A randomized controlled trial of a physiology‐guided percutaneous coronary intervention optimization strategy: rationale and design of the TARGET FFR study

Collison, D., McClure, J. D. , Berry, C. and Oldroyd, K. G. (2020) A randomized controlled trial of a physiology‐guided percutaneous coronary intervention optimization strategy: rationale and design of the TARGET FFR study. Clinical Cardiology, 43(5), pp. 414-422. (doi: 10.1002/clc.23342) (PMID:32037592) (PMCID:PMC7244297)

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Abstract

Post‐percutaneous coronary intervention (PCI) fractional flow reserve (FFR) ≥0.90 confers an improved cardiac prognosis. There are currently limited data available to determine how often it is possible to improve an angiographically acceptable but physiologically suboptimal result. A physiology‐guided optimization strategy can achieve a clinically meaningful increase in the proportion of patients achieving a final post‐PCI FFR ≥0.90 compared to standard care. Following angiographically successful PCI procedures, 260 patients will be randomized (1:1) to receive either a physiology‐guided incremental optimization strategy (intervention group) or blinded post‐PCI coronary physiology measurements (control group). Patients undergoing successful, standard‐of‐care PCI for either stable angina or non‐ST‐segment‐elevation myocardial infarction who meet the study's inclusion and exclusion criteria will be eligible for randomization. The primary endpoint is defined as the proportion of patients with a final post‐PCI FFR result ≥0.90. Secondary endpoints include change from baseline in Seattle Angina Questionnaire and EQ‐5D‐5L scores at 3 months and the rate of target vessel failure and its components (cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalization with target vessel revascularization) at 3 months and 1 year. 260 individual patients were successfully randomized between March 2018 and November 2019. Key baseline demographics of the study population are reported within. TARGET FFR is an investigator‐initiated, prospective, single‐center, randomized controlled trial of an FFR‐guided PCI optimization strategy. The study has completed recruitment and is now in clinical follow‐up. It is anticipated that primary results will be presented in Autumn 2020.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Collison, Dr Damien and Oldroyd, Dr Keith and Berry, Professor Colin and McClure, Dr John
Authors: Collison, D., McClure, J. D., Berry, C., and Oldroyd, K. G.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
Journal Name:Clinical Cardiology
Publisher:Wiley
ISSN:0160-9289
ISSN (Online):1932-8737
Published Online:10 February 2020
Copyright Holders:Copyright © 2020 The Authors
First Published:First published in Clinical Cardiology 43(5): 414-422
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
190721Microvascular Dysfunction in Patients with Angina: The CE-MARC2 Microvascular SubstudyColin BerryBritish Heart Foundation (BHF)FS/14/15/30661Institute of Cardiovascular & Medical Sciences
301454CORonary MICrovascular Angina (CorMicA): a pilot trial with a nested MRI sub-studyColin BerryBritish Heart Foundation (BHF)PG/17/25/32884CAMS - Cardiovascular Science