Rationale and design of the Prospective LongitudinAl Trial of FFR_CT: Outcome and Resource IMpacts study

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• 作者：Gianluca Pontone ; MD ; PhD^a ; ^{gianluca.pontone@ccfm.it" class="auth_mail" title="E-mail the corresponding author} ; Manesh R. Patel ; MD^b ; Mark A. Hlatky ; MD^c ; Karen Chiswell ; PhD^b ; Daniele Andreini ; MD ; PhD^a ; Bjarne Linde Norgaard ; MD ; PhD^d ; Robert A. Byrne ; MB ; BCh ; PhD^e ; Nick Curzen ; BM ; PhD^f ; Ian Purcell ; MD^g ; Matthias Gutberlet ; MD ; PhD^h ; Gilles Rioufol ; MD ; PhDⁱ ; Ulrich Hink ; MD^j ; Herwig W. Schuchlenz ; MD ; PhD^k ; Gudrun Feuchtner ; MD^l ; Martine Gilard ; MD^m ; Bernard de Bruyne ; MD ; PhDⁿ ; Campbell Rogers ; MD^o ; Pamela S. Douglas ; MD^b
• 刊名：American Heart Journal
• 出版年：2015
• 出版时间：September 2015
• 年：2015
• 卷：170
• 期：3
• 页码：438-446.e44
• 全文大小：20726 K

文摘

Fractional flow reserve (FFR) measured by coronary computed tomography angiography (FFR_CT) has been validated against invasive FFR. However, there are no data on how the use of FFR_CT affects patient care and outcomes. The aim of this study is to compare standard practice guided by usual care testing to FFR_CT-guided management in symptomatic subjects with suspected coronary artery disease (CAD).

Methods

In this prospective nonrandomized trial, symptomatic patients with suspected CAD will be enrolled in 2 consecutive cohorts: a usual care-guided pathway (cohort 1) and an FFR_CT-guided pathway (cohort 2). Each cohort is divided into 2 groups according to whether noninvasive or invasive diagnostic testing was planned before enrollment. In all subjects, the patient's clinical team will review all diagnostic test results and determine a treatment strategy. A total sample size of 580 subjects will be enrolled and followed up for 12 months.

Results

The primary end point is the comparison of the percentage of patients with planned invasive testing who have a catheterization (invasive coronary angiography) within 90 days from initial assessment, which does not show a significant stenosis (defined as coronary artery stenosis >50% or invasive FFR ≤0.80). Secondary end points include the rate of invasive coronary angiography without obstructive CAD in those with planned noninvasive testing and, in all groups, noninferiority of resource use, quality of life, medical radiation exposure, and major adverse cardiac events up to 365 days of follow-up.

Conclusions

The study compares clinical and economic outcomes based on diagnostic evaluation using FFR_CT with that based on standard diagnostic strategies