Status:
COMPLETED
Five-year Patency of No-touch Saphenous Vein Grafts in On-pump Versus Clamp-less Off-pump Coronary Artery Bypass Surgery
Lead Sponsor:
Örebro County Council
Conditions:
Coronary Artery Stenoses
Eligibility:
All Genders
55+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Patients were eligible if they:
- provided written informed consent;
- were \>21 years of age;
- required isolated CABG with median sternotomy;
- had at least one of the following risk factors:
- had peripheral vascular disease (previous peripheral bypass, amputation or anklebranchial index \<0.90),
- had cerebrovascular disease (history of stroke, transient ischemic attach or carotid stenosis ≥70%),
- had renal insufficiency (creatinine above upper limit of normal),
- were ≥70 years of age, or
- 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
- 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
- Patients were excluded if they:
- required a concomitant cardiac procedure associated with CABG;
- had a contraindication to off-pump or on-pump CABG (e.g., calcified aorta, intramuscular left anterior descending artery, calcified coronaries, small target vessels);
- had a concomitant life-threatening disease likely to limit life expectancy to less than 2 years;
- were previously enrollment in the CORONARY Trial;
- required emergency CABG surgery (i.e., immediate revascularization for hemodynamic instability); OR
- required a redo CABG.
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03447197
Start Date
September 1 2015
End Date
December 31 2017
Last Update
February 27 2018
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