遠隔地患者に対するPCIのための移送有益性

NORDISTEMI:長時間の移送により治療が遅延する地域のSTEMI患者に対する血栓溶解術直後の血管形成術は予後を改善する
NORDISTEMI: Immediate angioplasty after fibrinolysis improves outcome of STEMI in areas with very long transfer delays
ノルウェイにおけるST上昇心筋梗塞遠隔治療(NORwegian study on DIstrict treatment of ST-Elevation Myocardial Infarction :NORDISTEMI)の結果がESC 2009において発表され、急性ST上昇心筋梗塞(STEMI)により受診した地方の患者は血栓溶解療法直後に移送し血管形成術を施行した方が、血栓溶解療法後保存的治療を行い地域病院でフォローするよりも予後が良好であることが示された。NORDISTEMIは、PCIを施行するのに長距離の移送を必要とする(距離中央値158km、移送時間中央値130分)ノルウェイの遠隔地域で施行された無作為化多施設スタディである。18~75歳のSTEMI患者計266人に血栓溶解療法を施行し、直後に移送し血管形成術/PCIを施行する群、または地域病院で標準的な管理を行い救助の適応のある場合または臨床的に増悪を認めた場合には移送する群に無作為に割り付けた。その結果、一次複合エンドポイント(死亡、再梗塞、脳卒中または12ヵ月以内の新たな虚血)は早期侵襲治療群において有意な低下は示さなかった(HR 0.72、95%CI 0.44~1.18、p=0.19)。しかし、死亡、再梗塞、または12ヵ月時点での脳卒中の合計は早期侵襲治療群において保存的治療群と比較し有意に少なかった(6.0%対15.9%、HR 0.36、95%CI 0.16~0.81、p=0.01)。出血および梗塞サイズは二群間で差がなく、移送に伴う合併症は少なかった。
Full Text

Results from the NORwegian study on DIstrict treatment of ST-Elevation Myocardial Infarction (NORDISTEMI) show that patients presenting with acute ST-elevation myocardial infarction (STEMI) in rural areas have a better treatment outcome with thrombolysis followed by immediate transfer for angiography than with thrombolysis and conservative, community-hospital follow-up.

NORDISTEMI is the first trial to study the effect of early PCI after fibrinolysis in rural areas with very long transfer delays. The median transfer distance to PCI was 158 km, and median transfer time was 130 minutes. Thrombolysis was given as pre-hospital treatment in 58% of patients; adjunctive anti-thrombotic medication was in accordance with the latest European guidelines. The results of the study suggest that in areas with long transfer delays an early invasive strategy (with angiography following thrombolysis) might be preferable to a more conservative approach.

The NORDISTEMI was a randomized, open, multicentre study conducted in Norway between February 2005 and April 2009. It compared two different strategies after fibrinolysis in a region with long transfer distances to PCI (100-400 km): to transfer all patients for immediate coronary angiography and intervention, or to manage the patients more conservatively.

A total of 266 STEMI patients, aged 18-75 years, received thrombolytic therapy and were randomized to either immediate transfer for angiography/PCI or to standard management in the community hospitals with urgent transfer only for a rescue indication or with clinical deterioration. All patients received aspirin, tenecteplase, enoxaparin and clopidogrel as anti-thrombotic medication.

The results showed a reduction in the primary composite endpoint of death, reinfarction, stroke or new ischemia within 12 months in the early invasive group, but the reduction did not reach statistical significance (hazard ratio 0.72, 95% CI 0.44-1.18, p=0.19). However, the composite of death, reinfarction or stroke at 12 months was significantly reduced in the early invasive group compared to the conservative group (6.0% versus 15.9%, hazard ratio 0.36, 95% CI 0.16-0.81, p=0.01). No significant differences in bleeding or infarct size were observed, and transfer-related complications were few.

Says associate professor Sigrun Halvorsen, the principal investigator of the study: "Our study indicates a potential for improving reperfusion strategies for patients living in rural areas with long transport distances. This may be achieved by applying a well-organized pharmaco-invasive approach, including pre-hospital thrombolysis and rapid transfer to a PCI centre".

NORDISTEMI is the first trial to study the effect of early PCI after fibrinolysis in rural areas with very long transfer delays.