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ROCKET AF Clinical Trial

XARELTO® was studied in nonvalvular AF patients with prior stroke and multiple comorbidities

XARELTO® was evaluated versus dose-adjusted warfarin in more than 14,000 patients with nonvalvular atrial fibrillation (AF) at moderate to high risk for stroke in a rigorously designed, multicenter, randomized, double-blind, double-dummy, event-driven trial.1 XARELTO® was shown to offer proven efficacy and safety outcomes for patients with prior stroke or multiple comorbidities. View the study

Subgroup analyses of the ROCKET AF trial were conducted in patients with moderate renal impairment, prior stroke or TIA, heart failure, and in the elderly.2-5

XARELTO® Trial Data in Nonvalvular Atrial Fibrillation

  • Patients had prior stroke or multiple comorbidities with CHADS2 scores ≥2 and 87% of patients had a CHADS2 score ≥3, reflecting an elevated risk for stroke1

  • Primary efficacy outcome: time to first occurrence of stroke (any type) or non-CNS systemic embolism

  • Principal safety outcome: composite of major and nonmajor clinically relevant bleeding1

Patient Characteristics in ROCKET AF1,7

ROCKET AF studied Xarelto in patients with prior stroke or multiple comorbidities

ROCKET AF inclusion criteria7

  • Adults ≥18 years of age with nonvalvular AF documented by ECG evidence within 30 days before randomization

    • Female patients were postmenopausal or using an effective method of birth control

  • Patients with newly diagnosed nonvalvular AF provided that cardioversion was not planned

  • History of prior ischemic stroke, TIA, or non-CNS embolism or with 2 or more of the following risk factors:

    • Heart failure or LVEF ≤35%

    • Hypertension

    • Age ≥75 years

    • Diabetes mellitus

The number of subjects without prior stroke, TIA, or non-CNS embolism and only 2 risk factors was limited to 10%.1

Efficacy and safety outcomes in the ROCKET AF trial

  • Effectively reduced stroke risk in nonvalvular AF

    • Mean CHADS2 score for study population was 3.5

  • Overall major bleed rates versus warfarin: XARELTO® 3.6, warfarin 3.5 per 100 patient-years

    • Lower rate of most concerning bleeds: fatal and critical-organ bleeding,* including ICH1

    • Higher GI bleeds and transfusions

Subgroup analyses of the ROCKET AF trial

The purpose of these post hoc analyses was to evaluate the efficacy and safety data of ROCKET AF across prespecified subgroups, including patients with moderate renal impairment, those with prior stroke or TIA, those with heart failure, and the elderly.

  • Efficacy and safety results in patients with moderate renal impairment (CrCl 30 to 49 mL/min) receiving XARELTO® 15 mg once daily were generally consistent with those with better renal function (CrCl ≥50 mL/min) given XARELTO® 20 mg once daily, and with the overall trial.2 View the study

  • Efficacy and safety outcomes of XARELTO® compared with warfarin were generally consistent in patients with and without previous stroke or TIA, and with the overall trial.3 View the study

  • Efficacy and safety outcomes of XARELTO® compared with warfarin were generally consistent in patients with and without heart failure, and with the overall trial.4 View the study

  • Efficacy and safety results in patients aged ≥75 years were generally consistent with those <75 years of age, and consistent with the trial.5 View the study

CHADS2 = CHF, hypertension, age ≥75 years, diabetes mellitus, prior stroke or TIA; CHF = congestive heart failure; CNS = central nervous system; CrCl = creatinine clearance; ECG = electrocardiogram; INR = international normalized ratio; LVEF = left ventricular ejection fraction; ROCKET AF = Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation; TIA = transient ischemic attack.

*The majority of critical-organ bleeding events were intracranial, and also included intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal.

Event rates per 100 patient-years, rivaroxaban versus warfarin: critical-organ bleeding 0.8 versus 1.2; fatal bleeding 0.2 versus 0.5.

Event rates per 100 patient-years, rivaroxaban versus warfarin: bleeding resulting in transfusion of ≥2 units of whole blood or packed red blood cells 1.7 versus 1.3; GI bleeding 2.0 versus 1.2.

 

Indications

 

IMPORTANT SAFETY INFORMATION

 

Indication and Important saftey Information

 

INDICATIONS

  • Reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). There are limited data on the relative effectiveness of XARELTO® (rivaroxaban) and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.
  • Treatment of deep vein thrombosis (DVT).
  • Treatment of pulmonary embolism (PE).
  • Reduction in the risk of recurrence of DVT and of PE following initial 6 months treatment for DVT and/or PE.
  • Prophylaxis of DVT, which may lead to PE in patients undergoing knee replacement surgery.
  • Prophylaxis of DVT, which may lead to PE in patients undergoing hip replacement surgery.

References:

  1. Patel MR, Mahaffey KW, Garg J, et al; and the ROCKET AF Steering Committee, for the ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883-891.
  2. Fox KAA, Piccini JP, Wojdyla D, et al. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur Heart J. 2011;32(19):2387-2394.
  3. Hankey GJ, Patel MR, Stevens SR, et al, for the ROCKET AF Steering Committee and Investigators. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol. 2012;11(4):315-322.
  4. van Diepen S, Hellkamp AS, Patel MR, et al. Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF. Circ Heart Fail. 2013;6(4):740-747.
  5. Halperin JL, Hankey GJ, Wojdyla DM, et al; on behalf of the ROCKET AF Steering Committee and Investigators. Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Circulation. 2014;130(2):138-146.
  6. The Executive Steering Committee, on behalf of the ROCKET AF Study Investigators. Rivaroxaban—Once daily, oral, direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010;159(3):340-347.e1.
  7. Online supplement to: Patel MR, Mahaffey KW, Garg J, et al; and the ROCKET AF Steering Committee, for the ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883-891. http://www.nejm.org/doi/suppl/10.1056/NEJMoa1009638/suppl_file/nejmoa1009638_appendix.pdf. Accessed March 2, 2015.