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

Örebro County Council

Status

Completed

Conditions

Coronary Artery Stenoses

Treatments

Procedure: The use of extracorporeal circulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03447197

OLL-689991

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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.