Why the study?
Does the addition of Danlou tablets to standard therapy reduce adverse left ventricular remodeling in patients with acute myocardial infarction after PCI?
Does the addition of Danlou tablets to standard therapy reduce adverse left ventricular remodeling in patients with acute myocardial infarction after PCI?
In patients with acute myocardial infarction undergoing PCI, the addition of Danlou tablets to standard medical therapy significantly reduced adverse left ventricular remodeling and improved ejection fraction at 90 days.
Danlou may attenuate post-MI remodeling; challenges low-certainty consensus against benefit and warrants larger outcome trials.
Danlou tablets, a patented Chinese Medicine, have been long approved for the treatment of ischemic heart disease in China. While numerous empirical observations suggested Danlou tablets could decrease frequency and duration of angina pectoris attacks, evidence supporting its efficacy on cardiac remodeling remains inadequate. Therefore, this pilot trial was designed to determine whether Danlou tablets would reduce adverse left ventricular (LV) remodeling in patients with myocardial infarction (MI). Eligible patients with acute MI were enrolled and randomly assigned to Danlou tablets or placebo groups, superimposed on standard treatment for MI. Then, in addition to assessment of the clinical outcome, the changes in LV volumes were evaluated by a serial echocardiography. In total, 83 patients (Danlou tablets 42 and placebo 41) completed 90 days of treatment and had complete baseline and outcome data. Standard echocardiographic evaluations revealed significant differences in the change of LV end-diastolic volume index (LVEDVi) between group of patients treated with Danlou tablets and the placebo group (−4.49 ± 7.29 vs. −0.34 ± 9.01 mL/m2, P < 0.001). The reduction in LVEDVi was independent of beta-blocker, ACE inhibitors/ARBs use. Furthermore, treatment with Danlou tablets significantly reduced LV end-systolic volume index (−4.09 ± 5.85 vs. −0.54 ± 5.72 mL/m2, P < 0.001) and improved the LV ejection fraction (4.83 ± 9.23 vs. 0.23 ± 8.15 %, P < 0.001), as compared to placebo. Meaningfully, the incidence of the major adverse cardiovascular events was also lower in patients receiving Danlou tablets (P < 0.05). Superimposed on the standard pharmacologic treatment, Danlou tablets significantly reversed post-MI adverse LV remodeling, thereby contributed to the overall positive clinical outcome. clinicaltrials.gov identifier NCT02675322 (February 1, 2016).
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Mao et al. (2016) studied this question.
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