Preoperative Use of Fractional Flow Reserve in CABG Use and Effectiveness of FFR-based CABG in Real-life Practice

NCT04379947 | Withdrawn

• 1 other identifier: UG-003
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The use of fractional flow reserve (FFR) to guide coronary artery bypass graft (CABG) is controversial and not ubiquitously adopted across the units. There is no definitive evidence that the use of FFR improves early clinical outcomes after CABG, with the exception of a simplification of the procedure. FFR use may help in defining the indication to the use arterial grafts, but there is no evidence that preoperative FFR lead to any benefits in terms of patency when venous grafts are used. On these grounds a large multicentric all-comers observational study is planned. The aim is to achieve a real-life picture of the FFR practice in CABG across several European and non-European units. This study will inform on the effective use rate of FFR in the CABG practice and its clinical effectiveness when compared to standard angiography-based CABG.

Conditions

Fracational Flow Reserve; Coronary Artery Disease; Coronary Artery Bypass Surgery

Outcome Measures

Primary Outcomes (7)

• Use rate of FFR in preoperative planning of surgical candidates

  Frequency and rate of usage of fractional flow reserve measurement in the routine practice of Cath labs

  10 years

• Effective adherence to FFR guidance during elective surgery and identification of factors eventually limiting observance to FFR information

  To check if CABG operations are performed according to the guidance provided by FFR in terms of location and number of lesions to be bypassed

  10 years

• Survival of FFR-based CABG in comparison to standard angiography-based CABG

  Comparing mortality rate among the two groups

  10 years

• Myocardial infarction rate in FFR-based CABG in comparison to standard angiography-based CABG

  Comparing onset of myocardial infarction among the two groups

  10 years

• Major cardiovascular events rate in FFR-based CABG in comparison to standard angiography-based CABG

  Comparing occurrence of major cardiovascular events among the two groups

  10 years

• Target vessel revascularization rate in FFR-based CABG in comparison to standard

  Comparing perioperative mortality, myocardial infarction, major cardiovascular events, target vessel revascularization, long-term survival, long-term freedom from coronary intervention among the two groups

  10 years

• Freedom from coronary intervention in FFR-based CABG compared to standard angiography-based CABG

  Comparing long-term freedom from coronary intervention among the two groups

  10 years

Secondary Outcomes (4)

• Type of conduit used

  10 years

• Completeness of revascularization

  10 years

• Surgeon experience effect

  10 years

• Volume/outcome relationship

  10 years

Study Arms (2)

FFR-CABG

Patients with at least one intermediate stenosis that received a preoperative FFR evaluation before being referred for CABG

Procedure: Fractional Flow reserve

Angio-CABG

Patients with at least one intermediate stenosis that did not received a preoperative FFR evaluation before being referred for CABG

Interventions

Fractional Flow reserve PROCEDURE

Measurement of fractional flow reserve in the preoperative work-up for oronary artery bypass surgery

FFR-CABG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be retrospectively included in the study from 1st December 2010 to 31st December 2019. All surgical candidates with at least one intermediate lesion will be included. Patients that received a preoperative FFR evaluation before being referred for CABG will be part of the FFR-CABG group. The rest of the patients will be included in the Angio-CABG group. Inclusion will be on an "all-comers" basis including both elective and urgent (and urgent in-house) isolated CABG cases. However, patients undergoing emergency revascularization for iatrogenic complications or other conditions that would prevent a careful analysis of angiographic severity of the lesions will be excluded.

You may qualify if:

• all-comers" including both elective and urgent (and urgent in-house) isolated CABG cases

You may not qualify if:

• patients undergoing emergency revascularization for iatrogenic complications or other conditions that would prevent a careful analysis of angiographic severity of the lesions

Sponsors & Collaborators

• University of Glasgow: lead

Related Publications (9)

• Sundermann S, Dademasch A, Praetorius J, Kempfert J, Dewey T, Falk V, Mohr FW, Walther T. Comprehensive assessment of frailty for elderly high-risk patients undergoing cardiac surgery. Eur J Cardiothorac Surg. 2011 Jan;39(1):33-7. doi: 10.1016/j.ejcts.2010.04.013.

  PMID: 20627611 BACKGROUND

• Coulson TG, Mullany DV, Reid CM, Bailey M, Pilcher D. Measuring the quality of perioperative care in cardiac surgery. Eur Heart J Qual Care Clin Outcomes. 2017 Jan 1;3(1):11-19. doi: 10.1093/ehjqcco/qcw027.

  PMID: 28927188 BACKGROUND

• Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

  PMID: 25173339 BACKGROUND

• Toth G, De Bruyne B, Casselman F, De Vroey F, Pyxaras S, Di Serafino L, Van Praet F, Van Mieghem C, Stockman B, Wijns W, Degrieck I, Barbato E. Fractional flow reserve-guided versus angiography-guided coronary artery bypass graft surgery. Circulation. 2013 Sep 24;128(13):1405-11. doi: 10.1161/CIRCULATIONAHA.113.002740. Epub 2013 Aug 28.

  PMID: 23985788 RESULT

• Fournier S, Toth GG, De Bruyne B, Johnson NP, Ciccarelli G, Xaplanteris P, Milkas A, Strisciuglio T, Bartunek J, Vanderheyden M, Wyffels E, Casselman F, Van Praet F, Stockman B, Degrieck I, Barbato E. Six-Year Follow-Up of Fractional Flow Reserve-Guided Versus Angiography-Guided Coronary Artery Bypass Graft Surgery. Circ Cardiovasc Interv. 2018 Jun;11(6):e006368. doi: 10.1161/CIRCINTERVENTIONS.117.006368.

  PMID: 29848611 RESULT

• Thuesen AL, Riber LP, Veien KT, Christiansen EH, Jensen SE, Modrau I, Andreasen JJ, Junker A, Mortensen PE, Jensen LO. Fractional Flow Reserve Versus Angiographically-Guided Coronary Artery Bypass Grafting. J Am Coll Cardiol. 2018 Dec 4;72(22):2732-2743. doi: 10.1016/j.jacc.2018.09.043.

  PMID: 30497559 RESULT

• Toth GG, De Bruyne B, Kala P, Ribichini FL, Casselman F, Ramos R, Piroth Z, Fournier S, Piccoli A, Van Mieghem C, Penicka M, Mates M, Nemec P, Van Praet F, Stockman B, Degriek I, Barbato E. Graft patency after FFR-guided versus angiography-guided coronary artery bypass grafting: the GRAFFITI trial. EuroIntervention. 2019 Dec 6;15(11):e999-e1005. doi: 10.4244/EIJ-D-19-00463.

  PMID: 31270037 RESULT

• 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 RESULT

• Spadaccio C, Glineur D, Barbato E, Di Franco A, Oldroyd KG, Biondi-Zoccai G, Crea F, Fremes SE, Angiolillo DJ, Gaudino M. Fractional Flow Reserve-Based Coronary Artery Bypass Surgery: Current Evidence and Future Directions. JACC Cardiovasc Interv. 2020 May 11;13(9):1086-1096. doi: 10.1016/j.jcin.2019.12.017. Epub 2020 Mar 25.

  PMID: 32222443 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Fractional Flow Reserve, Myocardial

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coronary Circulation; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Cristiano Spadaccio, MD, PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 8, 2020
• Study Start: May 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: January 1, 2021
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share