Background Primary percutaneous coronary intervention （PCI） has been identified as the first therapeutic option for patients with acute ST-segment elevation myocardial infarction （STEMI）. The strategy of transferr...Background Primary percutaneous coronary intervention （PCI） has been identified as the first therapeutic option for patients with acute ST-segment elevation myocardial infarction （STEMI）. The strategy of transferring patient to a PCI center was recently recommended for those with acute STEMI who were present to PCI incapable hospitals, which include lack of facilities or experienced operators. In China, some local hospitals have been equipped with PCI facilities, but they have no interventional physicians qualified for performing primary PCI. This study was conducted to assess the feasibility, safety and efficacy of the strategy of transferring physician to a PCI-equipped hospital to perform primary PCI for patients with acute STEMI. Methods Three hundred and thirty-four consecutive STEMI patients with symptom presentation 〈12 hours in five local hospitals from November 2005 to November 2007 were randomized to receive primary PCI by either physician transfer （physician transfer group, n=165） or patient transfer （patient transfer group, n=169） strategy. Door-to-balloon time, in-hospital and 30-day major adverse cardiac events （MACE, including death, non-fatal re-infarction, and target vessel revascularization） were compared between the two groups. Results Baseline characteristics between the two groups were comparable. Thrombolysis in myocardial infarction （TIMI） 3 flow was revealed in more patients in the physician transfer group at initial angiography （17.6% vs 10.1%, P〈0.05）. The success rate of primary PCI （96.3% vs 95.4%, P〉0.05） and length of hospital stay were similar between the two groups （（15±4） days vs （14±3） days, P〉0.05）. In the physician transfer group, door-to-balloon time was significantly shortened （（95±20） minutes vs （147±29） minutes, P〈0.0001） and more patients received primary PCI with door-to-balloon time less than 90 minutes （21.2% vs 7.7%, P〈0.001）. During hospitalization, MACE occurred in 6.7% and 11.2% of patients in the physician and patient transfer groups, respectively （P=0.14）. At 30-day clinical follow-up, the occurrence rates of death, non-fatal re-infarction, and target vessel revascularization （TVR） were 3.6% vs 5.9%, 4.2% vs 8.9%, and 1.2% vs 2.4% in the physician and patient transfer groups, respectively （all P〉0.05）. The cumulative composite of MACE was significantly reduced （8.9% vs 17.2%, P=0.03） and MACE free survival （91.0% vs 82.9%, P〈0.05） was significantly improved in the physician transfer group at 30 days. Conclusion The strategy of transferring physician to local hospital to perform primary PCI for patients with acute STEMI is feasible,safe and efficient in reducing the door-to-balloon time and 30-day MACE rate.展开更多
Background Current guidelines support primary percutaneous coronary intervention （primary PCI） as the first treatment of choice （as opposed to thrombolytic therapy） for patients with acute ST-segment elevation myo...Background Current guidelines support primary percutaneous coronary intervention （primary PCI） as the first treatment of choice （as opposed to thrombolytic therapy） for patients with acute ST-segment elevation myocardial infarction （STEMI） especially when delivered within 12 hours of symptom onset. We aimed to evaluate the impact of different clinical pathways on reduction of reperfusion delay and subsequent improvement in outcomes in patients with STEMI. Methods From November 2005 to November 2007, 546 consecutive patients with definite STEMI, who upon arrival at the emergency room were triaged to undergo primary PCI, were included. Of them, 271 patients were brought directly to catheterization laboratory （rapid group）, and 275 patients were admitted to the coronary care unit （CCU） or cardiac ward first, and then transferred to the catheterization laboratory （non-rapid group）. Primary endpoint was door-to-balloon （D2B） time, and secondary endpoints included infarct size assessed by peak CK-MB level and rates of major cardiac adverse events （MACE） including death, reinfarction, or target-vessel revascularization during hospitalization and at 30-day clinical follow-up.Results Baseline clinical characteristics, angiographic features and procedural success rates were comparable between the two groups, except that more patients received glycoprotein lib/Ilia receptor inhibitors before angiography （84.0% and 77.1, P=0.042） and had TIMI 3 flow in the culprit vessel at initial angiogram （17.1% and 9.2%, P=0.007） in the non-rapid group. The D2B time was shortened （（108±44） minutes and （138±31） minutes, P 〈0.0001）, and number of patients with D2B time 〈90 minutes was greater （22.6% and 10.9%, P 〈0.0001） in the rapid group. The advantages associated with rapid intra-hospital transfer were enhanced if the patients presented to the hospital at regular hours. Peak CK-MB level was significantly reduced in the rapid group. In-hospital mortality （4.1% and 5.8%） and cumulative MACE rate （7.0% and 9.8%） did not significantly differ between rapid and non-rapid groups. At 30 days, cumulative death- and MACE-free survival rates were improved in the rapid group （94.5% and 89.5%, P=0.035; 90.1% and 84.0%, P=0.034, respectively）.Conclusions Clinical pathway with bypass of CCU/cardiac ward admission was associated with rapid reperfusion, smaller infarct size, and improved short-term survival for patients with STEMI undergoing primary PCI. In the future, it is essential to reduce the time delay for patients presenting at off-hours.展开更多
Background No randomized trial has been performed to compare the efficacy of an intracoronary bolus of tirofiban versus urokinase during primary percutaneous coronary intervention （PCI）.We investigated whether the e...Background No randomized trial has been performed to compare the efficacy of an intracoronary bolus of tirofiban versus urokinase during primary percutaneous coronary intervention （PCI）.We investigated whether the effects of adjunctive therapy with an intracoronary bolus of urokinase was noninferior to the effects of an intracoronary bolus of tirofiban in patients with ST-elevation myocardial infarction （STEMI） undergoing PCI.Methods A total of 490 patients with acute STEMI undergoing primary PCI were randomized to an intracoronary bolus of tirofiban （10 μg/kg; n=247） or urokinase （250 kU/20 ml; n=243）.Serum levels of P-selectin,von Willebrand factor （vWF）,CD40 ligand （CD40L）,and serum amyloid A （SAA） in the coronary sinus were measured before and after intracoronary drug administration.The primary endpoint was the rate of complete （＞70％） ST-segment resolution （STR） at 90 minutes after intervention,and the noninferiority margin was set to 15％.Results In the intention-to-treat analysis,complete STR was achieved in 54.4％ of patients treated with an intracoronary bolus of urokinase and in 60.6％ of those treated with an intracoronary bolus of tirofiban （adjusted difference：-7.0％;95％ confidence interval：-15.7％ to 1.8％）.The corrected TIMI frame count of the infarct-related artery was lower,left ventricular ejection fraction was higher,and the 6-month major adverse cardiac event-free survival tended to be better in the intracoronary tirofiban group.An intracoronary bolus of tirofiban resulted in lower levels of P-selectin,vWF,CD40L,and SAA in the coronary sinus compared with an intracoronary bolus of urokinase after primary PCI （P＜0.05）.Conclusions An intracoronary bolus of urokinase as an adjunct to primary PCI for acute STEMI is not equally effective to an intracoronary bolus of tirofiban with respect to improvement in myocardial reperfusion assessed by STR.This may be caused by less reduction in coronary circulatory platelet activation and inflammation.展开更多
Background Multiple randomized clinical trials have demonstrated that drug eluting stents can significantly reduce the rates of restenosis and subsequent adverse events across lesion and patient. We investigated the m...Background Multiple randomized clinical trials have demonstrated that drug eluting stents can significantly reduce the rates of restenosis and subsequent adverse events across lesion and patient. We investigated the medium term clinical efficacy and safety of Firebird sirolimus eluting stent （SES） in coronary artery disease. Methods The sample was 509 consecutive patients with coronary artery disease （CAD） who were treated by Firebird SES and finished three-year clinical follow-up. The occurrences of major adverse cardiac events （MACE） and Academic Research Consortium defined stent thrombosis （ST） were evaluated in patients with and without diabetes mellitus. Results Three hundred and thirty three patients （65. 4%） were treated by Firebird SES by off label indications. Angiographic success was achieved in 98.3% of the lesions. MACE and target vessel revascularization rates at 6-month, 1 year＇s and 3 years＇ clinical follow-up were 2.4% and 1.4%, 4.1% and 2.8%, 7.9% and 5.1%, respectively. The cumulative 3-year MACE free survival rate was 92.1%. After 3 years, DM patients had significantly higher rates of MACE （13.7% vs 6.4%, P 〈0.05） and TVR （9.8% vs 4.0%, P 〈0.05） and the cumulative MACE free survival rate was very significantly lower in the DM group （86.4% vs 93;6%, P 〈0.05）. ST occurred in 7 patients （1.4%） at the end of 3 years＇ follow-up, 5 of them had definite ST with 4 cases presenting with myocardial reinfarction and 1 with unstable angina, the other 2 with probable ST had reinfarction in the stented coronary territory without angiographic follow-up. There was no difference in occurrence of ST between off label （1.5%） and on label groups （1.1%, P=-0.07）. Conclusions In daily practice, about 2/3 of patients were treated by Firebird SES by off label indications. Medium term clinical follow-up of 3 years indicated CAD patients treated by Firebird SES had a low MACE and acceptable ST rate. DM patients had higher rates of adverse events and than non DM.展开更多
Background Transradial access has been increasingly used during primary percutaneous coronary intervention （PCI） for patients with acute ST-segment elevation myocardial infarction （STEMI） in last decade. Clinical ...Background Transradial access has been increasingly used during primary percutaneous coronary intervention （PCI） for patients with acute ST-segment elevation myocardial infarction （STEMI） in last decade. Clinical benefits of upstream use of tirfiban therapy in STEMI patients treated by primary PCI have been reported. We investigated the merits of transradial vs. transfemoral access in primary PCI for STEMI patients with upstream use of tirofiban. Methods Patients with STEMI treated with tirofiban between December 2006 and October 2012 then by primary PCI were compared between transradial （n=298） and transfemoral （n=314） access. Baseline demographics, angiographic and PCI features and primary endpoint of major adverse cardiac events （MACE） at 30-day clinical follow-up were recorded. Results Baseline and procedural characteristics were comparable between the two groups, apart from more patients in transradial group had hypertension and were treated by thrombus aspiration during primary PCI. Significantly fewer MACE occurred in the transradial group （5.4%） compared with the transfemoral group （9.9%） at 30-day clinical follow-up. Major bleeding events at 30-day clinical follow-up were 0 in transradial group and in 2.9% of transfemoral group. Multivariate analysis confirmed transradial approach as an independent negative predictor of 30-day MACE （HR 0.68; 95% CI 0.35-0.91; P=0.03）. Conclusions Using transradial approach in primary PCI for acute STEMI infarction patients treated with tirofiban was clearly beneficial in reducing bleeding complications and improving 30-day clinical outcomes.展开更多
文摘Background Primary percutaneous coronary intervention （PCI） has been identified as the first therapeutic option for patients with acute ST-segment elevation myocardial infarction （STEMI）. The strategy of transferring patient to a PCI center was recently recommended for those with acute STEMI who were present to PCI incapable hospitals, which include lack of facilities or experienced operators. In China, some local hospitals have been equipped with PCI facilities, but they have no interventional physicians qualified for performing primary PCI. This study was conducted to assess the feasibility, safety and efficacy of the strategy of transferring physician to a PCI-equipped hospital to perform primary PCI for patients with acute STEMI. Methods Three hundred and thirty-four consecutive STEMI patients with symptom presentation 〈12 hours in five local hospitals from November 2005 to November 2007 were randomized to receive primary PCI by either physician transfer （physician transfer group, n=165） or patient transfer （patient transfer group, n=169） strategy. Door-to-balloon time, in-hospital and 30-day major adverse cardiac events （MACE, including death, non-fatal re-infarction, and target vessel revascularization） were compared between the two groups. Results Baseline characteristics between the two groups were comparable. Thrombolysis in myocardial infarction （TIMI） 3 flow was revealed in more patients in the physician transfer group at initial angiography （17.6% vs 10.1%, P〈0.05）. The success rate of primary PCI （96.3% vs 95.4%, P〉0.05） and length of hospital stay were similar between the two groups （（15±4） days vs （14±3） days, P〉0.05）. In the physician transfer group, door-to-balloon time was significantly shortened （（95±20） minutes vs （147±29） minutes, P〈0.0001） and more patients received primary PCI with door-to-balloon time less than 90 minutes （21.2% vs 7.7%, P〈0.001）. During hospitalization, MACE occurred in 6.7% and 11.2% of patients in the physician and patient transfer groups, respectively （P=0.14）. At 30-day clinical follow-up, the occurrence rates of death, non-fatal re-infarction, and target vessel revascularization （TVR） were 3.6% vs 5.9%, 4.2% vs 8.9%, and 1.2% vs 2.4% in the physician and patient transfer groups, respectively （all P〉0.05）. The cumulative composite of MACE was significantly reduced （8.9% vs 17.2%, P=0.03） and MACE free survival （91.0% vs 82.9%, P〈0.05） was significantly improved in the physician transfer group at 30 days. Conclusion The strategy of transferring physician to local hospital to perform primary PCI for patients with acute STEMI is feasible,safe and efficient in reducing the door-to-balloon time and 30-day MACE rate.
文摘Background Current guidelines support primary percutaneous coronary intervention （primary PCI） as the first treatment of choice （as opposed to thrombolytic therapy） for patients with acute ST-segment elevation myocardial infarction （STEMI） especially when delivered within 12 hours of symptom onset. We aimed to evaluate the impact of different clinical pathways on reduction of reperfusion delay and subsequent improvement in outcomes in patients with STEMI. Methods From November 2005 to November 2007, 546 consecutive patients with definite STEMI, who upon arrival at the emergency room were triaged to undergo primary PCI, were included. Of them, 271 patients were brought directly to catheterization laboratory （rapid group）, and 275 patients were admitted to the coronary care unit （CCU） or cardiac ward first, and then transferred to the catheterization laboratory （non-rapid group）. Primary endpoint was door-to-balloon （D2B） time, and secondary endpoints included infarct size assessed by peak CK-MB level and rates of major cardiac adverse events （MACE） including death, reinfarction, or target-vessel revascularization during hospitalization and at 30-day clinical follow-up.Results Baseline clinical characteristics, angiographic features and procedural success rates were comparable between the two groups, except that more patients received glycoprotein lib/Ilia receptor inhibitors before angiography （84.0% and 77.1, P=0.042） and had TIMI 3 flow in the culprit vessel at initial angiogram （17.1% and 9.2%, P=0.007） in the non-rapid group. The D2B time was shortened （（108±44） minutes and （138±31） minutes, P 〈0.0001）, and number of patients with D2B time 〈90 minutes was greater （22.6% and 10.9%, P 〈0.0001） in the rapid group. The advantages associated with rapid intra-hospital transfer were enhanced if the patients presented to the hospital at regular hours. Peak CK-MB level was significantly reduced in the rapid group. In-hospital mortality （4.1% and 5.8%） and cumulative MACE rate （7.0% and 9.8%） did not significantly differ between rapid and non-rapid groups. At 30 days, cumulative death- and MACE-free survival rates were improved in the rapid group （94.5% and 89.5%, P=0.035; 90.1% and 84.0%, P=0.034, respectively）.Conclusions Clinical pathway with bypass of CCU/cardiac ward admission was associated with rapid reperfusion, smaller infarct size, and improved short-term survival for patients with STEMI undergoing primary PCI. In the future, it is essential to reduce the time delay for patients presenting at off-hours.
基金The study was supported by grants from the Shanghai Science and Technology Foundation （No. 05DZ19503） and the National Natural Science Foundation of China （No. 30900589） Conflict of interest： None
文摘Background No randomized trial has been performed to compare the efficacy of an intracoronary bolus of tirofiban versus urokinase during primary percutaneous coronary intervention （PCI）.We investigated whether the effects of adjunctive therapy with an intracoronary bolus of urokinase was noninferior to the effects of an intracoronary bolus of tirofiban in patients with ST-elevation myocardial infarction （STEMI） undergoing PCI.Methods A total of 490 patients with acute STEMI undergoing primary PCI were randomized to an intracoronary bolus of tirofiban （10 μg/kg; n=247） or urokinase （250 kU/20 ml; n=243）.Serum levels of P-selectin,von Willebrand factor （vWF）,CD40 ligand （CD40L）,and serum amyloid A （SAA） in the coronary sinus were measured before and after intracoronary drug administration.The primary endpoint was the rate of complete （＞70％） ST-segment resolution （STR） at 90 minutes after intervention,and the noninferiority margin was set to 15％.Results In the intention-to-treat analysis,complete STR was achieved in 54.4％ of patients treated with an intracoronary bolus of urokinase and in 60.6％ of those treated with an intracoronary bolus of tirofiban （adjusted difference：-7.0％;95％ confidence interval：-15.7％ to 1.8％）.The corrected TIMI frame count of the infarct-related artery was lower,left ventricular ejection fraction was higher,and the 6-month major adverse cardiac event-free survival tended to be better in the intracoronary tirofiban group.An intracoronary bolus of tirofiban resulted in lower levels of P-selectin,vWF,CD40L,and SAA in the coronary sinus compared with an intracoronary bolus of urokinase after primary PCI （P＜0.05）.Conclusions An intracoronary bolus of urokinase as an adjunct to primary PCI for acute STEMI is not equally effective to an intracoronary bolus of tirofiban with respect to improvement in myocardial reperfusion assessed by STR.This may be caused by less reduction in coronary circulatory platelet activation and inflammation.
文摘Background Multiple randomized clinical trials have demonstrated that drug eluting stents can significantly reduce the rates of restenosis and subsequent adverse events across lesion and patient. We investigated the medium term clinical efficacy and safety of Firebird sirolimus eluting stent （SES） in coronary artery disease. Methods The sample was 509 consecutive patients with coronary artery disease （CAD） who were treated by Firebird SES and finished three-year clinical follow-up. The occurrences of major adverse cardiac events （MACE） and Academic Research Consortium defined stent thrombosis （ST） were evaluated in patients with and without diabetes mellitus. Results Three hundred and thirty three patients （65. 4%） were treated by Firebird SES by off label indications. Angiographic success was achieved in 98.3% of the lesions. MACE and target vessel revascularization rates at 6-month, 1 year＇s and 3 years＇ clinical follow-up were 2.4% and 1.4%, 4.1% and 2.8%, 7.9% and 5.1%, respectively. The cumulative 3-year MACE free survival rate was 92.1%. After 3 years, DM patients had significantly higher rates of MACE （13.7% vs 6.4%, P 〈0.05） and TVR （9.8% vs 4.0%, P 〈0.05） and the cumulative MACE free survival rate was very significantly lower in the DM group （86.4% vs 93;6%, P 〈0.05）. ST occurred in 7 patients （1.4%） at the end of 3 years＇ follow-up, 5 of them had definite ST with 4 cases presenting with myocardial reinfarction and 1 with unstable angina, the other 2 with probable ST had reinfarction in the stented coronary territory without angiographic follow-up. There was no difference in occurrence of ST between off label （1.5%） and on label groups （1.1%, P=-0.07）. Conclusions In daily practice, about 2/3 of patients were treated by Firebird SES by off label indications. Medium term clinical follow-up of 3 years indicated CAD patients treated by Firebird SES had a low MACE and acceptable ST rate. DM patients had higher rates of adverse events and than non DM.
文摘Background Transradial access has been increasingly used during primary percutaneous coronary intervention （PCI） for patients with acute ST-segment elevation myocardial infarction （STEMI） in last decade. Clinical benefits of upstream use of tirfiban therapy in STEMI patients treated by primary PCI have been reported. We investigated the merits of transradial vs. transfemoral access in primary PCI for STEMI patients with upstream use of tirofiban. Methods Patients with STEMI treated with tirofiban between December 2006 and October 2012 then by primary PCI were compared between transradial （n=298） and transfemoral （n=314） access. Baseline demographics, angiographic and PCI features and primary endpoint of major adverse cardiac events （MACE） at 30-day clinical follow-up were recorded. Results Baseline and procedural characteristics were comparable between the two groups, apart from more patients in transradial group had hypertension and were treated by thrombus aspiration during primary PCI. Significantly fewer MACE occurred in the transradial group （5.4%） compared with the transfemoral group （9.9%） at 30-day clinical follow-up. Major bleeding events at 30-day clinical follow-up were 0 in transradial group and in 2.9% of transfemoral group. Multivariate analysis confirmed transradial approach as an independent negative predictor of 30-day MACE （HR 0.68; 95% CI 0.35-0.91; P=0.03）. Conclusions Using transradial approach in primary PCI for acute STEMI infarction patients treated with tirofiban was clearly beneficial in reducing bleeding complications and improving 30-day clinical outcomes.
