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

GAO Run-lin L(U) Shu-zheng WEI Meng ZENG Ding-yin CHEN Ji-lin QIN Xue-wen XU Bo DU Chang-hui HAN Ya-ling YANG Xin-chun MAO Jie-ming FANG Wei-yi WANG Lei SHEN Wei-feng LI Zhan-quan JIA Guo-liang

中华医学杂志（英文版）2010，Vol.123Issue(11)：1365-1372,8.

中华医学杂志（英文版）2010，Vol.123Issue(11)：1365-1372,8.DOI:10.3760/cma.j.issn.0366-6999.2010.11.002

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

GAO Run-lin ¹L(U) Shu-zheng ²WEI Meng ³ZENG Ding-yin ⁴CHEN Ji-lin ¹QIN Xue-wen ¹XU Bo ¹DU Chang-hui ⁵HAN Ya-ling ⁶YANG Xin-chun ⁷MAO Jie-ming ⁸FANG Wei-yi ⁹WANG Lei ¹⁰SHEN Wei-feng ¹¹LI Zhan-quan ¹²JIA Guo-liang¹³

作者信息

1. Department of Cardiology, Cardiovascular Institute & Fu Wai Hospital, Chinese Academy of Medical Sciences, Beijing 100037, China
2. Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China
3. Department of Cardiology, Shanghai Sixth People's Hospital, Shanghai 200233, China
4. Department of Cardiology, First Affiliated Hospital of China Medical University, Shenyang 110001, China
5. Western China Public Health Institute, Sichuan University, Chengdu, Sichuan 610041, China
6. Department of Cardiology, Shenyang Northern Hospital, Shenyang, Liaoning 110840, China
7. Department of Cardiology, Beijing Chaoyang Hospital, Beijing 100020, China
8. Department of Cardiology, Peking University Third Hospital, Beijing 100083, China
9. Department of Cardiology, First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China
10. Department of Cardiology, Beijing Friendship Hospital, Beijing 100050, China
11. Department of Cardiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
12. Department of Cardiology, Liaoning Provincial People's Hospital, Shenyang, Liaoning 110016, China
13. Department of Cardiology, Xijing Hospital, Forth Military Medical University, Xi'an, Shaanxi 710032, China
折叠

摘要

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 ≤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 ≤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/Ml 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/Ml and hemorrhagic complications at 30 days, as compared with primary PCI in this group of Chinese STEMI patients with late presentation and delayed treatments.

关键词

acute myocardial infarction/ thorombolytic therapy/ rescue percutaneous coronary intervention/ primary percutaneous coronary intervention

Key words

acute myocardial infarction/ thorombolytic therapy/ rescue percutaneous coronary intervention/ primary percutaneous coronary intervention

引用本文复制引用

GAO Run-lin,L(U) Shu-zheng,WEI Meng,ZENG Ding-yin,CHEN Ji-lin,QIN Xue-wen,XU Bo,DU Chang-hui,HAN Ya-ling,YANG Xin-chun,MAO Jie-ming,FANG Wei-yi,WANG Lei,SHEN Wei-feng,LI Zhan-quan,JIA Guo-liang..Thorombolytic therapy with rescue percutaneous coronary intervention versus primary percutaneous coronary intervention in patients with acute myocardial infarction: a multicenter randomized clinical trial[J].中华医学杂志（英文版）,2010,123(11):1365-1372,8.

基金项目

There is no potential conflict of interests in this study.This study was funded by the National Tenth Five Key Project of Ministry of Science and Technology of China (No. 2001 BA703B10). （No. 2001 BA703B10）

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