Guidance by both optical coherence tomography (OCT) and fractional flow reserve (FFR) showed benefit in the assessment of angiographically intermediate coronary lesions (AICLs) and in percutaneous coronary intervention (PCI) optimization, with a potential better benefit from OCT guidance, according to trial results presented Sunday at Transcatheter Cardiovascular Therapeutics 2019 in San Francisco.
Francesco Burzotta, MD, PhD, of Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, presented results of the FORZA trial.
The decision of whether to treat an AICL with a PCI or conservatively manage with medication continues to be an ongoing clinical issue. Previous trials have demonstrated that FFR is able to accurately identify lesions to be treated by using ischemia burden, while OCT is valuable in optimizing PCI results. Investigators in the FORZA trial (a randomized trial of Fractional flow reserve vs. Optical coherence tomography to guide RevasculariZAtion of intermediate coronary stenoses) sought to compare OCT-guidance and FFR-guidance in patients with AICLs in a single-center, prospective, 1:1 randomized trial.
In this trial, patients with one or more AICLs were randomized in a 1:1 fashion to assessment either FFR or OCT. The trial was investigator-driven and non-sponsored. For subjects randomized to FFR, PCI was performed if the FFR was ≤0.80, which is common practice. PCI optimization was determined by FFR with the aim of achieving post-PCI FFR ≥0.90. In the OCT arm, PCI was performed if area stenosis was ≥75% or 50% to 75% with minimal lumen area <2.5 mm2 or plaque rupture. PCI with OCT optimization was done by minimizing major stent malapposition, major stent underexpansion or major edge dissection. The primary endpoint was a composite of major cardiac events (MACE) or significant angina (defined as a Seattle Angina Questionnaire frequency scale <90) at 13 months. Secondary endpoints included cost per patient, rate of medically managed patients, MACE, and target vessel failure.
A total of 350 patients were enrolled in the study, 176 in the FFR arm and 174 in the OCT arm. A total of 446 AICLs were assessed, 225 lesions in the FFR arm and 221 in the OCT arm. The primary endpoint of MACE or significant angina at 13 months occurred in 8.0% of the OCT arm and in 14.8% of the FFR arm (p=0.048). However, the rate of medically managed patients was significantly higher (p<0.001) and total cost significantly lower (p<0.001) with FFR in comparison to OCT.
The investigators concluded that in patients with AICLs, both OCT and FFR are suitable. OCT guidance is safe, and although it causes initially higher number of PCIs, it is associated with a lower occurrence of the combined endpoint of MACE or significant angina after 13 months. FFR guidance is associated with a higher rate of medical management and lower costs. These findings will need to be confirmed with a larger, multicenter randomized clinical trial, the investigators say.