International Circulation:  What are the objectives and design of SAMMPRIS trial?  

国际循环：能介绍一下SAMMPRIS研究的目的和试验设计吗？

 

Prof. Chimowitz:  The SAMMPRIS was designed to answer the question of whether stenting of intracranial artery adds benefit to aggressive medical therapy alone in treating patients with intracranial arterial stenosis.  Stenting has emerged as a treatment option but has not yet proven to be better than medical therapy so the purpose of SAMMPRIS is to see whether it is better than medical therapy. 

Chimowitz教授：SAMMPRIS研究主要是回答了在颅内动脉狭窄患者在单独药物治疗情况下颅内动脉支架术是否对患者有益。支架置入术可以作为一种治疗的手段，但是还没有证据表明支架置入术优于药物治疗，故SAMMPRIS研究的目的是观察支架置入术是否优于药物治疗。

 

International Circulation:  Can you comment on the enrollment and progress of the SAMMPRIS trial?  Are there any trends in the preliminary results?

国际循环：您能介绍一下SAMMPRIS研究的入组情况和研究进展吗？初步的研究结果有什么趋势吗？

 

Prof. Chimowitz:  The enrollment is actually going quite well; we are a little ahead of schedule.  We do not have trends because the comparison data are not available for to see until the study is over.  So it probably be another five or six years befire we know. 

Chimowitz教授：实验入组很顺利，并且在预期之前完成了患者入组。因为到研究完成才能拿到数据，所以我们并没有初步的结果。所以我们有可能在5、6年之后才能知道研究的结果。

 

International Circulation:  How can we reduce the risk of in-stent stenosis when we treat the symptomatic intracranial arterial stenosis patients with stent placement?

国际循环：在症状性颅内动脉狭窄支架置入术患者中，我们怎样来降低支架内再狭窄的危险性？

 

Prof. Chimowitz:  That is a difficult question.  Re-stenosis has emerged as a potential problem; From earlier studies， we know that it has occurred with the stent we are using in probably about 25 to 30% of the patients but the vast majority of those patients do not have any new symptoms.  So whether it will actually turn out to be an important cause of stroke still needs to be determined. 

Chimowitz教授：这是一个难题。再狭窄成为支架置入术的一个潜在问题。通过早期的研究，我们知道支架置入术再狭窄的发生率为25%~30%，绝大部分患者不会出现新的症状。所以再狭窄是否是引起卒中的重要原因仍需进一步的证实。

 

International Circulation:  In recent years， drug-eluting stents have been widely used in the treatment of coronary artery disease. In contrast， progress in the use of DES among symptomatic intracranial arterial stenosis patients has been limited. What do you think may be the reason for this?

国际循环：近年来药物洗脱支架广泛的用于冠状动脉疾病的治疗。与此形成鲜明对比的是，DES在症状性颅内动脉狭窄患者中的应用仍有一定的局限性。您认为出现这种情况的原因是什么？

 

Prof. Chimowitz:  Actually the main reason is that the U.S. FDA has not approved drug-eluting stents for treatment of brain arteries.  Also the drug eluting stents that are available are coronary designed stents which are hard to maneuver in the intracranial circulation， so they are much harder to deliver.  So these are the main reasons why they have not become part of the established treatment for intracranial stenosis. 

Chimowitz教授：实际上主要原因是美国FDA没有批准药物洗脱支架用于脑动脉的治疗。同时因为药物洗脱支架是基于冠状动脉设计的支架，所以在颅内动脉很难操作，也很难传送至目的位置。上述因素就是药物洗脱支架没有成为颅内动脉狭窄患者治疗方法的主要原因。