Quantitative Flow Ratio on Radial Artery Graft Outcome After Coronary Artery Bypass Grafting

NCT05556590 | Completed

• 1 other identifier: KY-2022144
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

In coronary artery bypass grafting (CABG), the use of radial artery (RA) is recommended by the guidelines only to significantly stenosed vessel, due to its high vulnerability to competitive flow. Fractional flow reserve (FFR) is the gold standard to measure physiological significance of coronary lesions and the potential for competitive flow. This study aims to investigate whether the preoperative quantitative flow ratio (QFR) measurement, a novel coronary angiography-based FFR, is associated with RA graft failure post-CABG, and to explore the best cut-off value of QFR for RA grafts using. Patients from ASRAB-pilot trial (NCT04310995) undergoing primary isolated CABG using RA grafts, and with preoperative coronary angiography (CAG) images available for QFR analysis will be enrolled in this prospective double-blind observational study. QFR analysis will be conducted for all RA-grafted vessels based on preoperative CAG. The primary outcome will RA graft failure (FitzGibbon Grade B,O or S) evaluated by coronary computer tomography angiography or CAG at 7 days and 6 months post-CABG.

Conditions

Coronary Artery Disease

Keywords

Coronary artery bypass grafting; Radial artery graft; Quantitative flow ratio

Outcome Measures

Primary Outcomes (2)

• 6-month radial artery graft failure

  Graft outcome will be evaluated by CCTA or CAG according to the Fitzgibbon classification criteria: Grade A, grade B, grade O and grade S (String Sign). Grade B, O and S are considered as graft failure.

  6 months after surgery

• 7-day radial artery graft failure

  Graft outcome will be evaluated by CCTA or CAG according to the Fitzgibbon classification criteria: Grade A, grade B, grade O and grade S (String Sign). Grade B, O and S are considered as graft failure.

  7 days after surgery

Secondary Outcomes (3)

• Major adverse cardiovascular event (MACE)

  within 6 months after surgery

• Myocardial infarction related to radial artery graft failure

  within 6 months after surgery

• Unplanned coronary revascularization related to radial artery graft failure

  within 6 months after surgery

Study Arms (2)

QFR-Low Group

Based on preoperative CAG, QFR analysis will be conducted for vessels bypassed with RA grafts. The RA-grafted vessels with QFR below the best cut-off value (0.50-0.55 assumed) will be allocated to QFR-Low group.

QFR-High Group

Based on preoperative CAG, QFR analysis will be conducted for vessels bypassed with RA grafts. The RA-grafted vessels with QFR over the best cut-off value (0.50-0.55 assumed) will be allocated to QFR-High group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

For patients enrolled in the ASRAB-pilot trial, those who with available preoperative CAG images for QFR analysis, will be enrolled in this study.

You may qualify if:

• All patients enrolled in the ASRAB-pilot study.

You may not qualify if:

• Preoperative CAG not available for QFR analysis.
• Age≥18 years.
• Male or female patients.
• Have signed informed consent.
• Have successfully accepted the first RA-CABG surgery.
• Previously experienced an allergy to active ingredients and/or excipients of experimental drugs.
• Hypotension (defined as systolic blood pressure \< 90mmHg or diastolic blood pressure \< 60mmHg) after surgery.
• Acute myocardial infarction, pulmonary congestion or cardiogenic shock after surgery.
• Concomitant medications with phosphodiesterase-5 inhibitors such as sildenafil, vardenafil, tadalafil, etc.
• Pathological sinus node syndrome, degree II or III atrioventricular block without cardiac pacemaker.
• History or evidence of ongoing alcohol or drug abuse.
• Life expectancy \< 1 year judged by investigators.
• Other inappropriate situations judged by investigators.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (19)

• Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 Dec 6;124(23):e652-735. doi: 10.1161/CIR.0b013e31823c074e. Epub 2011 Nov 7. No abstract available.

  PMID: 22064599 BACKGROUND

• Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.

  PMID: 30165437 BACKGROUND

• Lytle BW, Blackstone EH, Loop FD, Houghtaling PL, Arnold JH, Akhrass R, McCarthy PM, Cosgrove DM. Two internal thoracic artery grafts are better than one. J Thorac Cardiovasc Surg. 1999 May;117(5):855-72. doi: 10.1016/S0022-5223(99)70365-X.

  PMID: 10220677 BACKGROUND

• Taggart DP, D'Amico R, Altman DG. Effect of arterial revascularisation on survival: a systematic review of studies comparing bilateral and single internal mammary arteries. Lancet. 2001 Sep 15;358(9285):870-5. doi: 10.1016/S0140-6736(01)06069-X.

  PMID: 11567701 BACKGROUND

• Yi G, Shine B, Rehman SM, Altman DG, Taggart DP. Effect of bilateral internal mammary artery grafts on long-term survival: a meta-analysis approach. Circulation. 2014 Aug 12;130(7):539-45. doi: 10.1161/CIRCULATIONAHA.113.004255. Epub 2014 Jun 10.

  PMID: 24916209 BACKGROUND

• Aldea GS, Bakaeen FG, Pal J, Fremes S, Head SJ, Sabik J, Rosengart T, Kappetein AP, Thourani VH, Firestone S, Mitchell JD; Society of Thoracic Surgeons. The Society of Thoracic Surgeons Clinical Practice Guidelines on Arterial Conduits for Coronary Artery Bypass Grafting. Ann Thorac Surg. 2016 Feb;101(2):801-9. doi: 10.1016/j.athoracsur.2015.09.100. Epub 2015 Dec 8.

  PMID: 26680310 BACKGROUND

• Glineur D, Poncelet A, El Khoury G, D'hoore W, Astarci P, Zech F, Noirhomme P, Hanet C. Fractional flow reserve of pedicled internal thoracic artery and saphenous vein grafts 6 months after bypass surgery. Eur J Cardiothorac Surg. 2007 Mar;31(3):376-81. doi: 10.1016/j.ejcts.2006.11.023. Epub 2006 Dec 14.

  PMID: 17174100 BACKGROUND

• Glineur D, Hanet C. Competitive flow in coronary bypass surgery: is it a problem? Curr Opin Cardiol. 2012 Nov;27(6):620-8. doi: 10.1097/HCO.0b013e3283583000.

  PMID: 23075821 BACKGROUND

• Glineur D, D'hoore W, El Khoury G, Sondji S, Kalscheuer G, Funken JC, Rubay J, Poncelet A, Astarci P, Verhelst R, Noirhomme P, Hanet C. Angiographic predictors of 6-month patency of bypass grafts implanted to the right coronary artery a prospective randomized comparison of gastroepiploic artery and saphenous vein grafts. J Am Coll Cardiol. 2008 Jan 15;51(2):120-5. doi: 10.1016/j.jacc.2007.09.030.

  PMID: 18191734 BACKGROUND

• Glineur D, Hanet C, D'hoore W, Poncelet A, De Kerchove L, Etienne PY, Noirhomme P, El Khoury G. Causes of non-functioning right internal mammary used in a Y-graft configuration: insight from a 6-month systematic angiographic trial. Eur J Cardiothorac Surg. 2009 Jul;36(1):129-35; discussion 135-6. doi: 10.1016/j.ejcts.2009.02.041. Epub 2009 Apr 15.

  PMID: 19372044 BACKGROUND

• Sabik JF 3rd, Lytle BW, Blackstone EH, Khan M, Houghtaling PL, Cosgrove DM. Does competitive flow reduce internal thoracic artery graft patency? Ann Thorac Surg. 2003 Nov;76(5):1490-6; discussion 1497. doi: 10.1016/s0003-4975(03)01022-1.

  PMID: 14602274 BACKGROUND

• White CW, Wright CB, Doty DB, Hiratza LF, Eastham CL, Harrison DG, Marcus ML. Does visual interpretation of the coronary arteriogram predict the physiologic importance of a coronary stenosis? N Engl J Med. 1984 Mar 29;310(13):819-24. doi: 10.1056/NEJM198403293101304.

  PMID: 6700670 BACKGROUND

• Xu B, Tu S, Qiao S, Qu X, Chen Y, Yang J, Guo L, Sun Z, Li Z, Tian F, Fang W, Chen J, Li W, Guan C, Holm NR, Wijns W, Hu S. Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3077-3087. doi: 10.1016/j.jacc.2017.10.035. Epub 2017 Oct 31.

  PMID: 29101020 BACKGROUND

• Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Botker HE, Wijns W, Christiansen EH, Holm NR. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc. 2018 Jul 6;7(14):e009603. doi: 10.1161/JAHA.118.009603.

  PMID: 29980523 BACKGROUND

• Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.

  PMID: 27712739 BACKGROUND

• Tu S, Westra J, Adjedj J, Ding D, Liang F, Xu B, Holm NR, Reiber JHC, Wijns W. Fractional flow reserve in clinical practice: from wire-based invasive measurement to image-based computation. Eur Heart J. 2020 Sep 7;41(34):3271-3279. doi: 10.1093/eurheartj/ehz918.

  PMID: 31886479 BACKGROUND

• Xu B, Tu S, Song L, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Yang J, Liu X, Guo L, Shen C, Zhang Y, Zhang Q, Pan H, Fu X, Liu J, Zhao Y, Escaned J, Wang Y, Fearon WF, Dou K, Kirtane AJ, Wu Y, Serruys PW, Yang W, Wijns W, Guan C, Leon MB, Qiao S, Stone GW; FAVOR III China study group. Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial. Lancet. 2021 Dec 11;398(10317):2149-2159. doi: 10.1016/S0140-6736(21)02248-0. Epub 2021 Nov 4.

  PMID: 34742368 BACKGROUND

• Glineur D, Grau JB, Etienne PY, Benedetto U, Fortier JH, Papadatos S, Laruelle C, Pieters D, El Khoury E, Blouard P, Timmermans P, Ruel M, Chong AY, So D, Chan V, Rubens F, Gaudino MF. Impact of preoperative fractional flow reserve on arterial bypass graft anastomotic function: the IMPAG trial. Eur Heart J. 2019 Aug 1;40(29):2421-2428. doi: 10.1093/eurheartj/ehz329.

  PMID: 31155673 BACKGROUND

• Glineur D, Rahouma M, Grau JB, Etienne PY, Fortier JH, Papadatos S, Laruelle C, Pieters D, El Khoury E, Gaudino M. FFR Cutoff by Arterial Graft Configuration and Location: IMPAG Trial Insights. JACC Cardiovasc Interv. 2020 Jan 13;13(1):143-144. doi: 10.1016/j.jcin.2019.08.013. No abstract available.

  PMID: 31918937 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Qiang Zhao, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Yunpeng Zhu, MD

  Ruijin Hospital

  STUDY DIRECTOR

• Jiaxi Zhu, MD

  Ruijin Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and director, Department of Cardiac Surgery,Vice President of Ruijin Hospital

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 27, 2022
• Study Start: October 9, 2022
• Primary Completion: March 31, 2023
• Study Completion: April 30, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)