Zhu Y, Shen X, Jiang Q, Wang Z, Wang Z, Dong X, Li J, Han Q, Zhao J, Wang B, Liu L
Dongzhimen Hospital, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, 100700, Beijing, China.
Cardiovascular Department of Dongzhimen Hospital, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, 100700, Beijing, China.
Herz. 2019 Jun;44(4):336-346. doi: 10.1007/s00059-017-4640-8. Epub 2017 Nov 7.
The present meta-analysis was designed to improve statistical power and review the effects of monoclonal antibodies against PCSK9 on clinical cardiovascular events.
PubMed, Embase, Web of Science, and the Cochrane Library were searched from inception to May 2017. Studies considered to be eligible were randomized controlled trials about the effects of monoclonal antibodies against PCSK9 on clinical cardiovascular events. The primary endpoint was positively adjudicated cardiovascular events; the secondary endpoint comprised cardiac mortality, myocardial infarction (MI), coronary revascularization, stroke, and hospitalization for unstable angina.
We included 20 randomized controlled trials involving 67,934 patients. Monoclonal antibodies against PCSK9 were associated with a significant reduction in positively adjudicated cardiovascular events (relative risk [RR] = 0.87; 95% confidence interval [CI] = 0.81-0.93; z = 4.03; p = 0.000), MI (RR = 0.78; 95% CI = 0.71-0.86; z = 4.96; p = 0.000), coronary revascularization (RR = 0.81, 95% CI = 0.75-0.88; z = 4.93; p = 0.000), and stroke (RR = 0.76, 95% CI = 0.65-0.89; z = 3.47; p = 0.001). Monoclonal antibodies against PCSK9 did not reduce hospitalization rates due to unstable angina. The results of subgroup analysis showed that evolocumab was associated with a lower risk of positively adjudicated cardiovascular events, MI, coronary revascularization, and stroke without reducing cardiac mortality. Alirocumab reduced the incidence of cardiac mortality but not of other cardiovascular events, while bococizumab was associated with a reduced risk of stroke.
Monoclonal antibodies against PCSK9 were associated with a lower risk of positively adjudicated cardiovascular events, MI, coronary revascularization, and stroke.
本荟萃分析旨在提高统计效能并评估抗前蛋白转化酶枯草溶菌素9（PCSK9）单克隆抗体对临床心血管事件的影响。
检索了从创刊至2017年5月的PubMed、Embase、Web of Science和Cochrane图书馆。符合条件的研究为关于抗PCSK9单克隆抗体对临床心血管事件影响的随机对照试验。主要终点为经积极判定的心血管事件；次要终点包括心脏死亡率、心肌梗死（MI）、冠状动脉血运重建、中风以及因不稳定型心绞痛住院。
我们纳入了20项随机对照试验，涉及67934例患者。抗PCSK9单克隆抗体与经积极判定的心血管事件显著减少相关（相对风险[RR]=0.87；95%置信区间[CI]=0.81 - 0.93；z=4.03；p=0.000）、MI（RR=0.78；95% CI=0.71 - 0.86；z=4.96；p=0.000）、冠状动脉血运重建（RR=0.81，95% CI=0.75 - 0.88；z=4.93；p=0.000）以及中风（RR=0.76，95% CI=0.65 - 0.89；z=3.47；p=0.001）。抗PCSK9单克隆抗体未降低因不稳定型心绞痛导致的住院率。亚组分析结果显示，依洛尤单抗与经积极判定的心血管事件、MI、冠状动脉血运重建和中风风险较低相关，且未降低心脏死亡率。阿利西尤单抗降低了心脏死亡率，但未降低其他心血管事件的发生率，而博考西尤单抗与中风风险降低相关。
抗PCSK9单克隆抗体与经积极判定的心血管事件、MI、冠状动脉血运重建和中风风险较低相关。
