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 o...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/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.O001, 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.展开更多
文摘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/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.O001, 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.
