Five-year Patency of No-touch Saphenous Vein Grafts in On-pump Versus Clamp-less Off-pump Coronary Artery Bypass Surgery

Study Overview
=================
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.

Official Title
-----------------
Five-year Patency of No-touch Saphenous Vein Grafts in On-pump Versus Clamp-less Off-pump Coronary Artery Bypass Surgery: A Sub-study of a Multicenter Randomized Controlled Trial

Conditions
-----------------
Coronary Artery Stenoses

Intervention / Treatment
-----------------
* Procedure: The use of extracorporeal circulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: On-Pump<br>Use of extracorporeal circulation | Procedure: The use of extracorporeal circulation<br>* The use or not of extracorporeal circulation during the coronary artery bypass procedure.<br>|
| No Intervention: Off-Pump<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft patency | Graft patency as assessed with computed tomography angiography | Five years postoperatively |