Medical Department,Federal Association of the Local Health Care
Medical Department,National Association of the Statutory Health Insurance Funds.
Int J Technol Assess Health Care. 2017 Jan;33(2):222-226. doi: 10.1017/S0266462317000411.
Enrolment into the SAMMPRIS trial published in September 2011 had to be stopped due to a 2.5 higher 30-day stroke and death rate in patients with percutaneous transluminal angioplasty and stenting (PTAS) compared with the control group with only medical therapy. After these results were published, one would have expected a change toward a clearer definition of indications for intracranial stent implantation in patients with intracranial artery stenosis, using this treatment only in patients suffering from recurrent strokes despite aggressive medical management.
The frequency of intracranial stenting and indication parameters in patients with intracranial artery stenosis were assessed from 2010 to 2013 using claims data for all inpatient episodes from Germany's largest provider of statutory health insurance.
The number of intracranial stenting procedures decreased slowly from 580 in 2010 to 375 in 2013. With a rate of 29 percent there was no change between 2010 and 2013 of patients who were admitted to hospital for stent implantation, without documentation of an acute stroke or transient ischemic attack (TIA). Before PTAS, one-third of patients were admitted twice because of a stroke or TIA over a period of 5 years, 17 percent of patients had been prescribed platelet aggregation inhibitors and at least two admissions to hospital were for an ischemic cerebrovascular event before PTAS.
Our analysis of German claims data provides little evidence of changed indications for stenting in cases of intracranial atherosclerotic disease which one might expect to be caused by the emergence of high-level evidence.
2011 年 9 月发表的 SAMMPRIS 试验由于经皮腔内血管成形术和支架置入术(PTAS)组 30 天内卒中及死亡率比单纯药物治疗的对照组高 2.5%,故必须停止入组。这些结果发表后,人们原本期望在颅内动脉狭窄患者中,对颅内支架植入的适应证有更明确的定义,仅在因强化药物治疗而反复发作卒中的患者中使用这种治疗方法。
利用德国最大的法定健康保险公司所有住院病例的索赔数据,评估 2010 年至 2013 年颅内动脉狭窄患者颅内支架置入的频率和适应证参数。
颅内支架置入术的数量从 2010 年的 580 例缓慢减少到 2013 年的 375 例。在 2010 年至 2013 年期间,没有因急性卒中或短暂性脑缺血发作(TIA)而住院接受支架植入的患者比例没有变化,为 29%。在 PTAS 之前,三分之一的患者因卒中或 TIA 在 5 年内两次住院,17%的患者接受了血小板聚集抑制剂治疗,在 PTAS 之前至少有两次因缺血性脑血管事件住院。
我们对德国索赔数据的分析几乎没有提供证据表明,颅内动脉粥样硬化性疾病的支架适应证发生了变化,而人们可能期望出现高级别的证据会导致这种变化。