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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: 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.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.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.Clinicaltrials.gov NCT01824030.

SUBMITTER: Burzotta F

PROVIDER: S-EPMC4001354 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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

Burzotta Francesco F Leone Antonio Maria AM De Maria Giovanni Luigi GL Niccoli Giampaolo G Coluccia Valentina V Pirozzolo Giancarlo G Saffioti Silvia S Aurigemma Cristina C Trani Carlo C Crea Filippo F

Trials 20140423

<h4>Background</h4>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 c ...[more]

PMID: 24758510

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Project description:Background Fractional flow reserve (FFR) and optical coherence tomography (OCT) may help both in assessment and in percutaneous coronary intervention optimization of angiographically intermediate coronary lesions. We designed a prospective trial comparing the clinical and economic outcomes associated with FFR or OCT in angiographically intermediate coronary lesions. Methods and Results Three hundred fifty patients with angiographically intermediate coronary lesions (n=446) were randomized to FFR or OCT guidance. In the FFR arm, percutaneous coronary intervention was performed if FFR was ≤0.80 aiming for a postprocedure FFR >0.90. In the OCT arm, percutaneous coronary intervention was performed if percentage of area stenosis was ≥75% or 50% to 75% with minimal lumen area <2.5 mm2 or plaque ulceration. Costs, angina frequency, and major adverse cardiac events were assessed at 1 month and at 13 months. We present early data at 1 month consistent with a prespecified analysis of secondary end points. Patients randomized to FFR, as compared with OCT, were significantly more commonly managed with medical therapy alone (67.7% versus 41.1%; P<0.001), required less contrast media (245±137 versus 280±129 mL; P=0.004), and exhibited a lower occurrence of contrast-induced acute kidney injury (1.7% versus 8.6%; P=0.034). At 1 month, in comparison to FFR, OCT was associated with increased total costs (2831±1288 versus 4292±3844 euros/patient; P<0.001) whereas occurrence of major adverse cardiac events or significant angina was similar. Conclusions In patients with angiographically intermediate coronary lesions, a functional guidance by FFR, as compared with OCT, increased the rate of patients treated with medical therapy alone. This translated into a significant reduction in administered contrast, contrast-induced acute kidney injury, and total costs at 1 month with FFR. Clinical Trial Registration URL: http://www.clinicaltrialsgov. Unique identifier: NCT01824030.

Dataset Information

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

Publications

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

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