Clinical trial NCT01540422: Study to Improve Long Term Vein Graft Patency After Coronary Bypass Surgery by Using a Novel Endoscopic Harvesting Technique
Official title: OPTION Trial: Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: vein grafts
coronary bypass
endoscopic harvest
endoscopic vein harvest
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Maquet Cardiovascular
First posted: 2012-02-28
Enrollment: 93
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital facility

Brief summary: 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.

Detailed description: 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:

1. Intra-operatively by transit time graft flow measurements.
2. Post-operative Day 30 through Cardiac CT Angiography.
3. Post-operative Month 12 through Cardiac CT Angiography.

Eligibility criteria: Inclusion Criteria:

* Males and females at least 18 years of age and able to sign consent
* Undergoing CABG surgery
* Eligible for endoscopic saphenous vein harvesting
* A minimum of two non-sequential vein grafts will be performed
* Subject willing to comply with the requirements of the protocol

Exclusion Criteria:

1. Previous CABG
2. Previous or concomitant valve surgery
3. Any other concomitant cardiac procedure other than surgical ablation or incidental PFO repair
4. Intolerance to Iodine or IV contrast that cannot be controlled with pre-medication
5. Renal insufficiency with GFR measurement ≤ 40, unless dialysis dependent
6. Abnormal platelet level defined as Plt Count \>400,000
7. Abnormal platelet function (hypercoagulable state) as evidenced by TEG testing
8. Allergy to or presence of a condition that the investigator feels may prevent safe administration of ASA or Plavix post-operatively.
9. Patient has a co-morbid condition that in the opinion of the investigator poses undue risk for successful endovascular harvesting of the vein

Primary outcomes:
measure: Improved vein graft patency
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Vein graft failure
timeFrame: Baseline, 30 days, and 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Medical City Hospital
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
Study officials:
References:
citation: Bolotin G, Kypson AP, Nifong LW, Chitwood WR Jr. A technique for evaluating competitive flow for intraoperative decision making in coronary artery surgery. Ann Thorac Surg. 2003 Dec;76(6):2118-20. doi: 10.1016/s0003-4975(03)00652-0.
citation: Lopes RD, Hafley GE, Allen KB, Ferguson TB, Peterson ED, Harrington RA, Mehta RH, Gibson CM, Mack MJ, Kouchoukos NT, Califf RM, Alexander JH. Endoscopic versus open vein-graft harvesting in coronary-artery bypass surgery. N Engl J Med. 2009 Jul 16;361(3):235-44. doi: 10.1056/NEJMoa0900708.
citation: Burris N, Schwartz K, Tang CM, Jafri MS, Schmitt J, Kwon MH, Toshinaga O, Gu J, Brown J, Brown E, Pierson R 3rd, Poston R. Catheter-based infrared light scanner as a tool to assess conduit quality in coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2007 Feb;133(2):419-27. doi: 10.1016/j.jtcvs.2006.09.056. Epub 2006 Dec 29.
citation: Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18.