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Prospective Randomized Comparison of Fractional Flow Reserve Versus Optical Coherence Tomography to Guide Revascularization of Intermediate Coronary Stenoses: One-Month Results.
- Source :
-
Journal of the American Heart Association [J Am Heart Assoc] 2019 Aug 06; Vol. 8 (15), pp. e012772. Date of Electronic Publication: 2019 Jul 23. - Publication Year :
- 2019
-
Abstract
- 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 mm <superscript>2</superscript> 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.
- Subjects :
- Aged
Coronary Angiography
Coronary Stenosis diagnostic imaging
Coronary Stenosis physiopathology
Female
Humans
Male
Middle Aged
Prospective Studies
Severity of Illness Index
Surgery, Computer-Assisted
Time Factors
Treatment Outcome
Coronary Stenosis surgery
Fractional Flow Reserve, Myocardial
Percutaneous Coronary Intervention methods
Tomography, Optical Coherence
Subjects
Details
- Language :
- English
- ISSN :
- 2047-9980
- Volume :
- 8
- Issue :
- 15
- Database :
- MEDLINE
- Journal :
- Journal of the American Heart Association
- Publication Type :
- Academic Journal
- Accession number :
- 31331219
- Full Text :
- https://doi.org/10.1161/JAHA.119.012772