Radial Artery Versus No-touch Saphenous Vein

Coronary Artery Disease Clinical Trial

Official title:

Graft Patency Between the Radial Artery and the No-touch Saphenous Vein in Coronary Artery Bypass Grafting Study (GRAFT-CAB Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06014047
• Other study ID #: 2023-2109
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: October 30, 2030

Study information

• Verified date: August 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: Shengshou Hu, M.D.
• Phone: +86-10-88398359
• Email: shengshouhu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the short-term and long-term patency of the radial artery and the No-touch vein in patients undergoing isolated on-pump/off-pump coronary artery bypass graft (CABG) surgery. A total of at least 774 patients undergoing isolated on-pump/off-pump CABG will be consecutively recruited from Fuwai Hospital and randomly assigned to receive radial artery or No-touch saphenous vein as their second graft. All participants will be invited for clinical follow-up and 64-slice multislice computed tomography angiography (MSCTA) analysis at 3 months and 12 months post-operatively.

Description:

CABG is still the treatment of choice for ischemic heart disease. However, restenosis or occlusion may occur to graft vessels, leading to postoperative myocardial ischemia and subsequent clinical events. Long-term angiographic follow-up demonstrated that vein graft restenosis and occlusion are common among those receiving CABG, with a vein graft patency of less than 50% at 15 years postoperatively.

A novel approach to harvesting the vein is called "No-touch" technique (NT), which can avoid mechanical damage to the vein wall. Previous studies showed that No-touch saphenous vein grafts (NT-SVG) has a 96.3% postoperative graft patency rate at 12 months, compared to 93.5% of conventional saphenous vein grafts (con-SVGs). Thus, the No-touch technique can significantly reduce postoperative graft occlusion. Radial artery(RA) as an arterial material for CABG surgery has a better long-term patency than con-SVG, up to 83% at 10 years. Using radial artery as the second graft for CABG may provide additional clinical benefit. However, the risk of perioperative vasospasm and graft occlusion due to competitive blood flow limit the using of radial artery. Therefore, only the No-touch vein and the radial artery can improve the graft patency. Only one randomized clinical trial(RCT) compared the RA and NT-vein, and this study is limited by irregular post-operative management and small sample size from single center.

This prospective single-center study aims to compare the short-term and long-term graft patency between the No-touch vein and the radial artery. This study will consecutively enroll at least 774 patients undergoing isolated on-pump/off-pump CABG. After obtaining informed written consent, participants will be randomly allocated to either the No-touch or the radial artery group. At baseline, participants will be interviewed to collect detailed information about on demographics, socioeconomic status, cardiovascular risk factors, clinical characteristics, treatments, in-hospital outcomes, general and disease-specific quality of life, function and mental status. During the follow-ups, the investigators will collect information about clinical outcomes events, long-term treatments, function, quality of life, symptoms, and medical care during the recovery period. All participants will be invited for 64-slice multi-slice computed tomography angiography (MSCTA) analysis at 3 months and 12 months post-operatively for graft patency evaluation.

The data adjudicators and computed tomography(CT) reviewers will be blinded to the study. Due to the nature of this study, the operating surgeons, anesthetists and other operative room staff will not be blind in this study. Owing to the use of radial artery need approved by the participant, so participants will also not be blind in this study,

By comparing the short-term and long-term graft patency between the No-touch vein and radial artery groups, this study will contribute major evidence of the possible superiority between two different grafts, so as to improve patient outcomes after CABG surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 774
• Est. completion date: October 30, 2030
• Est. primary completion date: October 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age more than 18 years old

• First time undergo isolated CABG surgery

• Severe three-vessel disease (Left anterior decending artery, Left circumflex artery, Right coronoary artery lesion with more than 75% stenosis)

Exclusion Criteria:

• Urgent or Redo CABG surgery

• Concomitant cardiac or vascular procedures (i.e. valve repair or replacement, Morrow procedure)

• A positive Allen test, radial artery plaque on ultrasound or a history of vasculitis or Raynaud's syndrome

• Varicose great saphenous vein or venous tortuosity and judged as can not be used in operation by surgeons

• Known allergy to radiographic contrast media

• Planed endarterectomy of coronary artery before surgery

• Malignant tumor or other severe systemic diseases

• Combined with other irreversible organ failures

• Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer

• Participant of other ongoing clinical trials in 30 days.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• No-touch vein graft
Two No-touch saphenous vein grafts anastomose to the right coronary and left coronary system. All participants also acquired Left intrathoracic artery(LITA)-left anterior decending artery(LAD) anastomosis to complete the revascularization.
• Radial artery graft
One radial artery graft and one conventional saphenous vein graft anastomose to the right coronary or left coronary system basing on surgeons' decision. All participants also acquired Left intrathoracic artery(LITA)-left anterior decending artery(LAD) anastomosis to complete the revascularization.

Locations

Country	Name	City	State
China	Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

References & Publications (2)

Nappi F, Bellomo F, Nappi P, Chello C, Iervolino A, Chello M, Acar C. The Use of Radial Artery for CABG: An Update. Biomed Res Int. 2021 Apr 7;2021:5528006. doi: 10.1155/2021/5528006. eCollection 2021. — View Citation

Tian M, Wang X, Sun H, Feng W, Song Y, Lu F, Wang L, Wang Y, Xu B, Wang H, Liu S, Liu Z, Chen Y, Miao Q, Su P, Yang Y, Guo S, Lu B, Sun Z, Liu K, Zhang C, Wu Y, Xu H, Zhao W, Han C, Zhou X, Wang E, Huo X, Hu S. No-Touch Versus Conventional Vein Harvesting — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of graft patency	All participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.	12 months after procedure
Secondary	Prevalence of graft patency	All participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.	3 months, 3 years and 5 years after procedure
Secondary	Overall major adverse cardiac or cerebrovascular events (MACCE) rate	MACCE includes death, myocardial infarction, stroke and/or repeat revascularization	3 months, 12 months, 3 years and 5 years after procedure
Secondary	Cardiac death	Death from any heart disease	3 months, 12 months, 3 years and 5 years after procedure
Secondary	Documented non-lethal myocardial infarction	Myocardial infarction is defined according to the most recent guideline	3 months, 12 months, 3 years and 5 years after procedure
Secondary	Stroke	An acute symptomatic episode of focal or global neurological dysfunction caused by brain, spinal, or retinal vascular injury as a result of hemorrhage or infarction	3 months, 12 months, 3 years and 5 years after procedure
Secondary	Target lesion revascularization	CABG or percutaneous coronary intervention	3 months, 12 months, 3 years and 5 years after procedure
Secondary	Recurrence of Angina	Recurrence of Angina	3 months, 12 months, 3 years and 5 years after procedure