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Risk of thromboembolism in heart failure: an analysis from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).
Circulation. 2007 May 22; 115(20):2637-41.Circ

Abstract

BACKGROUND

In patients with heart failure, rates of clinically apparent stroke range from 1.3% to 3.5% per year. Little is known about the incidence and risk factors in the absence of atrial fibrillation. In the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), 2521 patients with moderate heart failure were randomized to receive amiodarone, implanted cardioverter-defibrillators (ICDs), or placebo.

METHODS AND RESULTS

We determined the incidence of stroke or peripheral or pulmonary embolism in patients with no history of atrial fibrillation (n=2114), predictors of thromboembolism and the relationship to left ventricular ejection fraction. Median follow-up was 45.5 months. Kaplan-Meier estimates (95% CIs) for the incidence of thromboembolism by 4 years were 4.0% (3.0% to 4.9%), with 2.6% (1.1% to 4.1%) in patients randomized to amiodarone, 3.2% (1.8% to 4.7%) in patients randomized to ICD, and 6.0% (4.0% to 8.0%) in patients randomized to placebo (approximate rates of 0.7%, 0.8%, and 1.5% per year, respectively). By multivariable analysis, hypertension (P=0.021) and decreasing left ventricular ejection fraction (P=0.023) were significant predictors of thromboembolism; treatment with amiodarone or ICD treatment was a significant predictor of thromboembolism-free survival (P=0.014 for treatment effect; hazard ratio [95% CI] versus placebo, 0.57 [0.33 to 0.99] for ICD; 0.44 [0.24 to 0.80] for amiodarone). Inclusion of atrial fibrillation during follow-up in the multivariable model did not affect the significance of treatment assignment as a predictor of thromboembolism.

CONCLUSIONS

In the SCD-HeFT patient cohort, which reflects contemporary treatment of patients with moderately symptomatic systolic heart failure, patients experienced thromboembolism events at a rate of 1.7% per year without antiarrhythmic therapy. Those treated with amiodarone or ICDs had lower risk of thromboembolism than those given placebo. Hypertension at baseline and lower ejection fraction were independent predictors of risk.

Authors+Show Affiliations

Department of Medicine, Robert Wood Johnson Medical School, Suite 6100, 125 Paterson St, New Brunswick, NJ 08903, USA. r.freudenberger@yahoo.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

17485579

Citation

Freudenberger, Ronald S., et al. "Risk of Thromboembolism in Heart Failure: an Analysis From the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)." Circulation, vol. 115, no. 20, 2007, pp. 2637-41.
Freudenberger RS, Hellkamp AS, Halperin JL, et al. Risk of thromboembolism in heart failure: an analysis from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Circulation. 2007;115(20):2637-41.
Freudenberger, R. S., Hellkamp, A. S., Halperin, J. L., Poole, J., Anderson, J., Johnson, G., Mark, D. B., Lee, K. L., & Bardy, G. H. (2007). Risk of thromboembolism in heart failure: an analysis from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Circulation, 115(20), 2637-41.
Freudenberger RS, et al. Risk of Thromboembolism in Heart Failure: an Analysis From the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Circulation. 2007 May 22;115(20):2637-41. PubMed PMID: 17485579.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Risk of thromboembolism in heart failure: an analysis from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). AU - Freudenberger,Ronald S, AU - Hellkamp,Anne S, AU - Halperin,Jonathan L, AU - Poole,Jeanne, AU - Anderson,Jill, AU - Johnson,George, AU - Mark,Daniel B, AU - Lee,Kerry L, AU - Bardy,Gust H, AU - ,, Y1 - 2007/05/07/ PY - 2007/5/9/pubmed PY - 2007/6/5/medline PY - 2007/5/9/entrez SP - 2637 EP - 41 JF - Circulation JO - Circulation VL - 115 IS - 20 N2 - BACKGROUND: In patients with heart failure, rates of clinically apparent stroke range from 1.3% to 3.5% per year. Little is known about the incidence and risk factors in the absence of atrial fibrillation. In the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), 2521 patients with moderate heart failure were randomized to receive amiodarone, implanted cardioverter-defibrillators (ICDs), or placebo. METHODS AND RESULTS: We determined the incidence of stroke or peripheral or pulmonary embolism in patients with no history of atrial fibrillation (n=2114), predictors of thromboembolism and the relationship to left ventricular ejection fraction. Median follow-up was 45.5 months. Kaplan-Meier estimates (95% CIs) for the incidence of thromboembolism by 4 years were 4.0% (3.0% to 4.9%), with 2.6% (1.1% to 4.1%) in patients randomized to amiodarone, 3.2% (1.8% to 4.7%) in patients randomized to ICD, and 6.0% (4.0% to 8.0%) in patients randomized to placebo (approximate rates of 0.7%, 0.8%, and 1.5% per year, respectively). By multivariable analysis, hypertension (P=0.021) and decreasing left ventricular ejection fraction (P=0.023) were significant predictors of thromboembolism; treatment with amiodarone or ICD treatment was a significant predictor of thromboembolism-free survival (P=0.014 for treatment effect; hazard ratio [95% CI] versus placebo, 0.57 [0.33 to 0.99] for ICD; 0.44 [0.24 to 0.80] for amiodarone). Inclusion of atrial fibrillation during follow-up in the multivariable model did not affect the significance of treatment assignment as a predictor of thromboembolism. CONCLUSIONS: In the SCD-HeFT patient cohort, which reflects contemporary treatment of patients with moderately symptomatic systolic heart failure, patients experienced thromboembolism events at a rate of 1.7% per year without antiarrhythmic therapy. Those treated with amiodarone or ICDs had lower risk of thromboembolism than those given placebo. Hypertension at baseline and lower ejection fraction were independent predictors of risk. SN - 1524-4539 UR - https://www.unboundmedicine.com/medline/citation/17485579/Risk_of_thromboembolism_in_heart_failure:_an_analysis_from_the_Sudden_Cardiac_Death_in_Heart_Failure_Trial__SCD_HeFT__ L2 - https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.106.661397?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -