Efficacy of Danlou Tablet in Patients with Non-ST Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Results from a Multicentre, Placebo-Controlled, Randomized Trial.

Lei Wang,Keji Chen,Xujie Zhao,Xinfeng Guo,Minzhou Zhang,Hongliang Cong,Liheng Guo,Haiyu Yang,Shuai Mao,Shaonan Liu,Phillip C Yang,Fuhai Zhao,Tinghai Du,Yang Wu,Keng Wu

doi:10.1155/2016/7960503

Abstract

This study seeks to investigate potential cardioprotection of Danlou Tablets in patients undergoing PCI with non-ST elevation acute coronary syndrome (NSTE-ACS). 219 patients with NSTE-ACS were randomised to Danlou Tablet pretreatment (n = 109) or placebo (n = 110). No patients received statins prior to PCI and all patients were given atorvastatin (10 mg/day) after procedure. The main endpoint was the composite incidence of major adverse cardiac events (MACEs) within 30 days after PCI. The proportion of patients with elevated levels of cTn I>5 × 99% of upper reference limit was significantly lower in the Danlou Tablet group at 8 h (22.0% versus 34.5%, p = 0.04) and 24 h (23.9% versus 38.2%, p = 0.02) after PCI. The 30-day MACEs occurred in 22.0% of the Danlou Tablet group and 33.6% in the placebo group (p = 0.06). The incidence of MACE at 90-day follow-up was significantly decreased in the Danlou Tablet group compared to the placebo group (23.9% versus 37.3%, p = 0.03). The difference between the groups at 90 days was the incidence of nonfatal myocardial infarction (22% versus 34.5%, p = 0.04). These findings might support that treatment with Danlou Tablet could reduce the incidence of periprocedural myocardial infarction in patients with ACS undergoing PCI.

Highlights

Over the past several decades, percutaneous coronary intervention (PCI) has emerged as the predominant therapeutic administration for ischemic heart disease
We evaluated the hypothesis that Danlou Tablet treatment in patients with non-st-segment elevation acute coronary syndromes (NSTE-ACS) undergoing PCI would decrease the incidence of periprocedural myocardial infarction (PMI) and improve the clinical outcome by a multicentre, randomized, prospective, double-blind, placebo-controlled trial
The proportion of patients with elevated levels of cardiac troponin I (cTn I)>5 × 99th percentile of upper reference limit (URL) was significantly lower in the Danlou Tablet group at 8 h (22.0% versus 35.4%, p = 0.04) and 24 h after PCI (23.9% versus 38.2%, p = 0.02) (Figure 5(b))

Summary

Introduction

Over the past several decades, percutaneous coronary intervention (PCI) has emerged as the predominant therapeutic administration for ischemic heart disease. The high incidence of periprocedural myocardial infarction (PMI) following PCI severely impaired the benefits of coronary revascularization. 30% of patients undergoing PCI therapy developed PMI, which is significantly associated with bad long-term prognosis [1, 2]. Clinical trials have revealed the efficacy of high-dose statin treatment in significantly reducing the incidence of PMI among patients after coronary revascularization [3,4,5]. High-dose statin administration has been associated with severe side effects, including increased risk of new-onset diabetes, liver damage, rhabdomyolysis, and intracerebral haemorrhage [6,7,8]. Recent studies endeavoured to discover alternative natural agents that could reduce the incidence of myocardial necrosis after coronary intervention with low risk of side effects [9, 10]

Methods

Results

Discussion

Conclusion