[ACC2013]心脏细胞疗法及STEMI相关治疗和研究——美国Abbott西北医院Timothy D. Henry教授专访
我认为目前心血管治疗正处于关键时期,该疗法极具潜力,对于将其应用于各种心血管疾病,如急性心肌梗死、充血性心力衰竭、难治性缺血性疾病及外周动脉疾病(重症下肢缺血和跛行)的治疗,我们非常激动。目前,该领域研究均处于较稳定的临床I、II期,大致呈出阳性结果。
<International Circulation>: Is PCI gradually going to replace other therapies? What techniques do foresee being used in the future?
《国际循环》:PCI会逐渐取代其他治疗吗?未来会采用何种新型技术?
Prof. Henry: We just had a paper in the European Heart Journal that looked at pharmaco-invasive strategy. One of the challenges that remains is that if you can get primary PCI within a 120 mintues, it is clearly preferred. However, there are many places in the world where it is challenge to meet. We have more evidence that if you use a pharmaco-invasive approach, or some combination of lytics before going into the cath lab, that is the preferred approach. Importantly, at this meeting, the results of the STREAM trial will be presented. This will have a major impact on the role of the pharmaco-invasive approach for the patient that has an expected delay. If you are less than 120 minutes, clearly PCI is the best strategy.
Henry教授:我们刚在European Heart Journal上发表一篇关于药物与有创治疗的文章,提到如果患者能在发病后120分钟内接受初始PCI,应是治疗首选。然而,目前仍有很多医院无法实现。大量证据显示,进入导管室前接受药物与有创治疗或抗栓药物联合治疗是理想的治疗方法。重要的是,STREAM研究结果将在本届ACC会议上公布,这将极大影响药物与有创治疗在延迟PCI治疗患者中的地位。很明显,PCI是发病2小时内STEMI患者的最佳治疗。
<International Circulation>: When talking about post PCI, what do you hope to see from the results of the TRANSLATE ACS and PARIS registry that are set to be released at this meeting? How will this change practice?
《国际循环》:对于PCI术后,您希望从今早公布的TRANSLATE ACS研究和PARIS注册研究中得到什么信息?这两项研究会对临床试验产生怎样的影响?
Prof. Henry: We were active participants in both TRANSLATE and PARIS registries. Both of these trials are large registries. There is clearly a role for randomized, placebo-controlled trials, but the nice thing about the registries is that they will both have a large number of patients that are more real world. You can see how it is working in real life. A number of abstract presented at the ACC will use both the TRANLSATE and PARIS registries. The most important thing about PARIS is to look at patient adherence. In real life, over 5000 patients are contacted and ask, are you still taking you medications? For what reason? We will then look at the impact of the patients who are compliant and those who are non-compliant, versus those patients who stop treatment because of their doctor. There is one group of people who still take their DUAP therapy; the 30% that stop have a variety of reasons for doing so. One reason is that your doctor told you so, or planned. The second is that your doctor tells you stop temporarily, such as when there is an elective surgery. The third way is that they are completely non-compliant. From the registry we are learning what predicts these patients stopping and what are the potential benefits or harms that may come of it. The worst is that if the patient simply stops the medications without consulting with physicians. With registries, you have to be careful, as the reason people continue with DUAP therapy they are doing well, they didn’t need surgery or have bleeding. Some people who stop have good reasons. Those with bad bleeding episodes should therapy. The PARIS registry helps us sort that out.
Henry教授:我们都积极参与了TRANSLATE和PARIS 注册研究,虽然随机、安慰剂对照研究非常重要,但注册研究优势在于,较之真实世界研究,能够纳入更多患者,也能了解到注册研究如何在真实世界中进行。ACC上发布了大量关于TRANLSATE 和 PARIS注册研究的摘要,PARIS研究中最重要的是患者的依从性。超过5000例患者在真实生活中接受调查,问题包括:您仍在服用药物吗?为什么服药?我们重点关注那些依从性良好和依从性差的患者,将这些患者与遵从医嘱而停药的患者相比,结果显示,仍在接受双向选择治疗的患者中,30%因各种原因停药。原因包括遵从医嘱停药,接受间断用药,或完全无依从性。从注册研究中,我们得知患者停药原因及由此带来的获益或危害,最糟糕的情况是患者自行停药而未向医生做任何咨询。在注册研究中,需注意接受双向选择疗法的患者,不需手术治疗或不存在出血风险。一些患者停药理由非常充分,存在严重的出血风险。PARIS注册研究帮助我们更好地对这种患者进行分类。
<International Circulation>: How does this impact your practice?
《国际循环》:这会影响您的临床实践吗?
Prof. Henry: In PARIS and TRANSLATE, we are getting predictors of who stops and who does not. Both of these trials will help us design systems of care that optimize patient compliance. This is very important.
Henry教授: 在PARIS 和TRANSLATE研究中,我们对那些停药和未停药的患者进行预测,这两项研究有助于我们设计出使患者依从性最佳的护理系统。这一点非常重要。