BACKGROUND Long-term clinical outcomes of early intravascular ultrasound (IVUS) findings in a prospective cohort of heart transplantation (HTx) patients have not been evaluated. METHODS 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. RESULTS 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). CONCLUSIONS 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.

中文翻译：

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依维莫司与硫唑嘌呤多国前瞻性研究的 10 年随访队列，侧重于血管内超声结果。


背景 尚未评估心脏移植 （HTx） 患者前瞻性队列中早期血管内超声 （IVUS） 结果的长期临床结果。方法 本研究包括 RAD B253 研究的原始队列中来自欧洲、北美和南美 20 个中心的患者。在这些患者中，91 例在基线和移植后 1 年有配对 IVUS 图像： 依维莫司 1.5 mg 组 （n = 25）、依维莫司 1.5 mg 组 （n = 33） 和硫唑嘌呤 3.0 组 （n = 33）。主要结局是 10 年随访期内心血管死亡、再移植、心肌梗死 （MI）、冠状动脉血运重建和心脏同种异体移植血管病变 （CAV） 的复合结局。次要结局是全因死亡、心血管死亡、再移植、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） >0.66 mm，快速进展定义为 1 年 MIT > 变化 0.59 mm。结果 供体疾病 （46 例患者） 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 例患者） 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 的高风险特征 （供体疾病阳性和快速进展） 与不良临床结局独立相关 （HR 4.800,95% CI 1.816-12.684，p = 0.002）。结论 基线 MIT 的增加和 HTx 后 IVUS 第一年 MIT 的变化与长达 10 年的不良结局相关。早期 IVUS 发现可被视为评估 HTx 临床试验中长期结果的替代终点。