Hybrid revascularization vs percutaneous coronary intervention: A Planning Grant

描述（由申请人提供）：本申请涉及广泛的挑战领域 (04) 临床研究和具体挑战主题，04-HL-115：使用混合冠状动脉血运重建治疗狭窄冠状动脉与使用药物洗脱支架 (DES) 进行多支血管经皮冠状动脉介入治疗。该提案旨在提供规划拨款，以完成启动评估混合冠状动脉血运重建（HCR）有效性的关键试验所需的剩余步骤。冠状动脉疾病（CAD）的巨大且不断增加的患病率、冠状动脉旁路移植术（CABG）、经皮冠状动脉介入治疗（PCI）和药物治疗的不断创新，以及血运重建的成本，激发了人们对冠状动脉血运重建的最佳技术和适应症的兴趣。混合冠状动脉血运重建术结合了 CABG 和 PCI，具有超越单独 CABG 或 PCI 的潜在优势，并且可能对医疗保健系统产生重大影响。能够提供一种新的 CAD 治疗方法，该疗法具有持久性，但没有传统 CABG 所特有的必然创伤和延长的恢复时间，这将是心血管医学领域的重大进步。虽然 HCR 方法在美国许多心脏中心稳步发展，但 HCR 的有效性和安全性取决于通过小型观察性研究获得的数据。初步观察数据表明，HCR 有潜力广泛推广，成为多支血管 CAD 患者的第三种主要介入治疗选择。然而，如果没有严格设计的临床试验，就没有足够的证据来指导这一潜在重要手术在主要患者群体中的持续传播。该规划拨款申请将为组织成功实施一项大规模随机试验至关重要的活动提供支持，该试验比较 HCR 与多支 PCI 与 DES 在三支血管 CAD 患者中的有效性和安全性。该提案的研究人员以心胸外科试验网络（[CTSN] (http://www.ctsurgerynet.org)：一个由 10 个临床中心和一个数据协调中心组成的 NHLBI 资助的网络）以及 HCR 领域的其他几个著名临床中心为基础。该提案的主要目标包括：(1) 最终确定关键试验的设计和方案，(2) 进行一项观察性研究，为关键试验设计；(3) 扩大研究人员、委员会和数据协调中心 (DCC) 的基础设施，以执行关键试验。这些活动应在 18 个月内完成关键试验的拨款申请，该试验可在该规划阶段后立即开始。该试验将从根本上改变对冠状动脉疾病患者的管理，为全国各地和 DCC 的教师和协调员提供支持。然而，这项研究的经济影响比提高治疗仍在扩大的疾病人群的有效性和效率要广泛得多。该试验产生的知识将为大学和工业公司的科学家、工程师和临床医生提供反馈，使他们能够开发新技术并完善治疗 CAD 的现有技术。混合冠状动脉血运重建（HCR）作为一种新的、经过科学验证的 CAD 方法将是心血管医学的重大进步，并对公众健康产生重大影响。此外，HCR 可能会弥合心脏病专家和心脏外科医生之间存在的治疗理念和方法上的分歧，最终将使患者、医院、付款人和医疗保健提供者受益。

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (04) Clinical Research and specific Challenge Topic, 04-HL-115: Treatment of stenosed coronary arteries with hybrid coronary revascularization versus multi-vessel percutaneous coronary intervention with drug eluting stents (DES). This proposal is for a planning grant to complete the remaining steps needed to start a pivotal trial evaluating the effectiveness of Hybrid coronary revascularization (HCR). The enormous and increasing prevalence of coronary artery disease (CAD), ongoing innovation in coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) and medical therapy, as well as the costs of revascularization have stimulated rising interest in optimal techniques and indications for coronary revascularization. Hybrid coronary revascularization, which combines CABG and PCI, offers potential advantages beyond CABG or PCI alone, and could have a major impact on the health care system. The ability to deliver a new therapy for CAD that provides durability, but without the obligatory trauma and prolonged recovery time characteristic of conventional CABG, would be a major advance in the field of cardiovascular medicine. While the HCR approach has been steadily growing in many heart centers in the US, the efficacy and safety of HCR rests upon data obtained through small observational studies. Preliminary observational data suggest that HCR has the potential to disseminate widely and become the third major interventional alternative for patients with multi-vessel CAD. However, without a rigorously designed clinical trial there is insufficient evidence to guide ongoing dissemination of this potentially important procedure for a major patient population. This planning grant application will provide the support for the organization of activities critical for the successful implementation of a large-scale randomized trial comparing the effectiveness and safety of HCR versus multi-vessel PCI with DES in patients with three-vessel CAD. The investigators of this proposal build on the already established infrastructure of the Cardiothoracic Surgical Trials Network ([CTSN] (http://www.ctsurgerynet.org): an NHLBI-funded Network of 10 clinical centers and a Data Coordinating Center] and several additional prominent clinical centers in the field of HCR. The key aims of this proposal include: (1) Finalizing the design and protocol for the pivotal trial, (2) Conducting an observational study that will inform the pivotal trial design, and (3) Expanding the infrastructure of investigators, committees and the data coordinating center (DCC) to execute the pivotal trial. These activities should culminate within 18 months in a grant application for the pivotal trial, which could start immediately following this planning phase. The results of the proposed clinical trial will fundamentally change the management of coronary artery disease patients. This trial, which will support faculty and coordinators in numerous clinical centers across the country and at the DCC, will provide evidence to guide and improve treatment decisions and optimize utilization of health care resources through data on the cost-effectiveness of alternative treatment options. The economic impact of the proposed research, however, is much broader than improving the effectiveness and efficiency of treating the still expanding disease population. Coronary artery disease therapeutics is a field with a high degree of innovation. The knowledge generated by the trial will provide feedback to an R&D enterprise of scientists, engineers, and clinicians in universities and industrial firms, which will allow them to develop new technologies and refine existing ones for the treatment of CAD. The ability to deliver hybrid coronary revascularization (HCR) as a new, scientifically-validated approach for CAD would be a major advance in cardiovascular medicine and a major impact on public health. Moreover, HCR is likely to bridge the divide in treatment philosophies and approaches that exist between cardiologists and cardiac surgeons. Collaboration rather than competition between these specialties will ultimately benefit patients, hospitals, payers and healthcare providers.