Data Management And Sharing System of China National Clinical Research Center for Neurological Diseases

Intravenous Thrombolysis in Chinese Patients with Different Subtype of Mild Stroke: Thrombolysis in Patients with Mild Stroke

First author:Weiqi Chen,Yuesong Pan

Corresponding author:Yilong Wang,Yongjun Wang

rt-PA mild stroke Chinese Patients

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2017-05-23

Published articles

Journal:Scientific reports

Publication type: Original Contributions

IF(IF): 4.379

PMID: 2017; 7(1):2299 Link To Pubmed Full text Download

Background And Purpose

Thrombolysis treatment for patients with mild stroke is controversial. The aim of our study was to investigate whether patients with mild stroke or its specific etiologic subtype might benefit from rt-PA therapy. Data were derived from two cohorts of patients with and without rt-PA treatment: (1) the Thrombolysis Implementation and Monitor of Acute Ischemic Stroke in China (TIMS-China) and (2) the China National Stroke Registry (CNSR) database. Patients with mild stroke (defined as National Institutes of Health Stroke Scale ≤5) receiving the rt-PA therapy and without rt-PA therapy were matched in 1:2 for age, sex, stroke severity and etiologic subtype. A total of 134 rt-PA-treated patients were matched to 249 non-rt-PA-treated patients in the study. Among them, 104 (76%) rt-PA-treated patients with mild stroke had good outcome after 3 months compared with 173 (69.5%) non-rt-PA- treated matching cases (odds ratio [OR], 1.48; 95% confidence interval [CI], 0.91–2.43; P= 0.12). Compared with non-rt-PA-treated group, rt-PA-treated patients had good outcome after 3 months in those with stroke subtype of large-artery atherosclerosis (LAA) (80.5% vs 65.1%; OR, 2.19; 95%CI, 1.14– 4.21; P= 0.02). For patients with mild stroke, intravenous rt-PA treatment may be effective. Patients with stroke subtype of LAA might benefit more from rt-PA treatment.

Method

Patients receiving rt-PA treatment were derived from the TIMS-China19. Patients not receiving rt-PA treatment were derived from the CNSR20 database which was conducted as the same period as TIMS-China. From both cohorts, we extracted the following variables: age, sex, medical history (including hypertension, diabetes mellitus, atrial fibrillation, history of stroke, smoking), stroke severity (measured by National Institutes of Health Stroke Scale, NIHSS), stroke subtype and treatment during hospitalization, et al. The detailed information of screening process was showed in Fig. 1. The good outcome of patients with mild stroke was defined as a modified Rankin Scale (mRS) of 0 to 1 at 3 months21, 26, 32. All patients with acute mild ischemic stroke were further classified according to the TOAST (Trial of Org 10172 in Acute Stroke Treatment)33 criteria: large-artery atherosclerosis (LAA), small-vessel occlusion (SAO), cardioembolism (CE), stroke of other determined etiology (other), and stroke of undetermined patho- genesis (UD)33. The overall inter-rater agreement for the TOAST classification was good (κ value of 0.73 [95% CI, 0.65–0.81])34.

Conclusion

In conclusion, administering intravenous rt-PA to patients with mild stroke (NIHSS ≤ 5) may lead to potential better clinical outcome compared to not receiving thrombolysis treatment. Patients with stroke subtype of LAA might be likely to benefit from intravenous thrombolysis therapy than other stroke subtypes but need further study to verify it.

Main results

Patient Characteristics. A total of 174 rt-PA treated patients with mild stroke and with complete base- line variables were identified in the Thrombolysis Implementation and Monitor of Acute Ischemic Stroke in China19 TIMS-China) registry, while 1225 non-rt-PA treated patients with mild stroke in the China National Stroke Registry (CNSR) registry20. According to the predefined matching method, we matched 134 rt-PA treated patients to 249 non-rt-PA treated patients in our study (Fig. 1). The mean age of rt-PA treated patients was 62.3 ± 10.5, and was 63.2 ± 10.6 in rt-PA untreated patients (Table 1). There were 48 patients (35.8%) in rt-PA treated group and 90 patients (36.1%) in rt-PA untreated group were female. A total of 68.7% of the patients had a history of hypertension, 17.9% had diabetes mellitus, and 7.5% had atrial fibrillation in rt-PA treated group, and the proportions were 62.7%, 23.7% and 8.4% in untreated group respectively. However, patients in untreated group had a higher proportion of history of stroke (P < 0.001). Outcome. We compared the outcomes at 3 months after mild stroke onset in rt-PA treated patients with matched rt-PA untreated patients. Figure 2 showed the distribution of mRS score at 3 months in matched patients with mild stroke. We found a shift toward upgraded outcome in rt-PA treated patients with mild stroke compared with rt-PA untreated patients. There were 77.6% of the patients in rt-PA treated group having good functional outcome (mRS 0–1) at 3 months, while the proportion in the untreated group was 69.5%. We found a favorable trend of better out- come in rt-PA treated patients, although the overall difference was not statistically significant (OR, 1.48; 95% CI, 0.91–2.43; P = 0.12). In the subgroup analysis according to stroke subtype (Fig. 3), 80.5% (62/77) rt-PA treated patients with LAA had good outcome (mRS 0–1) at 3 months, compared with 65.1% (99/152) rt-PA untreated patients with LAA had good outcome at 3 months after stroke onset (OR, 2.19; 95% CI, 1.14–4.21; p= 0.02). This benefit effect was not observed in the SVO, CE and “other” determined etiology and UD subtype groups (p = 0.42, p = 0.60 and p = 0.48, respectively). The ORs with 95% CIs of rt-PA treated and untreated groups are shown in Fig. 3. The mortality rate was 1.5% (2 of 134) in rt-PA-treated patients, while 1.2% (3 of 249) in patients without rt-PA treatment (OR, 1.00; 95% CI, 0.16–6.14; p = 1.00). Only one (0.7%) patient in rt-PA treatment group had symptomatic intracranial hemorrhage (sICH) defined by ECASS II (second European- Australasian acute stroke study) criteria during three months.