Hybrid Coronary Revascularization Trial- DCC

混合冠状动脉血运重建试验 - DCC

基本信息

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
项目类别：
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

项目摘要

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）：摘要/摘要混合冠状动脉血运重建（HCR）是使用左乳内动脉（LIMA）进行左前降支（LAD）冠状动脉微创手术移植与经皮冠状动脉介入治疗的有意组合（全国范围内的追随者正在采用非 LAD 冠状动脉狭窄的 PCI），以努力降低发病率、死亡率、恢复时间。重复再干预以及多支冠状动脉患者的血运重建费用迄今为止，还没有涉及 HCR 是否达到这些结果的随机对照试验，并且在没有坚实证据基础的情况下，越来越多地采用 HCR。旨在填补这一知识空白，并为临床实践提供证据基础，评估 HCR 与多支血管 PCI 相比的有效性和安全性。该试验将招募 2354 名患者。涉及 LAD 分布和血运重建临床指征且符合 HCR 资格的多支血管 CAD 主要结局是使用药物洗脱支架的多血管 PCI，其定义为全因死亡率、心肌梗死、卒中以及随机化后至少 5 年随访期间的重复血运重建。在试验的第一年进行，以确定集中收集 MACCE 事件的注册可行性和数据完整性。试验的创新设计将最少的试验特定数据的收集和裁决与国家注册数据结合起来。（STS 和 NCDR），导致一项简化且非常具有成本效益的试验（RC1 HL100951-01，主要研究者，J. Puskas，D. Asheim）为该试验的设计提供了信息，证明了这一点。 10-15% 的 CAD 患者在解剖学上符合 HCR 条件，并证实心脏病专家和外科医生之间存在平衡，可以对此类患者进行随机分组。我们已经组建了一个由 49 个选定的临床中心组成的混合试验网络，这些临床中心在多血管 PCI、微创 LIMA-LAD 移植方面拥有丰富的经验，并且来自心脏病学和心脏外科的 HCR 联合研究人员在过去的两年中都签署了合作书。多年来，混合网络站点已为具有合适解剖结构的患者实施了超过 6500 例 CABG 冠状动脉手术和大约 15,000 例多支血管 PCI 手术，因此，有大量患者符合条件HCR 的结果可能会从根本上改变 CAD 患者的治疗，CAD 是美国第一大死因。这项试验将为全国各地的众多临床中心以及 DCC 和 CCC 提供证据。指导和改进治疗决策，并为不断增长的患者群体优化医疗保健资源的利用。