Long-Term Survival After Ischaemic Stroke: Ebrictus Study
Condition: Ischemic Stroke; Thrombolytic (t-PA) Treatment; Gender Bias; Long Term Adverse Effects
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia; Long Term Adverse Effects
Study type: Observational [Patient Registry]

Summary: 
      A number of large trials have confirmed the benefits of thrombolysis in acute stroke, but
      there are gender differences. The authors sought to examine the relationship between sex and
      outcome after thrombolysis.

      Previous reports [1-6] concerning sex-related differences in stroke management and outcome
      are inconsistent and sometimes difficult to interpret, and so the reasons for gender
      disparities in stroke outcome have remained unclear. Functional outcomes and quality of life
      after stroke are consistently poorer in women despite adjustment for baseline differences in
      age and prestroke function, and the fact that comorbidities and clinical outcomes were not
      different between women and men [3, 7] . Once the reasons for these differences are better
      understood, intervention might be possible to help provide the best care for all patients.
      This work is a continuation and extension of the Ebrictus Study [8-10] . Prior work has
      suggested sex-based differences in thrombolytic therapy in subjects with acute stroke [11]
      .The authors will explore whether sex might modify the effect of thrombolysis on survival and
      functional outcomes in patients with acute ischemic stroke [12] beyond the usually evaluated
      time period of 6 months after stroke and compared this with the group without thrombolytic
      treatment.
    

Detailed description: 
      This is a reprospective, observational cohort study including incident strokes from January
      1, 2011 to December 31, 2012 and followed up in December 31, 2016. Statistical approaches are
      used to analyze survival outcomes. It is a longitudinal study of a population-based cohort of
      all registered cases of a first episode of stroke that occurred in Catalonia (Spain).
      Demographic Patterns and Epidemic Characteristics. Life expectancy at birth is 81.34 years
      globally, 78.26 years for men and 84.74 years for women.

      Case Definition The definition of stroke corresponds to that set by the World Health
      Organization.

      Patients were included by using the automated operation of the database of patients with a
      diagnosis code of stroke (I60-I69).

      The inclusion criteria were: age ≥ 15 up to ≤ 90; a diagnosis of stroke explicitly recorded
      in their medical record at any of the registration systems in the health centers; it should
      be a first stroke episode, and relevant episode information should be available in clinical
      records: (a) outpatient clinic, (b) hospital clinic, or (c) access to medical/sociosanitary
      reports.

      The variables on which information was collected were grouped as follows: sociodemographic;
      clinics: type (ischemic or hemorrhagic stroke) and event date (day/month/year); NIHSS score
      on admission; whether or not there was thrombolytic therapy; duration of hospital stay;
      hospital discharge destination (home, higher-level acute hospital, long-term care hospital,
      death and date thereof); pre- and poststroke functional autonomy [the Barthel score was
      classified as follows: <20 (total dependence), 20-35 (severe dependence), 40-55 (moderate
      dependence), ≥ 60 (mild dependence), or 100 (independence) registered for preepisode and for
      discharge in the medical history of the patient, the hospital, or the primary care center];
      functional status of the patient at discharge: death, home-autonomous, home address
      caregiver, referral to another acute hospital, or convalescent center (temporary or long-term
      stay), and vital status (alive/dead) of the patient, specifying the date (day/month/year) of
      death, if any.

      Statistical Analysis Computerized statistical analysis was undertaken with the following: (1)
      descriptive basic statistics and standard deviation of key variables stratified by age and
      sex and (2) differences in functional outcome and its evolution before and after the episode
      determined the possible effects on mortality and different residual deficits categorized with
      the statistical Cox regression model. Mortality should be interpreted as overall mortality
      and cause-specific, no stroke. Patients who died during hospitalization or within the 1st
      month are considered 'immediate death'. During follow-up the deceased are described as
      'subsequent mortality'.
    

Intervention name(s): IV thrombolytic (t-PA) treatment vs not
Intervention type(s): Drug
Intervention description(s): Acute Stroke Protocol
Other intervention name(s): IV thrombolysis; IV thrombolytic (t-PA) treatment
Intervention MeSH terms: Fibrinolytic Agents
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients were included by using the automated operation of the database of patients with a
        diagnosis code of stroke (I60-I69).