Background and Objective Previous study showed tenecteplase and alteplaxe were equovalent for 30-day mortality in the treatment of acute myocardial infarction.The purpose of this open-label,randomized,multi-center,ang...Background and Objective Previous study showed tenecteplase and alteplaxe were equovalent for 30-day mortality in the treatment of acute myocardial infarction.The purpose of this open-label,randomized,multi-center,angiographic trial was to assess the efficacy and safety of tenecteplase compared with alteplase in Chinese patients with acute myocardial infarction.Methods We recruited patients with acute ST-elevation myocardial infarction presenting within 6 hours of symptom onset from October,2002 to March,2004,in 5 hospitals in Beijing.After giving informed consent,patients were randomly assigned a single-bolus injection of tenecteplase(30-50 mg according to body weight)or front loaded alteplase(100 mg),and underwent coronary angiography at 90 min after starting the study drug.All patients received aspirin and heparin(target activated partial thromboplastin time 50-70 s).The primary efficacy end point was the rate of TIMI grade 3 flow at 90 minutes.Other efficacy end points included TIMI grade 2/3 flow at 90 minutes.Safety end points included all stroke,intracranial hemorrhage(ICH),moderate/severe hemorrhage(except for ICH),all-cause mortality at 30-days,and major non-fatal cardiac events at 30 days.Results Overall 110 patients were eligible for statistical analysis,with 58 patients assigned to receive tenecteplase and 52 patients to alteplase.Tenecteplase produced a rate of TIMI grade 3 flow at 90 minutes after the start of thrombolysis(68.4%)similar to that of alteplase(66.7%,P=1.0);the rates of TIMI grade 2 or 3 were similar for patients treated with tenecteplase versus alteplase(89.5%versus 80.4%,respectively,P=0.278).At 30 days,rates for all strokes were similar for the two groups(5.17%for tenecteplase and 1.92%for alteplase,P=0.62);rates of ICH were 3.45%and 1.92%(tenecteplase and rt-PA,P=1.00)respectively.The rate of moderate/severe hemorrhage was 8.62%with tenecteplase and 5.77%with alteplase(P=0.72);total mortality was almost identical in the two groups(13.8%versus 9.6%,respectively,P=0.565)while the rates of non-fatal cardiac complications were 10.35%and 11.54%(tenecteplase and alteplase,P=1.0).Conclusions The efficacy of a single-bolus,weight-adjusted tenecteplase fibrinolytic regimen is equivalent to front-loaded alteplase in terms of the rates of TIMI grade 3 flow,and TIMI 2 or 3 flow,but the 30-day mortality and ICH in both groups was so high that the use of tenecteplase is not permitted in China.These negative safety results might be due to the high rate of percutaneous coronary intervention(PCI)and high dose of bolus heparin and suboptimal concomitant medical therapy during hospitalization,so further studies are needed to confirm the safety for tenecteplase in Chinese patients.展开更多
Background：Numerous previous studies have shown that renal insufficiency （RI） in patients with acute coronary syndrome is associated with poor cardiovascular outcomes.These studies do not well address the impact of...Background：Numerous previous studies have shown that renal insufficiency （RI） in patients with acute coronary syndrome is associated with poor cardiovascular outcomes.These studies do not well address the impact of RI on the long-term outcome of patients with acute ST-elevation myocardial infarction （STEMI） in China.The aim of this study was to investigate the association of admission RI and inhospital and long-term mortality of patients with acute STEMI.Methods：This was a multicenter,observational,prospective-cohort study.718 consecutive patients were admitted to 19 hospitals in Beijing within 24 hours of onset of STEMI,between January 1,2006 and December 31,2006.Estimation of glomerular filtration rate （eGFR） was calculated using the modified abbreviated modification of diet in renal disease equation-based on the Chinese chronic kidney disease patients.The patients were categorized according to eGFR,as normal renal dysfunction （eGFR ≥ 90 ml·min^-1·1.73 m^-2）,mild RI （60 ml·min^-1· 1.73 m^-2 〈 eGFR 〈 90 ml·min^-1· 1.73 m^2） and moderate or severe RI （eGFR 〈 60 ml·min^-1· 1.73 m^2）.The association between RI and inhospital and 6-year mortality of was evaluated.Results：Seven hundred and eighteen patients with STEMI were evaluated.There were 551 men and 167 women with a mean age of 61.0 ＆#177; 13.0 years.Two hundred and eighty patients （39.0%） had RI,in which 61 patients （8.5%） reached the level of moderate or severe RI.Patients with RI were more often female,elderly,hypertensive,and more patients had heart failure and stroke with higher killip class.Patients with RI were less likely to present with chest pain.The inhospital mortality （1.4% vs.5.9% vs.22.9%,P 〈 0.001）,6-year all-cause mortality （9.5% vs.19.8 vs.45.2%,P 〈 0.001） and 6-year cardiac mortality （2.9% vs.12.2% vs.23.8%,P 〈 0.001） were markedly increased in patients with RI.After adjusting for other confounding factors,classification of admission renal function was an independent predictor of inhospital mortality （Odd ratio,1.966; 95% confidence interval [CO,1.002-3.070,P =0.019）,6-year all-cause mortality （relative risk [RR] =1.501,95% CI：1.018-4.373,P =0.039） and 6-year cardiac mortality （RR =1.663,95% CI：1.122-4.617,P =0.042）.Conclusions：RI is very common in STEMI patients.RI evaluated by eGFR is an important independent predictor of short-term and long-term outcome in patients with acute STEMI.展开更多
文摘Background and Objective Previous study showed tenecteplase and alteplaxe were equovalent for 30-day mortality in the treatment of acute myocardial infarction.The purpose of this open-label,randomized,multi-center,angiographic trial was to assess the efficacy and safety of tenecteplase compared with alteplase in Chinese patients with acute myocardial infarction.Methods We recruited patients with acute ST-elevation myocardial infarction presenting within 6 hours of symptom onset from October,2002 to March,2004,in 5 hospitals in Beijing.After giving informed consent,patients were randomly assigned a single-bolus injection of tenecteplase(30-50 mg according to body weight)or front loaded alteplase(100 mg),and underwent coronary angiography at 90 min after starting the study drug.All patients received aspirin and heparin(target activated partial thromboplastin time 50-70 s).The primary efficacy end point was the rate of TIMI grade 3 flow at 90 minutes.Other efficacy end points included TIMI grade 2/3 flow at 90 minutes.Safety end points included all stroke,intracranial hemorrhage(ICH),moderate/severe hemorrhage(except for ICH),all-cause mortality at 30-days,and major non-fatal cardiac events at 30 days.Results Overall 110 patients were eligible for statistical analysis,with 58 patients assigned to receive tenecteplase and 52 patients to alteplase.Tenecteplase produced a rate of TIMI grade 3 flow at 90 minutes after the start of thrombolysis(68.4%)similar to that of alteplase(66.7%,P=1.0);the rates of TIMI grade 2 or 3 were similar for patients treated with tenecteplase versus alteplase(89.5%versus 80.4%,respectively,P=0.278).At 30 days,rates for all strokes were similar for the two groups(5.17%for tenecteplase and 1.92%for alteplase,P=0.62);rates of ICH were 3.45%and 1.92%(tenecteplase and rt-PA,P=1.00)respectively.The rate of moderate/severe hemorrhage was 8.62%with tenecteplase and 5.77%with alteplase(P=0.72);total mortality was almost identical in the two groups(13.8%versus 9.6%,respectively,P=0.565)while the rates of non-fatal cardiac complications were 10.35%and 11.54%(tenecteplase and alteplase,P=1.0).Conclusions The efficacy of a single-bolus,weight-adjusted tenecteplase fibrinolytic regimen is equivalent to front-loaded alteplase in terms of the rates of TIMI grade 3 flow,and TIMI 2 or 3 flow,but the 30-day mortality and ICH in both groups was so high that the use of tenecteplase is not permitted in China.These negative safety results might be due to the high rate of percutaneous coronary intervention(PCI)and high dose of bolus heparin and suboptimal concomitant medical therapy during hospitalization,so further studies are needed to confirm the safety for tenecteplase in Chinese patients.
文摘Background：Numerous previous studies have shown that renal insufficiency （RI） in patients with acute coronary syndrome is associated with poor cardiovascular outcomes.These studies do not well address the impact of RI on the long-term outcome of patients with acute ST-elevation myocardial infarction （STEMI） in China.The aim of this study was to investigate the association of admission RI and inhospital and long-term mortality of patients with acute STEMI.Methods：This was a multicenter,observational,prospective-cohort study.718 consecutive patients were admitted to 19 hospitals in Beijing within 24 hours of onset of STEMI,between January 1,2006 and December 31,2006.Estimation of glomerular filtration rate （eGFR） was calculated using the modified abbreviated modification of diet in renal disease equation-based on the Chinese chronic kidney disease patients.The patients were categorized according to eGFR,as normal renal dysfunction （eGFR ≥ 90 ml·min^-1·1.73 m^-2）,mild RI （60 ml·min^-1· 1.73 m^-2 〈 eGFR 〈 90 ml·min^-1· 1.73 m^2） and moderate or severe RI （eGFR 〈 60 ml·min^-1· 1.73 m^2）.The association between RI and inhospital and 6-year mortality of was evaluated.Results：Seven hundred and eighteen patients with STEMI were evaluated.There were 551 men and 167 women with a mean age of 61.0 ＆#177; 13.0 years.Two hundred and eighty patients （39.0%） had RI,in which 61 patients （8.5%） reached the level of moderate or severe RI.Patients with RI were more often female,elderly,hypertensive,and more patients had heart failure and stroke with higher killip class.Patients with RI were less likely to present with chest pain.The inhospital mortality （1.4% vs.5.9% vs.22.9%,P 〈 0.001）,6-year all-cause mortality （9.5% vs.19.8 vs.45.2%,P 〈 0.001） and 6-year cardiac mortality （2.9% vs.12.2% vs.23.8%,P 〈 0.001） were markedly increased in patients with RI.After adjusting for other confounding factors,classification of admission renal function was an independent predictor of inhospital mortality （Odd ratio,1.966; 95% confidence interval [CO,1.002-3.070,P =0.019）,6-year all-cause mortality （relative risk [RR] =1.501,95% CI：1.018-4.373,P =0.039） and 6-year cardiac mortality （RR =1.663,95% CI：1.122-4.617,P =0.042）.Conclusions：RI is very common in STEMI patients.RI evaluated by eGFR is an important independent predictor of short-term and long-term outcome in patients with acute STEMI.
