ROCKET AF Substudy: Rivaroxaban as Good as Warfarin in Elderly Patients
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Regardless of their age, patients with nonvalvular atrial fibrillation (A-fib) obtain similar safety and efficacy with rivaroxaban as they do with warfarin. The findings support use of the novel antiplatelet in the elderly, according to a substudy of the ROCKET AF trial published online June 3, 2014, ahead of print in Circulation.
| Methods |
| The ROCKET AF trial demonstrated the noninferiority of rivaroxaban (15 or 20 mg daily) compared with dose-adjusted warfarin (target international normalized ratio [INR] 2.0-3.0) for stroke (hemorrhagic or ischemic) and systemic embolism among 14,264 patients with nonvalvular A-fib at moderate-to-high risk of stroke. Patients randomized to rivaroxaban also showed less intracranial and fatal bleeding. |
For the substudy, researchers led by Jonathan L. Halperin, MD, of Mount Sinai Medical Center (New York, NY), analyzed results using an age cutoff of 75 years. Though older patients, who made up 44% of the cohort, tended to be female and have lower BMIs and more hypertension than younger patients, there were no significant differences in baseline characteristics according to treatment arm. Median age was 79 years in the older group and 66 years in the younger group. |
Age Has Little Effect on Efficacy, Safety
After 10,866 patient-years of follow-up, stroke or systemic embolism (primary efficacy endpoint) was more common in older than younger patients (2.57 vs 2.05 per 100 patient-years; P = .0068). Even so, within each age group, both drugs showed comparable efficacy. Elderly patients had higher risk of major or clinically relevant nonmajor bleeding (primary safety endpoint) with rivaroxaban than with warfarin, though the difference was driven by GI bleeding rather than intracranial hemorrhage (table 1).
Table 1. Risk per 100-Patient Years: Rivaroxaban vs Warfarin
HR (95% CI) |
Age ≥ 75 Years |
Age < 75 Years |
P Value for Interaction |
Primary Efficacy Endpoint |
0.80 (0.63-1.02) |
0.95 (0.76-1.19) |
.3131 |
Primary Safety Endpoint |
1.13 (1.02-1.25) |
0.93 (0.84-1.04) |
.0090 |
Major Bleeding |
1.11 (0.92-1.34) |
0.96 (0.78-1.19) |
.3357 |
Intracranial Hemorrhage |
0.80 (0.50-1.28) |
0.54 (0.33-0.89) |
.2654 |
In younger patients, rivaroxaban was associated with decreased rates of intracranial hemorrhage compared with warfarin (P = .0156). However, in both older and younger patients, rivaroxaban treatment increased GI bleeding (P = .0002 and P = .0136, respectively).
A Patient-Friendly Alternative
Formerly the only option for severe thromboembolic indications, warfarin maintenance has proven to be difficult in elderly patients, Dr. Halperin and colleagues point out. “Management of warfarin therapy in clinical practice is challenging and often suboptimal even in well-organized centers,” they explain, adding that major bleeding may even be higher in clinical practice, where INR is less likely to be optimally managed.
The need for frequent monitoring due to increased bleeding risk, “sensitivity to warfarin, polypharmacy, and comorbidities make it difficult for elderly patients to maintain stable anticoagulation,” the authors elaborate.
As such, “simplifying anticoagulation management in the elderly is a substantial advantage,” they continue. “The availability of rivaroxaban and other factor Xa inhibitors may allow anticoagulation of a higher proportion of high-risk elderly patients with A-fib, offering protection against stroke.”
Source:
Halperin JL, Hankey GJ, Wojdyla DM, et al. Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the ROCKET AF trial. Circulation. 2014;Epub ahead of print.
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ROCKET AF Substudy: Rivaroxaban as Good as Warfarin in Elderly Patients
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Disclosures
- ROCKET AF was funded by Bayer HealthCare AG and Johnson & Johnson.
- Dr. Halperin reports receiving consulting fees from Astellas Pharma, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Pfizer, and Sanofi Aventis and serving as chair on the data safety monitoring committee for the EUCLID trial, sponsored by AstraZeneca.
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