1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI: DEFINE PCI Trial

Abstract

Objectives: The aim of this study was to identify the post-percutaneous coronary intervention (PCI) target value of instantaneous wave-free ratio (iFR) that would best discriminate clinical events at 1 year in the DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) study.

Background: The impact of residual ischemia detected by iFR post-PCI on clinical and symptom-related outcomes is unknown.

Methods: Blinded iFR pull back was performed after successful stent implantation in 500 patients. The primary endpoint was the rate of residual ischemia, defined as iFR ≤0.89, after operator-assessed angiographically successful PCI. Secondary endpoints included clinical events at 1 year and change in Seattle Angina Questionnaire angina frequency (SAQ-AF) score during follow-up.

Results: As reported, 24.0% of patients had residual ischemia (iFR ≤0.89) after successful PCI, with 81.6% of cases attributable to angiographically inapparent focal lesions. Post-PCI iFR ≥0.95 (present in 182 cases [39%]) was associated with a significant reduction in the composite of cardiac death, spontaneous myocardial infarction, or clinically driven target vessel revascularization compared with post-PCI iFR <0.95 (1.8% vs 5.7%; P = 0.04). Baseline SAQ-AF score was 73.3 ± 22.8. For highly symptomatic patients (baseline SAQ-AF score ≤60), SAQ-AF score increased by ≥10 points more frequently in patients with versus without post-PCI iFR ≥0.95 (100.0% vs 88.5%; P = 0.01).

Conclusions: In DEFINE PCI, despite angiographically successful PCI, highly symptomatic patients at baseline without residual ischemia by post-PCI iFR had greater reductions in anginal symptoms at 1 year compared with patients with residual ischemia. Achieving post-PCI iFR ≥0.95 was also associated with improved 1-year event-free survival. (Physiologic Assessment of Coronary Stenosis Following PCI [DEFINE PCI]; NCT03084367).

Keywords: Seattle Angina Questionnaire Angina Frequency; instantaneous wave-free ratio; percutaneous coronary intervention; physiological measurements; residual ischemia.

Conflict of interest statement

Funding Support and Author Disclosures This study was supported by funding from Philips/Volcano Corporation. The funding source was uninvolved with the design of the protocol and the analysis and interpretation of the study results. Dr Patel has received research grants from Bayer, Janssen, Amgen, Novartis, the National Heart, Lung, and Blood Institute, Phillips, and HeartFlow; and is an advisory board member for Bayer, Janssen, and HeartFlow. Dr Jeremias has received institutional funding (unrestricted education grant) from Philips/Volcano; and is a consultant for Philips/Volcano, Abbott Vascular, Acist Medical, and Boston Scientific. Dr Maehara has received institutional research grants from Boston Scientific and Abbott Vascular; and is a consultant for Boston Scientific and Philips, outside the submitted work. Dr Matsumura is a consultant for Terumo. Dr Shammas has received educational and research grants from Boston Scientific, Phillips, VentureMed Group, Angiodynamics, and Bard/BD; and is a member of the Speakers Bureau of Janssen, Eli Lilly, Esperion, and Boehringer Ingelheim. Dr Seto has received research grants from Phillips and Acist Medical; and has received honoraria from Terumo, General Electric, and Janssen. Dr Samady has received institutional grants from Medtronic; is a consultant to Abbott, Philips, Valo, and Vigilant Labs; and is a cofounder and equity holder of Covanos. Dr Sharp is a consultant to Medtronic, Recor Medical, Boston Scientific, and Philips. Dr Ali has received institutional grants from Abbott and Cardiovascular Systems; has received personal fees from Amgen, AstraZeneca, and Boston Scientific; and holds equity in Shockwave Medical, outside the submitted work. Dr Mintz has received honoraria from Boston Scientific, Philips, Medtronic, and Abiomed. Dr Davies is a consultant for Volcano-Philips; and has patents pertaining to iFR technology licensed by Imperial College to Volcano-Philips. Dr Stone has received speaker or other honoraria from Cook and Terumo; is a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, CardioMech, Elucid Bio, and Occlutech; and holds equity or options in Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, the MedFocus family of funds, and Valfix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Copyright © 2022. Published by Elsevier Inc.