对心力衰竭进行心脏间转移治疗:随机RELIEVE-HF试验
Gregg W Stone1, JoAnn Lindenfeld2, Josep Rodés-Cabau3,4
1The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (G.W.S.).
Circulation
|September 23, 2024
概括
在心力衰竭 (HF) 患者中,穿过导管心腔间分离器植入是安全的,但没有改善整体结果. 然而,它对左心室喷射分数 (LVEF) 减少的人有好处,对LVEF保持的人有伤害.
科学领域:
- 心脏病学
- 干预心脏病学
- 心脏衰竭的治疗方法
背景情况:
- 心房间间隔分流的目的是降低左心房压力,改善心力衰竭 (HF) 的症状和预后.
- 本研究研究了在HF患者中通过导管进行心脏间分流植入的疗效和安全性.
研究的目的:
- 在有症状的HF患者中评估穿透管心腔间分流器植入的安全性和有效性.
- 通过左心室喷射分数 (LVEF) 状态分层评估结果 (减少或保留).
主要方法:
- 在508名HF患者中,随机对照试验比较了心房间间的分流植入与安慰剂手术.
- 通过LVEF对患者进行分层 (≤40%降低,>40%保持).
- 通过30天的重大不良事件来评估主要安全性;通过2年的分层综合结果来评估主要有效性.
主要成果:
- 没有发生主要安全事件;分流植入是安全的 (1.5%的上置信限).
- 在分离组和安慰剂组之间的2年初级疗效结果没有显著差异 (胜率0.86,P=0.20).
- 减少LVEF患者的心血管事件较少 (RR0. 55,P< 0. 0001),而保持LVEF患者的心血管事件较多 (RR1. 68,P= 0. 0001).
结论:
- 通过导管插入心房间的分流装置是安全的,但不会改善整体HF结果.
- 探索性分析表明,在低 LVEF HF 患者中可能有益处,在保持 LVEF HF 患者中可能有危害.
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