Occluded Artery Trial: Long Term Follow-Up

动脉闭塞试验：长期随访

• 批准号: 7871492
• 负责人: Judith S Hochman
• 金额: $ 56.56万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7871492
• 关键词: Age; Ancillary Study; Arteries; Award; Benefits and Risks; Cardiology; Cardiovascular Diseases; Caring; Categories; Cessation of life; Characteristics; Clinical; Clinical Research; Clinical Trials; Collaborations; Communities; Companions; Complex; Congestive Heart Failure; Coronary Occlusions; Coronary artery; Country; Data; Data Analyses; Data Coordinating Center; Databases; Development; EFRAC; Economics; Electrocardiogram; Enrollment; Event; Functional disorder; Funding; Grant; Guidelines; Health; Hospitalization; Howard Temin Award; Infarction; International; Investigation; Investments; Laboratories; Leadership; Left Ventricular Function; Left Ventricular Remodeling; Location; Maryland; Medical; Medical Research; Medical center; Myocardial Infarction; National Heart, Lung, and Blood Institute; New York; Outcome; Patients; Phase; Population; Procedures; Quality of life; Race; Randomized; Recurrence; Research Institute; Research Personnel; Resources; Risk; Risk Factors; SF-36; Site; Specific qualifier value; Subgroup; Symptoms; Testing; Time; United States National Institutes of Health; Universities; Weight; Well in self; Work; acute coronary syndrome; adjudicate; arm; artery occlusion; base; clinical research site; cohort; cost; design; exhaust; follow-up; functional status; high risk; insight; medical schools; operation; outcome forecast; percutaneous coronary intervention; primary outcome; programs; randomized trial; repaired; sex; treatment strategy; trend

DESCRIPTION (provided by applicant): The Occluded Artery Trial (OAT) is an NHLBI-funded international, multicenter, randomized trial testing the hypothesis that percutaneous coronary intervention with optimal medical therapy is superior in reducing clinical events compared to optimal medical therapy alone in stable, but high-risk, post-myocardial infarction patients. OAT patients have totally occluded infarct-related arteries 3-28 days after myocardial infarction (Ml) and at least one additional high risk feature, either reduced left ventricular function (ejection fraction < 50%) or proximal coronary artery occlusion. Patients were randomized between 2000 and 2005 to either medical management or medical management plus percutaneous coronary intervention and stenting. The primary endpoint was a composite of death, class IV congestive heart failure (CHF) and recurrent Ml. After an average of three years of follow up of 2,166 enrolled patients, there was no significant difference between the treatment groups for the primary endpoint. This application for a competitive renewal proposes: A) to extend follow up by an additional 3 years to achieve an average follow up of approximately 6 years on the OAT cohort to examine late trends in events and quality of life and B) to perform additional in depth analyses on the original OAT cohort followed by 3 years. Extended follow up will also increase power to examine prespecified subgroups. Extension of follow up in OAT is designed to provide the medical community with definitive data on the risks and benefits of a strategy of routine PCI of persistently occluded infarct-related arteries in stable patients last post-Mi. OAT has over 200 participating clinical sites, a Clinical Coordinating Center (CCC) at New York University Medical School, a Co-CCC at Mount Sinai Medical Center (Miami), a Data Coordinating Center (DCC) at Maryland Medical Research Institute and an Economics and Quality of Life Coordinating Center at Duke Clinical Research Institute.

描述（由申请人提供）： 动脉闭塞试验 (OAT) 是一项由 NHLBI 资助的国际、多中心、随机试验，测试以下假设：对于稳定但高风险的心肌梗死后患者，经皮冠状动脉介入治疗结合最佳药物治疗比单独采用最佳药物治疗更能减少临床事件。 OAT患者在心肌梗塞(M1)后3-28天具有完全闭塞的梗塞相关动脉，并且具有至少一种额外的高风险特征，左心室功能降低(射血分数<50％)或近端冠状动脉闭塞。 2000 年至 2005 年间，患者被随机分配接受药物治疗或药物治疗加经皮冠状动脉介入治疗和支架置入术。主要终点是死亡、IV级充血性心力衰竭(CHF)和复发性MI的复合终点。对 2,166 名入组患者进行平均三年的随访后，治疗组之间的主要终点没有显着差异。此竞争性更新申请建议：A) 将随访时间再延长 3 年，以实现对 OAT 队列的平均随访时间约为 6 年，以检查事件和生活质量的最新趋势；B) 在 3 年之后对原始 OAT 队列进行额外的深入分析。延长随访也将增强检查预先指定的亚组的能力。 OAT 随访的延长旨在为医学界提供关于对最后 Mi 后稳定患者持续闭塞的梗死相关动脉进行常规 PCI 策略的风险和益处的明确数据。 OAT 拥有 200 多个参与临床中心，其中包括纽约大学医学院的临床协调中心 (CCC)、西奈山医学中心（迈阿密）的 Co-CCC、马里兰州医学研究所的数据协调中心 (DCC) 以及杜克临床研究所的经济和生活质量协调中心。

项目成果

Angiographic and clinical outcomes of drug-eluting versus bare metal stent deployment in the Occluded Artery Trial.

• DOI: 10.1002/ccd.21930
• 发表时间: 2009-05-01
• 期刊: CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS
• 影响因子: 2.3
• 作者: Dzavik, Vladimir;Buller, Christopher E.;Devlin, Gerard;Carere, Ronald G.;Mancini, G. B. John;Cantor, Warren J.;Buszman, Pawel E.;Rankin, James M.;Vozzi, Carlos;Ross, John R.;Forman, Sandra;Barton, Bruce A.;Lamas, A. Gervasio A.;Hochman, Judith S.
• 通讯作者: Hochman, Judith S.

Myocardial perfusion grade after late infarct artery recanalization is associated with global and regional left ventricular function at one year: analysis from the Total Occlusion Study of Canada-2.

晚期梗死动脉再通后的心肌灌注等级与一年时的整体和区域左心室功能相关：来自 Canada-2 完全闭塞研究的分析。

• DOI: 10.1161/circinterventions.109.918722
• 发表时间: 2010
• 期刊: Circulation. Cardiovascular interventions
• 作者: Steigen,TerjeK;Buller,ChristopherE;Mancini,GBJohn;Jorapur,Vinod;Cantor,WarrenJ;Rankin,JamesM;Thomas,Boban;Webb,JohnG;Kronsberg,ShariS;Atchison,DeborahJ;Lamas,GervasioA;Hochman,JudithS;Dzavik,Vladimir
• 通讯作者: Dzavik,Vladimir

Relationship of female sex to outcomes after myocardial infarction with persistent total occlusion of the infarct artery: analysis of the Occluded Artery Trial (OAT).

女性性别与梗塞动脉持续完全闭塞的心肌梗塞后结局的关系：闭塞动脉试验（OAT）分析。

• DOI: 10.1016/j.ahj.2012.01.005
• 发表时间: 2012
• 期刊: American heart journal
• 影响因子: 4.8
• 作者: Reynolds,HarmonyR;Forman,SandraA;Tamis-Holland,JacquelineE;Steg,PhilippeGabriel;Mark,DanielB;Pearte,CamilleA;Carvalho,AntonioC;Sopko,George;Liu,Li;Lamas,GervasioA;Kruk,Mariusz;Loboz-Grudzien,Krystyna;Ruzyllo,Witold;Hochma
• 通讯作者: Hochma

Percutaneous revascularization and long term clinical outcomes of diabetic patients randomized in the Occluded Artery Trial (OAT).

动脉闭塞试验 (OAT) 中随机分配的糖尿病患者的经皮血运重建和长期临床结果。

• DOI: 10.1016/j.ijcard.2013.02.004
• 发表时间: 2013
• 期刊: International journal of cardiology
• 影响因子: 3.5
• 作者: Overgaard,ChristopherB;Džavík,Vladimír;Buller,ChristopherE;Liu,Li;Banasiak,Waldemar;Devlin,Gerard;Maggioni,AldoP;Leor,Jonathan;Burton,JefferyR;Reis,Gilmar;Ruzyllo,Witold;Forman,SandraA;Lamas,GervasioA;Hochman,JudithS;OAT
• 通讯作者: OAT

Impact of percutaneous coronary intervention on biomarker levels in patients in the subacute phase following myocardial infarction: the Occluded Artery Trial (OAT) biomarker ancillary study.

经皮冠状动脉介入治疗对心肌梗死后亚急性期患者生物标志物水平的影响：闭塞动脉试验（OAT）生物标志物辅助研究。

• DOI: 10.1186/1471-2261-13-91
• 发表时间: 2013
• 期刊: BMC cardiovascular disorders
• 影响因子: 2.1
• 作者: Kruk,Mariusz;Menon,Venu;Kądziela,Jacek;Sadowski,Zygmunt;Rużyłło,Witold;Janas,Jadwiga;Roik,Marek;Opolski,Grzegorz;Zmudka,Krzysztof;Czunko,Piotr;Kurowski,Michal;Busz-Papież,Benita;Zinka,Elzbieta;Jablonski,Wojciech;Jaworska,Kryst
• 通讯作者: Jaworska,Kryst