An Evaluation of a Physiology-guided PCI Optimisation Strategy

NCT03259815 | Completed

• 2 other identifiers: 17/CARD/10IRAS ID 223780
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

There has recently been renewed interest in the measurement of post percutaneous coronary intervention (PCI) Fractional Flow Reserve (FFR). Previous studies have suggested that post-PCI FFR values ≥0.90 are associated with better clinical outcomes for patients but the available data suggest that despite angiographically satisfactory results, this is actually achieved in less than 40% of cases. The main mechanisms for sub-optimal post-PCI FFR measurements have been proposed to be suboptimal stent deployment, unmasking of a second lesion in the target vessel post PCI, residual diffuse disease in the untreated segments and pressure drift (a technical artefact of pressure wire technology). Using post-PCI FFR to guide stent optimisation and/or further intervention in the target vessel has been shown to increase the frequency of achieving optimal post-PCI FFR results (and therefore presumably better clinical outcomes). However, there are additional costs involved in the routine use of post-PCI FFR and it is not clear just how often it is even possible to increase the initial post-PCI FFR to ≥0.90. This uncertainty means that it is currently difficult to either recommend the routine use of post-PCI FFR or justify its cost. The investigators propose a prospective study to assess the feasibility of achieving post-PCI FFR ≥0.90 during standard PCI procedures in consecutive patients. The study would also attempt to elucidate the mechanisms for sub-optimal FFR results when they occur. The investigators anticipate using the data from this developmental study to support a subsequent funding application for a definitive phase 3 study of the impact of FFR targeted PCI on clinical outcomes.

Conditions

Coronary Artery Disease; Coronary Stenosis

Keywords

FFR Targeted PCI; Post-PCI FFR; Physiology-guided PCI Optimisation

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with a final post-PCI FFR result ≥0.90

  The proportion of patients with a final post-PCI FFR result ≥0.90 will be compared between the randomised groups

  1 day

Secondary Outcomes (22)

• The proportion of patients with final post-PCI FFR ≤0.80

  1 day

• Change from baseline in self-reported health outcomes at 3 months using a disease-specific quality of life measurement tool.

  3 months

• Change from baseline in self-reported health outcomes at 3 months using a generic quality of life measurement tool.

  3 months

• The rate of target vessel failure (TVF) and its component features at 3 months.

  3 months

• The rate of target vessel failure (TVF) and its component features at 1 year.

  1 year

Other Outcomes (18)

• 'As Treated' analysis of the proportion of patients with a final post-PCI FFR result ≥0.90

  1 day

• 'As Treated' analysis of the proportion of patients with final post-PCI FFR ≤0.80

  1 day

• 'As Treated' analysis of the change from baseline in self-reported health outcomes at 3 months as assessed by the Seattle Angina Questionnaire (SAQ)

  3 months

Study Arms (2)

PIOS Intervention Group

EXPERIMENTAL

Operator-blinded pre and post-PCI coronary physiology measurements will be recorded. If FFR is \<0.90, the result will be disclosed to the operator and a hyperaemic pressure wire pullback will be performed during a standard peripheral intravenous adenosine infusion (140mcg/kg/min). The operator will then follow the PIOS protocol to attempt to obtain the target optimal post-PCI FFR result.

Procedure: P.I.O.S.; Diagnostic Test: Pre and post-PCI coronary physiology measurements

Control Group

ACTIVE COMPARATOR

Operator-blinded pre and post-PCI coronary physiology measurements will be recorded and the angiographically defined result will be accepted.

Diagnostic Test: Pre and post-PCI coronary physiology measurements

Interventions

P.I.O.S. PROCEDURE

Physiologically-Guided Incremental Optimisation Strategy

PIOS Intervention Group

Pre and post-PCI coronary physiology measurements DIAGNOSTIC_TEST

Pre and post-PCI coronary physiology measurements will be performed but not disclosed to the operator

Control Group; PIOS Intervention Group

Eligibility Criteria

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

You may qualify if:

• Patients \>18 years of age with coronary artery disease (including stable angina and stabilised non-ST-elevation myocardial infarction (NSTEMI)) who are able to provide informed consent.

You may not qualify if:

• PCI in a coronary artery bypass graft
• PCI to an in-stent restenosis (ISR) lesion
• PCI to a target artery providing Rentrop grade 2 or 3 collateral blood supply to another vessel
• Inability to receive adenosine (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker).
• Recent (within 1 week prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion).
• Severe cardiomyopathy (ejection fraction \<30%).
• Renal insufficiency such that an additional 20 to 30 mL of contrast would, in the opinion of the operator, pose unwarranted risk to the patient.

Sponsors & Collaborators

• NHS National Waiting Times Centre Board: lead

Study Sites (1)

Golden Jubilee National Hospital

Glasgow, G81 4DY, United Kingdom

Location

Related Publications (5)

• Collison D, McClure JD, Berry C, Oldroyd KG. A randomized controlled trial of a physiology-guided percutaneous coronary intervention optimization strategy: Rationale and design of the TARGET FFR study. Clin Cardiol. 2020 May;43(5):414-422. doi: 10.1002/clc.23342. Epub 2020 Feb 10.

  PMID: 32037592 BACKGROUND

• Collison D, Didagelos M, Aetesam-Ur-Rahman M, Copt S, McDade R, McCartney P, Ford TJ, McClure J, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Post-stenting fractional flow reserve vs coronary angiography for optimization of percutaneous coronary intervention (TARGET-FFR). Eur Heart J. 2021 Dec 1;42(45):4656-4668. doi: 10.1093/eurheartj/ehab449.

  PMID: 34279606 RESULT

• Seki R, Collison D, Ikeda K, Sonck J, Munhoz D, Bertolone DT, Ko B, Maeng M, Otake H, Koo BK, Storozhenko T, Bouisset F, Belmonte M, Leone A, Shumkova M, Ford TJ, Mahendiran T, Berry C, De Bruyne B, Oldroyd K, Sakai K, Mizukami T, Collet C. Validation of virtual fractional flow reserve pullback curves. Catheter Cardiovasc Interv. 2024 Nov;104(6):1178-1188. doi: 10.1002/ccd.31222. Epub 2024 Sep 29.

  PMID: 39342486 DERIVED

• Collison D, Copt S, Mizukami T, Collet C, McLaren R, Didagelos M, Aetesam-Ur-Rahman M, McCartney P, Ford TJ, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Angina After Percutaneous Coronary Intervention: Patient and Procedural Predictors. Circ Cardiovasc Interv. 2023 Apr;16(4):e012511. doi: 10.1161/CIRCINTERVENTIONS.122.012511. Epub 2023 Mar 28.

  PMID: 36974680 DERIVED

• Collet C, Collison D, Mizukami T, McCartney P, Sonck J, Ford T, Munhoz D, Berry C, De Bruyne B, Oldroyd K. Differential Improvement in Angina and Health-Related Quality of Life After PCI in Focal and Diffuse Coronary Artery Disease. JACC Cardiovasc Interv. 2022 Dec 26;15(24):2506-2518. doi: 10.1016/j.jcin.2022.09.048. Epub 2022 Nov 30.

  PMID: 36543445 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Keith G Oldroyd, MB, MD

  NHS National Waiting Times Centre Board (NHS Golden Jubilee)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Operator blinded pre and post PCI coronary physiology measurements will be performed in both arms of the study. Post-PCI FFR results \<0.90 in the interventional arm will be disclosed to the operator to allow further intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 24, 2017
• Study Start: March 8, 2018
• Primary Completion: November 22, 2019
• Study Completion: December 4, 2020
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)