Safety and efficacy of intracoronary nicorandil as hyperaemic agent for invasive physiological assessment: a patient-level pooled analysis.
OBJECTIVE
Our aim was to evaluate the safety and efficacy of intracoronary (IC) nicorandil as an alternative choice of hyperaemic agent for invasive physiologic studies.


RESULTS
A total of 480 intermediate coronary lesions from 429 patients enrolled from six Japanese and Korean centres were analysed. IC nicorandil showed earlier achievement of hyperaemia (time to the lowest FFR: 18.0 s [1st and 3rd quartile value 15.6-21.5] vs. 44.0 s [36.0-60.0], p<0.001) with similar hyperaemic efficacy, compared with intravenous (IV) adenosine/ATP (FFR 0.82 [0.75-0.87] vs. 0.82 [0.74-0.88], p=0.207). FFR measurements with both agents showed excellent correlation and classification agreement (CA) for FFR ≤0.80 (r=0.941, ICC 0.980, CA 90.8%, kappa=0.814, AUC of nicorandil 0.980, all p<0.001). Only three patients (0.7%) showed changes in classification across the grey zone (0.75-0.80). IC nicorandil produced fewer changes in blood pressure (BP) and heart rate (HR) and showed less chest pain than IV adenosine/ATP (all p<0.001). When comparing ΔFFR according to ΔBP or ΔHR between IV adenosine/ATP and IC nicorandil, there were no correlations, either between ΔFFR and ΔBP (r=-0.114, p=0.091), or between ΔFFR and ΔHR (r=1.000, p=0.151).


CONCLUSIONS
Nicorandil IC bolus injection is a simple, safe and effective hyperaemic method for FFR measurement and can be used as a substitute for adenosine.
Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Seoul, South Korea.
Joo Myung
JM
Lee
Daiki
D
Kato
Maki
M
Oi
Mamoru
M
Toyofuku
Hiroaki
H
Takashima
Katsuhisa
K
Waseda
Tetsuya
T
Amano
Akiyoshi
A
Kurita
Hiroki
H
Ishihara
Woo-Hyun
WH
Lim
Joon-Hyung
JH
Doh
Chang-Wook
CW
Nam
Nobuhiro
N
Tanaka
Bon-Kwon
BK
Koo
Nobukiyo
N
Tanaka
D000241:Adenosine / Q000378:metabolism; D000368:Aged; D000369:Aged, 80 and over; D003326:Coronary Circulation / Q000187:drug effects*; D005260:Female; D053805:Fractional Flow Reserve, Myocardial / Q000187:drug effects*; D006801:Humans; D006940:Hyperemia / Q000188:drug therapy* / Q000503:physiopathology; D007262:Infusions, Intravenous / Q000379:methods; D008297:Male; D008875:Middle Aged; D020108:Nicorandil / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D014665:Vasodilator Agents; D020108:Nicorandil; D000241:Adenosine