Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California; Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, Republic of Korea.
Department of Cardiovascular Medicine, Heart and Vascular Institute, Kaufman Center for Heart Failure, Cleveland Clinic, Cleveland, Ohio.
J Heart Lung Transplant. 2024 Nov;43(11):1788-1794. doi: 10.1016/j.healun.2024.07.021. Epub 2024 Jul 30.
Long-term clinical outcomes of early intravascular ultrasound (IVUS) findings in a prospective cohort of heart transplantation (HTx) patients have not been evaluated.
This study included patients from 20 centers across Europe and North and South America among the original cohort of the RAD B253 study. Among these patients, 91 had paired IVUS images at baseline and 1-year post-transplant: everolimus 1.5 mg group (n = 25), everolimus 1.5 mg group (n = 33), and azathioprine 3.0 group (n = 33). The primary outcome was a composite of cardiovascular death, retransplantation, myocardial infarction (MI), coronary revascularization, and cardiac allograft vasculopathy (CAV) within a 10-year follow-up period. The secondary outcome was all-cause death, cardiovascular death, retransplantation, MI, coronary revascularization, and CAV. Donor disease was defined as baseline maximal intimal thickness (MIT) >0.66 mm, and rapid progression was defined as a change in MIT > 0.59 mm at 1 year.
Donor disease (46 patients) was associated with a higher incidence of the primary outcome (hazard ratio (HR) 4.444, 95% confidence interval [CI] 1.946-10.146, p < 0.001). Rapid progression (44 patients) was associated with a significantly higher incidence of the primary outcome (HR 2.942, 95% CI 1.383-6.260, p = 0.005). Higher-risk features on IVUS (positive both donor disease and rapid progression) were independently associated with poor clinical outcomes (HR 4.800, 95% CI 1.816-12.684, p = 0.002).
An increase in baseline MIT and a change in first-year MIT in IVUS post HTx was associated with poor outcomes up to 10 years. Early IVUS findings can be considered as surrogate endpoints for evaluating long-term outcomes in HTx clinical trials.
尚未评估前瞻性心脏移植（HTx）患者队列中早期血管内超声（IVUS）发现的长期临床结果。
这项研究包括来自欧洲、北美和南美 20 个中心的患者，他们是 RAD B253 研究原始队列中的一部分。在这些患者中，91 名患者在基线和移植后 1 年时具有配对的 IVUS 图像：依维莫司 1.5mg 组（n=25）、依维莫司 1.5mg 组（n=33）和硫唑嘌呤 3.0mg 组（n=33）。主要结局是在 10 年随访期间发生心血管死亡、再次移植、心肌梗死（MI）、冠状动脉血运重建和心脏移植物血管病（CAV）的复合结局。次要结局是全因死亡、心血管死亡、再次移植、MI、冠状动脉血运重建和 CAV。供体疾病定义为基线最大内膜厚度（MIT）>0.66mm，快速进展定义为 1 年内 MIT 变化>0.59mm。
供体疾病（46 例）与主要结局的发生率较高相关（风险比（HR）4.444，95%置信区间[CI]1.946-10.146，p<0.001）。快速进展（44 例）与主要结局的发生率显著升高相关（HR 2.942，95%CI 1.383-6.260，p=0.005）。IVUS 上的高危特征（供体疾病和快速进展均为阳性）与不良临床结局独立相关（HR 4.800，95%CI 1.816-12.684，p=0.002）。
HTx 后 IVUS 基线 MIT 增加和第一年 MIT 变化与 10 年内不良结局相关。早期 IVUS 发现可作为 HTx 临床试验中评估长期结局的替代终点。
