Fractional flow reserve or optical coherence tomography guidance to revascularize intermediate coronary stenosis using angioplasty (FORZA) trial: study protocol for a randomized controlled trial

Abstract

BackgroundThe 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/DesignPatients 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.DiscussionThe 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 registrationClinicaltrials.gov NCT01824030

The association of leukocyte telomere length and intermediate coronary lesions—a retrospective study

“…In case of disagreement between the reviewers, a third reader was involved to reach a consensus. In this retrospective study, PCI was performed when at least one of the following criteria was met: (I) area stenosis (AS) between 50% and 70% and minimal luminal area (MLA) <2.5 mm 2 ; (II) AS between 50% and 70% and plaque rupture (15). Patient's symptoms, electrocardiogram, echocardiography, and other examination results should be considered sometimes.…”

Coronary optical coherence tomography: A practical overview of current clinical applications

“…28 An ongoing randomized trial (FORZA) is evaluating the feasibility of PCI guided by OCT in angiographically intermediate lesions with stenosis area ≥75% assessed by OCT, or 50---75% with MLA <2.5 mm 2 , or if a major plaque ulceration is detected. 29 Recently, OCT has been used to guide treatment in ACS in a different way. The unique ability of the method to detect thrombus and plaque rupture adds an unprecedented level of confidence in determining the underlying mechanism of plaque instability.…”

Invasive FFR — Current Applications and New Developments

“…At the same time, the cost-efficiency ratio evaluated by the rate of re-hospitalizations is optimal, thus the 2014 guidelines for revascularization include as a class I indication the use of FFR measurements in the establishing of the functional significance of coronary stenoses, before commencing to stress testing, and class IIa indication of FFR measurements for patients with multi-vessel coronary artery disease in establishing the indication for revascularization of lesions that are angiographically estimated at 50-70%. 17,29,30 There are several undergoing trials that use FFR measurements, such as FAME 3, which compares PCI and coronary artery bypass grafting (CABG) in multi-vessel CAD patients, and which follows the rate of reinfarction, death, stroke and repeated revascularization at 1 year. SYNTAX II trial compares treatment options for multi-vessel CAD with the use of FFR; the MITNECB5 trial compares the sensitivity of FFR with various imaging methods (stress echocardiography, perfusion magnetic resonance imaging, SPECT with technetium 99m, or perfusion CT angiography).…”