Author + information
- Michael Szarek, PhDa,∗ (, )
- Pierre Amarenco, MDb,
- Alfred Callahan, MDc,
- David DeMicco, PharmDd,
- Rana Fayyad, PhDd,
- Larry B. Goldstein, MDe,
- Rachel Laskey, PhDd,
- Henrik Sillesen, MD, DMScif,
- K. Michael Welch, MB, ChBg,
- for the SPARCL Committees and Investigators
- aSUNY Downstate Health Sciences University, Brooklyn, NY
- bParis University, Paris, France
- cMeharry Medical College, Nashville, TN
- dPfizer, Inc., New York, NY
- eUniversity of Kentucky, Lexington, KY
- fUniversity of Copenhagen, Copenhagen, Denmark
- gRosalind Franklin University, North Chicago, IL
- ↵∗Address for correspondence Michael Szarek 450 Clarkson Avenue, MS 43, Brooklyn NY 11203 Telephone: 646-696-8447 Fax: 718-270-2533
Background The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial compared atorvastatin with placebo in 4,731 participants with recent stroke or transient ischemic attack and no known coronary heart disease. Atorvastatin reduced the first occurrence of stroke and the first occurrence of a composite of vascular events.
Objectives This post hoc analysis assessed the occurrence of all (first and subsequent) vascular events and the effect of atorvastatin to reduce these events by vascular territory (cerebrovascular, coronary, or peripheral) in SPARCL.
Methods Treatment effects on total adjudicated vascular events, overall and by vascular territory, were summarized by marginal proportional hazards models. Vascular event rates were estimated for each treatment group with cumulative incidence functions.
Results The placebo group had an estimated 41.2 first and 62.7 total vascular events per 100 participants over six years. There were 164 fewer first and 390 fewer total vascular events in the atorvastatin group (total events hazard ratio 0.68, 95% confidence interval 0.60 to 0.77). The total events reduction included 177 fewer cerebrovascular, 170 fewer coronary, and 43 fewer peripheral events. Over six years, an estimated 20 vascular events per 100 participants were avoided with atorvastatin treatment.
Conclusions In participants with recent stroke or transient ischemic attack, the total number of vascular events prevented with atorvastatin was more than twice the number of first events prevented. Total event reduction provides a comprehensive metric to capture the totality of atorvastatin clinical efficacy in reducing disease burden after stroke or transient ischemic attack.
This study was sponsored by Pfizer.
Michael Szarek: Consultant/advisory board for CiVi and Esperion; DSMB for Resverlogix and Baxter; Steering Committee for Sanofi and Regeneron Pharmaceuticals.
Pierre Amarenco: Unrestrictive grants: Sanofi, BMS, AstraZeneca, Pfizer, Merck, Boston Scientific; Executive and steering committees: Pfizer, AstraZeneca, Kowa, Bayer, BMS, Jansen,Portola; DSMB: Fibrinogen, Shingpoon; Endpoint committee: GSK; Advisory board and speaking activities: Amgen, Sanofi, Jansen, Shingpoon, Bayer, BMS Servier.
Alfred Callahan: Speaking activities: BMS and Pfizer.
David DeMicco: Employee of Pfizer.
Rana Fayyad: Employee of Pfizer.
Larry B. Goldstein: None.
Rachel Laskey: Employee of Pfizer.
Henrik Sillesen: Consulting and speaking activities: Bayer, Novo Nordisk, Philips Ultrasound and Gore; research grants: Cook Medical, Bayer and Philips Ultrasound
K. Michael Welch: None.
- Received January 23, 2020.
- Revision received March 3, 2020.
- Accepted March 6, 2020.
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