Two Dutch guidelines (Stroke and Cardiovascular Risk Management) provide conflicting advice on optimal statin treatment in older patients. In the SAFEST-cohort, the investigators will assess the impact of continuing versus discontinuing a statin in frail individuals aged 70 and above with a recent ischemic stroke or transient ischemic attack (TIA) on their health-related quality of life and MACE free survival during a two-year follow-up period.
age = 70 years or older at the time of ischemic stroke or TIA;
inclusion within 6 weeks after diagnosis of ischemic stroke or TIA;
already using statin therapy at the time of the index event;
frailty as defined by a pre-event score of 4-7 and/or post-event score of 6-7 on the validated Clinical Frailty Scale.
Previous serious adverse drug reactions (defined as an adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisa-tion, results in persistent or significant disability or incapacity, or is a birth defect32) to statins or other contraindications to statin use.
Very severe frailty or very limited life expectancy (< 6 months) as defined by a score >= 8 points on the validated Clinical Frailty Scale.
Inability to communicate in Dutch.
Inability to respond to questions, either independently or with the assistance of a proxy.
frail individuals aged 70 and above with a recent ischemic stroke or transient ischemic attack (TIA)
Cohort
Prospective
Statin
DrugStatin use
Health-Related Quality of Life (HrQoL)
This will be measured using the PROMIS-10 scale scores (ranging from 0 to 100, with higher scores indicating better health), including global mental health and global physical health subscales. Measurements at 3, 6, 12, 18, 24 (and 36) months. months.
Major Adverse Cardiovascular Events (MACE) free survival
Classical 3-point MACE (cardiovascular death, nonfatal MI, or nonfatal stroke) and non-cardiovascular death. Measurements at 3, 6, 12, 18, 24 (and 36) months.
Functional outcome
This will be assessed using the modified Rankin Scale (mRS), with scores ranging from 0 to 6 (lower scores indicating better function).
Cognition
This will be measured using the Montreal Cognitive Assessment (MoCA) with scores ranging from 0 (worst) to 30 (best) or the Telephone version of the MoCA (TMoCA) with scores ranging from 0 (worst) to 22 (best)
Number of falls
Falls, measured using the falls calender. Participant returns the fall calender every 3 months.
Time to first fall
Falls, measured using the falls calender. Participant returns the fall calender every 3 months.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Amsterdam UMC, location AMC
Sponsor institution
VU University of Amsterdam
Collaborator
