急性心肌梗死伴或不伴支架植入的冠状动脉血管成形术。心肌梗死支架直接血管成形术研究组。

Coronary angioplasty with or without stent implantation for acute myocardial infarction. Stent Primary Angioplasty in Myocardial Infarction Study Group.

作者信息

Grines C L, Cox D A, Stone G W, Garcia E, Mattos L A, Giambartolomei A, Brodie B R, Madonna O, Eijgelshoven M, Lansky A J, O'Neill W W, Morice M C

机构信息

Division of Cardiology, William Beaumont Hospital, Royal Oak, Mich 48073-6769, USA.

出版信息

N Engl J Med. 1999 Dec 23;341(26):1949-56. doi: 10.1056/NEJM199912233412601.

DOI:10.1056/NEJM199912233412601

PMID:10607811

Abstract

BACKGROUND

Coronary-stent implantation is frequently performed for treatment of acute myocardial infarction. However, few studies have compared stent implantation with primary angioplasty alone.

METHODS

We designed a multicenter study to compare primary angioplasty with angioplasty accompanied by implantation of a heparin-coated Palmaz-Schatz stent. Patients with acute myocardial infarction underwent emergency catheterization and angioplasty. Those with vessels suitable for stenting were randomly assigned to undergo angioplasty with stenting (452 patients) or angioplasty alone (448 patients).

RESULTS

The mean (+/-SD) minimal luminal diameter was larger after stenting than after angioplasty alone (2.56+/-0.44 mm vs. 2.12+/-0.45 mm, P<0.001), although fewer patients assigned to stenting had grade 3 blood flow (according to the classification of the Thrombolysis in Myocardial Infarction trial) (89.4 percent, vs. 92.7 percent in the angioplasty group; P=0.10). After six months, fewer patients in the stent group than in the angioplasty group had angina (11.3 percent vs. 16.9 percent, P=0.02) or needed target-vessel revascularization because of ischemia (7.7 percent vs. 17.0 percent, P<0.001). In addition, the combined primary end point of death, reinfarction, disabling stroke, or target-vessel revascularization because of ischemia occurred in fewer patients in the stent group than in the angioplasty group (12.6 percent vs. 20.1 percent, P<0.01). The decrease in the combined end point was due entirely to the decreased need for target-vessel revascularization. The six-month mortality rates were 4.2 percent in the stent group and 2.7 percent in the angioplasty group (P=0.27). Angiographic follow-up at 6.5 months demonstrated a lower incidence of restenosis in the stent group than in the angioplasty group (20.3 percent vs. 33.5 percent, P<0.001).

CONCLUSIONS

In patients with acute myocardial infarction, routine implantation of a stent has clinical benefits beyond those of primary coronary angioplasty alone.

摘要

背景

冠状动脉支架植入术常用于治疗急性心肌梗死。然而，很少有研究比较支架植入术与单纯直接血管成形术。

方法

我们设计了一项多中心研究，比较直接血管成形术与血管成形术联合肝素涂层的帕尔马兹-施查茨支架植入术。急性心肌梗死患者接受紧急导管插入术和血管成形术。血管适合植入支架的患者被随机分配接受带支架血管成形术（452例患者）或单纯血管成形术（448例患者）。

结果

尽管分配到支架植入组的患者中达到3级血流（根据心肌梗死溶栓试验的分类）的较少（89.4%，血管成形术组为92.7%；P = 0.10），但支架植入术后的平均（±标准差）最小管腔直径大于单纯血管成形术后（2.56±0.44 mm对2.12±0.45 mm，P<0.001）。6个月后，支架组发生心绞痛的患者少于血管成形术组（11.3%对16.9%，P = 0.02），或因缺血需要靶血管血运重建的患者也少于血管成形术组（7.7%对17.0%，P<0.001）。此外，支架组因死亡、再梗死、致残性中风或因缺血进行靶血管血运重建组成的联合主要终点事件的患者少于血管成形术组（12.6%对20.1%，P<0.01）。联合终点的降低完全归因于靶血管血运重建需求的减少。支架组6个月死亡率为4.2%，血管成形术组为2.7%（P = 0.27）。6.5个月时的血管造影随访显示，支架组再狭窄发生率低于血管成形术组（20.3%对33.5%，P<0.001）。