心不全の血液動力学主導治療 (GUIDE-HF):ランダム化対照試験
JoAnn Lindenfeld1, Michael R Zile2, Akshay S Desai3
1Vanderbilt Heart and Vascular Institute, Vanderbilt University Medical Center, Nashville, TN, USA.
Lancet (London, England)
|August 30, 2021
まとめ
心不全の管理のためのリモート肺動脈圧モニタリングは,死亡率または心不全のイベントを全体的に有意に減少させませんでした. しかし,COVID-19以前の分析では,心臓機能不全による入院を減少させる可能性が示唆された.
科学分野:
- 心臓病科
- 医療機器
- 臨床試験
背景:
- 以前の研究では,血液動力学による治療がNYHAクラスIIIの患者の心不全入院を減少させることが示されました.
- NYHAクラスII-IVの患者およびナトリウレチンペプチド値が上昇したものの,最近入院していない患者における効果については不確実性があった.
研究 の 目的:
- 肺動脈圧のリモートモニタリングがNYHAクラスII-IVにおける心不全および死亡率を減少させるかどうかを評価する.
- 最近入院していないナトリウレチンペプチド値が上昇した患者での有効性を評価する.
主な方法:
- 慢性心不全の患者1022人を対象とした多センター単盲ランダム化試験 (GUIDE- HF)
- 患者は肺動脈圧のモニタリングによる血液動力学による管理または通常の治療を受けた.
- 主要エンドポイントは,全因死亡率と12ヶ月の心不全事件の複合です.
主要な成果:
- 総合分析: 主要エンドポイントの有意な減少はありません (HR 0. 88, p=0. 16).
- COVID-19以前の分析: 主要イベントの有意な減少 (HR 0. 81, p=0. 049) と心不全イベントの有意な減少 (HR 0. 76, p=0. 014)
- COVID-19の間:プライマリエンドポイントの差は減少した.グループ間の有意な差はありません (HR 1.11, p=0.53).
結論:
- ヘモダイナミック・ガイデッド・マネジメントは,研究集団全体における複合エンドポイントを有意に低下させなかった.
- COVID-19以前の分析では,主に心不全の入院が減少したことで,潜在的な利益が示唆された.
- COVID-19 パンデミックは,発生率と観察された治療効果に影響を及ぼしたようです.
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