Abstract:
For almost two decades, 12-month dual antiplatelet therapy (DAPT) in acute coronary syndrome (ACS) has been the only class I recommendation on DAPT in American and European guidelines, which has resulted in 12-month durations of DAPT therapy being the most frequently implemented in ACS patients undergoing percutaneous coronary intervention (PCI) across the globe. Twelve-month DAPT was initially grounded in the results of the CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Events) trial, which, by design, studied DAPT versus no DAPT rather than the optimal DAPT duration. The average DAPT duration in this study was 9 months, not 12 months. Subsequent ACS studies, which were not designed to assess DAPT duration, rather its composition (aspirin with prasugrel or ticagrelor compared with clopidogrel) were further interpreted as supportive evidence for 12-month DAPT duration. In these studies, the median DAPT duration was 9 or 15 months for ticagrelor and prasugrel, respectively. Several subsequent studies questioned the 12-month regimen and suggested that DAPT duration should either be fewer than 12 months in patients at high bleeding risk or more than 12 months in patients at high ischemic risk who can safely tolerate the treatment. Bleeding, rather than ischemic risk assessment, has emerged as a treatment modifier for maximizing the net clinical benefit of DAPT, due to excessive bleeding and no clear benefit of prolonged treatment regimens in high bleeding risk patients. Multiple DAPT de-escalation treatment strategies, including switching from prasugrel or ticagrelor to clopidogrel, reducing the dose of prasugrel or ticagrelor, and shortening DAPT duration while maintaining monotherapy with ticagrelor, have been consistently shown to reduce bleeding without increasing fatal or nonfatal cardiovascular or cerebral ischemic risks compared with 12-month DAPT. However, 12-month DAPT remains the only class-I DAPT recommendation for patients with ACS despite the lack of prospectively established evidence, leading to unnecessary and potentially harmful overtreatment in many patients. It is time for clinical practice and guideline recommendations to be updated to reflect the totality of the evidence regarding the optimal DAPT duration in ACS.
摘要:
近二十年来,12个月的双重抗血小板治疗(DAPT)在急性冠脉综合征(ACS)是美国和欧洲指南中DAPT的唯一I类推荐,这导致在全球接受经皮冠状动脉介入治疗(PCI)的ACS患者中最常用的是12个月的DAPT治疗.12个月的DAPT最初基于CURE(氯吡格雷治疗不稳定型心绞痛预防复发事件)试验的结果,which,通过设计,研究了DAPT与无DAPT,而不是最佳DAPT持续时间。这项研究的平均DAPT持续时间为9个月,不是12个月。随后的ACS研究,不是为了评估DAPT持续时间而设计的,相反,其成分(阿司匹林联合普拉格雷或替格瑞洛与氯吡格雷相比)被进一步解释为12个月DAPT持续时间的支持性证据.在这些研究中,替格瑞洛和普拉格雷的中位DAPT持续时间为9或15个月,分别。随后的几项研究对12个月的治疗方案提出质疑,并建议高出血风险患者的DAPT持续时间应少于12个月,或高缺血风险患者的DAPT持续时间应超过12个月,这些患者可以安全地耐受治疗。出血,而不是缺血风险评估,已成为最大化DAPT净临床效益的治疗调节剂,由于出血过多,并且在高出血风险患者中延长治疗方案没有明确的益处。多种DAPT降阶梯治疗策略,包括从普拉格雷或替格瑞洛转换为氯吡格雷,减少普拉格雷或替格瑞洛的剂量,缩短DAPT持续时间,同时维持替格瑞洛单药治疗,与12个月的DAPT相比,一直被证明可减少出血,而不会增加致死性或非致死性心血管或脑缺血风险.然而,12个月DAPT仍然是ACS患者唯一的I类DAPT建议,尽管缺乏前瞻性证据,导致许多患者不必要和潜在有害的过度治疗。现在是更新临床实践和指南建议的时候了,以反映关于ACS中最佳DAPT持续时间的全部证据。