Eui Im1, Yun-Hyeong Cho2, Yongsung Suh2, Deok-Kyu Cho2, Ae-Young Her3, Yong Hoon Kim3, Kyounghoon Lee4, Woong Chol Kang4, Kyeong Ho Yun5, Sang-Yong Yoo6, Sang-Sig Cheong6, Dong-Ho Shin7, Chul-Min Ahn7, Jung-Sun Kim8, Byeong-Keuk Kim8, Young-Guk Ko8, Donghoon Choi8, Yangsoo Jang9, Myeong-Ki Hong10. 1. Department of Internal Medicine, Yongin Severance Hospital, Yonsei University Health System, Yongin, Korea. 2. Department of Internal Medicine, Myongji Hospital, Goyang, Korea. 3. Department of Internal Medicine, School of Medicine, Kangwon National University, Chuncheon, Korea. 4. Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea. 5. Department of Internal Medicine, Wonkwang University Hospital, Iksan, Korea. 6. Department of Internal Medicine, GangNeung Asan Hospital, GangNeung, Korea. 7. Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea. 8. Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea; Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Korea. 9. Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea; Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Korea; Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Korea. 10. Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea; Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Korea; Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Korea. Electronic address: mkhong61@yuhs.ac.
Abstract
INTRODUCTION AND OBJECTIVES: Current guidelines on the treatment of blood cholesterol recommend continuous maintenance of high-intensity statin treatment in drug-eluting stent (DES)-treated patients. However, high-intensity statin treatment is frequently underused in clinical practice after stabilization of DES-treated patients. Currently, the impact of continuous high-intensity statin treatment on the incidence of late adverse events in these patients is unknown. We investigated whether high-intensity statin treatment reduces late adverse events in clinically stable patients on aspirin monotherapy 12 months after DES implantation. METHODS: Clinically stable patients who underwent DES implantation 12 months previously and received aspirin monotherapy were randomly assigned to receive either high-intensity (40mg atorvastatin, n = 1000) or low-intensity (20mg pravastatin, n = 1000) statin treatment. The primary endpoint was adverse clinical events at 12-month follow-up (a composite of all death, myocardial infarction, revascularization, stent thrombosis, stroke, renal deterioration, intervention for peripheral artery disease, and admission for cardiac events). RESULTS: The primary endpoint at 12-month follow-up occurred in 25 patients (2.5%) receiving high-intensity statin treatment and in 40 patients (4.1%) receiving low-intensity statin treatment (HR, 0.58; 95%CI, 0.36-0.92; P = .018). This difference was mainly driven by a lower rate of cardiac death (0 vs 0.4%, P = .025) and nontarget vessel myocardial infarction (0.1 vs 0.7%, P = .033) in the high-intensity statin treatment group. CONCLUSIONS: Among clinically stable DES-treated patients on aspirin monotherapy, high-intensity statin treatment significantly reduced late adverse events compared with low-intensity statin treatment. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01557075.
RCT Entities:
INTRODUCTION AND OBJECTIVES: Current guidelines on the treatment of blood cholesterol recommend continuous maintenance of high-intensity statin treatment in drug-eluting stent (DES)-treated patients. However, high-intensity statin treatment is frequently underused in clinical practice after stabilization of DES-treated patients. Currently, the impact of continuous high-intensity statin treatment on the incidence of late adverse events in these patients is unknown. We investigated whether high-intensity statin treatment reduces late adverse events in clinically stable patients on aspirin monotherapy 12 months after DES implantation. METHODS: Clinically stable patients who underwent DES implantation 12 months previously and received aspirin monotherapy were randomly assigned to receive either high-intensity (40mg atorvastatin, n = 1000) or low-intensity (20mg pravastatin, n = 1000) statin treatment. The primary endpoint was adverse clinical events at 12-month follow-up (a composite of all death, myocardial infarction, revascularization, stent thrombosis, stroke, renal deterioration, intervention for peripheral artery disease, and admission for cardiac events). RESULTS: The primary endpoint at 12-month follow-up occurred in 25 patients (2.5%) receiving high-intensity statin treatment and in 40 patients (4.1%) receiving low-intensity statin treatment (HR, 0.58; 95%CI, 0.36-0.92; P = .018). This difference was mainly driven by a lower rate of cardiac death (0 vs 0.4%, P = .025) and nontarget vessel myocardial infarction (0.1 vs 0.7%, P = .033) in the high-intensity statin treatment group. CONCLUSIONS: Among clinically stable DES-treated patients on aspirin monotherapy, high-intensity statin treatment significantly reduced late adverse events compared with low-intensity statin treatment. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01557075.