Low-dose rt-PA may not decrease the incidence of symptomatic intracranial haemorrhage in patients with high risk of symptomatic intracranial haemorrhage

Abstract

ABSTRACT Background: Recombinant tissue plasminogen activator (rt-PA) has been used as the standard treatment for acute ischemic stroke (AIS). The following study investigates whether low-dose rt-PA can decrease the incidence of symptomatic intracranial haemorrhage (sICH) in AIS patients with high-risk sICH compared to standard-dose rt-PA. Materials and Methods: Data from the Thrombolysis Implementation and Monitor of Acute Ischemic Stroke in China (TIMS-China) studies were assessed to explore risk factors for sICH after intravenous thrombolysis. For high-risk sICH patients (age ≧70 years old, or with diabetes, or serum glucose on admission >9.0 mmol/L, or NIHSS on admission>20, or with cardioembolism), standard-dose rt-PA (0.85 to 0.95 mg/kg) and low- dose rt-PA (0.5 to 0.7 mg/kg) were compared. Primary outcome measure was the incidence of sICH, and the secondary outcome measures were 7-day mortality and 90-day functional independence outcome (modified Rankin scale, 0–2). Results: A total of 554 patients were enrolled (60 cases for low dose, and 494 cases for standard dose). Median rt-PA doses were 0.63 and 0.90 mg, respectively. After adjustment for the baseline variables, low-dose rt-PA did not decrease the incidence of sICH (per SITS-MOST criteria, 3.33% versus 2.23%, P = 0.3467) compared to low dose. The low-dose group revealed less functional independence outcomes (modified Rankin scale, 0–2) compared to standard-dose group (36.67% versus 52.43%; odds ratio = 0.49; p = 0.0204) at 90 days. Conclusions: Our study suggests that low-dose intravenous rt-PA for high-risk sICH stroke in Chinese patients may not decrease the incidence of sICH, and concomitant with a poor outcome compared to standard-dose rt-PA.Abbreviations: rt-PA: recombinant tissue plasminogen activator; AIS: acute ischemic stroke; sICH: symptomatic intracranial haemorrhage