Death from vascular disease accounts for about one-third of all causes of death.
Important regulatory factors in cardiovascular disease include dyslipidemia, high blood
pressure, and diabetes, and keeping LDL cholesterol low among dyslipidemia levels,
especially after cardiovascular stent treatment, is an essential factor to prevent
another event in the future. Statin is currently the most widely used LDL cholesterol
control drug with multifunctional effects such as controlling inflammatory reactions,
controlling the movement and proliferation of vascular smooth muscle cells, and
inhibiting the production of blood clots in addition to LDL cholesterol control.In
addition, in several clinical studies, statins have shown many effects in primary and
secondary prevention of cardiovascular disease, and several studies have been published
that lower LDL cholesterol results in more benefits. Based on these findings, the 2016
European Heart Association (ESC), 2018 American Heart Association (ACC), and most
recently changed 2022 Korean guidelines recommend controlling LDL cholesterol to <55mg/dL
for patients with coronary artery disease. However, high-dose statins alone are still
difficult to maintain for a long time due to increased liver levels, diabetes, and muscle
pain, and recently, a drug that lowers LDL cholesterol has been developed in the small
intestine called Ezetimib and is widely used in combination with statins in actual
clinical trials. In fact, the RACING trial published in LANCET for domestic patients
reported that the combination of moderate-intensity statins (Rosuvastatin 10mg) and
ezetimib had fewer side effects for three years and better compliance, resulting in a
better rate of maintaining LDL cholesterol at 70mg/dL or less than high-intensity statins
alone. However, in this study, the rate at which LDL cholesterol remained below 55 mg/dL
after one year was only 42% for moderate statins/esetimibe and 25% for high-intensity
statins, and remained similar for three years. Therefore, high-intensity statins and
ezetimibes may be essential treatments to reduce LDL cholesterol to less than 55 mg/dL
and more than 50% under the current new guidelines. High-strength statins usually refer
to more than 40 mg of atovastatin and 20 mg of Rosuvastatin, and drugs that combine
ezetimibe with these high-strength statins are currently widely used to lower LDL
cholesterol to 55 mg/dL or less if there are no special side effects in clinical
practice, but research on compliance is very insufficient. This study aims to observe the
rate of discontinuation or intolerance in patients taking Rosuvastatin/Ezetimib 20/10mg
and Atovastatin/Ezetimib 40/10mg, with no previous comparison, RACING trial reported a 5%
rate of discontinuation at rosuvastain 20mg administered, and atovatin/10mg/10mg.
Referring to On the use of a pilot sample for sample size determination. the hospital
conducts about 60 PCI cases a month, and about 1/5 of them are expected to be able to
enroll 100 patients per group for about two years to conduct a total of 200 patients.
