NEW YORK - October 16, 2020 - Results from the randomized controlled TARGET FFR trial show that while a physiology-guided percutaneous coronary intervention (PCI) optimization strategy did not achieve a significant increase in the proportion of patients with final FFR ?0.90, it reduced the proportion of patients with a residual FFR ?0.80 following PCI.
Findings were reported today at TCT Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation (CRF). TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.
260 patients were successfully randomized between March 2018 and November 2019 at a single site. Following angiographically successful PCI procedures, patients were randomized (1:1) to receive either a physiology-guided incremental optimization strategy (PIOS intervention group, n=131) or blinded post-PCI coronary physiology measurements (control group, n=129). Patients undergoing successful, standard-of-care PCI for either stable angina or medically stabilized non-ST-segment-elevation myocardial infarction (NSTEMI) were eligible for randomization.
The trial's primary endpoint was defined as the proportion of patients with a final post-PCI FFR result ?0.90. The study found that the incidence of final FFR ?0.90 was 10% higher in the PIOS group than the control group but that the difference was not statistically significant (38.1% vs. 28.1%, p=0.099). However, the study's secondary endpoint, the proportion of patients with final FFR ?0.80, was significantly lower in the PIOS group (18.6% vs 29.8%, p=0.045).
Based on FFR pullback assessment of the stented vessel, a target for further optimization was present in 60 of the 131 (46%) patients randomized to PIOS, and operators considered it appropriate to perform additional post-dilatation +/- stenting in 40 of these 60 (66%) patients. Among patients who had further intervention/optimization performed, mean post-PCI FFR increased significantly from 0.76 to 0.82 (p<.001) and mean Coronary Flow Reserve (CFR) increased from 3.0 to 4.0 (p=.02).
"When assessing the proposed optimal post-PCI FFR cutoff value of ?0.90, we found that the majority of patients with angiographically acceptable PCI results actually have a physiologically suboptimal outcome," said Damien Collison, MD, Interventional Cardiologist at the Golden Jubilee National Hospital, Glasgow, Scotland. "Up to 30% of patients may even have a final FFR result that remains below the guideline-directed threshold for performing revascularization in the first place. In our randomized controlled trial, application of an FFR-guided optimization strategy after stenting led to improvements in both FFR and CFR and significantly reduced the proportion of patients with a final post-PCI FFR ?0.80."
The TARGET FFR trial was funded by NHS National Waiting Times Centre Board endowment funds. Dr. Collison reported the following disclosures: consulting fees/honoraria from Abbott Medical and MedAlliance.
The Cardiovascular Research Foundation (CRF) is one of the world's leading nonprofit organizations specializing in interventional cardiology innovation, research, and education. CRF is dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For nearly 30 years, CRF has helped pioneer medical advances and educated doctors on the latest treatments for heart disease. CRF is comprised of the CRF Skirball Center for Innovation, CRF Clinical Trials Center, CRF Center for Education, CRF Digital, TCTMD, and Structural Heart: The Journal of the Heart Team.
Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the premier educational meeting specializing in interventional cardiovascular medicine. Now in its 32nd year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.