Prior CABG Patients Evaluated for Saphenous VeIn grAft DysfUnction and Progression of Coronary arTery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Recurrent Angina After Coronary Artery Bypass Graft, Graft Failure, Coronary Artery Disease Progression. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Patients With Prior Coronary Artery Bypass Graft Surgery Evaluated for Saphenous VeIn grAft DysfUnction and Progression of Coronary arTery Disease
Overview
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.
Detailed description
Despite advances in secondary prevention, a wide variety of vascular grafts available, and evolving surgical techniques, long-term efficacy of CABG is hampered by bypass graft failure and native CAD progression. Therefore, patients with prior CABG often present with recurrent ischemic symptoms. Indeed, many prior CABG patients undergo repeat cardiac catheterization and require subsequent revascularization therapy. The clinical evaluation and diagnostic work-up of patients with recurrent angina after CABG is challenging. Patients with previous CABG are generally older, have a higher prevalence of cardiac risk factors and comorbidities, more extensive CAD, and complex atherosclerotic lesion morphology. Furthermore, current guideline recommendations on patient management are limited since post-CABG patients have often been underrepresented or excluded in large diagnostic and revascularization trials. This registry will include patients presenting with recurrent ischemic symptoms with a history of CABG and ≥1 SVGs that are referred to the Amsterdam University Medical Centers. Patients will be eligible for inclusion in the VIADUCT registry after consideration of in- and exclusion criteria. Subsequently, patients will be approached for study participation. Patients are free to refuse or to withdraw from participation in the registry at any moment. The primary objective is to investigate clinical outcomes in patients with recurrent symptoms who are evaluated for bypass graft failure and native CAD progression. In addition, results from non-invasive and invasive diagnostic tools that are used during clinical work-up to assess graft patency, the hemodynamic significance of native CAD progression, left ventricular function, and myocardial viability will be collected. We aim to evaluate the value of such tools to guide optimal repeat revascularization strategy.
Primary outcome measures
- Major adverse cardiovascular events (MACE) [Time frame: 3 year follow-up]
- Saphenous vein graft failure [Time frame: At the time of referral and during subsequent 3 and 5 years follow-up]
Secondary outcome measures (6)
- Major Adverse Cardiac Events [Time frame: 3 and 5 years follow-up]
- Procedural success and mortality in patients who underwent percutaneous coronary intervention of a saphenous vein graft [Time frame: In hospital and during subsequent 3 and 5 years follow-up]
- Procedural success and mortality in patients who underwent percutaneous coronary intervention of a (bypassed) native coronary artery [Time frame: In hospital and during subsequent 3 and 5 years follow-up]
- Quality of life assessed by the Canadian Cardiovascular Society (CCS) Grading Scale [Time frame: At baseline and during subsequent 3 and 5 years follow-up]
- Quality of life assessed by Rose dyspnea scale questionnaire (RDS) [Time frame: At baseline and during subsequent 3 and 5 years follow-up]
- Composite score of quality of life [Time frame: At baseline and during subsequent 3 and 5 years follow-up]
Eligibility criteria
Inclusion criteria
- Prior coronary artery bypass grafting
- One or more saphenous vein grafts
- Recurrent angina symptoms
Exclusion criteria
- <18 years of age
- ≥ 90 years of age
- Cardiogenic shock
- Pregnancy
- Failure to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Amsterdam University Medical Centers, Department of Cardiology — Amsterdam
Publications
- Hoek R, de Winter RW, Peters RT, Somsen YBO, van Diemen PA, Jukema RA, Twisk JW, Verouden NJ, den Hartog AW, Raijmakers PG, Nap A, Danad I, Knaapen P. Comparison of Fractional Flow Reserve and Myocardial Perfusion Imaging in Saphenous Vein Grafts. Catheter Cardiovasc Interv. 2025 May;105(6):1365-1374. doi: 10.1002/ccd.31467. Epub 2025 Feb 24. PMID 39991799
Identifiers
NCT: NCT04772768 · Amsterdam UMC 2019.457