Clinical trial NCT01051986: A Prospective Randomized Study for Comparison of Y-Composite Grafts
Official title: A Randomized Comparison of the SAphenous VEin Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE-RITA Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery bypass
off-pump surgery
composite graft
saphenous vein
internal thoracic artery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-01-20
Enrollment: 224
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare early and 1-year graft patency rates of saphenous vein composite grafts with those of right internal thoracic artery composite graft and mid-term clinical outcomes in patients who undergo off-pump coronary artery bypass grafting(OPCAB). We also evaluate microscopic findings of saphenous vein graft harvested no touch technique and used as composite graft.

Detailed description: The SAVERITA trial was designed as a randomized, controlled trial to recruit 224 patients who undergo off-pump coronary artery bypass using Y-composite graft based on the left internal thoracic artery. Patients were randomized by use of a randomization table. Composite conduit was made using saphenous vein or right internal thoracic artery according to the randomization result. The primary end point is to evaluate early and 1-year postoperative graft patency. The secondary end points are overall survival, freedom from cardiac death and freedom from MACCE(major adverse cardiac or cerebrovascular events). In saphenous vein group, 20 remnant saphenous vein specimen was evaluated histologically to compare the difference between composite grafted vein and manually dilated saphenous vein.

Eligibility criteria: Inclusion Criteria:

* age equal or more than 40
* age equal or less than 75
* patients who agree to the enrollment

Exclusion Criteria:

* Patients with heart failure (left ventricular ejection fraction \< 25%)
* patients who have intractable ventricular arrhythmia
* patients who has been treated for cancer
* patients who has infectious disease
* patients who are planned to undergo combined cardiac surgery
* patients who has medical co-morbidity with expected survival less than 1 year
* patients who has a problem using right internal thoracic artery or saphenous vein
* patients with a history of previous cardiac surgery
* Patients with chronic renal failure
* patients who undergo emergency operation

Primary outcomes:
measure: 1 Year Graft Patency Rates
timeFrame: one year
Secondary outcomes:
measure: Overall Survival
timeFrame: 4 years
measure: Freedom From Cardiac Death
timeFrame: 4 years
measure: Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)
timeFrame: 4 years
measure: Early Angiographic Patency Rates
timeFrame: 1.4days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National Uinversity Hospital
Study officials:
affiliation: Department of throacic and cardiovascular surgery, Seoul National University Hospital
name: Ki-Bong Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim KB, Hwang HY, Hahn S, Kim JS, Oh SJ. A randomized comparison of the Saphenous Vein Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE RITA) trial: One-year angiographic results and mid-term clinical outcomes. J Thorac Cardiovasc Surg. 2014 Sep;148(3):901-7; discussion 907-8. doi: 10.1016/j.jtcvs.2014.03.057. Epub 2014 May 16.