Valgimigli Marco, Smits Pieter C, Frigoli Enrico, Bongiovanni Dario, Tijssen Jan, Hovasse Thomas, Mafragi Al, Ruifrok Willem Theodoor, Karageorgiev Dimitar, Aminian Adel, Garducci Stefano, Merkely Bela, Routledge Helen, Ando Kenji, Diaz Fernandez Josè Francisco, Cuisset Thomas, Nesa Malik Fazila Tun, Halabi Majdi, Belle Loic, Din Jehangir, Beygui Farzin, Abhyankar Atul, Reczuch Krzysztof, Pedrazzini Giovanni, Heg Dik, Vranckx Pascal
Cardiocentro Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana (USI), CH-6900 Lugano, Switzerland.
Department of Cardiology, Maasstad Hospital, Rotterdam, The Netherlands.
Eur Heart J. 2022 Sep 1;43(33):3100-3114. doi: 10.1093/eurheartj/ehac284.
To assess the effects of 1- or ≥3-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients who received biodegradable-polymer sirolimus-eluting stents for complex percutaneous coronary intervention (PCI) and/or acute coronary syndrome (ACS).
In the MASTER DAPT trial, 3383 patients underwent non-complex (abbreviated DAPT, n = 1707; standard DAPT, n = 1676) and 1196 complex (abbreviated DAPT, n = 588; standard DAPT, n = 608) PCI. Co-primary outcomes at 335 days were net adverse clinical events [NACE; composite of all-cause death, myocardial infarction, stroke, and bleeding academic research consortium (BARC) 3 or 5 bleeding events]; major adverse cardiac or cerebral events (MACCE; all-cause death, myocardial infarction, and stroke); and Types 2, 3, or 5 BARC bleeding. Net adverse clinical events and MACCE did not differ with abbreviated vs. standard DAPT among patients with complex [hazard ratio (HR): 1.03, 95% confidence interval (CI): 0.69-1.52, and HR: 1.24, 95% CI: 0.79-1.92, respectively] and non-complex PCI (HR: 0.90, 95% CI: 0.71-1.15, and HR: 0.91, 95% CI: 0.69-1.21; Pinteraction = 0.60 and 0.26, respectively). BARC 2, 3, or 5 was reduced with abbreviated DAPT in patients with and without complex PCI (HR: 0.64; 95% CI: 0.42-0.98, and HR: 0.70; 95% CI: 0.55-0.89; Pinteraction = 0.72). Among the 2816 patients with complex PCI and/or ACS, NACE and MACCE did not differ and BARC 2, 3, or 5 was lower with abbreviated DAPT.
In HBR patients free from recurrent ischaemic events at 1 month, DAPT discontinuation was associated with similar NACE and MACCE and lower bleeding rates compared with standard DAPT, regardless of PCI or patient complexity.
This trial is registered with ClinicalTrials.gov, number NCT03023020, and is closed to new participants, with follow-up completed.
评估接受生物可降解聚合物西罗莫司洗脱支架进行复杂经皮冠状动脉介入治疗（PCI）和/或急性冠状动脉综合征（ACS）的高出血风险（HBR）患者，1个月或≥3个月双重抗血小板治疗（DAPT）的效果。
在MASTER DAPT试验中，3383例患者接受了非复杂PCI（简化DAPT组，n = 1707；标准DAPT组，n = 1676）和1196例复杂PCI（简化DAPT组，n = 588；标准DAPT组，n = 608）。335天时的共同主要结局为净不良临床事件[NACE；全因死亡、心肌梗死、卒中以及出血学术研究联盟（BARC）3或5级出血事件的复合事件]；主要不良心脏或脑血管事件（MACCE；全因死亡、心肌梗死和卒中）；以及BARC 2、3或5级出血。在接受复杂PCI的患者中，简化DAPT与标准DAPT相比，净不良临床事件和MACCE无差异[风险比（HR）分别为1.03，95%置信区间（CI）：0.69 - 1.52，以及HR：1.24，95% CI：0.79 - 1.92]，非复杂PCI患者中也是如此（HR：0.90，95% CI：0.71 - 1.15，以及HR：0.91，95% CI：0.69 - 1.21；交互P值分别为0.60和0.26）。在有或无复杂PCI的患者中，简化DAPT均可降低BARC 2、3或5级出血的发生率（HR：0.64；95% CI：0.42 - 0.98，以及HR：0.70；95% CI：0.55 - 0.89；交互P值 = 0.72）。在2816例接受复杂PCI和/或ACS的患者中，NACE和MACCE无差异，简化DAPT组的BARC 2、3或5级出血发生率更低。
在1个月时无复发性缺血事件的HBR患者中，与标准DAPT相比，停用DAPT与相似的NACE和MACCE以及更低的出血率相关，无论PCI或患者情况的复杂性如何。
本试验已在ClinicalTrials.gov注册，编号为NCT03023020，已停止招募新参与者，随访已完成。
