A Randomized Trial for the Secondary Prevention by Azithromycin in Korean Patients with Acute Coronary Syndrome after Percutaneous Coronary Intervention

Kim, Weon; Jeong, Myung Ho; Hong, Young Joon; Lee, Sang Hyun; Lim, Sang Yup; Hong, Seo Na; Park, Hyung Wook; Kim, Ju Han; Ahn, Young Keun; Cho, Jeong Gwan; Suh, Soon Pal; Park, Jong Chun; Kang, Jung Chae

Abstract

BACKGROUND AND OBJECTIVES
There is serological and epidemiological evidence of an association between Chlamydia pneumoniae infection and coronary artery disease. We conducted a randomized study using azithromycin treatment in Korean patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) to determine whether azithromycin treatment reduced the inflammatory markers and major adverse cardiac events (MACE).
SUBJECTS AND METHODS
One hundred twenty nine patients were randomly selected to receive 500 mg azithromycin daily for 3 days before and after PCI, followed by 500 mg/week for 2 weeks (Group l: 64 patients, 43 male, 60.0+/-10.0 years), or they received a placebo (Group ll: 65 patients, 45 male, 59.6+/-10.1 years). Patients were followed up for 12 months. The primary endpoints were cardiac death, recurrent myocardial infarction (MI), target lesion revascularization (TLR) and Non-TLR during the 12-month follow-up.
RESULTS
There were no differences between the two groups in baseline characteristics, coronary angiography finding, lesion characteristics, baseline inflammatory markers and baseline antibody titers of Chlamydia pneumoniae, Helicobacter pyroli and Mycoplasma. After the antibiotic treatment, ESR and CRP decreased from 19.6+/-20.7 mg/dL and 0.75+/-0.99 mg/dL to 9.36+/-10.5 mg/dL and 0.22+/-0.20 mg/dL in group l (p=0.002, 0.001 respectively), and from 19.6+/-21.5 mg/dL, 1.44+/-2.69 mg/dL to 10.4+/-10.8 mg/dL, 0.55+/-1.48 mg/dL in group ll (p=0.052, <0.0001 respectively). However, there were no significant changes in the serologic markers. MACE developed in 17 (26.6%) out of 64 patients in group l with 2 death, 2 MI and 13 TLR. In group ll, 14 (21.5%) out of 65 patients had MACE with 2 death, 1 MI and 10 TLR during the 12-month clinical follow-up (p=NS).
CONCLUSION
Short-term treatment with azithromycin does not reduce the major adverse cardiac events in Korean patients with ACS after PCI.