Hybrid Coronary Revascularization Trial- DCC

混合冠状动脉血运重建试验 - DCC

• 批准号: 9534725
• 负责人: Emilia Bagiella
• 金额: $ 166.44万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-15 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9534725
• 关键词: Address; Admission activity; Adopted; Adoption; Agreement; Amendment; American; Anatomy; Anterior; Anterior Descending Coronary Artery; Archives; Arteries; Cardiac; Cardiac Surgery procedures; Cardiology; Cardiovascular system; Case Report Form; Cause of Death; Clinical; Clinical Data; Clinical Investigator; Clinical Management; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Collaborations; Collection; Communication; Coronary; Coronary Arteriosclerosis; Coronary Artery Bypass; Coronary Stenosis; Coronary Vessels; Coronary artery; Country; Data; Data Collection; Data Coordinating Center; Data Quality; Effectiveness; Enrollment; Ensure; Equipoise; Event; Foundations; Funding; Health Status; Hybrids; Individual; Institutional Review Boards; Ischemia; Knowledge; Leadership; Left; Letters; Link; Manuals; Measures; Mediation; Methods; Monitor; Morbidity - disease rate; Myocardial Infarction; National Heart, Lung, and Blood Institute; Observational Study; Online Systems; Operative Surgical Procedures; Organ Transplantation; Outcome; Outcome Measure; Patient Recruitments; Patients; Pharmaceutical Preparations; Phase; Principal Investigator; Procedures; Process; Protocols documentation; Publications; Quality of life; Randomized; Randomized Controlled Trials; Recovery; Registries; Reporting; Research Personnel; Resources; Safety; Services; Site; Societies; Solid; Stents; Stroke; Surgeon; Surrogate Endpoint; System; Teleconferences; Telephone; Thoracic Surgeon; Time; Training; United States; United States National Institutes of Health; Validation; Work; adjudication; cerebrovascular; clinical practice; clinical research site; college; cost effective; cost effectiveness; data integrity; data management; data registry; design; dissemination research; evidence base; experience; follow-up; health care service utilization; improved; innovation; internal thoracic artery; intervention cost; meetings; minimally invasive; mortality; operation; patient population; percutaneous coronary intervention; primary endpoint; primary outcome; programs; public health relevance; quality assurance; randomized trial; recruit; research data dissemination; screening; secondary outcome; trial design

 DESCRIPTION (provided by applicant): Summary/Abstract Hybrid coronary revascularization (HCR) is the intentional combination of minimally invasive surgical grafting of the left anterior descending artery (LAD) coronary artery using the left internal mammary artery (LIMA) with percutaneous coronary intervention (PCI) of non-LAD coronary stenosis. HCR procedures are being adopted by clinicians nationwide, in an effort to reduce morbidity, mortality, recovery time, repeat re-interventions, and the costs of revascularization for patients with multi-vessel coronary artery disease (CAD) involving the LAD and/or left main coronary arteries. To date, there has been no randomized controlled trial to establish whether HCR achieves these results, and increasing adoption of HCR is proceeding without a solid evidence base. The proposed trial is designed to fill this knowledge gap and provide an evidence base for clinical practice. We propose a pragmatic, large-scale clinical trial that evaluates the effectiveness and safety of HCR compared to multi-vessel PCI. The trial will enroll 2354 patients with multi-vessel CAD involving the LAD distribution and a clinical indication for revascularization, who are eligible for both HCR and multi-vessel PCI with drug eluting stents. The primary outcome will be occurrence of MACCE, defined as all-cause mortality, myocardial infarction, stroke, and repeat revascularization over a minimum of 5 year follow-up after randomization. A vanguard phase will be conducted over the first year of the trial to establish feasibility of enrollment and data completeness of centralized collection of MACCE events. The innovative design of the trial combines collection and adjudication of minimal trial-specific data with national registry data (STS and NCDR), resulting in a streamlined and very cost-effective trial. A previous NIH-funded observational study (RC1 HL100951-01, Principal Investigators, J. Puskas, D. Ascheim), informing the design of this trial, demonstrated that 10-15% of patients with CAD are anatomically eligible for HCR and confirmed that equipoise exists among cardiologists and surgeons to randomize such patients. To conduct this trial, we have assembled a Hybrid Trial Network of 49 selected clinical sites experienced in multi-vessel PCI, minimally invasive LIMA-LAD grafting, and HCR. Co-Investigators from cardiology and cardiac surgery have signed Letters of Collaboration from all sites. In the past two years the Hybrid Network sites have performed >6500 CABG procedures and approximately 15,000 multi-vessel PCI procedures for patients with suitable coronary anatomy, and, therefore, have a large volume of patients eligible for HCR. The results of the Hybrid Trial could fundamentally change management of patients with CAD, the number one cause of death in the United States. This trial, which will support numerous clinical centers across the country and the DCC and CCC, will provide evidence to guide and improve treatment decisions and optimize the utilization of health care resources for this growing patient population.

 描述（由申请人提供）：总结/摘要混合冠状动脉血运重建术（HCR）是使用左乳内动脉（LIMA）对左前降支（LAD）冠状动脉进行微创手术移植与非LAD冠状动脉狭窄的经皮冠状动脉介入治疗（PCI）的有意组合。HCR程序正在全国范围内被临床医生采用，以减少发病率，死亡率，恢复时间， 多支冠状动脉患者的重复再介入和血运重建费用 涉及LAD和/或左主干冠状动脉的动脉疾病（CAD）。到目前为止，还没有随机对照试验来确定HCR是否达到这些结果，并且越来越多的HCR采用正在进行中，没有坚实的证据基础。拟议的试验旨在填补这一知识空白，并为临床实践提供证据基础。我们提出了一个实用的，大规模的临床试验，评价HCR的有效性和安全性相比，多血管PCI。该试验将入组2354例患有涉及LAD分布的多血管CAD和血运重建的临床适应症的患者，这些患者符合HCR 和多血管PCI与药物洗脱支架。主要结局将是随机化后至少5年随访期间发生的MACCE，定义为全因死亡、心肌梗死、卒中和重复血运重建。将在试验的第一年进行先锋阶段，以确定入组的可行性和集中收集MACCE事件的数据完整性。该试验的创新设计将最少试验特定数据的收集和裁定与国家登记数据（STS和NCDR）相结合，从而实现了简化且极具成本效益的试验。先前由NIH资助的观察性研究（RC 1 HL 100951 -01，主要研究者，J. Puskas，D. Ascheim）的研究表明，10-15%的CAD患者在解剖学上符合HCR的条件，并证实心脏病专家和外科医生之间存在平衡，可以随机分配此类患者。为了进行这项试验，我们组建了一个混合试验网络，其中包括49家在多血管PCI、微创LIMA-LAD移植和HCR方面经验丰富的选定临床研究中心。来自心脏病学和心脏外科的合作研究者已签署了来自所有研究中心的合作函。在过去的两年中，混合网络站点已经为具有合适冠状动脉解剖结构的患者进行了超过6500例CABG手术和约15，000例多血管PCI手术，因此具有大量符合HCR条件的患者。混合试验的结果可能从根本上改变CAD患者的管理，CAD是美国的头号死亡原因。这项试验将支持全国各地的许多临床中心以及DCC和CCC，将提供证据来指导和改善治疗决策，并优化这一不断增长的患者群体的医疗保健资源利用。