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）临床研究和特定的挑战主题，04-HL-115：采用混合冠状动脉血运重建术治疗狭窄冠状动脉与采用药物洗脱支架（DES）进行多血管经皮冠状动脉介入治疗。该提案是一项计划拨款，用于完成启动一项关键试验所需的剩余步骤，以评估混合冠状动脉血运重建术（HCR）的有效性。冠状动脉疾病（CAD）的巨大和日益增加的患病率，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，刺激了对冠状动脉血运重建的最佳技术和适应症的兴趣不断增加。混合冠状动脉血运重建术结合了CABG和PCI，提供了超越CABG或PCI的潜在优势，并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，提供耐久性，但没有常规CABG的强制性创伤和延长的恢复时间，这将是心血管医学领域的一个重大进步。虽然HCR方法在美国许多心脏中心稳步发展，但HCR的疗效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有可能广泛传播，并成为多血管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种潜在的重要手术在主要患者人群中的持续传播。该计划资助申请将为组织活动提供支持，这些活动对于成功实施一项大规模随机试验至关重要，该试验比较了HCR与DES多血管PCI在三支血管CAD患者中的有效性和安全性。本提案的研究者建立在心胸外科手术试验网络（[CTSN]（http：//www.example.com））已经建立的基础设施上www.ctsurgerynet.org：一个由NHLBI资助的10个临床中心和一个数据协调中心组成的网络]以及HCR领域的其他几个著名临床中心。该提案的主要目的包括：（1）最终确定关键试验的设计和方案，（2）进行观察性研究，为关键试验设计提供信息，以及（3）扩大研究者、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个月内达到高潮，为关键试验申请赠款，这可以在规划阶段之后立即开始。拟议的临床试验结果将从根本上改变冠状动脉疾病患者的管理。这项试验将为全国各地和DCC的众多临床中心的教师和协调员提供支持，将提供证据来指导和改善治疗决策，并通过替代治疗方案的成本效益数据优化医疗资源的利用。然而，拟议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。冠状动脉疾病治疗学是一个具有高度创新性的领域。试验产生的知识将为大学和工业公司的科学家，工程师和临床医生的研发企业提供反馈，这将使他们能够开发新技术并改进现有的CAD治疗技术。将混合冠状动脉血运重建（HCR）作为一种新的、经科学验证的CAD方法的能力将是心血管医学的重大进步，并对公共卫生产生重大影响。此外，HCR可能会弥合心脏病学家和心脏外科医生之间存在的治疗理念和方法的分歧。这些专业之间的合作而不是竞争最终将使患者，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.