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Results from the DEFINE-FLOW examine reported

A brand new observational examine of deferred lesions following mixed fractional circulation reserve (FFR) and coronary circulation reserve (CFR) assessments discovered that untreated vessels with irregular FFR however intact CFR should not have non-inferior outcomes in comparison with these with an FFR larger than zero.eight and a CFR larger than or equal to 2 when handled medically.

Findings have been reported right now at TCT Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation (CRF).

The function for invasive CFR evaluation within the present period stays unclear since FFR has turn into a reference normal guiding choices for revascularization. While observational information from invasive and noninvasive tools has indicated that lesions with intact CFR do properly, few of those research concurrently assessed FFR. To deal with the constraints of the present literature, researchers designed and carried out the DEFINE-FLOW examine.

A complete of 455 sufferers have been enrolled from 12 websites in six international locations. Of these enrolled, 430 sufferers (533 lesions) have been protocol-treated and adopted for 2 years. Stable coronary lesions underwent simultaneous FFR and CFR measurement in a minimum of duplicate with central core lab assessment of the tracings. Treatment adopted the native measurements in keeping with a uniform protocol whereby solely lesions with each FFR≤zero.eight and CFR2.zero, obtained preliminary medical remedy.

The major endpoint was the composite of all-cause loss of life, myocardial infarction, and revascularization at two years. The examine findings for MACE have been 5.eight% for FFR-/CFR-, 10.eight% for FFR+/CFR-, 12.four% for FFR-/CFR+, and 14.four% for FFR+/CFR+ (after PCI). The distinction of FFR+/CFR- in comparison with FFR-/CFR- was 5.zero% (95%CI -1.5% to +11.5%, p-value zero.065 for non-inferiority). Therefore, the examine discovered that vessels with irregular FFR≤zero.eight however intact CFR≥2.zero didn’t have non-inferior outcomes in comparison with FFR>zero.eight and CFR≥2.zero when handled medically.

“Because the study was observational, it is not clear what the outcomes among FFR+/CFR- lesions would have been had they undergone PCI instead of medical therapy,” stated Nils Johnson, MD, MS, Associate Professor of Medicine and Weatherhead Distinguished Chair of Heart Disease, Division of Cardiology, Department of Medicine and the Weatherhead PET Imaging Center at McGovern Medical School at UT Health (Houston) and Memorial Hermann Hospital—Texas Medical Center. “There were a number of limitations to this study such as few lesions with severe FFR/CFR as well as unblinded subjects and physicians. The limitations coupled with the results makes this a hypothesis-generating study that can help to further understand the role of invasive CFR and how to treat CFR/FFR discordance.”


Results from COMBINE (OCT-FFR) reported at TCT Connect


Provided by
Cardiovascular Research Foundation

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Results from the DEFINE-FLOW examine reported (2020, October 17)
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