Nifekalant versus lidocaine for in-hospital shock-resistant ventricular fibrillation or tachycardia

Shiga, Tsuyoshi; Tanaka, Keiji; Kato, Rinya; Amino, Mari; Matsudo, Yuji; Honda, Toshihiro; Sagara, Koichi; Takahashi, Atsushi; Katoh, Takao; Urashima, Mitsuyoshi; Ogawa, Satoshi; Takano, Teruo; Kasanuki, Hiroshi; for the Refractory VT/VF, Prospective Evaluation to Differentiate Lidocaine Efficacy from Nifekalant (RELIEF) Study Investigators,

doi:10.1016/j.resuscitation.2009.09.027

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Volume 81, Issue 1 , Pages 47-52, January 2010

Nifekalant versus lidocaine for in-hospital shock-resistant ventricular fibrillation or tachycardia☆

Tsuyoshi Shiga
- Department of Cardiology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
- Corresponding author. Tel.: +81 3 3353 8111; fax: +81 3 3356 0441.
Keiji Tanaka
- Intensive and Cardiac Care Unit, Nippon Medical School, Tokyo, Japan
Rinya Kato
- Department of Cardiology, Nagoya Ekisaikai Hospital, Nagoya, Japan
Mari Amino
- Department of Cardiology, Tokai University School of Medicine, Isehara, Japan
Yuji Matsudo
- Department of Cardiology, Kimitsu Chuo Hospital, Kisarazu, Japan
Toshihiro Honda
- Department of Cardiology, Saisei-kai Kumamoto Hospital, Kumamoto, Japan
Koichi Sagara
- Department of Cardiology, The Cardiovascular Institute, Tokyo, Japan
Atsushi Takahashi
- Department of Cardiology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
Takao Katoh
- Department of Internal Medicine, Nippon Medical School, Tokyo, Japan
Mitsuyoshi Urashima
- Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan
Satoshi Ogawa
- International University of Health and Welfare Mita Hospital, Tokyo, Japan
Teruo Takano
- Department of Internal Medicine, Nippon Medical School, Tokyo, Japan
Hiroshi Kasanuki
- Faculty of Science and Engineering, Waseda University, Tokyo, Japan
for the Refractory VT/VF, Prospective Evaluation to Differentiate Lidocaine Efficacy from Nifekalant (RELIEF) Study Investigators

Received 6 June 2009; received in revised form 15 August 2009; accepted 20 September 2009. published online 16 November 2009.

Abstract

Objective

To compare the efficacy and safety of nifekalant, a pure class III anti-arrhythmic drug, and lidocaine in patients with shock-resistant in-hospital ventricular fibrillation (VF) or ventricular tachycardia (VT).

Patients and methods

Between August 2005 and March 2008, we conducted a prospective, two-arm, cluster observational study, in which participating hospitals were pre-registered either to the nifekalant arm or the lidocaine arm. Patients were enrolled if they had in-hospital VF or VT resistant to at least two defibrillation shocks. Congenital or drug-induced long QT syndrome was excluded. The primary end-point was termination of VF or VT with/without additional shock. The secondary end-points were return of spontaneous circulation (ROSC), 1-month survival and survival to hospital discharge. We also assessed the frequency of adverse events, including asystole, pulseless electrical activity and torsade de pointes.

Results

In total, 55 patients were enrolled. After nifekalant, 22 of 27 patients showed termination of VF or VT, as compared with 15 of 28 patients treated with lidocaine with/without additional shock (odds ratio (OR): 3.8; 95% confidence interval (CI): 1.1–13.0; P=0.03). Twenty-three of 27 patients given nifekalant showed ROSC, as compared with 15 of 28 patients given lidocaine (OR: 5.0; 95% CI: 1.4–18.2; P=0.01). There was no difference in 1-month survival or survival to hospital discharge between the nifekalant and lidocaine arms. There was a higher incidence of asystole with lidocaine (7 of 28 patients) than with nifekalant (0 of 27 patients) (P=0.005). Torsade de pointes was not observed.

Conclusion

Nifekalant was more effective than lidocaine for termination of arrhythmia and for ROSC in patients with shock-resistant in-hospital VF or VT (umin-CTR No. UMIN 000001781).

Keywords: Anti-arrhythmic drug, Defibrillation, Ventricular fibrillation, Nifekalant, Lidocaine