Clinical Studies – Targeting Acute and Chronic Thromboembolic Disorders
ROCKET AF: Stroke Prevention in Atrial Fibrillation
ROCKET AF:
rivaroxaban for stroke prevention in atrial fibrillation
- Atrial fibrillation ( AF ) is the most common sustained cardiac arrhythmia and it markedly increases the risk of stroke1,2
- Additional risk factors such as age, gender and concomitant medical conditions (including heart failure and diabetes mellitus) further exacerbate the risk of stroke3,4,5
- Vitamin K antagonists, such as warfarin and acenocoumarol, are the current standard of care for stroke prevention in AF but are challenging to manage in clinical practice6
- Although effective, vitamin K antagonists have an unpredictable pharmacological profile that necessitates routine coagulation monitoring and dose adjustment to ensure that patients remain within the therapeutic range7
ROCKET AF : once-daily rivaroxaban versus dose-adjusted warfarin
ROCKET AF compared the efficacy and safety of once-daily rivaroxaban with warfarin for the prevention of stroke and systemic embolism in patients with non-valvular AF for whom guidelines recommend oral anticoagulation.
Objective
The main objective of ROCKET AF was to determine if once-daily rivaroxaban was as effective as dose-adjusted warfarin for the prevention of thromboembolic events in patients with non-valvular AF who are at increased risk of stroke.
Study design
ROCKET AF was a prospective, randomised, double-blind, multicentre, parallel-group, active-control, event-driven study of 14,264 patients with non-valvular AF and a history of stroke, TIA or systemic embolism or with at least two risk factors for stroke. The patients were randomised to receive either:
- Rivaroxaban 20 mg once-daily (15 mg once-daily for patients with moderate renal impairment at entry [creatinine clearance of 30–49 ml/min])
- Warfarin titrated to an international normalised ratio of 2.5 (range 2.0–3.0)
To preserve blinding, all groups underwent routine coagulation monitoring as required with warfarin. Sham international normalised ratio values were provided for patients receiving rivaroxaban.10
Inclusion criteria
The study was designed to evaluate a moderate-to-high risk adult patient population with persistent or paroxysmal AF and either:
- Prior stroke, transient ischaemic attack or systemic embolism; or
- Two or more risk factors for stroke including: clinical heart failure and/or left ventricular ejection fraction ≤35%, hypertension, age ≥75 years or diabetes mellitus
- Patients with only two risk factors for stroke were capped at 10% of the overall trial population, with the remaining patients requiring three or more risk factors, or a prior stroke, transient ischaemic attack or systemic embolism
Study endpoints
- The primary efficacy endpoint was the composite endpoint of stroke (ischaemic or haemorrhagic) and systemic embolism
- The principal safety outcome was the composite of major and non-major clinically relevant bleeding
PP-XAR-ALL-1821-1
References
- National Heart Lung and Blood Institute. Atrial Fibrillation. 2009. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_what.html [accessed 19 November 2019]. National Heart Lung and Blood Institute. Atrial Fibrillation. 2009. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_what.html [accessed 19 November 2019]. Return to content
- Wolf PA, et al. Stroke. 1991;22:983–988. Wolf PA, et al. Stroke. 1991;22:983–988. Return to content
- Go AS, et al. JAMA 2001;285:2370–2375. Go AS, et al. JAMA 2001;285:2370–2375. Return to content
- Heeringa J, et al. Eur Heart J. 2006;27:949–953. Heeringa J, et al. Eur Heart J. 2006;27:949–953. Return to content
- Benjamin EJ, et al. JAMA. 1994;271:840–844. Benjamin EJ, et al. JAMA. 1994;271:840–844. Return to content
- Verheugt FW. Neth Heart J. 2010;18:314–318. Verheugt FW. Neth Heart J. 2010;18:314–318. Return to content
- Ansell J, et al. Chest. 2008;133:160S–198S. Ansell J, et al. Chest. 2008;133:160S–198S. Return to content
- Gladstone DJ, et al. Stroke. 2009;40:235–240. Gladstone DJ, et al. Stroke. 2009;40:235–240. Return to content
- Waldo AL, et al. J Am Coll Cardiol. 2005;46:1729–1736. Waldo AL, et al. J Am Coll Cardiol. 2005;46:1729–1736. Return to content
- Patel MR, et al. N Engl J Med. 2011;365:883–891. Patel MR, et al. N Engl J Med. 2011;365:883–891. Return to content
