Thursday, March 8, 2012

Rivaroxaban non inferior to adjusted warfarin dose in patients with prior history of stroke or TIA -Study published in Lancet 7th March-12


Subgroup analysis of the ROCKET AF study, reveals Xarelto is non-inferior to adjusted dose warfarin in prevention of stroke or systemic embolism in patients with prior history of stroke or transient ischemic attack.

About 52% patients enrolled in ROCKET AF had prior stroke (n=4907) or Transient ischemic attach (2561).  In this subgroup, 2.79% patients on Xarelto (rivaroxaban) compared to 2.96% on warfarin experienced a recurrent stroke or systemic embolism. While the two drugs were also comparable in terms of major and non-major bleeding (13.31-Xarelto vs 13.87% -warfarin).


Table 2. ROCKET-AF Subanalysis: Safety Endpoints
Endpoint
Rivaroxaban
Warfarin
Hazard Ratio (95% Confidence Interval)
Safety outcome events (events per 100 patient-years)
13.31
13.87
0.96 (0.87 – 1.07)
Intracerebral hemorrhage (events per 100 patient-years)
0.59
0.8
0.74 (0.47 – 1.15)


Table 1. ROCKET-AF Subanalysis: Secondary Stroke Prevention
Endpoint
Rivaroxaban
Warfarin
Hazard Ratio (95% Confidence Interval)
Recurrent stroke or systemic embolism (events per 100 patient-years)
2.26
2.60
0.87 (0.69 – 1.10)