Jolicoeur E Marc, Granger Christopher B, Henry Timothy D, Holmes David J, Pepine Carl J, Mark Daniel, Chaitman Bernard R, Gersh Bernard J, Ohman E Magnus
Duke University, Durham, NC, USA.
Am Heart J. 2008 Mar;155(3):418-34. doi: 10.1016/j.ahj.2007.12.004. Epub 2008 Jan 31.
The following report is based on a working group meeting about advanced coronary artery disease for patients with refractory ischemia who cannot receive revascularization. The aims were to review currently available treatment strategies, define unmet clinical needs, explore clinical trial design issues, and identify promising novel therapeutic targets and approaches for patients with chronic ischemia. The Working Group brought together medical experts in the management of refractory angina with representatives from regulatory agencies, Centers for Medicare and Medicaid Services, and industry. The meeting began with presentations reviewing the limitations of the current medical therapies and revascularization strategies and focused on lessons learned from past therapeutic attempts to optimize outcomes and on what are considered to be the most promising new approaches. Perspectives from clinical experts and from regulatory agencies were juxtaposed against needs and concerns of industry regarding development of new therapeutic strategies. This report presents the considerations and conclusions of the meeting on December 4-5, 2006. This document has been developed as a 2-part article, with contemporary and emerging therapies for advanced coronary artery disease reviewed first. Trial design, end points, and regulatory issues will be discussed in the second part of the article.
以下报告基于一次关于无法接受血运重建的难治性缺血患者的晚期冠状动脉疾病的工作组会议。其目的是回顾当前可用的治疗策略，明确未满足的临床需求，探讨临床试验设计问题，并为慢性缺血患者确定有前景的新型治疗靶点和方法。该工作组汇聚了难治性心绞痛管理方面的医学专家以及来自监管机构、医疗保险和医疗补助服务中心及行业的代表。会议首先进行了演讲，回顾了当前药物治疗和血运重建策略的局限性，重点讨论了从过去优化治疗结果的尝试中吸取的经验教训以及被认为最有前景的新方法。临床专家和监管机构的观点与行业在新治疗策略开发方面的需求和关注点并列呈现。本报告介绍了2006年12月4日至5日会议的审议情况和结论。本文档已编写为一篇分两部分的文章，首先回顾了晚期冠状动脉疾病的当代和新兴疗法。文章的第二部分将讨论试验设计、终点和监管问题。
