了解 ENDURANCE 试验中中风亚型的风险因素和预测因素。
Understanding risk factors and predictors for stroke subtypes in the ENDURANCE trials.
机构信息
Neuroscience Critical Care, Departments of; Neurology, Neurosurgery; Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
出版信息
J Heart Lung Transplant. 2020 Jul;39(7):639-647. doi: 10.1016/j.healun.2020.01.1330. Epub 2020 Jan 29.
BACKGROUND
Stroke is a devastating morbidity associated with left ventricular assist device (LVAD) support. We report a comprehensive analysis of stroke subtypes in the ENDURANCE destination therapy (DT) and ENDURANCE Supplemental (DT2) trials.
METHODS
Patients in the combined HeartWare LVAD (HVAD) cohorts of the DT and DT2 trials were included. Neurologic events included ischemic stroke (ischemic cerebrovascular accident [ICVA]), hemorrhagic stroke (hemorrhagic cerebrovascular accident [HCVA]), and transient ischemic attack (TIA). Peri-operative strokes were defined as occurring within 2 weeks of the implant.
RESULTS
A total of 604 patients received an HVAD in the DT (n = 296) and DT2 (n = 308) trials. Over 2 years, 178 (29.5%) had at least 1 cerebrovascular accident (CVA). Forty-four (7.3%) had HCVAs, 116 (19.2%) had ICVAs, and 44 (7.3%) had TIAs. Thirty (5.0%) had peri-operative stroke. In multivariable analysis, sub-therapeutic international normalized ratio (INR) values were independently associated with peri-operative stroke. Supra- and/or sub-therapeutic INR values, peripheral vascular disease, and presence of left ventricular thrombus were independently associated with ICVA. No aspirin and supra- and/or sub-therapeutic INR values were independently associated with TIA. No aspirin, supra- and/or sub-therapeutic INR values, and prior stroke and/or TIA were associated with HCVA. In further analysis, mean arterial pressure (MAP) was higher in the ICVA (86.8mm Hg, p = 0.002 4) and TIA (88.8mm Hg, p<0.0001) groups, but not in HCVA, than in the No-CVA group (81.4mm Hg). Time in therapeutic range for INR was 65.3% for the No-CVA group, 62.9% (p = 0.59) for HCVA, 65.1% (p = 0.97) for ICVA, and 63.2% (p = 0.62) for TIA.
CONCLUSIONS
Supra- and sub-therapeutic INR values at the time of CVA were associated with all stroke subtypes >14 days post-implant. MAP was higher among those with ICVA and TIA but not with HCVA compared to without CVA. Our study demonstrates the challenges of anti-thrombotic therapy and blood pressure management in LVAD population.
背景
中风是一种与左心室辅助装置（LVAD）支持相关的破坏性发病率。我们报告了 ENDURANCE 治疗（DT）和 ENDURANCE 补充（DT2）试验中中风亚型的综合分析。
方法
纳入了联合 HeartWare LVAD（HVAD）队列的 DT 和 DT2 试验中的患者。神经事件包括缺血性中风（缺血性脑血管意外[ICVA]）、出血性中风（出血性脑血管意外[HCVA]）和短暂性脑缺血发作（TIA）。围手术期中风定义为植入后 2 周内发生。
结果
共有 604 例患者在 DT（n=296）和 DT2（n=308）试验中接受了 HVAD。在 2 年期间，178 例（29.5%）至少发生了 1 次脑血管意外（CVA）。44 例（7.3%）发生 HCVA，116 例（19.2%）发生 ICVA，44 例（7.3%）发生 TIA。30 例（5.0%）发生围手术期中风。多变量分析显示，治疗范围国际标准化比值（INR）值低于治疗范围与围手术期中风独立相关。低于治疗范围和/或高于治疗范围的 INR 值、外周血管疾病和左心室血栓存在与 ICVA 独立相关。未使用阿司匹林和低于治疗范围和/或高于治疗范围的 INR 值与 TIA 独立相关。未使用阿司匹林、低于治疗范围和/或高于治疗范围的 INR 值以及既往中风和/或 TIA 与 HCVA 相关。进一步分析显示，ICVA（86.8mmHg，p=0.0024）和 TIA（88.8mmHg，p<0.0001）组的平均动脉压（MAP）高于无 CVA 组（81.4mmHg），但 HCVA 组无差异（p=0.59）。INR 在治疗范围内的时间为无 CVA 组 65.3%，HCVA 组 62.9%（p=0.59），ICVA 组 65.1%（p=0.97），TIA 组 63.2%（p=0.62）。
结论
中风发生时 INR 值低于治疗范围和高于治疗范围与植入后>14 天的所有中风亚型相关。与无 CVA 相比，ICVA 和 TIA 患者的 MAP 较高，但与 HCVA 患者无差异。我们的研究表明，LVAD 人群的抗血栓治疗和血压管理存在挑战。
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