I want Xa's to work. I want them to show non-inferiority across all measures. Unfortunately The Rocket AF trial that came out yesterday in the Journal of the American College of Cardiology throws a wet towel on this. Death rates were the same (And very low) in both groups, but rivaroxaban caused significant GI bleeding compared to warfarin with a NNH of 100 patient-years of treatment (or 100 patients for 1 year). Bummer.
I have seen a couple of articles suggesting that overall cost of factor Xa for course of treatment is likely not higher than for LMW-heparain/warfarin. Lovenox is still expensive and patients still need repeat visits for INR checks and those costs add up when compared to factor Xa.
Suggestion for Sanjay and Mike in the area of imaging decision and shared decision making (sorry this is out of context but it was how I was told to drop something in the suggestion box) :
AJEM December 2015 "Can physician and patient gestalt lead to a shared decision to reduce unnecessary radiography in extremity trauma?" Michael Mouw, MD, MPAff
Abstract Study Objective: To study the predictive value of patient and physician gestalt regarding the presence or absence of fracture or dislocation in minor extremity trauma. Methods: This was a prospective observational study of patients presenting to an urban teaching hospital emergency department with minor extremity trauma, but without obvious deformity. Subjects were enrolled after radiography had been ordered by a physician. Exclusion criteria included arrival by ambulance, torso injury, and unreliable clinical examination. A questionnaire assessed patient’s and physician’s pretest prediction of abnormality (fracture or dislocation,) and the outcome was radiologist finding of an abnormality. Chi-squared analysis was done to evaluate the predictive value of patient and physician gestalt for radiographic abnormality. Results: 191 subjects with 195 injuries were analyzed. Fifty-four (27.7%) were found to have abnormalities. There were 14 cases where the patient predicted there was “definitely not” an abnormality. All 14 had no abnormality, for an NPV of 100%. There were 87 cases where an attending emergency physician predicted <10% likelihood of abnormality - of these there were 5 (6%) abnormal x-rays. Multivariate regression analysis found that pain scores did not predict the presence of abnormality but that patients with abnormalities presented sooner after their injury than patients without. Conclusions: In patients estimated to have a fracture risk of <10%, only 6% had fractures. When patients felt there was “definitely not” a fracture, there were no fractures. These results suggest that patient and physician gestalt should be studied further as variables for inclusion in future imaging decision rules.
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Joshua Michael, MD - December 3, 2015 11:50 AM
I want Xa's to work. I want them to show non-inferiority across all measures. Unfortunately The Rocket AF trial that came out yesterday in the Journal of the American College of Cardiology throws a wet towel on this. Death rates were the same (And very low) in both groups, but rivaroxaban caused significant GI bleeding compared to warfarin with a NNH of 100 patient-years of treatment (or 100 patients for 1 year). Bummer.
Clay S. - December 13, 2015 1:47 PM
I have seen a couple of articles suggesting that overall cost of factor Xa for course of treatment is likely not higher than for LMW-heparain/warfarin. Lovenox is still expensive and patients still need repeat visits for INR checks and those costs add up when compared to factor Xa.
http://www.ncbi.nlm.nih.gov/pubmed/26111453
Michael M., MD - December 15, 2015 10:56 AM
Suggestion for Sanjay and Mike in the area of imaging decision and shared decision making (sorry this is out of context but it was how I was told to drop something in the suggestion box) :
AJEM December 2015
"Can physician and patient gestalt lead to a shared decision to reduce
unnecessary radiography in extremity trauma?"
Michael Mouw, MD, MPAff
Abstract
Study Objective: To study the predictive value of patient and physician gestalt regarding the presence or absence of fracture or dislocation in minor extremity trauma.
Methods: This was a prospective observational study of patients presenting to an urban teaching hospital emergency department with minor extremity trauma, but without obvious deformity. Subjects were enrolled after radiography had been ordered by a physician. Exclusion criteria included arrival by ambulance, torso injury, and unreliable clinical examination. A questionnaire assessed patient’s and physician’s pretest prediction of abnormality (fracture or dislocation,) and the outcome was radiologist finding of an abnormality. Chi-squared analysis was done to evaluate the predictive value of patient and physician gestalt for radiographic abnormality.
Results: 191 subjects with 195 injuries were analyzed. Fifty-four (27.7%) were found to have abnormalities. There were 14 cases where the patient predicted there was “definitely not” an abnormality. All 14 had no abnormality, for an NPV of 100%. There were 87 cases where an attending emergency physician predicted <10% likelihood of abnormality - of these there were 5 (6%) abnormal x-rays. Multivariate regression analysis found that pain scores did not predict the presence of abnormality but that patients with abnormalities presented sooner after their injury than patients without.
Conclusions: In patients estimated to have a fracture risk of <10%, only 6% had fractures. When patients felt there was “definitely not” a fracture, there were no fractures. These results suggest that patient and physician gestalt should be studied further as variables for inclusion in future imaging decision rules.