Improving the Results of Heart Bypass Surgery Using New Approaches to Surgery and Medication
SUPERIORSVG
Surgical and Pharmacological Novel Interventions to Improve Overall Results of Saphenous Vein Graft Patency in Coronary Artery Bypass Grafting Surgery: An International Multi-Center Randomized Controlled Clinical Trial
1 other identifier
interventional
250
1 country
1
Brief Summary
Surgery for blocked arteries in the heart (coronary artery bypass grafting) can be accomplished using veins from the leg sewn onto the heart to provide an alternate path for blood flow, i.e. 'bypassing' the blockages. These veins themselves can block over time. This may result in part simply from the trauma from the surgery, in other words, by removing the vein from the leg and then sewing it to the heart. Another mechanism may be the abnormal metabolic processes within the body responsible for the plaque build-up of the heart arteries in the first place - this may lead to the blockages of the veins used for bypass. In the present era of heart bypass surgery, this incidence of veins blocking remains high despite advances in blood thinners and cholesterol medications. This study is designed to determine whether two new interventions may potentially reduce the incidence of blockages in the veins used for heart bypass surgery. One is a surgical technique significantly reducing the trauma associated with removing the leg vein prior to use as a bypass graft onto the heart. The second intervention is the use of a nutritional supplement before and after surgery which is composed of fish oils. The study will recruit sufficient patients to provide strong and relevant conclusions regarding both study questions. It will be highly applicable also because it will include approximately 1,550 patients from approximately 50 hospitals across many countries. We believe these techniques will result in significantly less vein blockages in patients one year after heart bypass surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Jul 2011
Longer than P75 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2010
CompletedFirst Posted
Study publicly available on registry
January 13, 2010
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2017
CompletedOctober 5, 2017
October 1, 2017
4.1 years
January 12, 2010
October 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Surgical Arm: Proportion of study SVGs which are totally occluded on cardiac CT angiography at 1-year post-CABG and death due to CV or unknown causes.
1 year post-operative
Pharmacological Arm: Proportion of patients with ≥1 graft (saphenous or arterial) totally (100%) occluded on cardiac CT angiography at 1-year post-CABG and death due to CV or unknown causes, comparing the fish-oil to placebo groups.
1-year post-operative
Secondary Outcomes (5)
Surgical Arm: i. To determine whether the "no touch" technique of SVG harvesting results in a lower proportion of study SVGs that have a significant stenosis (50-99%) on 1-year post-CABG angiography compared to conventional SVG harvesting techniques.
1 year post-operavtive
Surgical Arm: ii. To determine whether the incidence and severity of adverse SVG harvesting events at 1-yr post-CABG (infection, haematoma, swelling, neuropathy, quality of life measures) are similar between the "no touch" and conventional groups.
1-year post-operative
Surgical Arm: iii. The incidence of the composite of non-fatal MI (new definition), all-cause mortality, and repeat revascularization (redo CABG or PCI) perioperatively ( major adverse cardiac events ,MACE ) and stroke at 1 yr is lowe
1-year post-operative
Pharmacological Arm: i. To determine whether fish oil supplementation results in a lower proportion of patients with ≥1 graft with a significant (50-99%) stenosis at 1-year post-CABG angiography, compared to those who received placebo.
1-year post-operative
Pharmacological Arm: ii. The incidence of the composite of n-fatal MI (new definition), all-cause mortality, and repeat revascularization (redo CABG or PCI) perioperatively ( major adverse cardiac events ,MACE ) and stroke at 1 yr i
1-year post-operative
Study Arms (4)
SVG harvest - conventional, placebo
ACTIVE COMPARATORSVG harvest - no-touch, fish oils
EXPERIMENTALSVG harvest - no-touch, placebo
PLACEBO COMPARATORSVG harvest - conventional, fish oils
ACTIVE COMPARATORInterventions
Saphenous vein harvested using the pedicled (no-touch) technique or using the conventional technique. Fish oil supplements/placebo (1g taken orally twice daily for 1 year post-op)
Fish oil supplementation \[1g tablets (55% fish oils - EPA:DHA 33%:22%)\] taken twice daily for 1 year post-op
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Able to provide informed consent
- Isolated CABG, non-emergent, on- or off-pump (cardiopulmonary bypass)
- Primary or re-do CABG (if re-do, all previous grafts must be occluded)
- Left ventricular ejection fraction \>20%
- Require at least one SVG as part of revascularization strategy
- Creatinine clearance of at least 30ml/min or higher
You may not qualify if:
- Unable to use greater SV due to previous vein stripping or poor quality on mandatory preoperative Duplex study and vein mapping
- Contraindication to receiving follow-up 64-slice cardiac CT angiography (allergy to contrast dye, renal failure with a creatinine \>180 µmol/L, uncontrolled atrial fibrillation precluding proper gating of study)
- Pregnant women, or women of child-bearing age
- Allergy to fish oil/fish products, and non-medicinal ingredients of the study product (corn oil,soybean oil,gelatin,glycerol, or carob colouring)
- Already taking fish oil supplements regularly (daily use in past 30 days)
- Congenital or acquired coagulation disorders
- Patients considered to be of excessive risk of wound infection according to the clinical judgement of the site surgical investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Related Publications (1)
Deb S, Singh SK, de Souza D, Chu MWA, Whitlock R, Meyer SR, Verma S, Jeppsson A, Al-Saleh A, Brady K, Rao-Melacini P, Belley-Cote EP, Tam DY, Devereaux PJ, Novick RJ, Fremes SE; SUPERIOR SVG Study Investigators. SUPERIOR SVG: no touch saphenous harvesting to improve patency following coronary bypass grafting (a multi-Centre randomized control trial, NCT01047449). J Cardiothorac Surg. 2019 May 2;14(1):85. doi: 10.1186/s13019-019-0887-x.
PMID: 31046806DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Fremes, MD
Sunnybrook Health Sciences Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head, Division of Cardiac & Vascular Surgery
Study Record Dates
First Submitted
January 12, 2010
First Posted
January 13, 2010
Study Start
July 1, 2011
Primary Completion
August 1, 2015
Study Completion
March 21, 2017
Last Updated
October 5, 2017
Record last verified: 2017-10