A multi-center, randomized controlled trial is set to investigate the efficacy of intracoronary tenecteplase (TNK) in preventing periprocedural myocardial infarction (PMI) in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). The study, led by Sir Run Run Shaw Hospital affiliated with Zhejiang University School of Medicine, aims to enroll 864 patients across multiple centers in China between August 2024 and August 2025.
Study Design and Patient Population
The trial will include CAD patients aged 18 years or older who are clinically indicated for elective PCI and can tolerate dual antiplatelet therapy. A key inclusion criterion is the presence of eroded plaques (EA) confirmed by intravascular ultrasound (IVUS), with lesion length ≥ 20 mm and specific ultrasound signal attenuation characteristics. Patients with positive cardiac troponin I (cTnI) prior to angiography, coronary artery bypass graft (CABG) lesions, chronic total occlusion (CTO), in-stent restenosis, severe calcification, left main coronary artery disease (LMCAD), or other significant complicating factors are excluded.
Intervention and Control
Participants will be randomized in a 1:1 ratio to either the intervention group, receiving an immediate intracoronary injection of 4 mL of 0.9% NaCl solution containing 4mg of TNK following balloon angioplasty, or the control group, receiving an immediate intracoronary injection of 4 mL of 0.9% NaCl solution following balloon angioplasty. Both groups will receive standard pharmacological treatments and hospital care. The use of other devices during PCI will be based on the operator’s experience.
Primary and Secondary Outcomes
The primary outcome measure is the incidence of PCI-related MI, defined as an increase in high-sensitivity cTnI to more than 5 times the 99th percentile upper reference limit (> 5 × 99th percentile URL) within 48 hours post-PCI in patients with normal baseline cTnI values. Secondary outcome measures include the proportion of patients with elevated postoperative high-sensitivity cTnI exceeding 5, 10, 35, and 70 times the normal baseline, incidence of slow-flow after stent implantation and post-dilation, frame count of angiographic flow, and incidence of major adverse cardiac events (MACE) during hospitalization and post-operative 1-month follow-up.
Safety Measures and Statistical Analysis
Safety endpoints include the proportion of major bleeding (BARC bleeding classification type 2 or type 3) occurring within 24 hours post-PMI. The sample size calculation, based on an assumed 20% incidence rate of PCI-related MI in the control group and a 35% lower incidence rate in the TNK group, requires at least 864 subjects to achieve 80% power with a two-sided alpha of 0.05, accounting for a 20% dropout rate.
Significance
This trial aims to determine whether intracoronary administration of TNK can effectively reduce the incidence of PMI, a significant complication associated with increased cardiac mortality and future MACE. The results could potentially alter clinical practice by providing a new strategy to improve outcomes for patients undergoing PCI.
