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Showing posts from August, 2013

Fibrinolysis or Primary PCI in ST-Segment Elevation Myocardial Infarction

Methodology Score: 3.5/5  Usefulness Score: 2.5/5
Armstrong PW, et al. STREAM Investigative Team. N Engl J Med. 2013 Apr 11;368(15):1379-87
Abstract Link
This open-label, prospective, randomized, parallel, comparative, international multicenter trial compared the efficacy and safety of pre-hospital fibrinolysis versus primary PCI. The composite outcome occurred 116 of 939 patients in the fibrinolysis group and 135 of 943 in the primary PCI group. (RR 0.86; 95% confidence interval, 0.68 to 1.09; P = 0.21). The group applauded the author’s amendment to the protocol to address increased rates of significant hemorrhage but the efficacy of half dose fibrinolysis in the elderly still needs further study.  By: Dr. Nathan Hecht
(Presented May 2013)

Epi lesson - Adjusting for Unbalanced Randomization

Moderate Pulmonary Embolism Treated With Thrombolysis (from the “MOPETT” Trial)

Methodology Score: 3.5/5               Usefulness Score: 1.5/5
Sharifi M, Bay C, Skrocki L, Rahimi F, Mehdipour M; “MOPETT” Investigators. Am J Cardiol. 2013 Jan 15;111(2):273-7
Article Link
This single-center, open label, randomized control trial found that administration of half-dose tPA in patients with “moderate” pulmonary embolus resulted in a significant reduction in pulmonary artery systolic pressure at 28 months as measured by ECHO, compared to standard treatment. JC attendee discussion centered around the fact that the endpoint was not necessarily clinically relevant and that the authors designated this half-dose tPA as “safe-dose tPA” despite providing no evidence that this is the case. Based on this article we would not change our current management of PE.  By: Dr. Sebastian Dewhirst  (Presented April 2013)

Epi lesson - Determining Safety of a Therapeutic Agent

Cast versus splint in children with minimally angulated fractures of the distal radius: a randomized controlled trial.

Methodology Score: 3/5                  Usefulness Score: 4/5 Boutis K, Willan A, Babyn P, Goeree R, Howard A. CMAJ. 2010 Oct 5;182(14):1507-12.
Article Link
This non-blinded, single-center RCT (N=96) of children aged 5-12 with minimally displaced or minimally angulated distal radius fractures, found that removable splinting was not inferior to short arm casting in terms of 6-week functional outcomes (mean Activities Scale for Kids score 92.8 vs. 91.4). While the authors asserted that splinting was inherently preferable to casting, the group questioned whether this study supported a benefit of splinting over casting from an institutional cost and patient comfort perspective.  By: Dr. George Mastoras

Epi Lesson - Equivalence or Non-Inferiority Trials