Intensity of statin treatment after acute coronary syndrome, residual risk, and its modification by alirocumab: insights from the ODYSSEY OUTCOMES trial

阿利罗库单抗 医学 他汀类 内科学 危险系数 PCSK9 急性冠脉综合征 不利影响 安慰剂 心肌梗塞 心脏病学 胆固醇 置信区间 脂蛋白 低密度脂蛋白受体 替代医学 病理 载脂蛋白A1
作者
Rafael Díaz,Qian H Li,Deepak L. Bhatt,Vera Bittner,Marie T. Baccara‐Dinet,Shaun G. Goodman,J. Wouter Jukema,Takeshi Kimura,Alexander Parkhomenko,Robert Pordy,Željko Reiner,Matthew W. Sherwood,Michael Szarek,Hung‐Fat Tse,Harvey D. White,Doron Zahger,Andreas M. Zeiher,Gregory G. Schwartz,Philippe Gabríel Steg
出处
期刊:European Journal of Preventive Cardiology [Oxford University Press]
卷期号:28 (1): 33-43 被引量:43
标识
DOI:10.1177/2047487320941987
摘要

Abstract Aims Statins are pivotal to the secondary prevention of major adverse cardiovascular events, but some patients are statin-intolerant. We examined the effects of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab on the risk of major adverse cardiovascular events according to the intensity of background statin treatment. Methods and results The ODYSSEY OUTCOMES trial compared alirocumab with placebo in 18,924 patients with acute coronary syndrome and dyslipidaemia despite intensive or maximum-tolerated statin treatment (including no statin if intolerance was documented). The primary outcome (major adverse cardiovascular events) comprised coronary heart disease death, non-fatal myocardial infarction, ischaemic stroke, or unstable angina. Median follow-up was 2.8 years. Baseline statin treatment was high-intensity (88.8%), low/moderate-intensity (8.7%) or none (2.4%). Median baseline low-density lipoprotein cholesterol was 86, 89 and 139 mg/dL (P < 0.001) in these statin treatment categories, respectively. Alirocumab produced similar relative reductions in low-density lipoprotein cholesterol from baseline across statin treatment subgroups, but the mean absolute reductions differed (52.9, 56.7 and 86.1 mg/dL, respectively; P < 0.001). With placebo, the incidence of major adverse cardiovascular events was highest in the no statin subgroup (10.8%, 10.7% and 26.0% respectively). Alirocumab reduced major adverse cardiovascular events in each statin subgroup (hazard ratio 0.88, 95% confidence interval (CI) 0.80–0.96; 0.68, 0.49–0.94; and 0.65, 0.44–0.97, respectively; Pinteraction = 0.14) with a gradient of absolute risk reduction: 1.25%, 95% CI 0.34–2.16; 3.16%, 0.38–5.94; 7.97%, 0.42–15.51; Pinteraction = 0.106). Conclusions PCSK9 inhibition with alirocumab reduces the relative risk of major adverse cardiovascular events after acute coronary syndrome irrespective of background statin treatment. However, patients on no statin are at high absolute risk for recurrent major adverse cardiovascular events; alirocumab substantially reduces that risk. PCSK9 inhibition may be an important therapeutic strategy for statin-intolerant patients with acute coronary syndrome.
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