Fernández-Avilés Francisco, Alonso Joaquín J, Peña Gonzalo, Blanco Jesús, Alonso-Briales Juan, López-Mesa Juan, Fernández-Vázquez Felipe, Moreu José, Hernández Rosa A, Castro-Beiras Alfonso, Gabriel Rafael, Gibson C Michael, Sánchez Pedro L
Servicio de Cardiología, Hospital General Universitario Gregorio Marañón, C/ Doctor Esquerdo 46, 28007, Madrid, Spain.
Eur Heart J. 2007 Apr;28(8):949-60. doi: 10.1093/eurheartj/ehl461. Epub 2007 Jan 23.
In patients with acute myocardial infarction and ST-segment elevation (STEMI), primary angioplasty is frequently not available or performed beyond the recommended time limit. We designed a non-inferiority, randomized, controlled study to evaluate whether lytic-based early routine angioplasty represents a reasonable reperfusion option for victims of STEMI irrespective of geographic or logistical barriers.
A total of 212 STEMI patients were randomized to full tenecteplase followed by stenting within 3-12 h of randomization (early routine post-fibrinolysis angioplasty; 104 patients), or to undergo primary stenting with abciximab within 3 h of randomization (primary angioplasty; 108 patients). The primary endpoints were epicardial and myocardial reperfusion, and the extent of left ventricular myocardial damage, determined by means of the infarct size and 6-week left ventricular function. The secondary endpoints were the acute incidence of bleeding and the 6-month composite incidence of death, reinfarction, stroke, or revascularization. Early routine post-fibrinolysis angioplasty resulted in higher frequency (21 vs. 6%, P = 0.003) of complete epicardial and myocardial reperfusion (TIMI 3 epicardial flow and TIMI 3 myocardial perfusion and resolution of the initial sum of ST-segment elevation > or = 70%) following angioplasty. Both groups were similar regarding infarct size (area under the curve of CK-MB: 4613 +/- 3373 vs. 4649 +/- 3632 microg/L/h, P = 0.94); 6-week left ventricular function (ejection fraction: 59.0 +/- 11.6 vs. 56.2 +/- 13.2%, P = 0.11; endsystolic volume index: 27.2 +/- 12.8 vs. 29.7 +/- 13.6, P = 0.21); major bleeding (1.9 vs. 2.8%, P = 0.99) and 6-month cumulative incidence of the clinical endpoint (10 vs. 12%, P = 0.57; relative risk: 0.80; 95% confidence interval: 0.37-1.74).
Early routine post-fibrinolysis angioplasty safely results in better myocardial perfusion than primary angioplasty. Despite its later application, this approach seems to be equivalent to primary angioplasty in limiting infarct size and preserving left ventricular function.
在急性ST段抬高型心肌梗死（STEMI）患者中，直接经皮冠状动脉腔内血管成形术（primary angioplasty）常常无法实施或超出推荐时限。我们设计了一项非劣效性随机对照研究，以评估基于溶栓的早期常规血管成形术对于STEMI患者而言，无论地域或后勤保障方面存在何种障碍，是否是一种合理的再灌注选择。
共212例STEMI患者被随机分为两组，一组在随机分组后3 - 12小时接受替奈普酶全量给药随后行支架置入术（早期常规溶栓后血管成形术；104例患者），另一组在随机分组后3小时内行阿昔单抗辅助的直接支架置入术（直接血管成形术；108例患者）。主要终点为心外膜和心肌再灌注，以及左心室心肌损伤程度，通过梗死面积和6周时左心室功能来确定。次要终点为出血的急性发生率以及6个月时死亡、再梗死、卒中或血运重建的综合发生率。早期常规溶栓后血管成形术使血管成形术后完全心外膜和心肌再灌注（TIMI 3级心外膜血流、TIMI 3级心肌灌注以及初始ST段抬高总和降低≥70%）的频率更高（21%对6%，P = 0.003）。两组在梗死面积（肌酸激酶同工酶曲线下面积：4613±3373对4649±3632μg/L/h，P = 0.94）、6周时左心室功能（射血分数：59.0±11.6对56.2±13.2%，P = 0.11；收缩末期容积指数：27.2±12.8对29.7±13.6，P = 0.21）、严重出血（1.9%对2.8%，P = 0.99）以及6个月时临床终点的累积发生率（10%对12%，P = 0.57；相对危险度：0.80；95%置信区间：0.37 - 1.74）方面相似。
早期常规溶栓后血管成形术比直接血管成形术能更安全地实现更好的心肌灌注。尽管其应用时间较晚，但这种方法在限制梗死面积和保留左心室功能方面似乎与直接血管成形术相当。
