Yangsoo Jang1, Junren Zhu2, Junbo Ge3, Young-Jo Kim4, Chen Ji5, William Lam6. 1. Division of Cardiology, Yonsei Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea. 2. Zhongshan Hospital, Fudan University, Shanghai, China. 3. Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: ge.junbo@zs-hospital.sh.cn. 4. Department of Intervention, Division of Cardiology, Yeungnam University Hospital, Nam-gu, Daegu, Republic of Korea. 5. Pfizer Ltd., Shanghai, China. 6. Pfizer Inc., New York, NY, USA.
Abstract
BACKGROUND: Data on atorvastatin pretreatment in Asian patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) are limited. However, there have been studies in other populations in Asia which demonstrated that statins can reduce the risk of periprocedural myocardial infarction (MI). METHODS AND RESULTS:Statin-naïve patients with non-ST-segment-elevation (NSTE)-ACS scheduled for PCI were randomized to usual care or atorvastatin preloading groups. All patients received usual care including atorvastatin 40 mg/day. The atorvastatin group received atorvastatin 80 mg 12 h and 40 mg 2 h pre-PCI. Of 499 patients randomized, 247 were assigned toatorvastatin preloading. Following coronary angiography, 335 patients (163 atorvastatin) received PCI. During the 30 days post-PCI, major adverse cardiac events (death, MI, and target vessel revascularization) occurred in 24 (15%) atorvastatin and 27 (16%) usual care patients (p=NS). Post hoc analyses showed that at 8 h post-PCI, 3.82% of the atorvastatin group and 7.22% of the usual care group had a post-procedural creatine kinase-myocardial band (CK-MB) above 3 times the upper limit of normal (p=0.27) and at 24 h post-PCI, the rate was 7.64% versus 9.47% (p=1.0). Safety profile suggests that high-dose atorvastatin (40 mg) for up to 1 month, in conjunction with usual care, is relatively safe and well tolerated. CONCLUSIONS: This study of statin-naïve Korean and Chinese patients with NSTE-ACS who receivedadditional atorvastatin loading doses of 80 mg at 12 h, and 40 mg at 2 h, pre-PCI did not find a beneficial effect compared with usual post-PCI atorvastatin 40 mg/day treatment. Atorvastatin was found to be well tolerated in Asian patients with NSTE-ACS undergoing PCI. Results of the current study merit further investigation of the early use of statins in patients with NSTE-ACS to delineate patient subgroups who may benefit from this therapy.
RCT Entities:
BACKGROUND: Data on atorvastatin pretreatment in Asian patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) are limited. However, there have been studies in other populations in Asia which demonstrated that statins can reduce the risk of periprocedural myocardial infarction (MI). METHODS AND RESULTS: Statin-naïve patients with non-ST-segment-elevation (NSTE)-ACS scheduled for PCI were randomized to usual care or atorvastatin preloading groups. All patients received usual care including atorvastatin 40 mg/day. The atorvastatin group received atorvastatin 80 mg 12 h and 40 mg 2 h pre-PCI. Of 499 patients randomized, 247 were assigned to atorvastatin preloading. Following coronary angiography, 335 patients (163 atorvastatin) received PCI. During the 30 days post-PCI, major adverse cardiac events (death, MI, and target vessel revascularization) occurred in 24 (15%) atorvastatin and 27 (16%) usual care patients (p=NS). Post hoc analyses showed that at 8 h post-PCI, 3.82% of the atorvastatin group and 7.22% of the usual care group had a post-procedural creatine kinase-myocardial band (CK-MB) above 3 times the upper limit of normal (p=0.27) and at 24 h post-PCI, the rate was 7.64% versus 9.47% (p=1.0). Safety profile suggests that high-dose atorvastatin (40 mg) for up to 1 month, in conjunction with usual care, is relatively safe and well tolerated. CONCLUSIONS: This study of statin-naïve Korean and Chinese patients with NSTE-ACS who received additional atorvastatin loading doses of 80 mg at 12 h, and 40 mg at 2 h, pre-PCI did not find a beneficial effect compared with usual post-PCI atorvastatin 40 mg/day treatment. Atorvastatin was found to be well tolerated in Asian patients with NSTE-ACS undergoing PCI. Results of the current study merit further investigation of the early use of statins in patients with NSTE-ACS to delineate patient subgroups who may benefit from this therapy.
Authors: Yuan Lu; Haibo Zhang; Yongfei Wang; Tianna Zhou; John Welsh; Jiamin Liu; Wenchi Guan; Jing Li; Xi Li; Xin Zheng; John A Spertus; Frederick A Masoudi; Harlan M Krumholz; Lixin Jiang Journal: JAMA Netw Open Date: 2018-12-07