Peng Chia-Hua, Huang Tsung-Pin, Chen Yu-Hung, Hsu Chia-Huei, Cheng I-Ling
Department of Pharmacy.
Department of Internal Medicine, Chi Mei Medical Center, Tainan, Taiwan.
Acta Cardiol Sin. 2022 Jul;38(4):425-434. doi: 10.6515/ACS.202207_38(4).20220319A.
This systematic review and meta-analysis of randomized controlled trials (RCTs) compared the clinical efficacy and safety of reduced-dose prasugrel (loading dose: 20 mg; daily maintenance dose: 3.75 mg) and clopidogrel in patients undergoing percutaneous coronary intervention (PCI).
PubMed, Embase, and the Cochrane Library database were searched for relevant articles from inception to March 8, 2021. Only RCTs that compared the clinical efficacy and safety of reduced-dose prasugrel and clopidogrel treatment in adult patients undergoing PCI were included. The primary outcome was the risk of major cardiovascular events (MACEs).
Four RCTs involving 2464 patients were included. The overall risk of MACEs was 8.3% (102/1235) in the study group (reduced-dose prasugrel) and 9.8% (121/1229) in the control group (clopidogrel). No significant difference was observed in the risk of MACEs between the study and control groups (risk ratio: 0.84, 95% confidence interval: 0.65-1.08, = 0%). In addition, cardiovascular-related death, all-cause death, nonfatal myocardial infarction, nonfatal stroke, revascularization, and stent thrombosis did not differ significantly between the two groups. Apart from a higher risk of minor bleeding in the study group, reduced-dose prasugrel had a similar bleeding risk to clopidogrel.
The clinical efficacy of reduced-dose prasugrel is comparable to that of clopidogrel; however, the risk of minor bleeding should be considered when prescribing this regimen for patients undergoing PCI.
本项对随机对照试验(RCT)的系统评价和荟萃分析比较了低剂量普拉格雷(负荷剂量:20 mg;每日维持剂量:3.75 mg)与氯吡格雷在接受经皮冠状动脉介入治疗(PCI)患者中的临床疗效和安全性。
检索了PubMed、Embase和Cochrane图书馆数据库,以查找从数据库建立至2021年3月8日的相关文章。仅纳入比较低剂量普拉格雷与氯吡格雷治疗在接受PCI的成年患者中的临床疗效和安全性的RCT。主要结局是主要心血管事件(MACE)风险。
纳入了4项涉及2464例患者的RCT。研究组(低剂量普拉格雷)的MACE总体风险为8.3%(102/1235),对照组(氯吡格雷)为9.8%(121/1229)。研究组和对照组之间的MACE风险未观察到显著差异(风险比:0.84,95%置信区间:0.65 - 1.08,P = 0%)。此外,两组在心血管相关死亡、全因死亡、非致命性心肌梗死、非致命性卒中、血运重建和支架血栓形成方面无显著差异。除研究组轻微出血风险较高外,低剂量普拉格雷的出血风险与氯吡格雷相似。
低剂量普拉格雷的临床疗效与氯吡格雷相当;然而,在为接受PCI的患者开具此治疗方案时应考虑轻微出血风险。