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

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.

Graphical Abstract

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.