Safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary CTA and FFR CT in patients with complex coronary artery disease: Study protocol of the FASTTRACK CABG study

Hideyuki Kawashima, Giulio Pompilio, Daniele Andreini, Antonio L. Bartorelli, Saima Mushtaq, Enrico Ferrari, Francesco Maisano, Ronny R. Buechel, Kaoru Tanaka, Mark La Meir, Johan De Mey, Ulrich Schneider, Torsten Doenst, Ulf Teichgräber, Gregg W. Stone, Faisal Sharif, Robbert De Winter, Brian Thomsen, Charles Taylor, Campbell RogersJonathon Leipsic, William Wijns, Yoshinobu Onuma, Patrick W. Serruys

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction The previously published SYNTAX III REVOLUTION trial demonstrated that clinical decision-making between coronary artery bypass graft (CABG) and percutaneous coronary intervention based on coronary CT angiography (CCTA) had a very high agreement with the treatment decision derived from invasive coronary angiography (ICA). The study objective of the FASTTRACK CABG is to assess the feasibility of CCTA and fractional flow reserve derived from CTA (FFR CT) to replace ICA as a surgical guidance method for planning and execution of CABG in patients with three-vessel disease with or without left main disease. Methods and analysis The FASTTRACK CABG is an investigator-initiated single-arm, multicentre, prospective, proof-of-concept and first-in-man study with feasibility and safety analysis. Surgical revascularisation strategy and treatment planning will be solely based on CCTA and FFR CT without knowledge of the anatomy defined by ICA. Clinical follow-up visit including CCTA will be performed 30 days after CABG in order to assess graft patency and adequacy of the revascularisation with respect to the surgical planning based on non-invasive imaging (CCTA) with functional assessment (FFR CT) and compared with ICA. Primary feasibility endpoint is CABG planning and execution solely based on CCTA and FFR CT in 114 patients. Primary safety endpoint based on 30 day CCTA is graft assessment and topographical adequacy of the revascularisation procedure. Automatic non-invasive assessment of functional coronary anatomy complexity is also evaluated with FFR CT for functional Synergy Between percutaneous coronary intervention With Taxus and Cardiac Surgery Score assessment on CCTA. CCTA with FFR CT might provide better anatomical and functional analysis of the coronary circulation leading to appropriate anatomical and functional revascularisation, and thereby contributing to a better outcome. Ethics and dissemination Each patient has to provide written informed consent as approved by the ethical committee of the respective clinical site. Results will be submitted for publication in peer-reviewed journals and will be disseminated at scientific conferences. Trial registration number NCT04142021.

Original languageEnglish
Article number38152
JournalBMJ Open
Volume10
Issue number12
DOIs
Publication statusPublished - Dec 10 2020

Keywords

  • cardiac surgery
  • cardiology
  • cardiothoracic surgery
  • cardiovascular imaging
  • coronary heart disease
  • ischaemic heart disease

ASJC Scopus subject areas

  • Medicine(all)

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