Division of Cardiology, Department of Medicine, University of Verona, Piazzale Aristide Stefani, 1, 37126, Verona, Italy.
Department of Cardiovascular Sciences, European Hospital, Rome, Italy.
Clin Res Cardiol. 2024 Jul;113(7):1017-1029. doi: 10.1007/s00392-023-02351-9. Epub 2024 Jan 3.
Cardiac allograft vasculopathy (CAV) is still the main drawback of heart transplantation (HTx) and percutaneous coronary intervention (PCI) is a palliative measure because of the high incidence of failure.
This study aimed to investigate the safety and efficacy of bioresorbable scaffolds (BRSs) as potential novel therapeutic tool for the treatment of coronary stenoses in CAV.
This is a multicenter, single-arm, prospective, open-label study (CART, NCT02377648), that included patients affected by advanced CAV treated with PCI and second-generation ABSORB BRS (Abbott Vascular). The primary endpoint was the incidence of 12-month angiographic in-segment scaffold restenosis (ISSR). Secondary endpoints were the incidence of major adverse cardiac events (MACEs) at 12- and 36-month follow-up and the incidence of ISSR at 36 months. A paired intracoronary imaging analysis at baseline and follow-up was also performed.
Between 2015 and 2017 35 HTx patients were enrolled and treated for 44 coronary lesions with 51 BRSs. The primary endpoint occurred in 13.5% of the lesions (5/37), with a cumulative ISSR rate up to 3 years of 16.2% (6/37). Angiographic lumen loss was 0.40 ± 0.62 mm at 12 months and 0.53 ± 0.57 mm at 36 months. Overall survival rate was 91.4% and 74.3%, and MACEs incidence 14.2% and 31.4% at 12 and 36 months, respectively. At the paired intracoronary imaging analysis, a significant increase of the vessel external elastic membrane area in the treated segment and some progression of CAV proximally to the BRS were detected.
BRS-based PCI for the treatment of CAV is feasible and safe, with an ISSR incidence similar to what reported in retrospective studies with drug-eluting stents.
心脏移植（HTx）后发生的心脏移植物血管病（CAV）仍然是主要的障碍，而经皮冠状动脉介入治疗（PCI）是一种姑息性治疗方法，因为其失败率较高。
本研究旨在探讨生物可吸收支架（BRS）作为治疗 CAV 相关冠状动脉狭窄的潜在新型治疗工具的安全性和有效性。
这是一项多中心、单臂、前瞻性、开放标签研究（CART，NCT02377648），纳入了接受 PCI 和第二代 ABSORB BRS（雅培血管）治疗的晚期 CAV 患者。主要终点是 12 个月时血管内节段支架再狭窄（ISSR）的发生率。次要终点是 12 个月和 36 个月时主要不良心脏事件（MACE）的发生率以及 36 个月时 ISSR 的发生率。还进行了基线和随访时的配对冠状动脉内影像学分析。
2015 年至 2017 年间，共纳入 35 例 HTx 患者，共 44 处冠状动脉病变，共植入 51 枚 BRS。主要终点在 13.5%的病变（5/37）中发生，累积 3 年 ISSR 发生率为 16.2%（6/37）。12 个月时的血管造影管腔丢失为 0.40±0.62mm，36 个月时为 0.53±0.57mm。总的生存率为 91.4%和 74.3%，12 个月和 36 个月时的 MACE 发生率分别为 14.2%和 31.4%。在配对的冠状动脉内影像学分析中，发现治疗节段的血管外弹性膜面积显著增加，并且在 BRS 近端处 CAV 有进展。
基于 BRS 的 PCI 治疗 CAV 是可行且安全的，其 ISSR 发生率与药物洗脱支架的回顾性研究报告相似。
