3剤併用療法と血管形成術との比較で有益性に差はなかった(LBCT 4/Abstract: 19533)

STREAM:STEMI後の生存率は血栓溶解薬を投与された群と血管形成術を施行された群とで差がなかった
STREAM: Survival following STEMI similar among patients receiving clot-busting medications and those undergoing angioplasty
ST上昇型心筋梗塞(STEMI)後の1年生存率は、最初に血栓溶解薬を投与された患者と迅速に血管形成術を施行された患者とで同等であったとのlate-breaking clinical trialの結果が2013年American Heart Association学会で発表された。Strategic Reperfusion Early After Myocardial Infarction(STREAM)トライアルにはSTEMIを発症したが病院到着1時間以内に血管形成術を施行することができなかった患者1,892人が組み入れられた。研究者らはこれらの患者の半分を、3種類の薬剤(年齢で補正した用量のtenecteplaseボーラス投与、クロピドグレルおよびエノキサパリン)を投与される群に無作為に割り付けた。彼らの症状が持続している場合には、血管形成術を施行した。残り半分の患者は血管形成術および標準的な抗凝固薬の投与を受けた。両群ともに心発作症状出現から3時間以内に治療を受けた。最初に薬剤併用療法を施行された患者のうち2.1%が心疾患や脳卒中などで死亡し、それと比較し最初に血管形成術を施行された群では1.5%であった。この差は有意ではなかった。このスタディの早期には、血栓溶解薬投与群患者の方が治療後30日間に合併症なく生存する確率がやや高かった。今回の最新の結果は、元のスタディの1年間フォローアップの結果を示している。
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The one-year survival rate after an ST-elevation myocardial infarction (STEMI) was similar among people who initially received clot-busting medications and those who immediately underwent angioplasty, according to a late-breaking clinical trial presented at the American Heart Association's Scientific Sessions 2013.

The Strategic Reperfusion Early After Myocardial Infarction (STREAM) Trial included 1,892 people who suffered a STEMI, but weren't able to undergo angioplasty with the first hour of arriving at the hospital. Researchers randomly assigned half of these patients to receive three medications: age-adjusted bolus tenecteplase, clopidogrel and enoxaparin. If their symptoms persisted, they also underwent angioplasty. The other half received angioplasty, and standard anticoagulants.  Both groups were treated within three hours of the onset of heart-attack symptoms.

Among those who first received the combined medications, 2.1 percent died, including from heart disease and stroke, compared to 1.5 percent of those who initially underwent angioplasty. This was not a significant difference.

In an earlier part of the study, patients who received clot-busting medications were slightly more likely to survive without complications 30 days after treatment. These latest findings represent the original study's one-year follow-up.

"In this study, the combined drug strategy proved a reasonable approach to take as an initial treatment immediately after severe heart attack when angioplasty is not immediately available," said Peter Sinnaeve, M.D., Ph.D., the study's lead author and assistant professor of cardiology at the University of Leuven in Belgium.

 The American Heart Association currently recommends clot-busting medication within the first 30 minutes and angioplasty within the first 90 minutes of hospital arrival and continues to review and adapt guidelines as appropriate. The association has developed the Mission Lifeline® program to help improve timely access to appropriate care.

Co-authors are Paul W. Armstrong, M.D.; Anthony H. Gershlick, M.D.; Patrick Goldstein, M.D.; Robert Wilcox, M.D.; Thierry Danays, M.D.; Yves Lambert, M.D.; Vitaly Sulimov, M.D., Ph.D.; Fernando Rosell Ortiz, M.D., Ph.D.; Miodrag Ostojic, M.D., Ph.D.; Robert C. Welsh, M.D.; Antonio C. Carvalho, M.D., Ph.D.; John Nanas, M.D., Ph.D.; Hans-Richard Arntz, M.D., Ph.D.; Sigrun Halvorsen, M.D., Ph.D.; Kurt Huber, M.D.; Stefan Grajek, M.D., Ph.D.; Claudio Fresco, M.D.; Erich Bluhmki, M.D., Ph.D.; Anne Regelin, Ph.D.; Louis Soulat, M.D.; Katleen Vandenberghe, Ph.D.; Kris Bogaerts, Ph.D.; and Frans Van de Werf, M.D., Ph.D. for the STREAM Investigative Team.

Boehringer Ingelheim Pharmaceuticals funded the study.