High-dose atorvastatin and risk of atrial fibrillation in patients with prior stroke or transient ischemic attack: Analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial

Gregory G. Schwartz, Bernard R. Chaitman, Jeffrey Goldberger, Michael Messig

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Abstract

Background: Observational analyses and short-term randomized trials have suggested that statins reduce occurrence or recurrence of atrial fibrillation (AF). We tested the hypothesis that long-term treatment with high-dose atorvastatin reduces occurrence of AF in patients with prior stroke or transient ischemic attack. Methods: We examined development of new AF in the SPARCL trial that compared atorvastatin 80 mg daily with placebo in 4,731 patients with prior stroke or transient ischemic attack. Patients who had chronic or paroxysmal AF or were taking medications for treatment or prophylaxis of AF at the time of enrollment were excluded. Atrial fibrillation was identified from electrocardiograms submitted to a blinded central electrocardiographic laboratory and from investigators' adverse event reports. Results: Patients were followed up for a median of 4.8 years, corresponding to >20,000 patient-years of observation with a median of 5 electrocardiograms per patient. The primary efficacy measure, the time from randomization to first occurrence of new AF, did not differ between treatment groups. By intention to treat, there were 139 cases of new AF in the atorvastatin group and 122 cases in the placebo group, corresponding to incidence rates of 1.32 and 1.14 cases per 100 patient-years observation (hazard ratio 1.15, 95% CI 0.90-1.46, P = .26). On-treatment analysis yielded similar findings, with incidence rates of 1.26 and 1.01 cases per 100 patient-years observation in the atorvastatin and placebo groups, respectively (hazard ratio 1.25, 95% CI 0.94-1.67, P = .12). Conclusion: High-dose atorvastatin does not prevent development of AF in patients with prior stroke or transient ischemic attack.

Original languageEnglish (US)
Pages (from-to)993-999
Number of pages7
JournalAmerican Heart Journal
Volume161
Issue number5
DOIs
StatePublished - May 1 2011
Externally publishedYes

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Transient Ischemic Attack
Atrial Fibrillation
Stroke
Cholesterol
Placebos
Observation
Electrocardiography
Atorvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Incidence
Therapeutics
Random Allocation
Research Personnel
Recurrence

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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title = "High-dose atorvastatin and risk of atrial fibrillation in patients with prior stroke or transient ischemic attack: Analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial",
abstract = "Background: Observational analyses and short-term randomized trials have suggested that statins reduce occurrence or recurrence of atrial fibrillation (AF). We tested the hypothesis that long-term treatment with high-dose atorvastatin reduces occurrence of AF in patients with prior stroke or transient ischemic attack. Methods: We examined development of new AF in the SPARCL trial that compared atorvastatin 80 mg daily with placebo in 4,731 patients with prior stroke or transient ischemic attack. Patients who had chronic or paroxysmal AF or were taking medications for treatment or prophylaxis of AF at the time of enrollment were excluded. Atrial fibrillation was identified from electrocardiograms submitted to a blinded central electrocardiographic laboratory and from investigators' adverse event reports. Results: Patients were followed up for a median of 4.8 years, corresponding to >20,000 patient-years of observation with a median of 5 electrocardiograms per patient. The primary efficacy measure, the time from randomization to first occurrence of new AF, did not differ between treatment groups. By intention to treat, there were 139 cases of new AF in the atorvastatin group and 122 cases in the placebo group, corresponding to incidence rates of 1.32 and 1.14 cases per 100 patient-years observation (hazard ratio 1.15, 95{\%} CI 0.90-1.46, P = .26). On-treatment analysis yielded similar findings, with incidence rates of 1.26 and 1.01 cases per 100 patient-years observation in the atorvastatin and placebo groups, respectively (hazard ratio 1.25, 95{\%} CI 0.94-1.67, P = .12). Conclusion: High-dose atorvastatin does not prevent development of AF in patients with prior stroke or transient ischemic attack.",
author = "Schwartz, {Gregory G.} and Chaitman, {Bernard R.} and Jeffrey Goldberger and Michael Messig",
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T1 - High-dose atorvastatin and risk of atrial fibrillation in patients with prior stroke or transient ischemic attack

T2 - Analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial

AU - Schwartz, Gregory G.

AU - Chaitman, Bernard R.

AU - Goldberger, Jeffrey

AU - Messig, Michael

PY - 2011/5/1

Y1 - 2011/5/1

N2 - Background: Observational analyses and short-term randomized trials have suggested that statins reduce occurrence or recurrence of atrial fibrillation (AF). We tested the hypothesis that long-term treatment with high-dose atorvastatin reduces occurrence of AF in patients with prior stroke or transient ischemic attack. Methods: We examined development of new AF in the SPARCL trial that compared atorvastatin 80 mg daily with placebo in 4,731 patients with prior stroke or transient ischemic attack. Patients who had chronic or paroxysmal AF or were taking medications for treatment or prophylaxis of AF at the time of enrollment were excluded. Atrial fibrillation was identified from electrocardiograms submitted to a blinded central electrocardiographic laboratory and from investigators' adverse event reports. Results: Patients were followed up for a median of 4.8 years, corresponding to >20,000 patient-years of observation with a median of 5 electrocardiograms per patient. The primary efficacy measure, the time from randomization to first occurrence of new AF, did not differ between treatment groups. By intention to treat, there were 139 cases of new AF in the atorvastatin group and 122 cases in the placebo group, corresponding to incidence rates of 1.32 and 1.14 cases per 100 patient-years observation (hazard ratio 1.15, 95% CI 0.90-1.46, P = .26). On-treatment analysis yielded similar findings, with incidence rates of 1.26 and 1.01 cases per 100 patient-years observation in the atorvastatin and placebo groups, respectively (hazard ratio 1.25, 95% CI 0.94-1.67, P = .12). Conclusion: High-dose atorvastatin does not prevent development of AF in patients with prior stroke or transient ischemic attack.

AB - Background: Observational analyses and short-term randomized trials have suggested that statins reduce occurrence or recurrence of atrial fibrillation (AF). We tested the hypothesis that long-term treatment with high-dose atorvastatin reduces occurrence of AF in patients with prior stroke or transient ischemic attack. Methods: We examined development of new AF in the SPARCL trial that compared atorvastatin 80 mg daily with placebo in 4,731 patients with prior stroke or transient ischemic attack. Patients who had chronic or paroxysmal AF or were taking medications for treatment or prophylaxis of AF at the time of enrollment were excluded. Atrial fibrillation was identified from electrocardiograms submitted to a blinded central electrocardiographic laboratory and from investigators' adverse event reports. Results: Patients were followed up for a median of 4.8 years, corresponding to >20,000 patient-years of observation with a median of 5 electrocardiograms per patient. The primary efficacy measure, the time from randomization to first occurrence of new AF, did not differ between treatment groups. By intention to treat, there were 139 cases of new AF in the atorvastatin group and 122 cases in the placebo group, corresponding to incidence rates of 1.32 and 1.14 cases per 100 patient-years observation (hazard ratio 1.15, 95% CI 0.90-1.46, P = .26). On-treatment analysis yielded similar findings, with incidence rates of 1.26 and 1.01 cases per 100 patient-years observation in the atorvastatin and placebo groups, respectively (hazard ratio 1.25, 95% CI 0.94-1.67, P = .12). Conclusion: High-dose atorvastatin does not prevent development of AF in patients with prior stroke or transient ischemic attack.

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