Abstract
Background
Health outcomes associated with atrial fibrillation (AF) continue to be poor and standard
management often does not provide clinical stability. The Standard versus Atrial Fibrillation
spEcific managemenT studY (SAFETY) compares the efficacy of a post-discharge, nurse-led,
multi-disciplinary programme to optimise AF management with usual care.
Methods
SAFETY is a prospective, multi-centre, randomised controlled trial with blinded-endpoint
adjudication. A target of 320 hospitalised patients with a chronic form of AF will
be randomised (stratified by “rate” versus “rhythm” control) to usual post-discharge
care or the SAFETY Intervention (SI). The SI involves home-based assessment, extensive
clinical profiling and the application of optimal gold-standard pharmacology which
is individually tailored according to a “traffic light” framework based on clinical
stability, risk profile and therapeutic management. The primary endpoint is event-free
survival from all-cause death or unplanned readmission during 18–36 months follow-up. Secondary endpoints include rate of recurrent hospital stay, treatment
success (i.e. maintenance of rhythm or rate control and/or application of anti-thrombotic
therapy without a bleeding event) and cost-efficacy.
Results
With study recruitment to be completed in early 2012, the results of this study will
be available in early 2014.
Conclusions
If positive, SAFETY will represent a potentially cost-effective and readily applicable
strategy to improve health outcomes in high risk individuals discharged from hospital
with chronic AF.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to International Journal of CardiologyAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study.Eur Heart J. 2006; 27: 949-953
- Lifetime risk for development of atrial fibrillation: the Framingham Heart study.Circulation. 2004; 110: 1042-1046
- Trends in hospital activity, morbidity and case fatality related to atrial fibrillation in Scotland, 1986–1996.Eur Heart J. 2001; 22: 693-701
- Population prevalence, incidence, and predictors of atrial fibrillation in the Renfrew/Paisley study.Heart. 2001; 86: 516-521
- A national survey of the prevalence, incidence, primary care burden and treatment of atrial fibrillation in Scotland.Heart. 2007; 93: 606-612
- Trends in out-of-hospital deaths due to coronary heart disease in Sweden (1991 to 2006).Circulation. 2011; 123: 46-52
Sliwa K, Carrington MJ, Klug E, et al. Predisposing factors and incidence of newly diagnosed atrial fibrillation in an urban African community: insights from the Heart of Soweto Study. Heart 2011;96(23):1878–82.
- Atrial fibrillation as an independent risk factor for stroke: the Framingham study.Stroke. 1991; 22: 983-988
- Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study.Stroke. 2005; 36: 1115-1119
- Predictors of congestive heart failure in the elderly: the cardiovascular health study.J Am Coll Cardiol. 2000; 35: 1628-1637
- International variations in the treatment and co-morbidity of left ventricular systolic dysfunction: data from the EuroHeart Failure Survey.Eur J Heart Fail. 2007; 9: 292-299
- A meta-analysis of the prognostic significance of atrial fibrillation in chronic heart failure.Eur J Heart Fail. 2009; 11: 676-683
- Apixaban versus warfarin in patients with atrial fibrillation.N Engl J Med. 2011; 365: 981-992
- Atrial fibrillation management by practice cardiologists: a prospective survey on the adherence to guidelines in the real world.Europace. 2008; 10: 674-680
- Dabigatran versus warfarin in patients with atrial fibrillation.N Engl J Med. 2009; 361: 1139-1151
- Stroke prevention and atrial fibrillation: reasons leading to an inappropriate management. Main results of the SAFE II study.Br J Clin Pharmacol. 2004; 57: 798-806
- Cost of an emerging epidemic—an economic analysis of atrial fibrillation in the U.K..Heart. 2004; 90: 286-292
- Multidisciplinary strategies for the management of heart failure patients at high risk for admission: a systematic review of randomized trials.J Am Coll Cardiol. 2004; 44: 810-819
- A new solution for an old problem? Effects of a nurse-led, multidisciplinary, home-based intervention on readmission and mortality in patients with chronic atrial fibrillation.J Cardiovasc Nurs. 2004; 19: 118-127
- An integrated chronic care program for patients with atrial fibrillation: study protocol and methodology for an ongoing prospective randomised controlled trial.Int J Nurs Stud. 2010; 47: 1310-1316
- Drug-induced proarrhythmic effects: assessment of changes in QT interval.Br J Clin Pharmacol. 2000; 50: 297-302
- Guidelines for the management of atrial fibrillation.Eur Heart J. 2010; 31: 2369-2429
- Meta-analysis of the effectiveness and safety of catheter ablation of atrial fibrillation in patients with versus without left ventricular systolic dysfunction.Am J Cardiol. 2010; 106: 1284-1291
- New anticoagulant drugs among elderly patients is caution necessary?.Arch Intern Med. 2011; 171: 1287-1288
- The use of dabigatran in elderly patients.Arch Intern Med. 2011; 171: 1285-1286
- Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation.JAMA. 2001; 285: 2864-2870
- A comparison of rate control and rhythm control in patients with atrial fibrillation.N Engl J Med. 2002; 347: 1825-1833
- Relationships between sinus rhythm, treatment, and survival in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) study.Circulation. 2004; 109: 1509-1513
- Rate control versus rhythm control for patients with persistent atrial fibrillation with mild to moderate heart failure: results from the RAte Control versus Electrical cardioversion (RACE) study.Am Heart J. 2005; 149: 1106-1111
- Randomized trial of rate-control versus rhythm-control in persistent atrial fibrillation: the Strategies of Treatment of Atrial Fibrillation (STAF) study.J Am Coll Cardiol. 2003; 41: 1690-1696
- Effect of dronedarone on cardiovascular events in atrial fibrillation.N Engl J Med. 2009; 360: 668-678
- Dronedarone trial suspended due to CV events in permanent atrial fibrillation.(Accessed July 7, 2011;)
- Effects of a multidisciplinary, home-based intervention on unplanned readmissions and survival among patients with chronic congestive heart failure: a randomised controlled study.Lancet. 1999; 354: 1077-1083
- Specialised atrial fibrillation clinic reduces cardiovascular morbidity and mortality in patients with atrial fibrillation.in: American College of Cardiology Scientific Sessions/i2 Summit SCAI annual meeting. 2011
- Prolonged effects of a home-based intervention in patients with chronic illness.Arch Intern Med. 2006; 166: 645-650
- Extending the horizon in chronic heart failure: effects of multidisciplinary, home-based intervention relative to usual care.Circulation. 2006; 114: 2466-2473
- Prediction of all-cause mortality from global longitudinal speckle strain: comparison with ejection fraction and wall motion scoring.Circ Cardiovasc Imaging. 2009; 2: 356-364
- Left ventricular volume measurement with echocardiography: a comparison of left ventricular opacification, three-dimensional echocardiography, or both with magnetic resonance imaging.Eur Heart J. 2009; 30: 98-106
- Platelet nitric oxide responsiveness: a novel prognostic marker in acute coronary syndromes.Arterioscler Thromb Vasc Biol. 2005; 25: 2661-2666
- Bridging the gap in heart failure prevention: rationale and design of the Nurse-led Intervention for Less Chronic Heart Failure (NIL-CHF) study.Eur J Heart Fail. 2010; 12: 82-88
- The balance between stroke prevention and bleeding risk in atrial fibrillation: a delicate balance revisited.Stroke. 2008; 39: 1406-1408
- Survival after stroke—the impact of CHADS2 score and atrial fibrillation.Int J Cardiol. 2010; 141: 18-23
- Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the Euro Heart Survey on Atrial Fibrillation.Chest. 2010; 137: 263-272
- A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation.Chest. 2010; 138: 1093-1100
- New ICD-10 version of the Charlson comorbidity index predicted in-hospital mortality.J Clin Epidemiol. 2004; 57: 1288-1294
- The time trade-off method: results from a general population study.Health Econ. 1996; 5: 141-154
Viney R, Norman R, King MT, et al. Time trade-off derived EQ-5D weights for Australia. Value Health 2011;14(6):928–936.
- The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment.J Am Geriatr Soc. 2005; 53: 695-699
- Screening for depression in primary care with two verbally asked questions: cross sectional study.Br Med J. 2003; 327: 1144-1146
- The CES-D scale: a self-report depression scale for research in the general population.Appl Psychol Meas. 1977; 1: 385-401
- Long-term risk of recurrent atrial fibrillation as documented by an implantable monitoring device: implications for optimal patient care.J Am Coll Cardiol. 2004; 43: 47-52
Article info
Publication history
Published online: November 14, 2011
Accepted:
October 18,
2011
Received:
September 22,
2011
Identification
Copyright
© 2011 Elsevier Ireland Ltd. Published by Elsevier Inc. All rights reserved.
