Effect of valsartan on the long-term prognosis of patients with coronary atherosclerotic heart disease following successful intervention therapy: Multicenter, double blind, randomized and controlled evaluation / 中国组织工程研究

ABSTRACT

BACKGROUND: Valsartan is an antagonist of angiotensin Ⅱ (Ang Ⅱ ) receptor. Many researches have proved that it can protect heart tissue. Val-PREST suggests that valsartan with a long-term administration can decrease restenosis rate in stent; however, effect of valsartan on restenosis rate of Chinese population is still unclear presently.OBJECTIVE: To evaluate the effect of oral valsartan for 6 months on patients with coronary heart disease (CHD) who undertook successful intervention therapy.DESIGN: Multicenter, double blind, randomized, and controlled evaluation and prospective design.SETTING: Beijing Friendship Hospital Affiliated to Capital Medical University; Beijing Anzhen Hospital Affiliated to Capital Medical University; Peking Union Hospital; People's Hospital of Peking University; Beijing Tongren Hospital Affiliated to Capital Medical University; Beijing Shijingshan Hospital; Beijing Fuxing Hospital Affiliated to Capital Medical University;Beijing Chuiyangliu Hospital.PARTICIPANTS: Eight three-grade A hospitals in Beijing participated in the study. Since December 2002 to October 2003, a total of 200 patients who underwent bare mental stent implantation were consented, but 196 patients were recruited in the end. All 196 patients were randomized into valsartan group (100 cases) and control group (96 cases).METHODS: Basic medicines in the two group included aspirin, clopidogrel, nitrides, statins, β-receptor antagonists, calcium channel antagonists, etc. Additionally, Patients in valsartan group were also given valsartan (Beijing Nuohua Pharmaceutical Co. Ltd., batch number SD 34004) in a dosage of 80 mg a day. Both groups were followed-up once a month for total 6 months.MAIN OUTCOME MEASURES: ① Major adverse cardiac events within 6 months on clinics (death, non-fatal myocardial infarction, hospitalisation once more due to recurrent myocardial ischemia, and target vessel revascularization); ② Results of duplicated coronary angiography or exercise treadmill test (ETT) of partial patients within 6 months.RESULTS: ① Two patients (2%) in valsartan group were excluded in this study because of intolerance, so 194 patients were involved in the final analysis. ② No significant differences of baseline characteristics in terms of lesion type, the number of diseased vessels and the cardiac function were found between the two groups (P ＜ 0.05). ③ During the period of 6-month follow-up, one case died in control group. One acute myocardial infarction occurred in each group, whilst one case undertook target vessel revascularization in valsartan group. It was found that the proportion of recurrent cardiac events was lower in valsartan group than that in control group (11.2% vs. 15.6%). However, this difference did not reach the statistic significance. ④ During the period of 6-month duplicated contrast examination, one case had restenosis of in-stent in valsartan group. ⑤ The positive rate of exercise treadmill test (ETT) was lower in valsartan group (25.7%) than that in control group (36.4%), but there was no statistic difference.CONCLUSION: Six-month oral valsartan on patients with coronary heart disease who undertook successful intervention therapy can decrease the trend of recurrent cardiac events and positive rate of ETT.