Safety and Effectiveness of Intravenous Thrombolytic Therapy for Acute Ischemic Stroke Patients with Renal Dysfunction in Taiwan

• Main Authors: Cheng-YangHsieh, 謝鎮陽
• Other Authors: Yea-Huei Kao Yang
• Format: Others
• Language: en_US
• Published: 2015
• Online Access: http://ndltd.ncl.edu.tw/handle/79964558346532971440

博士 === 國立成功大學 === 臨床藥學與藥物科技研究所 === 103 === Background: Stroke is the third leading cause of death and first leading cause of adult disability, while acute ischemic stroke (AIS) is the most common type of stroke in Taiwan. Intravenous thrombolytic therapy with recombinant tissue-type plasminogen activator (rtPA) is currently the only approved effective treatment for AIS worldwide. Partly due to concern of the devastating symptomatic intracranial hemorrhage (SICH), rtPA is underutilized in Taiwanese AIS patients. However, the exact utilization pattern has not been determined. Furthermore, renal dysfunction, a common comorbidity of stroke patients, might be associated with SICH after treatment with rtPA in AIS patients. However, such association is controversial and increases the uncertainty when deciding rtPA treatment. Objective: We aimed to determine the real utilization rate, and factors predicting utilization of rtPA in all Taiwanese AIS patients from 2003 through 2010. Then we aimed to determine the safety and effectiveness of rtPA in our AIS patients with renal dysfunction. Method: Firstly, the nationwide survey of intravenous rtPA for AIS patients was done using the National Health Insurance Research Database from 2003 through 2010. Then we used a multicenter stroke registry database to determine the association of renal dysfunction and SICH in AIS patients treated with intravenous rtPA, and the effect of renal dysfunction and rtPA, as well as their interaction on poor outcome (modified Rankin Scale 3-6 at 3 months) for all AIS patients admitted within 4.5 hours of onset. Results: Firstly, of the 394,988 AIS admission from 2003 through 2010, only 0.60% received rtPA. The utilization rate increased from 0.03% in 2003 to 1.51% in 2010. Patients with more comorbidities were less likely to receive rtPA (adjusted odds ratio [OR] for Charlson comorbidity index [CCI] = 1: 0.45; 95% CI: 0.40-0.50; OR for CCI ≥ 2: 0.30; 95% CI: 0.26-0.34, compared to those with CCI = 0). After multivariable analysis of 657 AIS patients treated with rtPA, renal dysfunction was not associated with SICH (OR: 1.03; 95% confidence interval [CI]: 0.55-1.92). In another analysis for 929 AIS patients within 4.5 hours of onset, the OR for rtPA and renal dysfunction on poor outcomes were 0.70 (95% CI: 0.51-0.96) and 0.97 (95% CI: 0.71-1.33), respectively, without significant interaction (p = 0.218). Conclusion: Intravenous thrombolytic therapy was underutilized in our AIS patients, partly due to concern of increased bleeding risk under certain comorbidity. From our practice-based data, renal dysfunction neither increased the risk of SICH after rtPA nor modified the effectiveness of rtPA for AIS. Renal dysfunction alone should not be a reason for withholding treatment from otherwise-eligible AIS patients.