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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Stenoses
• Intervention / Treatment: Procedure: The use of extracorporeal circulation

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Örebro County Council

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: February 25, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 25, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis
• Other Study ID Numbers: OLL-689991

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No