LFFRはPCIガイドの解決策ではない(LBCT.02)

FUTURE：冠血流予備量比ガイド下血管形成術の有益性はほとんどなく有害である可能性がある
FUTURE: Little benefit, possible harm to fractional flow-reserve-guided angioplasty
冠血流予備量比を用いた経皮的冠動脈インターベンションの有益性はほとんどなく有害である可能性がある、と2016年American Heart Association学術集会で発表された。FUTUREトライアルは、無作為化された初めの836例の解析結果から、FFRガイド群における12か月の総死亡率が過剰であった（p=0.02）ため、早期に中止された。中間解析の結果、血管形成術での比較において、FFR群では有意ではない死亡率過剰の傾向があり、FFRの臨床上の有益性は認められないことが示された。研究者らは、複雑な高リスク患者において、FFRは治療方針決定に役立たず、安全上好ましくない徴候と関連があり得る、と結論付けている。
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Using a technique to measure pressure differences across clogged arteries known as fractional flow-reserve (FFR) to guide percutaneous coronary intervention (PCI) in selected patients has been shown to improve clinical outcomes in comparison to medical therapy alone or angioplasty without FFR.  The FUTURE trial was part of a Late Breaking Clinical Trial session at the American Heart Association's Scientific Sessions 2016.

FFR has not been evaluated as a treatment strategy decision tool in multivessel disease patients to choose between PCI, surgery or medical therapy alone.  FUTURE, a multicenter, controlled, randomized trial explored FFR-guided revascularization in comparison with angioplasty alone among patients with multivessel coronary artery disease.

Acute coronary syndrome and stable coronary artery disease consecutive patients were randomized to either FFR-guided management or traditional management.  The primary end point was a composite of major adverse cardiovascular events, including all-cause death, non-fatal heart attack, stroke and repeat coronary revascularization at one year.

The trial was scheduled to include 1,728 patients over 39 centers in France. The study independent data safety monitoring board recommended to stop study enrollment due to an excess in the 12-month all cause mortality (p=0.02) in the FFR-group after analysis of the first 836 randomized patients.

Interim analysis for the 933 included patients (average age 66) showed at least a non-significant excess of mortality trend in the FFR group and no clinical benefit of FFR in comparison with angioplasty.

Researchers conclude that in complex, high-risk patients, FFR may not help for treatment decisions and could be associated with a negative safety signal.