Departments of Surgery and Medicine, Duke University School of Medicine, Durham, North Carolina.
Departments of Surgery and Medicine, Duke University School of Medicine, Durham, North Carolina.
JACC Heart Fail. 2018 Sep;6(9):792-802. doi: 10.1016/j.jchf.2018.05.012. Epub 2018 Jul 11.
The aim of this study was to prospectively evaluate the impact of blood pressure management on stroke rates in patients receiving the HeartWare HVAD System.
The ENDURANCE trial demonstrated noninferiority of the HeartWare HVAD System versus control (HeartMate II) in patients with advanced heart failure ineligible for heart transplantation. However, stroke was more common in HVAD subjects. Post hoc analyses demonstrated increased mean arterial blood pressure as a significant independent risk factor for stroke.
The ENDURANCE Supplemental Trial was a prospective, multicenter evaluation of 465 patients with advanced heart failure ineligible for transplantation, randomized 2:1 to HVAD (n = 308) or control (n = 157). The primary endpoint was the 12-month incidence of transient ischemic attack or stroke with residual deficit 24 weeks post-event. Secondary endpoints included the composite of freedom from death, disabling stroke, and need for device replacement or urgent transplantation, as well as comparisons of stroke or transient ischemic attack rates in HVAD cohorts in ENDURANCE Supplemental and ENDURANCE.
The enhanced blood pressure protocol significantly reduced mean arterial blood pressure. The primary endpoint was not achieved (14.7% with HVAD vs. 12.1% with control, noninferiority [margin 6%] p = 0.14). However, the secondary composite endpoint demonstrated superiority of HVAD (76.1%) versus control (66.9%) (p = 0.04). The incidence of stroke in HVAD subjects was reduced 24.2% in ENDURANCE Supplemental compared with ENDURANCE (p = 0.10), and hemorrhagic cerebrovascular accident was reduced by 50.5% (p = 0.02).
The ENDURANCE Supplemental Trial failed to demonstrate noninferiority of HVAD versus control regarding the pre-specified primary endpoint. However, the trial confirmed that BP management is associated with reduced stroke rates in HVAD subjects. HVAD subjects, relative to control subjects, more commonly achieved the composite endpoint (freedom from death, disabling stroke, and device replacement or urgent transplantation). (A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System [ENDURANCE SUPPLEMENTAL TRIAL] [DT2]; NCT01966458).
本研究旨在前瞻性评估血压管理对接受 HeartWare HVAD 系统治疗的患者中风发生率的影响。
ENDURANCE 试验表明，在不适合心脏移植的晚期心力衰竭患者中，HeartWare HVAD 系统与对照组（HeartMate II）相比非劣效。然而，HVAD 组的中风更为常见。事后分析表明，平均动脉压升高是中风的一个显著独立危险因素。
ENDURANCE 补充试验是一项前瞻性、多中心评估，纳入 465 名不适合移植的晚期心力衰竭患者，随机分为 2:1 接受 HVAD（n=308）或对照组（n=157）治疗。主要终点是事件后 24 周时短暂性脑缺血发作或中风伴残留缺陷的 12 个月发生率。次要终点包括死亡率、致残性中风和设备更换或紧急移植的无事件率，以及 ENDURANCE 补充试验和 ENDURANCE 中 HVAD 队列中风或短暂性脑缺血发作率的比较。
强化血压方案显著降低了平均动脉压。主要终点未达到（HVAD 组为 14.7%，对照组为 12.1%，非劣效性[边界 6%]p=0.14）。然而，次要复合终点显示 HVAD 优于对照组（HVAD 组为 76.1%，对照组为 66.9%）（p=0.04）。与 ENDURANCE 相比，HVAD 组在 ENDURANCE 补充试验中的中风发生率降低了 24.2%（p=0.10），出血性脑血管意外发生率降低了 50.5%（p=0.02）。
ENDURANCE 补充试验未能证明 HVAD 与对照组在预先指定的主要终点上非劣效。然而，该试验证实血压管理与 HVAD 患者中风发生率降低相关。与对照组相比，HVAD 组更常见达到复合终点（免于死亡、致残性中风、设备更换或紧急移植）。
