Circulation Journal
Online ISSN : 1347-4820
Print ISSN : 1346-9843
ISSN-L : 1346-9843
Late Breaking Clinical Trials (JCS 2011)
Azelnidipine and Amlodipine Anti-Coronary Atherosclerosis Trial in Hypertensive Patients Undergoing Coronary Intervention by Serial Volumetric Intravascular Ultrasound Analysis in Juntendo University (ALPS-J)
Takahiko Kojima, Katsumi Miyauchi, Takayuki Yokoyama, Ken Yokoyama, Takeshi Kurata, Satoru Suwa, Masaki Kawamura, Hiroshi Tamura, Shinya Okazaki, Kenji Inoue, Yasumasa Fujiwara, Masataka Sumiyoshi, Kosei Tanimoto, Yuji Nakazato, Shinichiro Yamagami, Takafumi Hiro, Nobuyuki Komiyama, Hiroyuki Daida
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Keywords: Calcium channel blocker, Hypertension, Intravascular ultrasound, Percutaneous coronary intervention, Plaque regression
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2011 Volume 75 Issue 5 Pages 1071-1079

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Abstract

Background: A previous study reported that amlodipine retarded coronary plaque progression in patients with coronary artery disease. The goal of this multicenter study was to determine which calcium-channel blockers (CCBs) other than amlodipine attenuated the progression of plaque volume (PV) accessed by intravascular ultrasound (IVUS). Methods and Results: ALPS-J was a prospective, randomized open-label study conducted at 5 centers. Patients who had hypertension and were scheduled for coronary intervention were enrolled. Subjects were randomly assigned to receive 16mg/day of azelnidipine or 5mg/day of amlodipine administered for 48 weeks. The primary endpoint was the percent change in coronary PV measured by IVUS. Between 2007 and 2009, 199 patients were enrolled; 115 had evaluable IVUS images at both baseline and after 48 weeks of treatment. Blood pressure significantly reduced to 128/68mmHg at follow-up. The lipid profiles in the 2 groups were comparable (low-density lipoprotein cholesterol: 97mg/dl). The %change in PV showed a significant regression of 4.67 and 4.85% in the azelnidipine and amlodipine groups, respectively. The upper limit of the 95% confidence interval of the mean difference in %change PV between the 2 groups (0.18%, 95% confidence interval 4.62 to 4.98%) did not exceed the pre-defined non-inferiority margin of 6.525%. Conclusions: ALPS-J demonstrated that azelnidipine was not inferior to amlodipine for primary efficacy. In addition to standard medical therapy, dihydropyridine CCBs will retard PV progression in hypertensive patients. (Circ J 2011; 75: 1071-1079)

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© 2011 THE JAPANESE CIRCULATION SOCIETY
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