STEMIにおいてプラスグレルとticagrelorの有効性は同等である(Abstract 5028)
ST上昇急性心筋梗塞（STEMI）患者において、抗血小板薬であるプラスグレルとticagrelorの安全性および有効性は同等であった、とのPRAGUE-18の結果が2016年ESC Congressで発表された。一次エンドポイントは死亡、再狭窄、標的病変緊急血行再建術施行、脳卒中、輸血を要する重症出血、または発症7日後の入院延長で定義された。中間解析において、エンドポイント発現率に両群間で差がなかった（プラスグレル群対ticagrelor 群でそれぞれ4.0% および4.1%；p=0.939）ことから、トライアルは予定より早期に中止された。これは、2剤を直接比較した初のランダム化試験である。
The antiplatelet drugs prasugrel and ticagrelor had similar safety and efficacy among patients with acute myocardial infarction and ST segment elevations (STEMI), according to results of PRAGUE-18, the first randomized, head-to-head comparison of the drugs.
"Our findings confirm previous indirect - non-randomized- comparisons of these two drugs, based on analyses of various registries," commented Petr Widimsky MD, DrSc, from the Cardiocenter of Charles University, in Prague, Czech Republic. "Thus, both drugs are very effective and safe and significantly contribute to the excellent outcomes of patients with acute myocardial infarction in modern cardiology."
The Hot Line study, presented at ESC Congress 2016, randomized 1,230 STEMI patients to receive either prasugrel or ticagrelor prior to primary percutaneous coronary intervention (pPCI).
The primary end-point was defined as death, re-infarction, urgent target vessel revascularization, stroke, serious bleeding requiring transfusion, or prolonged hospitalization at 7 days.
The trial was halted prematurely after an interim analysis showed no difference in the rate of this endpoint between groups (4.0% and 4.1% in the prasugrel and ticagrelor groups, respectively; P=0.939).
There was also no difference between groups in the rate of the key secondary end-point, composed of cardiovascular death, non-fatal myocardial infarction or stroke within 30 days (2.7% and 2.5%, respectively; P=0.864).
"These study results offer more freedom to clinicians to select the antiplatelet agent added on top of aspirin for patients with STEMI who receive dual antiplatelet therapy," commented Prof. Widimsky.
Final follow-up will be at 1 year for all patients, and will be completed in 2017.
The PRAGUE acronym refers to a series of academic randomized trials coordinated by the Cardiocenter, Charles University Prague, starting with PRimary Angioplasty in patients with myocardial infarction transferred from General community hospitals to angioplasty Units of tertiary cardiology centers with or without Emergency thrombolysis (2000).
Administrative costs were covered by the Charles University Cardiovascular Research Program P35. The investigators have no relevant disclosures.
