Outcomes of Treatment with Recombinant Tissue Plasminogen Activator in Patients Age 80 Years and Older Presenting with Acute Ischemic Stroke

Journal of Clinical Outcomes Management. 2015 February;February 2015, VOL. 22, NO. 2:

February 9, 2015|Journal of Clinical Outcomes Management

Jennifer C. Drost, DO, MPH;Susana M. Bowling, MD

Methods

The study setting was a 540-bed acute care hospital that is a community-based certified stroke center. This study was deemed nonhuman subjects research by the institutional review board as the goal was to evaluate processes and outcomes of this institution’s stroke team in treating a subgroup of patients according to clinically accepted practice (quality improvement initiative). All patients presenting to the emergency department (ED) between 1 January 2011 and 30 November 2013 with the onset of stroke-like neurological deficits underwent evaluation and treatment by a neurologist and/or specially trained stroke team. This team consists of the attending neurologist, ED physician, resident physicians, advanced practice nurses, and ED staff nurses and emergency medicine technicians. Team members involved in the evaluation and treatment of these patients undergo routine clinical education and testing to ensure standardization. Patients undergo emergent evaluation including the National Institutes of Health Stroke Scale (NIHSS) and obtain brain imaging with computed tomography (CT).

Patients ≥ 80 years were identified among all those who presented to the ED with ischemic stroke. Patients were included if they were subsequently diagnosed with ischemic stroke or transient ischemic attacks (TIA). They were excluded from analysis if neurological changes were due to primary hemorrhagic stroke, intracranial hemorrhage, subarachnoid hemorrhage, seizure, conversion disorder, or metabolic derangements. They were also excluded from analysis if the acute ischemic stroke treatment included intra-arterial administration of tPA or endovascular revascularization.

Patient data collected included age, NIHSS at presentation to ED, time to presentation at ED, treatment with tPA, contraindications to tPA, discharge disposition, length of stay and in-hospital mortality. Raw NIHSS values were collected at the time of presentation. NIHSS were categorized into mild symptoms (NIHSS < 6), moderate symptoms (NIHSS 6–19), or severe symptoms (NIHSS ≥ 20). Clinical indications for receiving tPA include NIHSS > 4, focal neurological deficit onset < 3 hours (for those ≥ 80 years old), and no evidence of acute hemorrhage or acute infarct on CT. Contraindications include rapidly improving symptoms (repeat NIHSS < 4), active or history of intracranial hemorrhage, history of stroke or head trauma in past 3 months, gastrointestinal or genitourinary hemorrhage within 21 days, major surgery within 14 days, arterial puncture at a noncompressible site in past 7 days, treatment with anticoagulation with therapeutic indices, systolic blood pressure > 185 mm Hg or diastolic blood pressure > 110 mm Hg and not responding to treatment, or platelet count < 100,000/mm³. Patients who were not eligible for tPA based on contraindications with the exception of being outside the treatment window (3 hours) were excluded from comparative analysis. Patient length of stay was rounded to nearest full day. Discharge disposition was categorized as home, acute rehabilitation hospital, skilled nursing facility, home or facility with hospice services, other hospital setting, or death.

Statistics were calculated using SPSS statistical software. Variables were reported as means and percentages. Group means were compared using t tests and differences in proportions were compared using the chi square test. Correlations were performed using Pearson’s correlation. A 2-tailed P < 0.05 was considered statistically significant.

Results

From 1 January 2011 to 30 November 2013, a total of 984 people presented to the ED with acute neurological changes concerning for ischemic stroke. Of those, 184 people (18.7%) were 80 years or older with an average age of 85.3 (range, 80–96). Patient characteristics are presented in Table 1. The average NIHSS was 12 (range, 1–32). Thirty-four (18.5%) patients presented with severe stroke symptoms (NIHSS ≥ 20), while moderate symptoms (NIHSS 6–19) and mild symptoms (NIHSS < 6) accounted for 97 (52.7%) and 52 (28%) cases, respectively. Age and presenting NIHSS were positively correlated (P = 0.002). The overall in-hospital mortality rate for the population was 23.4%. Those with presenting NIHSS > 20 were more likely to experience in-hospital death (P < 0.001).

Thirty-eight patients (20.7%) received tPA and had an average age of 84.8 years, while 146 (79.3%) did not receive tPA and had an average age of 85.4 years. Of those that did not receive tPA, 128 (87.7%) had 1 or more clearly documented contraindications (Table 2). Ten patients (6.8%) were excluded due to clinical concerns including comorbidities, debility, or advanced dementia. Fifty-three (36.3%) of patients had rapidly improving stroke symptoms with repeat NIHSS < 4. Of those with contraindications, 49 (33.6%) had arrival outside the 3-hour treatment window, unknown time of onset, or developing radiographic changes on CT representing the natural history of stroke progression. Fourteen (9.6%) were on anticoagulants including warfarin and dabigatran with elevated INR or thrombocytopenia. Seven (4.8%) had a history of intracranial hemorrhages and 11 (7.5%) had recent surgery or bleeding episodes. One patient was not treated due to hospice enrollment. Only 8 (5.5%) patients declined treatment with tPA.

Those with contraindications including rapidly improving symptoms, treatment with anticoagulants with therapeutic indices, recent bleeding episodes, or family refusal were excluded from comparative analyses. The remaining 50 patients were included in comparative analysis (Table 3). There was no difference between the tPA and non-tPA groups in age (P = 0.26). While overall there was no difference between groups in initial NIHSS (P = 0.598), more patients with moderate symptoms (NIHSS 6-19) received tPA (P = 0.023). Similarly, those who did not receive tPA were more likely to have presented with mild or severe symptoms (P = 0.023). There was no significant difference in length of stay between the tPA group (6.4 days) and non-tPA group (5.8 days) (P =0.606). Sixteen (42.1%) patients who received tPA were discharged to acute rehabilitation hospitals, compared to 7 (14%) of those that did not receive tPA (P =0.003). There was no difference between groups in the numbers discharged to home (P = 0.40) or to skilled nursing facilities (P = 0.121). Those who receive tPA were less likely to experience in hospital death (P = 0.048). Only 1 patient (2.6%) who received tPA, versus zero who did not receive tPA, developed symptomatic ICH (P = 0.249).

References