1. Intracoronary administration of tenecteplase to prevent PCI-related myocardial infarction in patients with echo-attenuated coronary plaques: study protocol for a multicenter, prospective, randomized controlled trial.
- Author
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Hong, Xu-Lin, Loh, Yi-Hao, Li, Duan-Bin, Luan, Yi, and Zhang, Wen-Bin
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MAJOR adverse cardiovascular events , *PERCUTANEOUS coronary intervention , *MYOCARDIAL infarction , *INTRAVASCULAR ultrasonography , *MICROCIRCULATION disorders - Abstract
Background: 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. Methods: 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. Discussion: 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. Trial registration: Chinese Clinical Trial Registry (ChiCTR2400084840). Registered on May 27, 2024. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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