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Analysis of the COMPARE-AMI trial: First report of long-term safety of CD133+ cells.

COMPARE-AMI 试验分析: 首次报告 CD133 + 细胞的长期安全性。

  • 影响因子:2.01
  • DOI:10.1016/j.ijcard.2020.06.004
  • 作者列表:"Haddad K","Potter BJ","Matteau A","Reeves F","Leclerc G","Rivard A","Gobeil F","Roy DC","Noiseux N","Mansour S
  • 发表时间:2020-06-15
Abstract

BACKGROUND:Data related to long-term safety of intracoronary (IC) injection of CD133+ bone marrow stem cells (BMSC) following an acute myocardial infarction (MI) are still lacking. METHODS:COMPARE-AMI is a double-blind, placebo-controlled phase II clinical trial evaluating the safety and efficacy of IC injection of CD133+ enriched hematopoietic BMSC in patients with ST-elevation myocardial infarction (STEMI) and persistent left ventricular (LV) dysfunction following successful primary percutaneous coronary intervention (PCI). Herein, we report outcomes up to ten years of follow-up. RESULTS:Between November 2007 and July 2012, we enrolled 38 patients in our study. Males were 89% and the median age was 50.5 years. Baseline left ventricular ejection fraction (LVEF) was 40.0%, and 90% of lesions were located in the left anterior descending (LAD) artery. The median follow-up time was 8.5 years IQR [7.9, 10.0]. Using Kaplan-Meier methods, MACE-free survival up to 10 years was 77.3% overall. IC injection of CD133+ BMSC was associated with a similar event-free survival rate compared to placebo (87.8% vs. 66.3%, p = .37). Two cancer cases in each group were recorded. No malignant arrhythmias were observed. CONCLUSIONS:IC injection of CD133+ BMSC is safe up to 10 years of follow-up. The long-term efficacy needs to be confirmed by a larger randomized trial.

摘要

背景: 急性心肌梗死 (MI) 后冠状动脉 (IC) 内注射 CD133 + 骨髓干细胞 (BMSC) 的长期安全性相关数据仍然缺乏。 方法: 比较-AMI 是一种双盲、安慰剂对照 II 期临床试验评价 IC 注射 CD133 + 富集造血 BMSC 治疗 ST 段抬高型心肌梗死 (STEMI) 和持续性左心室 (LV) 患者的安全性和有效性直接经皮冠状动脉介入治疗 (PCI) 成功后的功能障碍。在此,我们报告长达十年的随访结果。 结果: 在 2007 年 11 月至 2012 年 7 月期间,我们在我们的研究中招募了 38 例患者。男性为 89%,中位年龄为 50.5 岁。基线左室射血分数 (LVEF) 为 40.0%,90% 病变位于左前降支 (LAD) 动脉。中位随访时间为 8.5 年 IQR [7.9,10.0]。使用 Kaplan-Meier 方法,长达 10 年的无 MACE 生存率总体为 77.3%。与安慰剂相比,IC 注射 CD133 + BMSC 与无事件生存率相似 (87.8% vs. 66.3%,p =.37)。每组记录两例癌症病例。未观察到恶性心律失常。 结论: IC 注射 CD133 + BMSC 在长达 10 年的随访中是安全的。长期疗效有待更大的随机试验证实。

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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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