Department of Cardiology, Department of Medical Sciences, University of Torino, Italy.
Department of Cardiology, University Hospital Álvaro Cunqueiro, Vigo, Spain.
Eur J Prev Cardiol. 2020 May;27(7):696-705. doi: 10.1177/2047487319836327. Epub 2019 Mar 12.
The benefits of short versus long-term dual antiplatelet therapy (DAPT) based on the third generation P2Y12 antagonists prasugrel or ticagrelor, in patients with acute coronary syndromes treated with percutaneous coronary intervention remain to be clearly defined due to current evidences limited to patients treated with clopidogrel.
All acute coronary syndrome patients from the REgistry of New Antiplatelets in patients with Myocardial Infarction (RENAMI) undergoing percutaneous coronary intervention and treated with aspirin, prasugrel or ticagrelor were stratified according to DAPT duration, that is, shorter than 12 months (D1 group), 12 months (D2 group) and longer than 12 months (D3 group). The three groups were compared before and after propensity score matching. Net adverse clinical events (NACEs), defined as a combination of major adverse cardiac events (MACEs) and major bleedings (including therefore all cause death, myocardial infarction and Bleeding Academic Research Consortium (BARC) 3-5 bleeding), were the primary end points, MACEs (a composite of all cause death and myocardial infarction) the secondary one. Single components of NACEs were co-secondary end points, along with BARC 2-5 bleeding, cardiovascular death and stent thrombosis.
A total of 4424 patients from the RENAMI registry with available data on DAPT duration were included in the model. After propensity score matching, 628 patients from each group were selected. After 20 months of follow up, DAPT for 12 months and DAPT for longer than 12 months significantly reduced the risk of NACE (D1 11.6% . D2 6.7% . D3 7.2%, = 0.003) and MACE (10% . 6.2% . 2.4%, < 0.001) compared with DAPT for less than 12 months. These differences were driven by a reduced risk of all cause death (7.8% . 1.3% . 1.6%, < 0.001), cardiovascular death (5.1% . 1.0% . 1.2%, < 0.0001) and recurrent myocardial infarction (8.3% . 5.2% . 3.5%, = 0.002). NACEs were lower with longer DAPT despite a higher risk of BARC 2-5 bleedings (4.6% . 5.7% . 6.2%, = 0.04) and a trend towards a higher risk of BARC 3-5 bleedings (2.4% . 3.3% . 3.9%, = 0.06). These results were not consistent for female patients and those older than 75 years old, due to an increased risk of bleedings which exceeded the reduction in myocardial infarction.
In unselected real world acute coronary syndrome patients treated with percutaneous coronary intervention, DAPT with prasugrel or ticagrelor prolonged beyond 12 months markedly reduces fatal and non-fatal ischaemic events, offsetting the increased risk deriving from the higher bleeding risk. On the contrary, patients >75 years old and female ones showed a less favourable risk-benefit ratio for longer DAPT due to excess of bleedings.
基于第三代 P2Y12 拮抗剂普拉格雷或替格瑞洛，在接受经皮冠状动脉介入治疗的急性冠状动脉综合征患者中，短期与长期双联抗血小板治疗（DAPT）的获益仍需明确界定，这是因为目前的证据仅限于接受氯吡格雷治疗的患者。
所有接受经皮冠状动脉介入治疗并接受阿司匹林、普拉格雷或替格瑞洛治疗的心肌梗死患者新抗血小板药物注册研究（REnAMI）中的急性冠状动脉综合征患者，根据 DAPT 持续时间分层，即短于 12 个月（D1 组）、12 个月（D2 组）和长于 12 个月（D3 组）。在进行倾向评分匹配前后对三组进行比较。净不良临床事件（NACEs），定义为主要不良心脏事件（MACEs）和主要出血（包括因此所有原因死亡、心肌梗死和 Bleeding Academic Research Consortium [BARC] 3-5 出血）的组合，是主要终点，MACEs（所有原因死亡和心肌梗死的复合）是次要终点。NACEs 的单一组成部分是次要终点，以及 BARC 2-5 出血、心血管死亡和支架血栓形成。
共有 4424 名来自 RENAMI 注册中心的患者有 DAPT 持续时间的数据纳入模型。在进行倾向评分匹配后，每组选择 628 名患者。在 20 个月的随访后，与 DAPT 少于 12 个月相比，DAPT 持续 12 个月和 DAPT 持续时间超过 12 个月显著降低了 NACE（D1 11.6%、D2 6.7%、D3 7.2%，=0.003）和 MACE（10%、6.2%、2.4%，<0.001）的风险。这些差异是由全因死亡风险降低（7.8%、1.3%、1.6%，<0.001）、心血管死亡风险降低（5.1%、1.0%、1.2%，<0.0001）和复发性心肌梗死风险降低（8.3%、5.2%、3.5%，=0.002）驱动的。尽管 BARC 2-5 出血风险较高（4.6%、5.7%、6.2%，=0.04）且 BARC 3-5 出血风险呈上升趋势（2.4%、3.3%、3.9%，=0.06），但延长 DAPT 时间可降低 NACEs。这些结果在女性患者和年龄大于 75 岁的患者中并不一致，这是因为出血风险的增加超过了心肌梗死的减少。
在未选择的接受经皮冠状动脉介入治疗的急性冠状动脉综合征患者中，普拉格雷或替格瑞洛延长超过 12 个月的 DAPT 可显著降低致命和非致命性缺血事件，抵消因更高出血风险而导致的风险增加。相比之下，年龄大于 75 岁和女性患者由于出血过多，延长 DAPT 的风险获益比不太有利。
