溶栓治疗联合补救性经皮冠状动脉介入术与直接经皮冠状动脉介入术治疗急性心肌梗死患者的多中心随机临床试验。

Thorombolytic therapy with rescue percutaneous coronary intervention versus primary percutaneous coronary intervention in patients with acute myocardial infarction: a multicenter randomized clinical trial.

机构信息

Department of Cardiology, Cardiovascular Institute & Fu Wai Hospital, Chinese Academy of Medical Sciences, Beijing 100037, China.

出版信息

Chin Med J (Engl). 2010 Jun;123(11):1365-72.

PMID:20819587

Abstract

BACKGROUND

Although thrombolytic therapy with rescue percutaneous coronary intervention (PCI) is a common treatment strategy for ST-segment elevation acute myocardial infarction (STEMI), scant data are available on its efficacy relative to primary PCI, and comparison was therefore the aim of this study.

METHODS

This multicenter, open-label, randomized, parallel trial was conducted in 12 hospitals on patients (age < or = 70 years) with STEMI who presented within 12 hours of symptom onset (mean interval > 3 hours). Patients were randomized to three groups: primary PCI group (n = 101); recombinant staphylokinase (r-Sak) group (n = 104); and recombinant tissue-type plasminogen activator (rt-PA) group (n = 106). For all patients allocated to the thrombolytic therapy arm, coronary angiography was performed at 90 minutes after drug therapy to confirm infarct-related artery (IRA) patency; rescue PCI was performed in cases with TIMI flow grade < or = 2. Bare-metal stent implantation was planned for all patients.

RESULTS

After randomization it required an average of 113.4 minutes to start thrombolytic therapy (door-to-needle time) and 141.2 minutes to perform first balloon inflation in the IRA (door to balloon time). Rates of IRA patency (TIMI flow grade 2 or 3) and TIMI flow grade 3 were significantly lower in the thrombolysis group at 90 minutes after drug therapy than in the primary PCI group at the end of the procedure (70.5% vs. 98.0%, P < 0.0001, and 53.0% vs. 85.9%, P < 0.0001, respectively). Rescue PCI with stenting was performed in 117 patients (55.7%) in the thrombolytic therapy arm. Rates of patency and TIMI flow grade 3 were still significantly lower in the rescue PCI than in the primary PCI group (88.9% vs. 97.9%, P = 0.0222, and 68.4% vs. 85.0%, P = 0.0190, respectively). At 30 days post-therapy, mortality rate was significantly higher in the thrombolysis combined with rescue PCI group than in primary PCI group (7.1% vs. 0, P = 0.0034). Rates of death/MI and bleeding complications were significantly higher in the thrombolysis with rescue PCI group than in the primary PCI group (10.0% vs. 1.0%, P = 0.0380, and 28.10% vs. 8.91%, P = 0.0001, respectively).

CONCLUSIONS

Thrombolytic therapy with rescue PCI was associated with significantly lower rates of coronary patency and TIMI flow grade 3, but with significantly higher rates of mortality, death/MI and hemorrhagic complications at 30 days, as compared with primary PCI in this group of Chinese STEMI patients with late presentation and delayed treatments.

摘要

背景

尽管溶栓联合补救性经皮冠状动脉介入治疗（PCI）是治疗 ST 段抬高型急性心肌梗死（STEMI）的常见策略，但关于其与直接 PCI 相比的疗效数据很少，因此本研究旨在进行比较。

方法

这项多中心、开放标签、随机、平行试验在 12 家医院进行，纳入发病 12 小时内（平均间隔 > 3 小时）的 STEMI 患者（年龄≤70 岁）。患者随机分为三组：直接 PCI 组（n = 101）；重组葡激酶（r-Sak）组（n = 104）；重组组织型纤溶酶原激活剂（rt-PA）组（n = 106）。对于所有接受溶栓治疗的患者，在药物治疗后 90 分钟进行冠状动脉造影以确认梗死相关动脉（IRA）通畅；对于 TIMI 血流分级<或=2 级的患者进行补救性 PCI。所有患者均计划行裸金属支架植入。

结果

随机分组后，溶栓治疗的平均启动时间为 113.4 分钟（门到针时间），IRA 首次球囊扩张的平均时间为 141.2 分钟（门到球囊时间）。药物治疗后 90 分钟，溶栓组 IRA 通畅率（TIMI 血流分级 2 或 3 级）和 TIMI 血流分级 3 级显著低于直接 PCI 组（分别为 70.5%比 98.0%，P < 0.0001，53.0%比 85.9%，P < 0.0001）。溶栓治疗组 117 例（55.7%）患者进行了补救性 PCI 及支架植入。补救性 PCI 组的通畅率和 TIMI 血流分级 3 级仍显著低于直接 PCI 组（分别为 88.9%比 97.9%，P = 0.0222，68.4%比 85.0%，P = 0.0190）。治疗后 30 天，溶栓联合补救性 PCI 组死亡率显著高于直接 PCI 组（7.1%比 0，P = 0.0034）。溶栓联合补救性 PCI 组死亡/心肌梗死（MI）和出血并发症发生率显著高于直接 PCI 组（10.0%比 1.0%，P = 0.0380，28.10%比 8.91%，P = 0.0001）。