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

Coronary Artery Stenoses Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447197
• Other study ID #: OLL-689991
• Status: Completed
• Phase: N/A
• First received: February 20, 2018
• Last updated: February 25, 2018
• Start date: September 1, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2018
• Source: Örebro County Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Stenoses
• Coronary Stenosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Örebro County Council

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft patency	Graft patency as assessed with computed tomography angiography	Five years postoperatively