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JIKEI HEART: Effect of valsartan in Japanese subjects with coronary heart disease: Sub-analysis of results of JIKEI HEART Study


Shimizu, Mitsuyuki 2010
Presenter | see Discussant report Webcasts become available 24h after the session
Shimizu, Mitsuyuki
Open presentation slides


List of Authors:

Mitsuyuki Shimizu, Hiroshi Yoshida, Katsunori Ikewaki, Ikuo Taniguchi, Michihiro Yoshimura, Björn Dahlöf, Seibu Mochizuki, for Jikei Heart Study group


The risk of cardiac events in hypertensive patients with coronary artery disease (CAD) was higher than in those without CAD. We here report the result of a sub-analysis of a large-scale trial [JIKEI HEART Study (JHS)] which demonstrated that the addition of the angiotensin II receptor blocker (ARB) valsartan to standard cardiovascular treatments significantly reduced the primary composite endpoint of cardiovascular complications as compared with conventional treatments without ARB in Japanese patients.

One thousand thirty six CAD patients in the JHS were subjected to this study. We assessed the following endpoints such as myocardial infarction, angina pectoris and congestive heart failure between valsartan group and non-ARB group. Electrocardiography and echocardiography were performed at baseline, 1, 2 and 3 years after randomization.

The addition of the ARB valsartan to standard cardiovascular therapy reduced angina pectoris (HR: 0.28: 0.12-0.53: p<0.00008) and heart failure (HR: 0.32: 0.15-0.86: p<0.02402) as compared with non-ARB treatment in patients with CAD. However, there was no significant difference in the incidence of myocardial infarction. The blood pressures and heart rate were not different between these two treatment groups throughout the trial. The significant reduction in left ventricular mass index (LVMI), evaluated by echocardiography, was observed in the valsartan group (p<0.001)

The present study provided convincing evidence that ARB valsartan significantly reduced the incidence of angina pectoris and congestive heart failure particularly in the high risk patients with CAD which may be attributed in part to the improvements of myocardial remodeling.

Aldo Pietro Maggioni
Discussant | see Presenter abstract Webcasts become available 24h after the session
Maggioni, Aldo Pietro
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The original trial
The JIKEI trial had the aim to investigate the effect of control of blood pressure (to a target of less than 130/80 mm Hg) with an added angiotensin receptor blocker, valsartan, compared with conventional treatment in a large Japanese population (3081 patients), aged 20–79 years, (mean 65 [SD 10] years), who were undergoing conventional treatment for hypertension, coronary heart disease, heart failure, or a combination of these disorders. The hypothesis was that treatment with valsartan would yield additional protective benefits, compared with conventional treatment, beyond those attributable to control of blood pressure. The trial concluded that the addition of valsartan to conventional treatment prevented more cardiovascular events than supplementary conventional treatment and that these benefits could not be entirely explained by a difference in blood pressure control.

The specific subanalysis
The data presented today are a post-hoc subgroup analysis of the JIKEI randomized clinical trial.
Rationale: The risk of cardiac events in hypertensive patients with CAD is higher than in those without CAD.
Aim: This subanalysis of the database of the JIKEI trial has the aim to demonstrate that valsartan can decrease the occurrence of major CV events, with respect to standard treatment, in the subgroup of patients with a story of CAD in a greater extent than in patients without CAD.
Main results: Valsartan significantly reduced the incidence of the primary end-point in the high risk patients with CAD which may be attributed in part to the improvements of myocardial remodeling. The primary endpoint was a composite of CV mortality and morbidity. The components of the endpoint included the following
  • hospital admissions for stroke or TIA
  • myocardial infarction
  • admission for congestive heart failure
  • admission because of angina pectoris
  • dissecting aneurysm of the aorta
  • doubling of serum creatinine; or transition to dialysis
The first of these events to arise in any specific patient was noted as the primary event: the reduction of this primary end-point in patients with CAD was quantifiable in more than 50%.
Some strenghts
  • Randomized trial conducted in Japan
  • More than 3,000 patients, 1,036 of whom with a documented CAD, object of this subanalysis
  • Low mean dose of valsartan (76 mg daily) but in the range for Japanise people (40-80 mg daily)
  • Electrocardiography and echocardiography performed in all patients at baseline,1 and 3 years after randomization
Relevant weaknesses
  • Prospective randomised open-blinded-label endpoint (PROBE) design with a long list of hard and soft end-points
  • No effects on all hard end-points (stroke, AMI, death)
  • Favorable effect just on softer end-points (hospitalization for angina or HF)
  • Post-hoc subgroup analysis
  • No p-value for interaction available

The JIKEI investigators are to be congratulated for this trial conducted in more than 3000 Japanise patients, 1036 of whon with a documented story of CAD, However, the data presented here cannot fully support the conclusions of the authors. For this reason, the results of this post-hoc subgroup analysis cannot be extrapolated to general practice.


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Clinical Trial Update III
The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.