Coronary Artery Stenoses
Conditions
Brief summary
Randomised controlled trials (RCTs) have shown high long-term patency for no-touch saphenous vein grafts (NTSVGs), comparable to the internal thoracic artery in on-pump coronary artery bypass grafting (CABG). RCTs on patency in NTSVGs in off-pump CABG have not been published yet. Orebro University Hospital participated in the CABG Off- or On-pump Revascularization study (CORONARY, ClinicalTrials.gov number, NCT00463294) and included fifty-six patients. Accordingly, this is a sub-study and the aim was to assess the midterm patency in NTSVGs in clamp-less off-pump versus on-pump CABG at five-year follow-up.
Interventions
PROCEDUREThe use of extracorporeal circulation
The use or not of extracorporeal circulation during the coronary artery bypass procedure.
Sponsors
Örebro County Council
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients were eligible if they: 1. provided written informed consent; 2. were \>21 years of age; 3. required isolated CABG with median sternotomy; 4. had at least one of the following risk factors: 1. had peripheral vascular disease (previous peripheral bypass, amputation or anklebranchial index \<0.90), 2. had cerebrovascular disease (history of stroke, transient ischemic attach or carotid stenosis ≥70%), 3. had renal insufficiency (creatinine above upper limit of normal), 4. were ≥70 years of age, or 5. were between the ages of 60-69 with one of the following: i. had diabetes and taking an oral hypoglycemic agent and/or insulin, ii. required urgent revascularization (i.e., waiting in hospital for revascularization after an acute coronary syndrome), iii. were a recent smoker (within 1 year of randomization), or iv. had left ventricular ejection fraction ≤35%, OR 6. were between the ages of 55-59 with two of the following: i. Diabetes and taking an oral hypoglycemic agent and/or insulin, ii. required urgent revascularization (i.e., waiting in hospital for revascularization after an acute coronary syndrome, iii. were a recent smoker (within 1 year of randomization), or iv. had a left ventricular ejection fraction ≤35%
Exclusion criteria
* Patients were excluded if they: 1. required a concomitant cardiac procedure associated with CABG; 2. had a contraindication to off-pump or on-pump CABG (e.g., calcified aorta, intramuscular left anterior descending artery, calcified coronaries, small target vessels); 3. had a concomitant life-threatening disease likely to limit life expectancy to less than 2 years; 4. were previously enrollment in the CORONARY Trial; 5. required emergency CABG surgery (i.e., immediate revascularization for hemodynamic instability); OR 6. required a redo CABG.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft patency | Five years postoperatively | Graft patency as assessed with computed tomography angiography |
Outcome results
None listed