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A pre-planned subgroup analysis of the ROCKET AF Phase III clinical study confirms that rivaroxaban is highly effective in the prevention of recurrent strokes in patients with atrial fibrillation (AF) who have experienced a prior stroke or transient ischemic attack (TIA). These findings were presented today at the 20^th European Stroke Conference by Professor Werner Hacke, Chair of the Department of Neurology at the University of Heidelberg, Germany, and member of the ROCKET AF Executive Steering Committee.

AF-related stroke is a leading cause of serious long-term disability and death globally. The current standard of care, warfarin, is a highly effective stroke prevention treatment, but its use is limited by side-effects including intra-cranial haemorrhage, numerous food and drug interactions, as well as the need for regular INR monitoring. Therefore, there is a large medical need for other highly effective prevention options with fewer limitations.

The ROCKET AF secondary prevention sub-analysis examined the benefits of rivaroxaban and warfarin in the highest number of prior-stroke AF patients studied to date (7,468 total patients). Rivaroxaban showed a numerically lower (13%) risk compared with warfarin in the combined endpoint of stroke and systemic embolism in this subgroup of patients, this being in line with the results of the main ROCKET AF trial. Overall bleeding rates were similar between both treatment arms, although fatal bleeding events, as well as ICH events, were less frequent in those receiving rivaroxaban. Overall, the benefit-risk profile favours rivaroxaban in these difficult to manage secondary prevention patients. These differences did not reach statistical significance as this subgroup analysis was not powered for these endpoints.

The investigators concluded that rivaroxaban is an effective alternative to warfarin for the protection of patients from both a first and recurrent strokes.

"The results are particularly significant for patients who have suffered a prior stroke and who are more difficult to manage when on current standard of care, as they have a higher stroke risk than those without prior history of an event." said Professor Werner Hacke "The ROCKET AF study has given us a unique opportunity to compare existing care with a new generation medicine that does not have the same limitations as warfarin."

"AF increases stroke risk fivefold, and for many patients the burden of required routine INR monitoring can have a negative impact on the quality of daily life," said Trudie Lobban, MBE, Founder and CEO of the Atrial Fibrillation Association (AFA). "The impact of secondary stroke can be devastating for patients and their families, who are already coping with the joint challenge of both AF and a prior, disabling event. For this reason alone, prevention of further stroke events is a critically important treatment goal."

About the ROCKET AF Secondary Analysis Findings

The secondary prevention subgroup of the ROCKET AF study, consisting of patients with a prior history of stroke or TIA (representing 55 per cent of the total study population), received either 20mg once daily rivaroxaban (or 15 mg for patients with moderate renal impairment), or dose-adjusted warfarin. The ROCKET AF principal safety outcome was major and non-major clinically relevant bleeding. Rivaroxaban showed a numerically lower (13%) risk compared to warfarin in the prevention of recurrent strokes or non-CNS embolism in the safety population while on-treatment (2.26 events per 100 patient-years for rivaroxaban and 2.60 events per 100 patient-years for warfarin, HR 0.87, 95% CI [0.69, 1.10]). Similar rates of overall bleeding to those seen in the primary ROCKET AF analysis were found, with no difference between the treatment groups (13.31 safety outcome-related events per 100 patient-years for rivaroxaban and 13.87 events per 100 patient-years for warfarin, HR 0.96, 95% CI [0.87, 1.07]). Rates of ICH were numerically lower in the rivaroxaban arm (0.59 events per 100 patient-years for rivaroxaban and 0.8 events per 100 patient-years for warfarin, HR 0.74, 95% CI [0.47, 1.15]).