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Prior coronary artery bypass grafting
One or more saphenous vein grafts
Recurrent angina symptoms
Disqualifiers
<18 years of age
≥ 90 years of age
Cardiogenic shock
Pregnancy
Trial population
Patients with recurrent angina symptoms and a cardiac history of CABG with one or more saphenous vein grafts evaluated for saphenous vein graft dysfunction and progression of coronary artery disease in the Amsterdam University Medical Centers, Department of Cardiology
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Major adverse cardiovascular events (MACE)
The total number and specification of major adverse cardiac events (all-cause mortality, non-fatal myocardial infarction, or clinically driven repeat revascularization)
Saphenous vein graft failure
Failure rate and duration of graft patency following prior CABG procedure
Secondary outcomes
Major Adverse Cardiac Events
Components of MACE (all-cause mortality, non-fatal myocardial infarction, or clinically driven repeat revascularization)
Procedural success and mortality in patients who underwent percutaneous coronary intervention of a saphenous vein graft
Procedural success defined by technical success and no major in-hospital complications (mortality, stroke, myocardial infarction, tamponade requiring centesis, emergency CABG/PCI, acute kidney failure requiring dialysis, vascular access site complication or major bleeding requiring transfusion or surgery)
Procedural success and mortality in patients who underwent percutaneous coronary intervention of a (bypassed) native coronary artery
Procedural success defined by technical success and no major in-hospital complications (mortality, stroke, myocardial infarction, tamponade requiring centesis, emergency CABG/PCI, acute kidney failure requiring dialysis, vascular access site complication or major bleeding requiring transfusion or surgery)
Quality of life assessed by the Canadian Cardiovascular Society (CCS) Grading Scale
Canadian Cardiovascular Society (CCS) Grading Scale measures whether patient have angina pectoris complaints, and to what extent patients experienced this. It uses a scale of 1-4 where 1 means angina pectoris (chest pain) only occurs with strenuous, rapid or prolonged exertion, and 4 means angina is present during little physical effort or even during rest.
Sponsors and contacts
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