The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

A Continuous Intracoronary Versus A Standard Intravenous Infusion of Adenosine for Fractional Flow Reserve Assessment – the HYPEREMIC Trial

DOI: 10.4244/EIJ-D-18-01067

1Cardiology Department, Northwick Park Hospital, London North West Healthcare NHS Trust, London, UK
2Sussex Cardiac Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK
3Division of Clinical and Experimental Medicine, Brighton and Sussex Medical School, Brighton, UK
4West of Scotland Regional Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK
5KCStats Consultancy, Leeds, UK
6Division of Cardiology, Columbia University Medical Centre and New York Presbyterian Hospital, New York, USA
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Aims: To evaluate the accuracy of a continuous intracoronary (IC) adenosine infusion, administered through a novel HYPEREM ™ IC over-the-wire microcatheter, to measure fractional flow reserve (FFR). 

Methods and results: The HYPEREMIC trial was a randomised, non-inferiority, crossover study in which patients with intermediate coronary lesions were enrolled for sequential pressure wire studies. FFR was measured using intravenous (IV) (140-180 mcg/kg/min) versus continuous non-weight-adjusted IC (360 mcg/min) adenosine. Patients were randomised and blinded to the order in which they received the adenosine, separated by a washout period. The primary endpoint was the mean hyperaemic FFR. Forty-one patients were enrolled at 3 UK sites between June and November 2016. The mean (standard deviation) FFR was 0.82 (±0.09) after IC versus 0.84 (±0.09) after IV adenosine. The difference of -0.02 (95% confidence interval [CI] -0.03 to -0.01) confirmed non-inferiority (margin <0.05) of IC to IV adenosine. Intracoronary adenosine was associated with a shorter mean time to maximal hyperaemia (difference -44 [95% CI -59 to -29] seconds; p<0.0001). Chest discomfort was reported in 32/41 (78.0%) patients during IV adenosine versus 12/41 (29.3%) patients during IC adenosine. 

Conclusions: Continuous IC adenosine was a reliable, faster and better-tolerated method of achieving maximal hyperaemia compared to IV adenosine.

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