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

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ClinicalTrials.gov Identifier: NCT03447197
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ninos Samano M.D., Örebro County Council

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Stenoses Procedure: The use of extracorporeal circulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2017

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Graft patency [ Time Frame: Five years postoperatively ]
    Graft patency as assessed with computed tomography angiography


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Ninos Samano M.D., Consultant in Cardiothoracic Surgery, Örebro County Council
ClinicalTrials.gov Identifier: NCT03447197    
Other Study ID Numbers: OLL-689991
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Stenosis
Coronary Disease
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases