Department of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Zhejiang Key Laboratory of Cardiovascular Intervention and Precision Medicine, Hangzhou, China.
Trials. 2024 Nov 25;25(1):794. doi: 10.1186/s13063-024-08605-9.
Percutaneous coronary intervention (PCI)-related myocardial infarction (MI), especially the distal type associated with microvascular dysfunction, is not an uncommon complication of the procedure. Specific lesion features, the echo-attenuated plaques (EA) in particular, are well-established contributors to the pathogenesis of distal-type MI. These plaques are prone to disruption during PCI, leading to microvascular thrombosis and distal embolism. Tenecteplase (TNK), a 3rd-generation thrombolytic drug, has demonstrated effective thrombolytic capacity without significantly increasing the bleeding risk. Our study aims to evaluate whether a low-dose intracoronary TNK administration prior to PCI in patients with intravascular ultrasound (IVUS)-detected EA can reduce the occurrence of PCI-related MI and improve clinical outcomes.
This trial is designed as a multicenter, prospective randomized controlled trial with a 1-month follow-up. The primary outcome of the study is the incidence of PCI-related myocardial infarction (MI) occurring within 48 h after PCI, which serves as a valid surrogate endpoint for assessing the efficacy of tenecteplase-based PCI in preventing future major adverse cardiovascular events (MACE) in patients with EA (Bulluck, et. al, Eur Heart J 42:2630-42, 2021) {1b.1}. Secondary outcomes include the proportion of patients with elevated postoperative high-sensitivity cTnI exceeding 5, 10, 35, and 70 times of the normal baseline, incidence of coronary slow flow after stent implantation and post-dilation, frame count of angiographic flow after stent implantation and post-dilation, as well as the incidence of MACE during hospitalization and at the 1-month follow-up.
This trial may demonstrate that an immediate intracoronary administration of low-dose TNK following PCI can effectively lower the incidence of PMI in patients with EA, while confirming the safety of this therapeutic approach.
Chinese Clinical Trial Registry ( ChiCTR2400084840 ). Registered on May 27, 2024.
经皮冠状动脉介入治疗（PCI）相关的心肌梗死（MI），特别是与微血管功能障碍相关的远端型 MI，是该手术常见的并发症之一。特定的病变特征，尤其是回声衰减斑块（EA），是导致远端型 MI 发病机制的重要因素。这些斑块在 PCI 过程中容易破裂，导致微血管血栓形成和远端栓塞。替奈普酶（TNK），一种第三代溶栓药物，已被证实具有有效的溶栓能力，而不会显著增加出血风险。我们的研究旨在评估在血管内超声（IVUS）检测到 EA 的患者中，在 PCI 前给予低剂量的冠状动脉内 TNK 是否可以降低 PCI 相关 MI 的发生并改善临床结局。
本试验设计为一项多中心、前瞻性随机对照研究，随访 1 个月。研究的主要结局是 PCI 后 48 小时内发生的 PCI 相关心肌梗死（MI）的发生率，这是评估 TNK 为基础的 PCI 预防 EA 患者未来主要不良心血管事件（MACE）的有效替代终点（Bulluck，et.al，Eur Heart J 42:2630-42, 2021）{1b.1}。次要结局包括术后高敏 cTnI 升高超过正常基线 5、10、35 和 70 倍的患者比例、支架植入后和后扩张时冠状动脉慢血流的发生率、支架植入后和后扩张时血管造影血流的帧数以及住院期间和 1 个月随访期间的 MACE 发生率。
本试验可能表明，在 PCI 后立即给予冠状动脉内低剂量 TNK 可以有效降低 EA 患者的 PMI 发生率，同时确认这种治疗方法的安全性。
中国临床试验注册中心（ChiCTR2400084840）。注册于 2024 年 5 月 27 日。
