Open AccessPrimary results from the Japanese Heart Failure and Sudden Cardiac Death Prevention Trial (HINODE)
Author(s) -
Aonuma Kazutaka,
Ando Kenji,
Kusano Kengo,
Asai Toru,
Inoue Koichi,
Inamura Yukihiro,
Ikeda Takanori,
Mitsuhashi Takeshi,
Murohara Toyoaki,
Nishii Nobuhiro,
Nogami Akihiko,
Shimizu Wataru,
Beaudoint Caroline,
Simon Torri,
Kayser Torsten,
Azlan Hussin,
Tachapong Ngarmukos,
Chan Joseph YatSun,
Kutyifa Valentina,
Sakata Yasushi
Publication year - 2022
Publication title -
esc heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.787
H-Index - 25
ISSN - 2055-5822
DOI - 10.1002/ehf2.13901
Subject(s) - medicine , cardiac resynchronization therapy , heart failure , implantable cardioverter defibrillator , cardiology , clinical endpoint , cohort , ejection fraction , sudden cardiac death , cohort study , clinical trial
Aims The HINODE study aimed to analyse rates of mortality, appropriately treated ventricular arrhythmias (VA), and heart failure in Japanese patients and compared with those in Western patients. Methods and results After treatment decisions following contemporary practice in Japan, patients were prospectively enrolled into four cohorts: (i) internal cardioverter‐defibrillator (ICD), (ii) cardiac resynchronization therapy (CRT) defibrillator (CRT‐D), (iii) standard medical therapy (‘non‐device’: ND), or (iv) pacing (indicated for CRT; received pacemaker or CRT pacing). Cohorts 1–3 required a left ventricular ejection fraction ≤35%, a history of heart failure, and a need for primary prevention of sudden cardiac death based on two to five previously identified risk factors. Endpoint outcomes were adjudicated by the independent committees. ICD and CRT‐D cohorts, considered as high‐voltage (HV) cohorts, were pooled for Kaplan–Meier analysis and propensity‐matched to Multicenter Automatic Defibrillator Implantation Trial‐Reduce Inappropriate Therapy (MADIT‐RIT) arm B and C patients. The study enrolled 354 patients followed for 19.6 ± 6.5 months, with a minimum of 12 months. Propensity‐matched HV cohorts showed comparable VA ( P = 0.61) and mortality rates ( P = 0.29) for HINODE and MADIT‐RIT. The ND cohort presented a high crossover rate to ICD therapy (6.1%, n = 7/115), and the CRT‐D cohort showed elevated mortality rates. The pacing cohort revealed that patients implanted with pacemakers had higher mortality (26.0%) than those with CRT‐Pacing (8.4%, P = 0.05). Conclusions The mortality and VA event rates of landmark trials are applicable to patients with primary prevention in Japan. Patients who did not receive guideline‐indicated CRT devices had poor outcomes.