HeartDrug Research Laboratories, Johns Hopkins University, Osler Medical Building, 7600 Osler Drive, Suite 307, Towson, Maryland, 21204, USA.
Thromb Haemost. 2013 Jul;110(1):5-10. doi: 10.1160/TH13-02-0142. Epub 2013 Jun 7.
Recent European Society of Cardiology (ESC) Guidelines declare superiority of prasugrel and ticagrelor over clopidogrel in non-ST segment elevation myocardial infarction (NSTEMI) and STEMI patients with acute coronary syndromes (ACS). The recommendations for NSTEMI and especially STEMI are based on a subgroup analyses yielded from a single trial with either prasugrel (TRITON), or ticagrelor (PLATO). In contrast, the United States (US) Guidelines present a more balanced, conservative, and evidence-based outlook suggesting no proven extra benefit of one P2Y12 antagonist over the other(s). It was the purpose of this study to scrutinise the evidence leading to the current ESC ACS Guidelines on oral antiplatelet agents and compare them with US recommendations. Matching the evidence from TRITON and PLATO primary publications with the data reported in the Food and Drug Administration (FDA) official reviews in light of their impact on current regional ACS Guidelines on antiplatelet P2Y12 inhibitors. The available body of evidence on the efficacy and safety of the new oral P2Y12 inhibitors challenge the ESC Guidelines, and supports the US recommendations. Some of the pivotal data with regard to the newer P2Y12 inhibitors (prasugrel and ticagrelor) on event definition, adjudication, questionable efficacy, and serious safety concerns were ignored by the European Task Force Members, while the other "beneficial" findings were exaggerated to a disproportional extent. We conclude that current ESC Guidelines, with regard to their recommendation of superiority of prasugrel or ticagrelor over clopidogrel, in contrast to the US, are overoptimistic, and not evidence based. Low clinical utilisation of prasugrel and especially ticagrelor worldwide in general, and Europe in particular suggests mismatch of prescription habits with issued ESC recommendations.
最近，欧洲心脏病学会（ESC）指南宣称，普拉格雷和替格瑞洛在非 ST 段抬高型心肌梗死（NSTEMI）和急性冠脉综合征（ACS）的 ST 段抬高型心肌梗死（STEMI）患者中的疗效优于氯吡格雷。NSTEMI 的推荐意见，特别是 STEMI 的推荐意见，是基于来自普拉格雷（TRITON）或替格瑞洛（PLATO）的单个试验的亚组分析结果。相比之下，美国（US）指南提出了一个更平衡、更保守、更基于证据的观点，表明一种 P2Y12 拮抗剂与其他拮抗剂相比，没有被证明有额外的益处。本研究旨在仔细审查导致目前 ESC ACS 指南中关于口服抗血小板药物的证据，并将其与美国的建议进行比较。根据对当前区域 ACS 指南中抗血小板 P2Y12 抑制剂的影响，将 TRITON 和 PLATO 主要出版物中的证据与食品和药物管理局（FDA）官方审查报告中的数据进行匹配。新的口服 P2Y12 抑制剂的疗效和安全性的现有证据对 ESC 指南提出了挑战，支持美国的建议。欧洲专家组的成员忽略了一些关于新型 P2Y12 抑制剂（普拉格雷和替格瑞洛）的关键性数据，这些数据涉及事件定义、裁决、可疑疗效和严重安全问题，而对其他“有益”的发现则夸大到不成比例的程度。我们得出结论，目前的 ESC 指南建议普拉格雷或替格瑞洛优于氯吡格雷，与美国相反，过于乐观，没有基于证据。在全球范围内，尤其是在欧洲，普拉格雷和替格瑞洛的临床应用率较低，这表明处方习惯与 ESC 发布的建议不匹配。
