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

NCT ID: NCT03447197

Last Updated: 2018-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2017-12-31

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.

Conditions

Coronary Artery Stenoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

On-Pump

Use of extracorporeal circulation

Group Type: ACTIVE_COMPARATOR

The use of extracorporeal circulation

Intervention Type: PROCEDURE

The use or not of extracorporeal circulation during the coronary artery bypass procedure.

Off-Pump

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The use of extracorporeal circulation

The use or not of extracorporeal circulation during the coronary artery bypass procedure.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Örebro County Council

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ninos Samano M.D.

Consultant in Cardiothoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

OLL-689991

Identifier Type: -

Identifier Source: org_study_id