Velders Matthijs A, Abtan Jérémie, Angiolillo Dominick J, Ardissino Diego, Harrington Robert A, Hellkamp Anne, Himmelmann Anders, Husted Steen, Katus Hugo A, Meier Bernhard, Schulte Phillip J, Storey Robert F, Wallentin Lars, Gabriel Steg Philippe, James Stefan K
Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Paris, France.
Heart. 2016 Apr;102(8):617-25. doi: 10.1136/heartjnl-2015-308963. Epub 2016 Feb 4.
The effects of ticagrelor in the subpopulation of patients with ST-elevation myocardial infarction (STEMI) were consistent with those observed in the overall Platelet Inhibition and Patient Outcomes (PLATO) study. However, this subgroup included patients initially or ultimately treated conservatively. The aim of this study is to compare treatment using ticagrelor with treatment using clopidogrel in patients with STEMI undergoing primary percutaneous coronary intervention (PCI).
This post-hoc subgroup analysis compared ticagrelor with clopidogrel in 4949 PLATO patients with STEMI that were treated with primary PCI within 12 h of admission. The primary endpoint was cardiovascular death, myocardial infarction or stroke. The safety endpoint consisted of any major bleeding. Secondary endpoints included stent thrombosis. The analysis was not adequately powered to establish significance of any treatment effects.
During a median of 286 days, the primary endpoint occurred in 7.9% of ticagrelor-treated patients versus 8.6% of clopidogrel-treated patients (HR 0.91, 95% CI 0.75 to 1.12, p=0.38). Major bleeding occurred in 6.7% in ticagrelor-treated patients versus 6.8% of clopidogrel-treated patients (HR 0.97, 95% CI 0.77 to 1.22, p=0.79). No interactions were observed for the treatment effect of ticagrelor versus clopidogrel on the primary efficacy (p=0.40) and primary safety endpoints (p=0.15) as compared with the full PLATO population. Treatment with ticagrelor versus clopidogrel reduced the occurrence of definite stent thrombosis (HR 0.58, 95% CI 0.37 to 0.89, p=0.013).
In the subset of patients with STEMI treated with primary PCI, ticagrelor compared with clopidogrel was safe, and efficacy outcomes were consistent with the overall PLATO trial.
NCT00391872; Results.
替格瑞洛在ST段抬高型心肌梗死（STEMI）患者亚组中的疗效与在整体血小板抑制和患者预后（PLATO）研究中观察到的一致。然而，该亚组包括最初或最终接受保守治疗的患者。本研究的目的是比较替格瑞洛与氯吡格雷在接受直接经皮冠状动脉介入治疗（PCI）的STEMI患者中的治疗效果。
这项事后亚组分析比较了替格瑞洛与氯吡格雷在4949例PLATO研究中入院12小时内接受直接PCI治疗的STEMI患者中的疗效。主要终点是心血管死亡、心肌梗死或卒中。安全终点包括任何严重出血。次要终点包括支架血栓形成。该分析没有足够的效力来确定任何治疗效果的显著性。
在中位286天期间，替格瑞洛治疗组主要终点发生率为7.9%，氯吡格雷治疗组为8.6%（风险比0.91，95%置信区间0.75至1.12，p = 0.38）。替格瑞洛治疗组严重出血发生率为6.7%，氯吡格雷治疗组为6.8%（风险比0.97，95%置信区间0.77至1.22，p = 0.79）。与整个PLATO人群相比，未观察到替格瑞洛与氯吡格雷在主要疗效（p = 0.40）和主要安全终点（p = 0.15）的治疗效果存在相互作用。与氯吡格雷相比，替格瑞洛治疗降低了明确支架血栓形成的发生率（风险比0.58，95%置信区间0.37至0.89，p = 0.013）。
在接受直接PCI治疗的STEMI患者亚组中，与氯吡格雷相比，替格瑞洛是安全的，疗效结果与整体PLATO试验一致。
NCT00391872；结果
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