Abstract
Background: In the SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) trial, atorvastatin was compared 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: The aim of this post hoc analysis was to assess 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 6 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 6 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.
| Original language | English |
|---|---|
| Pages (from-to) | 2110-2118 |
| Number of pages | 9 |
| Journal | Journal of the American College of Cardiology |
| Volume | 75 |
| Issue number | 17 |
| DOIs | |
| State | Published - May 5 2020 |
Bibliographical note
Publisher Copyright:© 2020 American College of Cardiology Foundation
Funding
The authors thank the patients, study coordinators, and investigators who participated in this trial. This study was sponsored by Pfizer. Dr. Szarek is a consultant and advisory board member for CiVi and Esperion; is a member of data and safety monitoring boards for Resverlogix and Baxter; and is a steering committee member for Sanofi and Regeneron Pharmaceuticals. Dr. Amarenco has received unrestrictive grants from Sanofi, Bristol-Myers Squibb, AstraZeneca, Pfizer, Merck, and Boston Scientific; is a member of executive and steering committees for Pfizer, AstraZeneca, Kowa, Bayer, Bristol-Myers Squibb, Janssen, and Portola; is a member of data and safety monitoring boards for Fibrinogen and Shingpoon; is an endpoint committee member for GlaxoSmithKline; and is an advisory board member and has participated in speaking activities for Amgen, Sanofi, Janssen, Shingpoon, Bayer, Bristol-Myers Squibb, and Servier. Dr. Callahan has participated in speaking activities for Bristol-Myers Squibb, and Pfizer. Drs. DeMicco, Fayyad, and Laskey are employees of Pfizer. Dr. Sillesen has participated in consulting and speaking activities for Bayer, Novo Nordisk, Philips Ultrasound, and Gore; and has received research grants from Cook Medical, Bayer, and Philips Ultrasound. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. This study was sponsored by Pfizer. Dr. Szarek is a consultant and advisory board member for CiVi and Esperion; is a member of data and safety monitoring boards for Resverlogix and Baxter; and is a steering committee member for Sanofi and Regeneron Pharmaceuticals. Dr. Amarenco has received unrestrictive grants from Sanofi, Bristol-Myers Squibb, AstraZeneca, Pfizer, Merck, and Boston Scientific; is a member of executive and steering committees for Pfizer, AstraZeneca, Kowa, Bayer, Bristol-Myers Squibb, Janssen, and Portola; is a member of data and safety monitoring boards for Fibrinogen and Shingpoon; is an endpoint committee member for GlaxoSmithKline; and is an advisory board member and has participated in speaking activities for Amgen, Sanofi, Janssen, Shingpoon, Bayer, Bristol-Myers Squibb, and Servier. Dr. Callahan has participated in speaking activities for Bristol-Myers Squibb, and Pfizer. Drs. DeMicco, Fayyad, and Laskey are employees of Pfizer. Dr. Sillesen has participated in consulting and speaking activities for Bayer, Novo Nordisk, Philips Ultrasound, and Gore; and has received research grants from Cook Medical, Bayer, and Philips Ultrasound. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
| Funders | Funder number |
|---|---|
| Philips Ultrasound | |
| Bristol-Myers Squibb | |
| Pfizer | |
| AstraZeneca | |
| GlaxoSmithKline | |
| Merck | |
| Sanofi | |
| Janssen Pharmaceuticals | |
| Cook Children's Medical Center | |
| Bayer Fund | |
| Kowa Company, Ltd. | |
| Novo Nordisk A/S |
Keywords
- atorvastatin
- stroke
- total events
- transient ischemic attack
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine