Promising stroke, bleeding rates after cardioversion reported with dabigatran use
Nagarakanti R. Circulation. 2011;123:131-136.
Stroke and major bleeding rates after cardioversion among patients from the RE-LY trial who were taking two doses of dabigatran were low and comparable with those who were treated with warfarin.
In the sub-analysis, investigators analyzed 1,983 cardioversions that were performed on 1,270 patients with nonvalvular atrial fibrillation from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial. Overall, 647 procedures were performed on patients assigned 110 mg dabigatran (Pradaxa, Boehringer Ingelheim) twice-daily, 672 procedures on those assigned 150 mg dabigatran twice-daily and 664 procedures in patients assigned warfarin (Coumadin, Bristol-Myers Squibb).
At 30 days, stroke and systemic embolism rates were 0.8% in the 110-mg dabigatran arm, 0.3% in 150-mg dabigatran arm and 0.6% in the warfarin group, with differences between both doses of dabigatran not reaching statistical significance when compared with warfarin. Similarly, major bleeding rates between 110 mg dabigatran (1.7%) and 150 mg dabigatran (0.6%) were comparable with warfarin (0.6%).
“The RE-LY trial confirmed the efficacy and safety of warfarin in cardioversion in a large cohort of warfarin-treated patients. It also allowed comparison with the new oral anticoagulant dabigatran. The results show that the two drugs are comparable in this setting,” the researchers concluded.
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Quality measurement of anticoagulation care delivery may lead to better outcomes
Rose A. Circ Cardiovasc Qual Outcomes.2011;doi:10.1161/circoutcomes.110.957738.
New study results have indicated that use of risk-adjusted percent time in therapeutic range data may help oral anticoagulant care delivery sites, especially in large integrated health systems, prevent adverse events from inadequate or excessive anticoagulation. The findings were published online by researchers from Boston University School of Medicine and Bedford Veterans Affairs Medical Center
The researchers profiled the performance of 100 VA outpatient anticoagulation sites based on their respective risk-adjusted percent time in therapeutic range (TTR). Two years of data were collected on 124,551 patients who had received warfarin (Coumadin, Bristol-Myers Squibb) for at least 30 days and had at least two valid intervals of 56 days or less without hospitalization between two INR values. Patients with valvular CVD or with INR values of no more than 1.2 were excluded.
The expected TTR for each patient and each site was calculated based on a risk-adjusted model that included demographics, comorbidities, medications and hospitalizations. The expected TTR site range was 54% to 62%; the observed TTR site range was 38% to 69%. The mean TTR for the entire sample was 58%. Site risk-adjusted performance was 18% less than to 12% more than expected. One site with a challenging patient population (expected TTR, 53.5%; 4.4% less than average) was ranked 27th before risk adjustment (observed TTR, 60.6%; 2.7% more than average) but seventh after risk adjustment, the researchers said. Conversely, another site was ranked 79th before risk adjustment (observed TTR, 53.8%; 4.1% less than average), but “because of its relatively easy case mix” (expected TTR, 58.9%), the site dropped to 92nd.
“Risk adjustment is important for enhancing the credibility of site profiling; without [it], sites could claim that their poor performance was solely because of their case mix,” the researchers wrote. They said risk-adjusted site rankings were consistent from year to year, suggesting their study measured a “quality of care that is stable over time.”
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