Department of Cardiology, Zhongshan Hospital Fudan University, Shanghai Institute of Cardiovascular Diseases, 180 Fenglin Road, Shanghai, 200032, China.
National Clinical Research Center for Interventional Medicine, Shanghai, China.
Trials. 2023 Jan 20;24(1):49. doi: 10.1186/s13063-022-07028-8.
Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is the standard of care after coronary stenting, including coronary stenting involving bioresorbable scaffolds (BRSs). Current clinical guidelines recommend at least 12 months of DAPT after BRS implantation. However, the correlation between prolonged DAPT and net clinical benefits remains unknown.
The SPARTA trial is designed to be a prospective, randomized, parallel-group, clinical trial. It aims to compare the benefits and risks of DAPT applied for either 12 or 36 months after XINSORB BRS implantation. The primary endpoints are the incidence of the composite endpoint of major adverse cardiac events (MACEs), including all-cause death, any myocardial infarction (MI), and all revascularizations, as well as Bleeding Academic Research Consortium Definition (BARC) type 3 or 5 bleeding events. The secondary endpoints of the study include the device-oriented composite endpoint of target lesion failure (defined as cardiac death, target vessel-related MI, or ischemia-driven target lesion revascularization), target vessel failure (defined as cardiac death, MI, or ischemia-driven target vessel revascularization), scaffold thrombosis, and minor bleeding events. This trial will enroll 2106 subjects treated with the XINSORB BRS only. All subjects will receive DAPT after the index procedure for 12 (± 1) months. Subjects without MACEs or major bleeding will be randomized to receive either 24 additional months of DAPT or aspirin alone.
This trial is designed to investigate the impact of extending the duration of DAPT up to 3 years after XINSORB BRS implantation by investigating the balance of risks and benefits in a broad population of treated patients.
ClinicalTrials.gov NCT04501900 . Registered on 6 August 2020.
双联抗血小板治疗（DAPT）联合阿司匹林和 P2Y12 抑制剂是冠状动脉支架置入术后的标准治疗方法，包括生物可吸收支架（BRS）置入后的治疗。目前的临床指南建议 BRS 置入后至少进行 12 个月的 DAPT。然而，延长 DAPT 与净临床获益之间的相关性仍不清楚。
SPARTA 试验是一项前瞻性、随机、平行组临床试验，旨在比较 XINSORB BRS 置入后 12 个月或 36 个月应用 DAPT 的获益与风险。主要终点是主要不良心脏事件（MACE）复合终点的发生率，包括全因死亡、任何心肌梗死（MI）和所有血运重建，以及出血学术研究联合会（BARC）定义的 3 型或 5 型出血事件。该研究的次要终点包括以器械为导向的复合终点靶病变失败（定义为心脏死亡、与靶血管相关的 MI 或缺血驱动的靶病变血运重建）、靶血管失败（定义为心脏死亡、MI 或缺血驱动的靶血管血运重建）、支架血栓形成和轻微出血事件。该试验将纳入 2106 例仅接受 XINSORB BRS 治疗的患者。所有患者在索引手术后将接受 12（±1）个月的 DAPT。无 MACE 或大出血的患者将被随机分为继续接受 24 个月的 DAPT 或单独服用阿司匹林。
本试验旨在通过研究广泛的治疗患者群体中风险与获益的平衡，来探讨将 XINSORB BRS 置入后 DAPT 的持续时间延长至 3 年的影响。
ClinicalTrials.gov NCT04501900，于 2020 年 8 月 6 日注册。
