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Randomized Controlled Trial
. 2019 Apr 1;4(4):370-374.
doi: 10.1001/jamacardio.2019.0175.

Association of Improvement in Fractional Flow Reserve With Outcomes, Including Symptomatic Relief, After Percutaneous Coronary Intervention

Stephane Fournier  1   2   3 , Giovanni Ciccarelli  1 , Gabor G Toth  4 , Anastasios Milkas  1 , Panagiotis Xaplanteris  1 , Pim A L Tonino  5 , William F Fearon  6 , Nico H J Pijls  5   7 , Emanuele Barbato  1   3 , Bernard De Bruyne  1   2
Affiliations
Randomized Controlled Trial

Association of Improvement in Fractional Flow Reserve With Outcomes, Including Symptomatic Relief, After Percutaneous Coronary Intervention

Stephane Fournier et al. JAMA Cardiol. .

Abstract

Importance: Whether the improvement in myocardial perfusion provided by percutaneous coronary intervention (PCI) is associated with symptomatic relief or improved outcomes has not been well investigated.

Objective: To investigate the prognostic value of the improvement in fractional flow reserve (FFR) after PCI (ΔFFR) on patients' symptoms and 2-year outcomes.

Design, setting, and participants: This study is a post hoc analysis of data from patients undergoing FFR-guided PCI in the randomized clinical trials Fractional Flow Reserve vs Angiography for Multivessel Evaluation (FAME) 1 (NCT00267774; 2009) and FAME 2 (NCT01132495; 2012), with inclusion of 2 years of follow-up data. The FAME 1 trial included patients with multivessel coronary artery disease from 20 medical centers in Europe and the United States. The FAME 2 trial included patients with stable coronary artery disease involving up to 3 vessels from 28 sites in Europe and North America. Lesions from the group in the FAME 1 trial from whom FFR was measured and the group in the FAME 2 trial who received FFR-guided PCI plus medical therapy were analyzed. Data analysis occurred from May 2017 to May 2018.

Interventions: Measure of post-PCI FFR.

Main outcomes and measures: Vessel-oriented clinical events at 2 years, a composite of cardiac death, target vessel-associated myocardial infarction, and target vessel revascularization.

Results: This analysis included 639 patients from whom pre-PCI and post-PCI FFR values were available. Of their 837 lesions, 277 were classified into the lowest tertile (ΔFFR≤0.18), 282 into the middle tertile (0.19≤ΔFFR≤0.31), and 278 into the highest tertile (ΔFFR>0.31). Vessel-oriented clinical events were significantly more frequent in the lowest tertile (n = 25 of 277 [9.1%]) compared with the highest tertile (n = 13 of 278 [4.7%]; hazard ratio, 2.01 [95% CI, 1.03-3.92]; P = .04). In addition, a significant association was observed between ΔFFR and symptomatic relief (odds ratio, 1.33 [95% CI, 1.02-1.74]; P = .02).

Conclusions and relevance: In this analysis of 2 randomized clinical trials, the larger the improvement in FFR, the larger the symptomatic relief and the lower the event rate. This suggests that measuring FFR before and after PCI provides clinically useful information.

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Conflict of interest statement

Conflict of Interest Disclosures: The Cardiovascular Center Aalst receives grant support from Abbott Vascular, Boston Scientific, and Biotronik and receives consulting fees on Dr De Bruyne’s behalf from Abbott, Opsens, and Boston Scientific, outside of the submitted work. Dr Barbato reports receiving personal fees from Boston Scientific outside the submitted work. Dr De Bruyne reports being a shareholder for Siemens, GE, Bayer, Philips, HeartFlow, Edwards Life Sciences, Sanofi, and Omega Pharma. Dr Toth reports receiving consulting fees from Abbott Vascular, Boston Scientific, and Biotronik AG. Dr Fearon reports receiving institutional research support from Medtronic, Abbott Vascular, ACIST Medical Systems, CathWorks, and Edwards LifeSciences and holding minor stock options with HeartFlow. Dr Pijls reports receiving personal fees as a consultant for Abbott Vascular Inc, Opsens Inc, and Boston Scientific Inc and being a shareholder for Philips Inc, ASML Inc, General Electrics, and Heartflow Inc. Dr Fournier reports receiving support by a research grant from the Swiss National Science Foundation during the conduct of this study. Dr Xaplanteris reports being supported by research grants from the European Association of Percutaneous Cardiovascular Interventions and the Hellenic Cardiological Society. No other disclosures were reported.

Figures

Figure.
Figure.. Changes in Patient Population at 1 Month and 2 Years
A, Probability of improvement of at least 2 Canadian Cardiovascular Society classes at 1 month based on the change in fractional flow reserve. B, Correlation between the change in fractional flow reserve and vessel-oriented clinical events at 2 years.
See this image and copyright information in PMC

References

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