Rashidi Mitra, Esmaily Sorosh, Fiane Arnt E, Gude Einar, A Tønseth Kim, Ueland Thor, Gustafsson Finn, Eiskjær Hans, Rådegran Göran, Dellgren Göran
Department of Cardiothoracic Surgery, Oslo University Hospital, Oslo, Norway; Department of Plastic and Reconstructive Surgery, Oslo University Hospital, Oslo, Norway.
Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden.
Int J Cardiol. 2016 May 1;210:80-4. doi: 10.1016/j.ijcard.2016.02.075. Epub 2016 Feb 9.
The use of mammalian target of rapamycin (mTOR) inhibitors have been limited by adverse events (AE), including delayed wound healing. We retrospectively reviewed all AE and serious AE (SAE) in The Scandinavian heart transplant (HTx) everolimus (EVE) de novo trial with early calcineurin (CNI) avoidance (SCHEDULE). The aim of the study was to compare wound complications between EVE and CNI based regimen.
A total of 115 patients (mean age 51 ± 13 years, 73% men) were randomized within five days post-HTx to low dose EVE and reduced dose Cyclosporine (CyA) followed by early CyA withdrawal (EVE group; n=56) or standard CyA regimen (CyA group; n=59). All AE/SAEs were prospectively recorded according to the SCHEDULE study protocol, and re-assessed retrospectively by two independent reviewers. Wound complication as primary endpoint was defined as any complication associated with failure of tissue healing. Secondary endpoint was total number of events involving surgical intervention.
There were no significant differences between the groups with regards to wound complications (EVE=20, CyA=12)(p=0.08) or total surgical events (EVE=38, CyA=34) (p=0.44). Age>54.5 years (median) was an overall risk factor for surgical wound complications regardless of treatment group (p=0.025). There was no difference in the EVE versus CyA group with regards to other surgical events. Majority of events were in 1/3 of the patients.
De novo initiation of EVE and early CyA withdrawal in HTx patients did not show any significant differences in wound complications or in total surgical events. Majority of complications were seen in a small number of patients.
雷帕霉素哺乳动物靶点（mTOR）抑制剂的使用受到不良事件（AE）的限制，包括伤口愈合延迟。我们回顾性分析了斯堪的纳维亚心脏移植（HTx）依维莫司（EVE）起始治疗并早期停用钙调神经磷酸酶抑制剂（CNI）（SCHEDULE）试验中的所有不良事件和严重不良事件（SAE）。本研究的目的是比较EVE方案和基于CNI方案的伤口并发症情况。
共115例患者（平均年龄51±13岁，73%为男性）在心脏移植术后5天内被随机分为低剂量EVE联合减量环孢素（CyA）并早期停用CyA组（EVE组；n = 56）或标准CyA方案组（CyA组；n = 59）。所有不良事件/严重不良事件均根据SCHEDULE研究方案进行前瞻性记录，并由两名独立评审员进行回顾性重新评估。将伤口并发症作为主要终点，定义为与组织愈合失败相关的任何并发症。次要终点是涉及手术干预的事件总数。
两组在伤口并发症方面（EVE组20例，CyA组12例）（p = 0.08）或手术事件总数方面（EVE组38例，CyA组34例）（p = 0.44）无显著差异。无论治疗组如何，年龄>54.5岁（中位数）是手术伤口并发症的总体危险因素（p = 0.025）。EVE组和CyA组在其他手术事件方面无差异。大多数事件发生在1/3的患者中。
心脏移植患者起始使用EVE并早期停用CyA在伤口并发症或手术事件总数方面未显示出任何显著差异。大多数并发症发生在少数患者中。
