September 28, 2019
Single-Center FORZA Trial Compares FFR and OCT Guidance for PCI
September 29, 2019—Findings from the FORZA trial were presented by Francesco Burzotta, MD, in a late-breaking trials session at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 25–29 in San Francisco, California. Simultaneous with their presentation, Dr. Burzotta et al published the findings online in Journal of the American College of Cardiology: Cardiovascular Interventions.
The purpose of the FORZA trial is to compare optical coherence tomography (OCT) guidance and fractional flow reserve (FFR) guidance for percutaneous coronary interventions (PCI) in the management of angiographically intermediate coronary lesions (AICL).
As summarized in JACC: Cardiovascular Interventions, the single-center, prospective, 1:1 randomized FORZA trial was conducted as follows:
- The trial enrolled 350 patients (with 446 AICL).
- Patients were randomized to FFR (n = 176) or OCT (n = 174).
- In the FFR arm, PCI was performed if FFR was ≤ 0.80.
- In the OCT arm, PCI was performed if area stenosis was ≥ 75% or 50–75% with minimal lumen area < 2.5 mm2 or plaque rupture.
- At the end of follow-up, investigators assessed angina (evaluated by Seattle Angina Questionnaire, SAQ), major adverse cardiac events (MACE), and cost.
- The predefined primary endpoint was the composite of MACE or significant angina (defined as SAQ frequency scale < 90) at 13 months.
The investigators reported that the primary endpoint of MACE or significant angina at 13-month follow-up occurred in 14.8% patients of FFR arm and in 8.0% of OCT arm (P = .048). This result was driven by a not statistically significant lower occurrence of all primary endpoint components. At up to 13-month follow-up, the rate of medically managed patients was significantly higher (P < .001) and total cost significantly lower (P < .001) with FFR in comparison to OCT.
In patients with AICL, OCT-guidance is associated with a lower occurrence of the composite of MACE or significant angina, whereas FFR-guidance is associated with a higher rate of medical management and lower costs, concluded Dr. Burzotta et al in JACC: Cardiovascular Interventions.