EBM Focus 2017 Year in Review

EBM Focus - Volume 12, Issue 52

PCI with drug-eluting stents in addition to optimized medical therapy might not increase exercise capacity at 6 weeks in adults with stable symptomatic single-vessel stenosis, and its effects on angina are unclear

Reference: ORBITA trial (Lancet 2017 Nov 1 early online) (level 2 [mid-level] evidence)

Percutaneous coronary intervention (PCI) with stents may be considered in patients with stable single-vessel stenosis that is symptomatic despite optimized medical therapy. Previous randomized trials assessing its potential benefit were not blinded. The ORBITA trial evaluated PCI with a sham-controlled double-blinded design in which 200 adults had intensive antianginal medication optimization and were then randomized to PCI vs. sham procedure. The ORBITA trial was powered to detect a 30 second difference in exercise capacity assessed as endurance on treadmill test that could be stopped for any one of a number of reasons. PCI did not significantly increase exercise capacity compared to the sham procedure at 6 weeks after the procedure, but several factors prevent this result from being definitive. The effects of PCI on angina are unclear: there were non-significant differences in favor of PCI in angina-specific outcomes, but this trial is likely underpowered to detect an effect on them.

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Routine prophylactic oxygen supplementation may not reduce mortality or disability at 90 days in nonhypoxic patients with acute stroke

Reference: SO2S trial (JAMA 2017 Sep 26;318(12):1125) (level 2 [mid-level] evidence)

The SO2S trial investigated whether routine prophylactic low-dose oxygen supplementation reduces mortality or disability in 8,003 patients with acute stroke and without hypoxemia. Patients were randomized to continuous oxygen for 72 hours vs. nocturnal oxygen for 3 nights vs. control (oxygen if clinically indicated). No significant differences in mortality or disability were found in comparisons of the combined oxygen groups vs. control or between continuous oxygen vs. nocturnal oxygen. These findings do not support the use of routine prophylactic low-dose oxygen supplementation in nonhypoxic patients with acute stroke.

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Single-dose oral dexamethasone 10 mg without concurrent antibiotics may increase rate of symptom resolution within 48 hours in adults with acute unselected pharyngitis

Reference: TOAST trial (JAMA 2017 Apr 18;317(15):1535) (level 2 [mid-level] evidence)

Antibiotics are often prescribed for acute pharyngitis despite recommendations against their routine use in patients without confirmed group A streptococcus infection. Corticosteroids may reduce symptoms, but evidence for corticosteroids without antibiotic therapy is lacking. In the TOAST trial, 565 adults with acute pharyngitis with suspected infectious etiology but not requiring immediate antibiotic therapy were randomized to dexamethasone 10 mg orally once vs. placebo. Dexamethasone was associated with a moderately increased likelihood of complete symptom relief at 48 hours (in 35.4% vs. 27.1%, 95% CI for risk difference 1.2% to 16.2%).

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In patients with atrial fibrillation using DOACs for thromboembolic prophylaxis, concurrent use of some medications may be associated with an increased risk of non-traumatic major bleeding

Reference: JAMA 2017 Oct 3;318(13):1250

In patients taking direct (non-vitamin K) oral anticoagulants (DOACs) for atrial fibrillation, evidence is limited regarding how the risk of bleeding is affected by the concurrent use of medications that share metabolic pathways with DOACs. A retrospective cohort study investigated the possible influence of these medications on risk of bleeding in over 90,000 adults in Taiwan who had nonvalvular atrial fibrillation and at least one DOAC prescription. Fluconazole, phenytoin, rifampin, and amiodarone were each associated with an increased risk of non-traumatic major bleeding. Concurrent medications that were not associated with an increased risk include atorvastatin, azoles other than fluconazole, cyclosporine, digoxin, diltiazem, dronedarone, erythromycin/clarithromycin, and verapamil.

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The Pediatric Sequential Organ Failure Assessment (pSOFA) score may predict in-hospital mortality in critically ill pediatric patients

Reference: JAMA Pediatr 2017 Aug 7 early online (level 2 [mid-level] evidence)

The Sepsis-3 task force recommends using the Sequential Organ Failure Assessment (SOFA) score for clinical characterization of organ dysfunction in adults, but its applicability to the pediatric population is unclear. A pediatric version of the SOFA (pSOFA) was developed and its performance to predict in-hospital mortality was evaluated in a retrospective prognostic cohort study including 8,711 admissions to a pediatric intensive care unit. The maximum of the daily pSOFA scores had strong discrimination for in-hospital mortality (c-statistic 0.94, 95% CI 0.92-0.95). Prognostic performance was statistically superior to or similar to other pediatric risk scores.

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