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Safety and efficacy of bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes with positive biomarkers undergoing percutaneous coronary intervention: a report from the Acute Catheterization and Urgent Intervention Triag

比伐卢定单药治疗经皮冠状动脉介入治疗生物标志物阳性的非 ST 段抬高型急性冠状动脉综合征患者的安全性和有效性: 急性导管插入术和紧急介入治疗报告

  • 影响因子:1.21
  • DOI:10.1097/MCA.0000000000000737
  • 作者列表:"Huang X","Chen S","Redfors B","Zhang Y","Souza CF","Mehran R","Bansilal S","Kirtane AJ","Brener SJ","Feite F","Dangas GD","Ben-Yehuda O","Stone GW
  • 发表时间:2020-01-01
Abstract

OBJECTIVES:There are limited data on bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) with positive biomarkers of myocardial necrosis (troponin and/or creatine kinase-myocardial band isoenzyme). We sought to evaluate the safety and efficacy of bivalirudin monotherapy in patients with positive biomarkers from the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. PATIENTS AND METHODS:We compared the net adverse clinical events [composite ischemia - (death, myocardial infarction, or unplanned ischemic revascularization) - or noncoronary artery bypass graft surgery (CABG)-related major bleeding] among patients with biomarker-positive NSTE-ACS in the ACUITY trial overall and by antithrombotic strategy. RESULTS:Among 13 819 patients with NSTE-ACS enrolled in ACUITY, 4728 patients presented with positive biomarkers and underwent an early invasive strategy. Of those, 1547 were randomized to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI), 1555 to bivalirudin plus GPI, and 1626 to bivalirudin monotherapy. Compared with biomarker-negative patients, biomarker-positive patients had higher 30-day rates of net adverse clinical events (14.0 vs. 12.4%; P = 0.04), all-cause death (1.3 vs. 0.5%; P = 0.001), cardiac death (1.1 vs. 0.5%; P = 0.005), and non-CABG-related major bleeding (6.5 vs. 5.2%, P = 0.03). At 30 days, bivalirudin monotherapy was associated with significantly less non-CABG-related major bleeding (bivalirudin monotherapy 4.1% vs. bivalirudin plus GPI 8.4% vs. heparin plus GPI 7.1%) with comparable rates of composite ischemia (bivalirudin monotherapy 9.2% vs. bivalirudin plus GPI 9.9% vs. heparin plus GPI 8.4%). In a multivariable model, bivalirudin monotherapy was associated with a significant reduction in non-CABG-related major bleeding but was not associated with an increased risk of death, myocardial infarction, unplanned revascularization or stent thrombosis. CONCLUSION:Compared with heparin plus GPI or bivalirudin plus GPI, bivalirudin monotherapy provides similar protection from ischemic events with less major bleeding at 30 days among patients with NSTE-ACS and positive biomarkers.

摘要

目的: 比伐卢定单药治疗非 ST 段抬高型急性冠状动脉综合征 (NSTE-ACS) 的数据有限具有心肌坏死的阳性生物标志物 (肌钙蛋白和/或肌酸激酶-心肌带同工酶)。我们试图评价比伐卢定单药治疗急性导尿和紧急干预分诊策略 (ACUITY) 试验中生物标志物阳性患者的安全性和有效性。 患者和方法: 我们比较了净不良临床事件 [复合缺血-(死亡、心肌梗死或计划外缺血性血运重建)-或非冠状动脉旁路移植手术 (CABG) -相关大出血] 总体和抗血栓治疗策略中生物标志物阳性 NSTE-ACS 患者。 结果: 在纳入 ACUITY 的 13 819 例 NSTE-ACS 患者中,4728 例患者呈现阳性生物标志物,并接受了早期侵入性策略。其中,1547 被随机分配到肝素加糖蛋白 IIb/IIIa 抑制剂 (GPI),1555 被随机分配到比伐卢定加 GPI,1626 被随机分配到比伐卢定单药治疗。与生物标志物阴性患者相比,生物标志物阳性患者的 30 天净不良临床事件发生率较高 (14.0 vs. 12.4%; p = 0.04),全因死亡 (1.3 vs. 0.5%; p = 0.001),心源性死亡 (1.1 vs. 0.5%; p = 0.005) 和非 CABG 相关大出血 (6.5 vs. 5.2%,p = 0.03)。30 天,比伐卢定单药治疗与非 CABG 相关大出血明显较少相关 (比伐卢定单药治疗 4.1% vs. 比伐卢定加 GPI 8.4% vs. 肝素加 GPI 7.1%),复合缺血发生率相当 (比伐卢定单药治疗 9.2% vs. 比伐卢定加 GPI 9.9% vs. 肝素加 GPI 8.4%)。在多变量模型中,比伐卢定单药治疗与非 CABG 相关大出血显著减少相关,但与死亡、心肌梗死、计划外血运重建或支架内血栓形成。 结论: 与肝素加 GPI 或比伐卢定加 GPI 相比,比伐卢定单药治疗对 NSTE-ACS 患者和阳性生物标志物患者 30 天的大出血较少,对缺血事件的保护作用相似。

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相关文献
影响因子:3.90
发表时间:2020-01-01
DOI:10.1055/s-0039-1700546
作者列表:["Tavenier AH","Hermanides RS","Fabris E","Lapostolle F","Silvain J","Ten Berg JM","Lassen JF","Bolognese L","Cantor WJ","Cequier Á","Chettibi M","Goodman SG","Hammett CJ","Huber K","Janzon M","Merkely B","Storey RF","Zeymer U","Ecollan P","Collet JP","Willems FF","Diallo A","Vicaut E","Hamm CW","Montalescot G","van 't Hof AWJ","ATLANTIC investigators."]

METHODS:BACKGROUND: Glycoprotein IIb/IIIa inhibitors (GPIs) in combination with clopidogrel improve clinical outcome in ST-elevation myocardial infarction (STEMI); however, finding a balance that minimizes both thrombotic and bleeding risk remains fundamental. The efficacy and safety of GPI in addition to ticagrelor, a more potent P2Y12-inhibitor, have not been fully investigated. METHODS: 1,630 STEMI patients who underwent primary percutaneous coronary intervention (PCI) were analyzed in this subanalysis of the ATLANTIC trial. Patients were divided in three groups: no GPI, GPI administration routinely before primary PCI, and GPI administration in bailout situations. The primary efficacy outcome was a composite of death, myocardial infarction, urgent target revascularization, and definite stent thrombosis at 30 days. The safety outcome was non-coronary artery bypass graft (CABG)-related PLATO major bleeding at 30 days. RESULTS: Compared with no GPI (n = 930), routine GPI (n = 525) or bailout GPI (n = 175) was not associated with an improved primary efficacy outcome (4.2% no GPI vs. 4.0% routine GPI vs. 6.9% bailout GPI; p = 0.58). After multivariate analysis, the use of GPI in bailout situations was associated with a higher incidence of non-CABG-related bleeding compared with no GPI (odds ratio [OR] 2.96, 95% confidence interval [CI] 1.32-6.64; p = 0.03). However, routine GPI use compared with no GPI was not associated with a significant increase in bleeding (OR 1.78, 95% CI 0.88-3.61; p = 0.92). CONCLUSION: Use of GPIs in addition to ticagrelor in STEMI patients was not associated with an improvement in 30-day ischemic outcome. A significant increase in 30-day non-CABG-related PLATO major bleeding was seen in patients who received GPIs in a bailout situation.

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影响因子:1.21
发表时间:2020-01-01
DOI:10.1097/MCA.0000000000000737
作者列表:["Huang X","Chen S","Redfors B","Zhang Y","Souza CF","Mehran R","Bansilal S","Kirtane AJ","Brener SJ","Feite F","Dangas GD","Ben-Yehuda O","Stone GW"]

METHODS:OBJECTIVES:There are limited data on bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) with positive biomarkers of myocardial necrosis (troponin and/or creatine kinase-myocardial band isoenzyme). We sought to evaluate the safety and efficacy of bivalirudin monotherapy in patients with positive biomarkers from the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. PATIENTS AND METHODS:We compared the net adverse clinical events [composite ischemia - (death, myocardial infarction, or unplanned ischemic revascularization) - or noncoronary artery bypass graft surgery (CABG)-related major bleeding] among patients with biomarker-positive NSTE-ACS in the ACUITY trial overall and by antithrombotic strategy. RESULTS:Among 13 819 patients with NSTE-ACS enrolled in ACUITY, 4728 patients presented with positive biomarkers and underwent an early invasive strategy. Of those, 1547 were randomized to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI), 1555 to bivalirudin plus GPI, and 1626 to bivalirudin monotherapy. Compared with biomarker-negative patients, biomarker-positive patients had higher 30-day rates of net adverse clinical events (14.0 vs. 12.4%; P = 0.04), all-cause death (1.3 vs. 0.5%; P = 0.001), cardiac death (1.1 vs. 0.5%; P = 0.005), and non-CABG-related major bleeding (6.5 vs. 5.2%, P = 0.03). At 30 days, bivalirudin monotherapy was associated with significantly less non-CABG-related major bleeding (bivalirudin monotherapy 4.1% vs. bivalirudin plus GPI 8.4% vs. heparin plus GPI 7.1%) with comparable rates of composite ischemia (bivalirudin monotherapy 9.2% vs. bivalirudin plus GPI 9.9% vs. heparin plus GPI 8.4%). In a multivariable model, bivalirudin monotherapy was associated with a significant reduction in non-CABG-related major bleeding but was not associated with an increased risk of death, myocardial infarction, unplanned revascularization or stent thrombosis. CONCLUSION:Compared with heparin plus GPI or bivalirudin plus GPI, bivalirudin monotherapy provides similar protection from ischemic events with less major bleeding at 30 days among patients with NSTE-ACS and positive biomarkers.

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影响因子:2.86
发表时间:2020-01-01
DOI:10.1016/j.amjcard.2019.09.045
作者列表:["Ravi V","Pulipati P","Vij A","Kodumuri V"]

METHODS:Atrial fibrillation (AF) and concomitant coronary artery disease (CAD) create a therapeutic dilemma as the risk of bleeding with triple antithrombotic therapy (TATT) must be balanced against the risk of ischemic events with double antithrombotic therapy (DATT). The aim of this meta-analysis is to compare the efficacy and safety of DATT versus TATT in AF and CAD. MEDLINE, Cochrane, and ClinicalTrials.gov databases were searched for relevant articles published from inception to May 1, 2019. Studies comparing the safety and efficacy of DATT versus TATT in patients with AF and CAD were included. Among 9 studies, where 6,104 patients received DATT and 7,333 patients received TATT, there was no statistically significant difference in the outcomes of mortality, nonfatal myocardial infarction, stent thrombosis, and stroke. There was a lower rate of major bleeding in DATT (risk ratio [RR] 0.64 [95% confidence interval [CI] 0.54 to 0.75]; p <0.001). There was no significant difference in stent thrombosis (RR 1.52 [95% CI 0.97 to 2.38]; p = 0.07). However, subgroup analysis of trials with direct oral anticoagulant use demonstrated a borderline higher rate of stent thrombosis in DATT (RR 1.66 [95% CI 1.01 to 2.73]; p = 0.05). In conclusion, DATT showed no difference in the outcomes of mortality, stroke, nonfatal myocardial infarction, and stent thrombosis compared with TATT. DATT demonstrated a lower rate of major bleeding. DATT demonstrated a borderline higher rate of stent thrombosis in the subgroup analysis of trials with direct oral anticoagulant which needs to be evaluated in further studies.

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