Thrombosis & Hemostasis Summit of North America 2012
Dabigatran Use in the Real World—Preliminary Results of a Prospective Trial Comparing Outcomes with Dabigatran and Warfarin Therapy
Mark W. Wurster1, Maureen Howard2, Cynthia Price2 , Barbara Chopin1, and Lindsay Felderman1
1Standing Stone Inc, Westport, USA; 2Staten Island University Hospital/Long Island Jewish, Staten Island, USA
Background: Little information is available regarding complications rates with real-world dabigatran use when compared with warfarin use in anticoagulation clinics. We report on the preliminary results of a study addressing dabigatran with warfarin as a comparison.
Methods: This is a prospective, observational cohort study at an anticoagulation clinic following 2,200 patients. From November 2010, all clinic patients who switched from warfarin to dabigatran were identified and followed prospectively. Outcome measures focus on clinical events that required discontinuation of agent, including thrombosis, bleeding, death, or other episodes. Event frequency was tracked throughout consecutive treatment periods on warfarin and dabigatran, and the results were compared with Fisher’s exact test.
Results: Preliminary results focus on the frequency of observed complications obtained from the first six months of dabigatran use and a 6 -month period of prior treatment on warfarin in 113 patients. Dabigatran mean exposure time was 3.9 months; for warfarin, mean exposure time was 6 months (TTR for patients while on warfarin was 70%). During warfarin treatment, outcomes included one hospitalization for warfarin toxicity. During dabigatran treatment, outcomes included one death ( GI bleed), four other bleeding episodes (two GI bleeds, one rectus sheath hemorrhage, and one intracranial hemorrhage), one DVT, one atrial thrombus, one TIA, one skin rash, and four GI reactions. Outcome frequency during warfarin treatment was 0.88% when compared with 11.5% during dabigatran treatment (P < 0. 0014). Mean age of patients who experienced complications on dabigatran was 73.4 years vs. 66.5 years overall. Females represented 29% of patients overall, but 71% of those with complications.
Conclusions: When compared with warfarin used in an organized clinic setting, dabigatran is associated with a significantly higher complication rate. Complications affected older patients and female patients more frequently. The final study report will include information on possible contributing factors including renal function, comorbid conditions, and medication use.
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