经导管房间隔分流装置治疗射血分数保留心力衰竭的一年安全性和临床结局：降低心力衰竭患者左心房压力（REDUCE LAP-HF I）试验：一项随机临床试验。
One-Year Safety and Clinical Outcomes of a Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction in the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (REDUCE LAP-HF I) Trial: A Randomized Clinical Trial.
机构信息
Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Associate Editor.
出版信息
JAMA Cardiol. 2018 Oct 1;3(10):968-977. doi: 10.1001/jamacardio.2018.2936.
IMPORTANCE
In patients with heart failure (HF) and left ventricular ejection fraction (LVEF) equal to or greater than 40%, a transcatheter interatrial shunt device (IASD; Corvia Medical) reduces exercise pulmonary capillary wedge pressure (PCWP) and is safe compared with sham control treatment at 1 month of follow-up. The longer-term safety and patency of the IASD has not yet been demonstrated in the setting of a randomized clinical trial (RCT).
OBJECTIVE
To evaluate the 1-year safety and clinical outcomes of the IASD compared with a sham control treatment.
DESIGN, SETTING, AND PARTICIPANTS: This phase 2, double-blind, 1-to-1 sham-controlled multicenter RCT of IASD implantation vs a sham procedure (femoral venous access and imaging of the interatrial septum without IASD) was conducted in 22 centers in the United States, Europe, and Australia on patients with New York Heart Association (NYHA) class III or ambulatory class IV HF, LVEF equal to or greater than 40%, exercise PCWP equal to or greater than 25 mm Hg, and PCWP-right atrial pressure gradient equal to or greater than 5 mm Hg.
MAIN OUTCOMES AND MEASURES
Safety was assessed by major adverse cardiac, cerebrovascular, or renal events (MACCRE). Exploratory outcomes evaluated at 1 year were hospitalizations for HF, NYHA class, quality of life, a 6-minute walk test, and device patency.
RESULTS
After 1 year, shunts were patent in all IASD-treated patients; MACCRE did not differ significantly in the IASD arm (2 of 21 [9.5%]) vs the control arm (5 of 22 [22.7%]; P = .41), and no strokes occurred. The yearly rate of hospitalizations for HF was 0.22 in the IASD arm and 0.63 in the control arm (P = .06). Median improvement in NYHA class was 1 class in the IASD arm (IQR, -1 to 0) vs 0 in the control arm (IQR, -1 to 0; P = .08). Quality of life and 6-minute walk test distance were similar in both groups. At 6 months, there was an increase in right ventricular size in the IASD arm (mean [SD], 7.9 [8.0] mL/m2) vs the control arm (-1.8 [9.6] mL/m2; P = .002), consistent with left-to-right shunting through the device; no further increase occurred in the IASD arm at 12 months.
CONCLUSIONS AND RELEVANCE
The REDUCE LAP-HF I phase 2, sham-controlled RCT confirms the longer-term patency of the IASD. Through 1 year of follow-up, IASD treatment appears safe, with no significant differences in MACCRE in patients receiving IASD compared with those who received sham control treatment.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT02600234.
重要性
在射血分数（LVEF）等于或大于 40%的心力衰竭（HF）和左心室患者中，与假对照治疗相比，经导管房间隔分流装置（IASD；Corvia Medical）可降低运动时肺毛细血管楔压（PCWP），且在 1 个月的随访中是安全的。IASD 的长期安全性和通畅性尚未在随机临床试验（RCT）中得到证实。
目的
评估与假对照治疗相比，IASD 的 1 年安全性和临床结局。
设计、地点和参与者：这项在美国、欧洲和澳大利亚的 22 个中心进行的 2 期、双盲、1:1 假对照、IASD 植入与假手术（股静脉入路和房间隔成像而不植入 IASD）的 RCT 中，纳入了纽约心脏协会（NYHA）心功能 III 级或有活动能力的 IV 级 HF、LVEF 等于或大于 40%、运动时 PCWP 等于或大于 25mmHg 和 PCWP-右心房压力梯度等于或大于 5mmHg 的患者。
主要结局和测量指标
主要不良心、脑、肾事件（MACCRE）评估安全性。在 1 年时评估的探索性结局包括 HF 住院、NYHA 分级、生活质量、6 分钟步行试验和设备通畅性。
结果
1 年后，所有接受 IASD 治疗的患者的分流器均保持通畅；IASD 组（21 例中有 2 例[9.5%]）与对照组（22 例中有 5 例[22.7%]）的 MACCRE 无显著差异（P=0.41），且均未发生卒中。IASD 组的 HF 住院年发生率为 0.22，对照组为 0.63（P=0.06）。IASD 组 NYHA 分级的中位数改善为 1 级（IQR，-1 至 0），对照组为 0 级（IQR，-1 至 0；P=0.08）。两组的生活质量和 6 分钟步行试验距离相似。在 6 个月时，IASD 组的右心室大小增加（平均[标准差]，7.9[8.0]mL/m2），而对照组则减少（-1.8[9.6]mL/m2；P=0.002），这与通过设备的左向右分流一致；在 12 个月时，IASD 组没有进一步增加。
结论和相关性
REDUCE LAP-HF I 期 2 期、假对照 RCT 证实了 IASD 的长期通畅性。在 1 年的随访中，IASD 治疗似乎是安全的，与接受假对照治疗的患者相比，接受 IASD 治疗的患者在 MACCRE 方面没有显著差异。
试验注册
ClinicalTrials.gov 标识符：NCT02600234。
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