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Randomized Controlled Trial
. 2021 Dec 1;42(45):4656-4668.
doi: 10.1093/eurheartj/ehab449.

Post-stenting fractional flow reserve vs coronary angiography for optimization of percutaneous coronary intervention (TARGET-FFR)

Damien Collison  1   2 , Matthaios Didagelos  1 , Muhammad Aetesam-Ur-Rahman  1 , Samuel Copt  3 , Robert McDade  1 , Peter McCartney  1   2 , Thomas J Ford  2 , John McClure  2 , Mitchell Lindsay  1 , Aadil Shaukat  1 , Paul Rocchiccioli  1 , Richard Brogan  1 , Stuart Watkins  1   2 , Margaret McEntegart  1   2 , Richard Good  1   2 , Keith Robertson  1 , Patrick O'Boyle  1 , Andrew Davie  1 , Adnan Khan  1 , Stuart Hood  1 , Hany Eteiba  1   2 , Colin Berry  1   2 , Keith G Oldroyd  1   2
Affiliations
Randomized Controlled Trial

Post-stenting fractional flow reserve vs coronary angiography for optimization of percutaneous coronary intervention (TARGET-FFR)

Damien Collison et al. Eur Heart J. .

Abstract

Aims: A fractional flow reserve (FFR) value ≥0.90 after percutaneous coronary intervention (PCI) is associated with a reduced risk of adverse cardiovascular events. TARGET-FFR is an investigator-initiated, single-centre, randomized controlled trial to determine the feasibility and efficacy of a post-PCI FFR-guided optimization strategy vs. standard coronary angiography in achieving final post-PCI FFR values ≥0.90.

Methods and results: After angiographically guided PCI, patients were randomized 1:1 to receive a physiology-guided incremental optimization strategy (PIOS) or a blinded coronary physiology assessment (control group). The primary outcome was the proportion of patients with a final post-PCI FFR ≥0.90. Final FFR ≤0.80 was a prioritized secondary outcome. A total of 260 patients were randomized (131 to PIOS, 129 to control) and 68.1% of patients had an initial post-PCI FFR <0.90. In the PIOS group, 30.5% underwent further intervention (stent post-dilation and/or additional stenting). There was no significant difference in the primary endpoint of the proportion of patients with final post-PCI FFR ≥0.90 between groups (PIOS minus control 10%, 95% confidence interval -1.84 to 21.91, P = 0.099). The proportion of patients with a final FFR ≤0.80 was significantly reduced when compared with the angiography-guided control group (-11.2%, 95% confidence interval -21.87 to -0.35], P = 0.045).

Conclusion: Over two-thirds of patients had a physiologically suboptimal result after angiography-guided PCI. An FFR-guided optimization strategy did not significantly increase the proportion of patients with a final FFR ≥0.90, but did reduce the proportion of patients with a final FFR ≤0.80.

Keywords: Coronary physiology; Fractional flow reserve; Functional optimization; Ischaemic heart disease; PCI Optimization.

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Figures

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Findings of initial post-percutaneous coronary intervention fractional flow reserve and pullback assessments. (A) Post-percutaneous coronary intervention fractional flow reserve results following standard-of-care stenting [*238/260 (92%) with core lab-adjudicated post-percutaneous coronary intervention fractional flow reserve results available for analysis]. (B) Summary findings of 259 initial post-percutaneous coronary intervention fractional flow reserve pullback assessments (pre-randomization) demonstrating the patterns of residual disease in the study vessels. Protocol-defined targets for additional optimization measure in red bars. Multiple findings may have co-existed within individual vessels. Focal lesion defined as an abrupt pressure drop ≥0.05 fractional flow reserve units on pullback. (C) Primary endpoint—Proportion of patients with final post-percutaneous coronary intervention fractional flow reserve value ≥0.90. (D) Secondary endpoint—Proportion of patients with final post-percutaneous coronary intervention fractional flow reserve ≤0.80. Diffuse Distal, diffuse pressure gradient distal to stented segment; Diffuse Proximal, diffuse pressure gradient proximal to stented segment; Focal Distal, focal pressure drop distal to stented segment; Focal Proximal, Focal pressure drop proximal to stented segment; FFR, fractional flow reserve; HTG, hyperaemic trans-stent gradient; PCI, percutaneous coronary intervention.
Figure 1
Figure 1
Physiology-guided incremental optimization strategy. FFR, fractional flow reserve; HTG, hyperaemic trans-stent gradient; NC, non-compliant.
Figure 2
Figure 2
Trial profile. CABG, coronary artery bypass graft surgery; CAD, coronary artery disease; CFR, coronary flow reserve; CKD, chronic kidney disease; CTO, chronic total occlusion; FFR, fractional flow reserve; IMR, index of microcirculatory resistance; LMS, left main stem; LVSD, left ventricular systolic dysfunction; MDT, multi-disciplinary team meeting; NOCAD, no obstructive coronary artery disease; PCI, percutaneous coronary intervention; PIOS, physiology-guided incremental optimization strategy; STO, sub-total occlusion; TO, total occlusion; VHD, valvular heart disease.
Figure 3
Figure 3
Procedural outcomes in the physiologically-guided incremental optimization strategy group. Following an initial post-percutaneous coronary intervention fractional flow reserve assessment, 29% of patients had a fractional flow reserve ≥0.90 and did not require optimization. Of the remaining 93 patients with fractional flow reserve <0.90, 33 had diffuse residual patterns, which did not meet the protocol-defined criteria for further intervention. Targets for additional intervention were identified in 60 patients. Operators attempted functional optimization in 40 of these patients. The remaining 20 cases in which optimization attempts were not undertaken are discussed in the Supplementary material online. FFR, fractional flow reserve; PIOS, physiologically guided incremental optimization strategy.
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