Journal Club SummaryMethodology Score: 2.5/5 Usefulness Score: 3/5
Pollack CVJr, et al. N Engl J Med. 2015 Aug 6;373(6):511-20 Full Article
This prospective cohort study demonstrated that a new dagbigatran reversal agent, idarucizumab, completely reverses dabigatran’s anticoagulant effects (as measured by dilute thrombin time and eccarin clotting time) in patients with serious bleeding or in need of an urgent procedure. JC attendees found the following weaknesses in this study: very small sample size, was an interim analysis with only 90 patients, lacked a control group, used laboratory tests as surrogate endpoints for the primary outcome, and lacked patient orientated, clinically important/safety outcomes. Dabigatran is currently the only novel oral anticoagulant with an FDA approved reversal agent. By: Dr. Laura Shoots (Presented February 2016)
Epi lesson: Surrogate endpoints
Can be used as a measure of effect for specific treatments and might correlate with clinical outcom…
Pollack CVJr, et al. N Engl J Med. 2015 Aug 6;373(6):511-20 Full Article
This prospective cohort study demonstrated that a new dagbigatran reversal agent, idarucizumab, completely reverses dabigatran’s anticoagulant effects (as measured by dilute thrombin time and eccarin clotting time) in patients with serious bleeding or in need of an urgent procedure. JC attendees found the following weaknesses in this study: very small sample size, was an interim analysis with only 90 patients, lacked a control group, used laboratory tests as surrogate endpoints for the primary outcome, and lacked patient orientated, clinically important/safety outcomes. Dabigatran is currently the only novel oral anticoagulant with an FDA approved reversal agent. By: Dr. Laura Shoots (Presented February 2016)
Epi lesson: Surrogate endpoints
Can be used as a measure of effect for specific treatments and might correlate with clinical outcom…