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

NCT03447197 | Completed

• 1 other identifier: OLL-689991
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Graft patency

  Graft patency as assessed with computed tomography angiography

  Five years postoperatively

Study Arms (2)

On-Pump

ACTIVE COMPARATOR

Use of extracorporeal circulation

Procedure: The use of extracorporeal circulation

Off-Pump

NO INTERVENTION

Interventions

The use of extracorporeal circulation PROCEDURE

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

On-Pump

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Örebro County Council: lead

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Cardiothoracic Surgery

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 27, 2018
• Study Start: September 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2017
• Last Updated: February 27, 2018

Record last verified: 2018-02