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Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
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糖尿病と安定した冠動脈疾患の患者のチカグレロは,以前から皮膚経冠動脈介入 (THEMIS- PCI) を受けた患者で,第3相,プラセボ対照,ランダム化試験

Deepak L Bhatt1, Philippe Gabriel Steg2, Shamir R Mehta3

  • 1Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School Boston, MA, USA.

Lancet (London, England)
|September 6, 2019
PubMed
まとめ

安定した冠動脈疾患の糖尿病患者および前回の皮膚経冠動脈介入 (PCI) の患者において,アスピリンにチカグレロルを添加すると,血栓不全が減少した. この併用治療は,出血のリスクが増加したにもかかわらず,良好な臨床効果を示した.

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科学分野:

  • 心臓病科
  • 薬理学について
  • 糖尿病 管理

背景:

  • 安定した冠動脈疾患 (CAD) や糖尿病 (DM) を患っている患者で,以前に皮膚経冠動脈介入 (PCI) を受けた患者は,不血症のリスクが高い.
  • これらの患者の標準的な治療は,通常アスピリン療法です.

研究 の 目的:

  • 以前PCIを患った安定したCADとDMの患者でアスピリンにチカグレロを添加する効果と安全性を評価する.
  • この高リスク集団におけるこの二重抗血小板治療の臨床的利益を決定する.

主な方法:

  • 糖尿病患者の健康結果に対するチカグレロの効果 介入試験 (THEMIS) は,第3相,ランダム化,ダブルブラインド,プラセボ対照試験でした.
  • 前回のPCIを患った事前のサブグループを分析した (n=11, 154).
  • 患者はチカグレロとアスピリン,またはプラセボとアスピリンを投与され,主効性アウトカムは心血管疾患による死亡,心筋梗塞または脳卒中でした.

主要な成果:

  • アスピリンに添加されたチカグレロは,PCIを患った患者における主要な有効性評価を有意に低下させた (HR 0. 85; p=0. 013).
  • 重度の出血はチカグレロールで増加した (2. 0% 対 1. 1%; p< 0. 0001),しかし致命的な出血と頭蓋内出血の割合は類似した.
  • 前回のPCI群では,チカグレローの臨床効果が好ましいことが示された (9. 3% vs 11. 0%; p=0. 005).

結論:

  • 安定したCADと以前のPCIを有する糖尿病患者では,チカグレロとアスピリンは,不血症イベントを減少させ,純臨床効果を改善します.
  • 長期チカグレロ治療は,低出血リスクの選択された高リスク患者にとって有益である可能性を示唆する出血リスクの増加を考慮する必要があります.
  • この研究は,長期にわたる二重抗血小板療法から利益を得られる大きな,特定可能な集団を特定しています.