Fractional flow reserve or optical coherence tomography guidance to revascularize intermediate coronary stenosis
Francesco Burzotta1, Antonio Maria Leone, Giovanni Luigi De Maria
1Department of Cardiovascular Sciences, Catholic University of the Sacred Heart, Largo A, Gemelli 8, 00168 Rome, Italy. f.burzotta@rm.unicatt.it.
Insights
This study compares fractional flow reserve (FFR) and optical coherence tomography (OCT) for managing intermediate coronary lesions. The FORZA trial aims to guide treatment decisions and optimize percutaneous coronary intervention outcomes.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Imaging
Background:
- Management of angiographically intermediate coronary lesions presents a significant clinical challenge.
- Fractional flow reserve (FFR) offers functional insights, while optical coherence tomography (OCT) provides high-resolution anatomical imaging.
- Both FFR and OCT can guide management and optimize percutaneous coronary intervention (PCI) outcomes in these patients.
Purpose of the Study:
- To compare the clinical and economic impact of FFR versus OCT guidance in patients with intermediate coronary lesions.
- To evaluate the effectiveness of FFR and OCT in guiding PCI procedures.
- To assess the impact of these imaging modalities on patient outcomes and healthcare costs.
Main Methods:
- Randomized controlled trial (RCT) comparing FFR and OCT guidance (1:1 ratio).
- FFR guidance: PCI if FFR ≤0.80, target post-PCI FFR ≥0.90.
- OCT guidance: PCI if AS% ≥75% or (AS% 50-75% and MLA <2.5 mm²), or major plaque ulceration; procedural guidance to minimize complications.
Main Results:
- Clinical outcomes and cost load will be prospectively assessed at 1 and 13 months.
- Primary clinical endpoints include major adverse cardiovascular events and significant angina.
- Secondary endpoints focus on procedural success and optimization guided by OCT.
Conclusions:
- The FORZA trial will provide crucial guidance for managing coronary artery disease patients.
- It prospectively assesses two gold-standard techniques for defining coronary plaques functionally and anatomically.
- Findings will inform clinical practice regarding the optimal use of FFR and OCT in intermediate coronary lesions.
Background:
The management of patients with angiographically intermediate coronary lesions is a major clinical issue. Fractional flow reserve provides validated functional insights while optical coherence tomography provides high resolution anatomic imaging. Both techniques may be applied to guide management in case of angiographically intermediate coronary lesions. Moreover, these techniques may be used to optimize the result of percutaneous coronary intervention. We aim to compare the clinical and economic impact of fractional flow reserve versus optical coherence tomography guidance in patients with angiographically intermediate coronary lesions.
Methods/Design:
Patients with at least one angiographically intermediate coronary lesion will be randomized (ratio 1:1) to fractional flow reserve or optical coherence tomography guidance. In the fractional flow reserve arm, percutaneous coronary intervention will be performed if fractional flow reserve value is ≤0.80, and will be conducted with the aim of achieving a post-percutaneous coronary intervention fractional flow reserve target value of ≥0.90. In the optical coherence tomography arm, percutaneous coronary intervention will be performed if percentage of area stenosis (AS%) is ≥75% or 50 to 75% with minimal lumen area <2.5 mm2, or if a major plaque ulceration is detected. In case of percutaneous coronary intervention, optical coherence tomography will guide the procedure in order to minimize under-expansion, malapposition, and edge dissections.Cost load and clinical outcome will be prospectively assessed at one and thirteen months. The assessed clinical outcome measures will be: major cardiovascular events and occurrence of significant angina defined as a Seattle Angina Questionnaire score <90 in the angina frequency scale.
Discussion:
The FORZA trial will provide useful guidance for the management of patients with coronary artery disease by prospectively assessing the use of two techniques representing the gold standard for functional and anatomical definition of coronary plaques.
Trial Registration:
Clinicaltrials.gov NCT01824030.
