Azelnidipine and Amlodipine Anti-Coronary Atherosclerosis Trial in Hypertensive Patients Undergoing Coronary Intervention by Serial Volumetric Intravascular Ultrasound Analysis in Juntendo University (ALPS-J)

作者：Kojima Takahiko; Miyauchi Katsumi; Yokoyama Takayuki; Yokoyama Ken; Kurata Takeshi; Suwa Satoru; Kawamura Masaki; Tamura Hiroshi; Okazaki Shinya; Inoue Kenji; Fujiwara Yasumasa; Sumiyoshi Masataka; Tanimoto Kosei; Nakazato Yuji; Yamagami Shinichiro; Hiro Takafumi; Komiyama Nobuyuki; Daida Hiroyuki^*

来源：Circulation Journal, 2011, 75(5): 1071-1079.

DOI：10.1253/circj.CJ-11-0141

• Calcium channel blocker
• Hypertension
• Intravascular ultrasound
• Percutaneous coronary intervention
• Plaque regression

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 16 mg/day of azelnidipine or 5 mg/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 128/68 mmHg at follow-up. The lipid profiles in the 2 groups were comparable (low-density lipoprotein cholesterol: 97 mg/di). 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)

• 出版日期2011-5