| ǥ : Clinical award session
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ȣ - 550608 2 |
| Safety and efficacy of a novel hyperemic agent, nicorandil, for invasive physiologic assessments in a catheterization laboratory: A prospective multicenter study |
| 서울대학교 의과대학 내과학교실¹, 계명대학교 동산의료원 내과학교실², 인제대학교 의과대학 일산백병원 비전 21 심장혈관센터³ |
| 장호준¹ , 구본권¹, 김지현¹, 서명기¹, 양한모¹, 박경우¹, 남창욱², 허승호², 도준형³, 이성윤³, 김효수¹, 오병희¹, 박영배¹ |
Background: Maximal hyperemia is a key element of invasive physiologic studies. Although continuous infusion of adenosine is considered to be the gold-standard, this requires large amount of adenosine and an additional procedure for central vein access. Nicorandil (Sigmart, JW Pharmaceutical, Korea) is a coronary vasodilator which acts on both macro- and microvascular systems. However, its safety and efficacy in various invasive physiologic studies has not been evaluated yet.
Methods: This study is a multicenter prospective study to enroll 210 patients to satisfy the non-inferiority margin of 0.02 and study power of 80%. Fractional flow reserve (FFR) was measured using a 0.014 inch coronary pressure wire. Hyperemic efficacy of the following methods was compared: intracoronary bolus injection (IC bolus) of adenosine, continuous intravenous infusion (140μg/min/kg) (IV infusion) of adenosine, nicorandil IC bolus (1 and 2 mg). Hyperemic mean transit time and index of microcirculatory resistance (IMR) were also measured.
Results: Hyperemic efficacy of nicorandil 2mg was not inferior to adenosine IV infusion (FFR 0.82±0.10 vs. 0.83±0.10, p for non-inferiority <0.001) (TABLE). The number of functionally significant stenosis (FFR≤0.75) was not different between nicorandil IC bolus and adenosine IV infusion (30 (23.4 %) vs. 32 (25.0 %), p=0.319). Nicorandil bolus caused less changes in mean blood pressure (p<0.001), heart rate (p<0.001), PR interval (p=0.016) and corrected QT interval (p<0.001) than adenosine IV infusion. Transient AV block occurred in 15 patients with adenosine, but none with nicorandil bolus administration. Chest pain was more severe with adenosine IV infusion than with nicorandil IC bolus (VAS pain score: 1.5±1.8 vs. 0.2±0.6, p<0.001). Additional nicorandil bolus during continuous IV infusion of adenosine does not have additive hyperemic effect when compared with nicorandil bolus alone (FFR 0.84±0.10 vs. 0.83±0.10, p=0.458).
Conclusions: This study suggests that IC bolus injection of nicorandil is simple, safe and effective way to induce steady-state hyperemia and can be used for invasive physiologic evaluations instead of IV infusion of adenosine.
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Hyperemic efficacy among 4 different methods
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Adenosine infusion |
Adenosine bolus |
Nicorandil 1mg |
Nicorandil 2mg |
P value |
|
FFR |
0.83±0.10 |
0.83±0.10 |
0.84±0.10 |
0.82±0.10 |
p<0.001 |
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Time to maximal hyperemia, s |
43.9±16.0 |
19.0±4.3 |
16.5±5.3 |
18.9±6.4 |
p<0.001 |
|
Plateau time, s |
21.9±9.5 |
12.9±6.8 |
12.2±5.5 |
25.7±12.8 |
p<0.001 |
|
Hyperemic mean transit time, s |
0.24±0.12 |
NA |
NA |
0.30±0.71 |
p=0.43 |
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IMR |
18.2±8.5 |
NA |
NA |
17.2±7.6 |
p=0.22 |
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