2014 Expert Consensus on Intensive Statin Therapy in Patients with Acute Coronary Syndromes

I. The need for consensus 1. Acute coronary syndrome and statins Acute coronary syndrome (ACS) is a group of clinical syndromes with acute myocardial ischemia as a common feature, including unstable angina pectoris (UA), non-ST-segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI). The main mechanism of ACS is rupture or ulceration of vulnerable plaques combined with thrombosis and/or vasospasm, resulting in a dramatic increase in coronary artery stenosis or acute occlusion.The offender lesion of ACS is usually caused by an unstable plaque leading to a stenosis that may not be severe, and in addition to offender plaques in patients with ACS, there is often coexistence of multiple unstable plaques in different segments or different coronary arteries, which leads to acute occlusion in patients. In addition to offender plaques, patients with ACS often have multiple unstable plaques in different segments of the same coronary artery or in different coronary arteries, which leads to an increased risk of acute death and recurrent ischemic events. 2011 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) Guidelines for the management of dyslipidemia continue to recognize statins as the most effective medications for the management of dyslipidemia. The 2011 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) Guidelines for the management of dyslipidemia continue to recognize the cornerstone of statin therapy in the management of patients with ACS, and actively recommend early initiation of statin therapy in these very high-risk patients. 2. The current status of statin application in ACS patients in China The proportion of Chinese ACS patients receiving statin therapy, especially intensive statin therapy, is generally low. In the Clinical Pathway for Acute Coronary Syndromes in China (CPACS) study, only 80% of ACS patients were taking statins at the time of hospital discharge. In the Clinical Pathway for Acute Coronary Syndromes in China (CPACS) study, only 80% of ACS patients were taking statins at hospital discharge, and only about 60% were still taking statins 1 year later. Even among patients treated with statins, a significant proportion did not achieve guideline-recommended target values. There is still a huge gap between guidelines or evidence-based medical evidence and clinical practice. Therefore, it is important to develop relevant guidelines and consensus to popularize statin treatment for ACS patients, especially for intensive treatment, so as to improve the prognosis of ACS patients. II. Recommendations for intensive statin therapy 1. Main indications All ACS patients, including those who receive emergency percutaneous coronary intervention (PCI), elective PCI, and drug therapy. 2. Definition of intensive therapy Statin therapy with high dose and/or substantial reduction in low density lipoprotein cholesterol (LDL-C) values. Acute intensive therapy is an intensification of the statin dose to the maximum tolerated dose recommended by the statin product insert, with the goal of protecting the myocardium and reducing the incidence of perioperative myocardial infarction and major adverse cardiac events; long-term intensive therapy is an intensification to achieve the therapeutic goal, with the recommendation to achieve an LDL-C level of less than 70 mg/dl (1.8 mmol/L) or a reduction of greater than 50%, with the goal of Reduce near- and long-term cardiovascular events and death, and ultimately improve the prognosis of ACS patients. (1) Intensive statin therapy should be initiated as soon as possible (within 24 h) after admission to the hospital in all patients with ACS. (2) Baseline lipid levels should be routinely measured within 24 h of admission, but intensive statin therapy is not dependent on baseline lipid levels, and patients with baseline LDL-C levels below 70 mg/dl can also benefit from intensive statin therapy. (3) High-dose statins, such as atorvastatin 80 mg (once daily), are usually used. (4) The goal of long-term intensive statin therapy is LDL-C<70>50%. (5) Intensive-dose statin therapy should be maintained for 3 to 6 months, during which time lipid levels should be reviewed and the statin dose may be adjusted appropriately to ensure that the LDL-C level is below 70 mg/dl or decreases by >50%. 4. Application process of intensive statin in ACS patients Application process of intensive statin in ACS patients III. Safety of intensive statin therapy The main reason for the low rate of intensive statin therapy in ACS patients is the concern about safety, and there is already evidence-based evidence showing that the overall safety of intensive statin therapy in patients with ACS is good, and the benefits far outweigh the risks. However, intensive statin therapy for different individuals should consider the side effects of liver, kidney, muscle and many other aspects, therefore, for patients with advanced age, abnormal liver and kidney function, history of statin adverse effects, low body weight, hypothyroidism, and the presence of potential drug-drug interactions, the clinical benefit and the risk of adverse drug effects should be weighed before initiating intensive statin therapy, and it is recommended to pay attention to the Monitoring of relevant indicators. 1. Liver safety All statin therapy can cause elevated liver enzymes with an incidence of less than 1%, and elevated liver enzymes alone do not represent liver injury. Cases of liver failure associated with statin therapy are rare, so routine periodic testing of liver enzymes is not recommended. Elevated transaminases <3×uln should not be considered a contraindication to statin therapy. If transaminases are >3 × ULN, statin should be discontinued and continuation or switching to statin therapy should be considered after normalization of liver enzymes. Non-alcoholic fatty liver disease, chronic liver disease, and compensated cirrhosis are not contraindications to statin therapy. However, patients with pre-existing severe acute liver injury or active hepatitis should be carefully evaluated for benefit versus risk. 2. MUSCLE SAFETY The incidence of serious muscle adverse events varies among statins, but the overall incidence is low. Asymptomatic mild creatine kinase (CK) elevations are common; therefore, routine monitoring of CK levels after statin administration is not recommended unless the patient develops muscle symptoms such as myalgia and muscle weakness. Statin therapy should be discontinued once a patient develops muscle symptoms with CK >5 × ULN. Retrospective analyses have shown that high-dose simvastatin increases the risk of muscle damage and should be used with clinical caution. 3. Renal safety Statins are heterogeneous in terms of renal safety. Statin use is safe in patients with good renal function. Dosage adjustments are required for statins other than atorvastatin and fluvastatin in patients with an estimated glomerular filtration rate (eGFR) <30 ml/(min?1.73 m2), and are contraindicated in patients with Rosuvastatin. 4. Other safety (1) New-onset diabetes: Statin therapy slightly increases the risk of new-onset diabetes, but the cardiovascular benefits of statin therapy far outweigh the risk of new-onset diabetes, so no change in existing treatment recommendations is needed. However, in patients with impaired fasting glucose or comorbid metabolic syndrome, it is recommended that monitoring of blood glucose levels may be considered with statins. (2) Neoplastic tumors: The relationship between statins and neoplastic tumors has not been established. Overall, statin therapy did not increase the risk of tumorigenesis. (3) Safety in Asian populations: Studies are limited, but the latest retrospective analysis shows that Asian patients with atorvastatin 10 to 80 mg (once daily) have a favorable safety profile, which is comparable to that of European and American patients.