Study to Improve Long Term Vein Graft Patency After Coronary Bypass Surgery by Using a Novel Endoscopic Harvesting Technique
The purpose of this study is to demonstrate improved vein graft patency rates at 12 months for endoscopically harvested saphenous vein grafts. The study will evaluate use modifications to existing techniques in vein graft handling during harvests. A secondary aim is to develop a standardized approach for harvesting, handling, and preparing vein grafts in the endoscopic approach.
Coronary Artery Disease
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||OPTION Trial: Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques|
- Improved vein graft patency [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]To demonstrate improved vein graft patency at 12 months for endoscopically harvested saphenous vein grafts by using modifications to existing vein harvest techniques in vein handling during harvest.
- Vein graft failure [ Time Frame: Baseline, 30 days, and 12 months ] [ Designated as safety issue: No ]
- Assess the incidence of vein graft failure at the time of initial CABG as evaluated by transit time graft flow measurements.
- Incidence of vein graft failure at postoperative day 30 as evaluated by Coronary CT angiography
- Incidence of vein graft failure at postoperative Month 12 as evaluated by Coronary CT angiography
Incidence of vein graft failure at each interval (30 day and 12 month) as categorized by:
- Harvested vessel (greater versus lesser saphenous vein)
- Vein graft destinations
- Vein graft quality
|Study Start Date:||October 2010|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
CABG w/saphenous vein grafts harvested using endoscopy
Those who have CABG surgery with saphenous vein grafts harvested using endoscopic techniques
Available data supports two facts: 1) Saphenous vein graft failure rates may be as high as 47% per patient at one year post coronary artery bypass grafting, and 2) Endoscopic vein-graft harvesting is independently associated with vein-graft failure and adverse clinical outcomes.
Multiple factors may contribute to the lower long term patency rates of endoscopically harvested grafts. Summarized, the two major contributing factors are theorized to be harvesting techniques and vein trauma during harvesting.
With recognized disadvantages of open vessel harvesting including higher incidence of infection, longer incisions, greater potential for poor healing, and longer length of hospital stay, reducing the failure rate of vein grafts harvested endoscopically is of utmost importance.
It is our hypothesis that modification of existing harvesting techniques can improve vein graft patency in endoscopic vein graft harvesting so that patency rates comparable to open vessel harvesting can be obtained.
In this prospective, multi-center non-randomized, observational study, 100 patients will undergo routine coronary artery bypass grafting. Eligible candidates will undergo lone coronary artery bypass graft (CABG) procedures with endoscopic vein graft harvesting using best harvesting practices. As a part of routine postoperative care, patients will be prescribed dual-antiplatelet therapy of aspirin and clopidogrel. Compliance with 3 months of dual-antiplatelet therapy will be monitored.
Vein graft patency will be evaluated:
- Intra-operatively by transit time graft flow measurements.
- Post-operative Day 30 through Cardiac CT Angiography.
- Post-operative Month 12 through Cardiac CT Angiography.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540422
|United States, Texas|
|Medical City Hospital|
|Dallas, Texas, United States, 75230|
|The Heart Hospital Baylor Plano|
|Plano, Texas, United States, 75093|