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[ESC2008]药物洗脱支架对糖尿病患者的安全性 Stephan Windecker 瑞士伯尔尼大学
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There has been concerned that drug eluting stent (DES) may be associated with increased mortality in diabetic patients. A record of earlier series of DES particularly the sirolimus-eluting stents showed a higher mortality as compared to the bare metal stent (BMS). But it is noted that in that study actually the mortality in diabetic patients was as low as in non-diabetic patients. Therefore, the question was raised whether this would be a chance-finding. We just published on Monday an extension of previously published network meta-analysis specifically analyzing diabetic patients. We found two principal messages: the first one was that as compared to BMS, the first-generation DES (both the Cypher stents and the TAXUS stents) did not have any indication of increased mortality at any time-point between one year and four years after stents implantation. So in this large-scale study with nearly 4000 diabetic patients, the concern can be abandoned that there is no increased mortality in diabetic patients. We have known that the risk of restenosis is increased in diabetic patients as compared to non-diabetic patients. Therefore, it was also of interest to use DES in those patients. What we have observed is that DES reduced the risk of restenosis by the same amount as in non-diabetic patients. However, since the absolute risk of restenosis is higher, still with DES the rate of restenosis remains somewhat higher, which is 1.54 higher than that in non-diabetic patients. So overall we can give up our concern regarding safety of DES in diabetic patients. At the same time we know DES is very effective in diabetic patients. Actually the number of patients who need to be treated in diabetic patients is lower than in non-diabetic patients. So that is why we should consider the use of DES in high-risk population.
And expanded duration of clopidogrel to at least 6 months may be important, because it is also reported that clopidogrel was given only for duration for less than 6 months (2~3 months) in this study, and there are some trend for increased mortality and incidence of myocardial infarction. So maybe in diabetic patients the close adhesion to clopidogrel at least 6 months is more important than in non-diabetic patients.
对于糖尿病患者,曾存在药物洗脱支架(DES)会提高死亡率的顾虑。较早的研究显示,应用DES尤其是西罗莫司洗脱支架的患者,其死亡率要高于裸金属支架(BMS)。但是我们应该注意到,在这项研究中糖尿病患者的死亡率其实与非糖尿病患者是一样低的,因此,不除外这样的结果存在偶然性。我们刚刚发表了一份关于糖尿病患者的荟萃研究,其中发现两条重要信息:第一,与BMS相比,第一代DES(Cypher支架和TAXUS支架)在术后1~4年内的任意时间点,均未显示死亡率升高。因此通过这项大规模、包含将近4000例糖尿病患者的试验,我们可以抛弃原先的顾虑。第二,我们知道,糖尿病患者再狭窄的风险要比非糖尿病患者高。因此,对这些患者采用DES是有利的。我们还观察到DES可以在非糖尿病患者与糖尿病患者中同等程度地降低再狭窄风险。但是,因为糖尿病患者再狭窄的绝对风险更高,因此即使采用DES,其再狭窄率还是会偏高,比非糖尿病患者高1.54倍。总之,我认为可以抛弃对糖尿病患者应用DES的安全性顾虑,同时明确DES对糖尿病患者是非常有效的。治疗过程中另一项非常重要的问题是应该延长术后氯吡格雷的使用时间达到≥6个月。因为在发现DES提高死亡率和心肌梗死发生率的研究中,氯吡格雷的平均应用时间均<6个月(2~3个月)。所以,在糖尿病患者中维持氯吡格雷的治疗时间具有更重要的意义。