Slaminen P, et al. Antibiotic therapy vs appendectomy for treatment of uncomplicated acute appendicitis. The APPAC randomized clinical trial. JAMA. 2015;313(23):2340-2348.
This was a noninferiority randomized clinical trial that compared outcomes between antibiotic therapy and appendectomy in CT confirmed acute appendicitis. Antibiotic therapy was IV ertapenem, 1 gram a day for 3 days while inpatient, followed by 7 days of levofloxacin and metronidazole. Primary endpoints were successful appendectomy and successful discharge from the hospital without need for surgery or recurrent appendicitis within a year. In the antibiotic group, 70/257 required open appendectomy within one year. The study had a prespecified noninferiority margin of 24% and the results yielded at 27% difference in treatment efficacy between the two groups. By their criteria, noninferiority of antibiotic therapy was not demonstrated. After discussion, there were a few questions that arose. Were the groups truly comparable? There was no mention of health or comorbidity equality between the groups that might effect outcome. Also, the secondary outcome, complication rates was better in the antibiotic group. Furthermore, it would have been nice to have some comparison of cost difference between the two groups. Which may provide another avenue for research. Our take is that this is interesting information but will not affect our standard practice of consulting surgery.
Claveau D, et al. Complications associated with nitrate use in patients presenting with acute pulmonary edema and concomitant moderate or severe aortic stenosis. Ann Emerg Med. 2015 Oct; 66(4):355-362 e1.
This was a cohort designed retrospective chart review study that evaluated the incidence of complications that occurred in patients who presented with acute cardiogenic pulmonary edema who were treated with nitrates, specifically between patients with moderate or severe aortic stenosis (AS) and those without AS. Patients were chosen if they had been given nitrates and had an echocardiography report available. They used data from two Canadian hospitals. They had a total of 195 that qualified, 65 in each category. Primary outcome was clinically relevant hypotension that required the nitrate discontinuation, IV fluid bolus, use of vasopressors or cardiac arrest. Secondary outcome was < 90 mmHg systolic hypotension that was sustained greater or equal to 30 minutes. This study found that nitrate administration was not associated with clinically relevant hypotension in the severe or moderate AS group when compared to those without AS. There were more significant outcomes with regards to the secondary outcome with more incidences occurring with higher disease presence. In discussion, it was interesting that this study excluded the patients that died in the ED. Also, it did not address whether or not the ED physician knew the patient's diagnosis, which might have affected the amount of nitrates given, thereby skewing the results. How would this information affect our practice? We think it is appropriate to consider nitrates as part of the treatment while taking into account disease burden and BP values on presentation. Also, it would probably be best with slower infusions to see how the patient is handling the treatment.
Pollack CV, et al. Idarucizumab for dabigatran reversal. N Engl J Med. 2015 Aug 6; 373(6):511-520.
This was a prospective cohort study to determine the safety of idarucizumab in patients who needed reversal of dabigatran therapy. They compared the outcome of two different groups; patients who had an overt, uncontrollable or life threatening bleeds and patients that required an urgent procedure or surgery that could not wait longer than 8 hours. Cohorts were given 5 grams of idarucizumab IV and looked for maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours of administration. Primary outcome measured percentage reversal by measuring the dilute thrombin time or ecarin clotting time. Secondary end point was restoration of hemostasis. Blood samples were taken at 10 and 30 minutes, and 1, 2, 4, 12 and 24 hours after administration. The results showed that administration of idarucizumab normalized test results in 98% of participants within minutes, with median maximum percent reversal of 100% in both groups. Clinical hemostasis, secondary measure, was 11.4 hours. After discussion, it would be helpful if there were more participants in this study. However, the patients in need of this treatment are in life threatening situations and given the results, this looks like it would be a viable treatment in patients taking dabigatran in need of emergent intervention.
Submitted by Dr. Christopher Branham, PGY1
This was a noninferiority randomized clinical trial that compared outcomes between antibiotic therapy and appendectomy in CT confirmed acute appendicitis. Antibiotic therapy was IV ertapenem, 1 gram a day for 3 days while inpatient, followed by 7 days of levofloxacin and metronidazole. Primary endpoints were successful appendectomy and successful discharge from the hospital without need for surgery or recurrent appendicitis within a year. In the antibiotic group, 70/257 required open appendectomy within one year. The study had a prespecified noninferiority margin of 24% and the results yielded at 27% difference in treatment efficacy between the two groups. By their criteria, noninferiority of antibiotic therapy was not demonstrated. After discussion, there were a few questions that arose. Were the groups truly comparable? There was no mention of health or comorbidity equality between the groups that might effect outcome. Also, the secondary outcome, complication rates was better in the antibiotic group. Furthermore, it would have been nice to have some comparison of cost difference between the two groups. Which may provide another avenue for research. Our take is that this is interesting information but will not affect our standard practice of consulting surgery.
Claveau D, et al. Complications associated with nitrate use in patients presenting with acute pulmonary edema and concomitant moderate or severe aortic stenosis. Ann Emerg Med. 2015 Oct; 66(4):355-362 e1.
This was a cohort designed retrospective chart review study that evaluated the incidence of complications that occurred in patients who presented with acute cardiogenic pulmonary edema who were treated with nitrates, specifically between patients with moderate or severe aortic stenosis (AS) and those without AS. Patients were chosen if they had been given nitrates and had an echocardiography report available. They used data from two Canadian hospitals. They had a total of 195 that qualified, 65 in each category. Primary outcome was clinically relevant hypotension that required the nitrate discontinuation, IV fluid bolus, use of vasopressors or cardiac arrest. Secondary outcome was < 90 mmHg systolic hypotension that was sustained greater or equal to 30 minutes. This study found that nitrate administration was not associated with clinically relevant hypotension in the severe or moderate AS group when compared to those without AS. There were more significant outcomes with regards to the secondary outcome with more incidences occurring with higher disease presence. In discussion, it was interesting that this study excluded the patients that died in the ED. Also, it did not address whether or not the ED physician knew the patient's diagnosis, which might have affected the amount of nitrates given, thereby skewing the results. How would this information affect our practice? We think it is appropriate to consider nitrates as part of the treatment while taking into account disease burden and BP values on presentation. Also, it would probably be best with slower infusions to see how the patient is handling the treatment.
Pollack CV, et al. Idarucizumab for dabigatran reversal. N Engl J Med. 2015 Aug 6; 373(6):511-520.
This was a prospective cohort study to determine the safety of idarucizumab in patients who needed reversal of dabigatran therapy. They compared the outcome of two different groups; patients who had an overt, uncontrollable or life threatening bleeds and patients that required an urgent procedure or surgery that could not wait longer than 8 hours. Cohorts were given 5 grams of idarucizumab IV and looked for maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours of administration. Primary outcome measured percentage reversal by measuring the dilute thrombin time or ecarin clotting time. Secondary end point was restoration of hemostasis. Blood samples were taken at 10 and 30 minutes, and 1, 2, 4, 12 and 24 hours after administration. The results showed that administration of idarucizumab normalized test results in 98% of participants within minutes, with median maximum percent reversal of 100% in both groups. Clinical hemostasis, secondary measure, was 11.4 hours. After discussion, it would be helpful if there were more participants in this study. However, the patients in need of this treatment are in life threatening situations and given the results, this looks like it would be a viable treatment in patients taking dabigatran in need of emergent intervention.
Submitted by Dr. Christopher Branham, PGY1
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