European Heart Journal Advance Access originally published online on April 4, 2009
European Heart Journal 2009 30(10):1203-1212; doi:10.1093/eurheartj/ehp101
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Angiotensin II receptor blocker-based vs. non-angiotensin II receptor blocker-based therapy in patients with angiographically documented coronary artery disease and hypertension: the Heart Institute of Japan Candesartan Randomized Trial for Evaluation in Coronary Artery Disease (HIJ-CREATE)
1 The Heart Institute of Japan, Tokyo Women’s Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
2 Sakakibara Heart Institute, Tokyo, Japan
3 Saisei-kai Kumamoto Hospital, Kumamoto, Japan
4 Osaka City General Hospital, Osaka, Japan
5 Division of Clinical Epidemiology and Biostatistics, Toyama University, Toyama, Japan
6 Division of Clinical Research and Development, Jikei University School of Medicine, Tokyo, Japan
Received 13 October 2008; revised 29 January 2009; accepted 25 February 2009; online publish-ahead-of-print 4 April 2009.
* Corresponding author. Tel: +81 3 3353 8111, Fax: +81 3 3356 0441, Email: mogawa{at}hij.twmu.ac.jp
See page 1164 for the editorial comment on this article (doi:10.1093/eurheartj/ehp155)
Aims: To test whether angiotensin II receptor blockers (ARBs) therapy can reduce the incidence of cardiovascular events compared with non-ARB-based standard pharmacotherapy in coronary artery disease (CAD) patients with hypertension.
Methods and results: Angiographically documented CAD patients with hypertension were randomly assigned to receive either candesartan-based (n= 1024) or non-ARB-based pharmacotherapy including angiotensin-converting enzyme-inhibitors (n = 1025). The primary endpoint was the occurrence of a first major adverse cardiovascular event (MACE). There were 552 primary events during a median follow-up of 4.2 years: 264 (25.8%) in the candesartan group and 288 (28.1%) in the non-ARB group (hazard ratio, 0.89; 95% confidence interval, 0.76–1.06). No significant differences existed between groups in terms of cardiovascular death (2.7 vs. 2.4%, 1.14; 0.66–1.95), non-fatal myocardial infarction (2.8 vs. 2.5%, 1.12; 0.66–1.88), or heart failure (3.9 vs. 4.3%, 0.91; 0.59–1.40). New-onset diabetes was diagnosed significantly less frequently with candesartan than with non-ARBs (0.37; 0.16–0.89). Incidence of study drug discontinuation due to adverse events was lower with candesartan than with non-ARBs (5.7 vs. 12.2%, P < 0.001).
Conclusion: Although candesartan showed no significant differences in MACE compared with the non-ARB treatment group, the drug significantly reduced the incidence of new-onset diabetes and was better tolerated.
This study is registered as International Standard Randomised Controlled Trial No. UMIN000000790.
Key Words: Randomized controlled trial • Coronary artery disease • Hypertension • Candesartan
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