Panagiotis Vardas 伊拉克利翁大学附属医院心内科
International Circulation: The ESC Guidelines on AF published one year ago use the EHRA scale for evaluating atrial fibrillation. What is your experience with the EHRA guidelines; why are they important; and how will they change the practice of ablation practice?
《国际循环》:欧洲心脏病学会(ESC)在2010年出版的新房颤指南中使用了欧洲心律学会(EHRA)评分进行房颤的评估。您认为EHRA指南为何如此重要?将怎样改变射频消融技术?
Dr Vardas: Firstly, only the ESC has the right, according to our rules, to publish guidelines. However, in many cases, as with atrial fibrillation, the guidelines are jointly developed by the ESC plus one of its associations, in this case, the EHRA. The guidelines that we published recently include at least four novel areas. Firstly, in these guidelines we included a score to evaluate the need for antithrombotic treatment in patients with atrial fibrillation – the CHA2DS2-VASc score. This score takes other risk factors into account to evaluate the need for antithrombotic therapy. There are three new risk factors; the female sex (one grade); the age of more than 65 years (one grade); and peripheral vascular disease. Previously we had the scoring system CHADS 2 in which these three risk factors were not included. Secondly, we included another scoring system to evaluate the possibility of bleeding and this is the HAS-BLED scoring system. Here again we take into account another nine factors to see how possible it is for the patient to experience bleeding due to anticoagulant therapy. Next, as a part of this, we have adopted in our guidelines some new pharmaceutical proposals. One of them is dronedarone therapy. Dronedarone has been evaluated in a number of well-organized trials (ATHENA, EURIDIS and DIONYSOS, for example, to name a few). I will also remind you that in order for someone to write guidelines, there need to be well-organized randomized prospective trial results. So with all of these trial results we decided to include dronedarone in our guidelines. In our decision and in our algorithm, we put dronedarone ahead of amiodarone. Dronedarone is similar to amiodarone; the only difference is in the molecule of dronedarone, iodine does not exist so there is no risk of thyroid dysfunction. Based on the results of all of these trials, we included dronedarone in these guidelines under the doctrine, safer but not the most effective. The most effective is amiodarone. However there have been new developments. About two months ago, another big trial related to dronedarone, the PALLAS trial, was unfortunately interrupted because we had monitored some deaths in the dronedarone arm mainly through strokes and sudden cardiac deaths. Immediately the monitoring committee of the PALLAS trial recognized the problem, they stopped the trial. As the taskforce for the AF Guidelines, Professor Camm, myself and others, immediately reacted and have decided to publish an updated report in the next two or three months where probably dronedarone will lose its classification.
Vardas:根据我们的法规,仅ESC有发布指南的权利,但在许多情况下,如房颤相关指南是ESC与其他相关协会,包括EHRA共同制定,新的房颤指南包括至少四个专项领域。首先,我们引入了CHA2DS2 VASC评分准则来评价房颤患者抗血栓治疗的需要性,此评分标准纳入了其他相关危险因素以评估抗栓治疗的需要,其中包括三个新的因素:女性(一级);年龄超过65岁(一级);周围血管疾病,之前的CHADS 2评分标准未将这三种因素纳入。其次,引入 HAS-BLED评分标准以评估出血的可能性,纳入九种新因素,评估接受抗凝治疗患者的出血可能性。再次,我们还将一些新的医药建议引入指南,比如决奈达隆,此种药物在一些评价良好的试验(ATHENA, EURIDIS和DIONYSOS等)中已证实有效。制定指南需要组织良好的前瞻性随机试验结果,因此,根据所有临床试验结果我们决定在指南中添加决奈达隆,并根据评估结果决定决奈达隆优选于胺碘酮,两者非常相似,唯一的区别在于决奈达隆不含碘,从而减少了甲状腺功能减退的风险。在所有这些试验结果的基础上,决奈达隆更安全,但并不是最有效的,最有效的仍是胺碘酮。不过也出现了新的进展,大约两个月前,一大型临床试验PALLAS,由于监管委员发现在决奈达隆组患者突发中风和心脏病导致死亡增加,故不得不中止试验。对于房颤指南,卡姆教授、我和小组其他工作人员立即作出反馈,并在指南发布的两三个月后补充新报告,指出决奈达隆或将失去其经典意义。