In this section, we will highlight the key high-impact studies, updates, and analyses published in medicine during the past week.
Current guidelines on STEMI management recommend PCI only to treat the occluded artery in patients with multi-vessel disease due to lack of evidence for the value of preventive PCI. In this single-blind randomized trial, 465 patients with acute STEMI and multilevel CAD (without indication for CABG or chronic total occlusion) at 5 coronary care centers in the UK were randomly assigned to no further PCI procedures or immediate preventative PCI in noninfarct arteries with >50% stenoses to study the primary outcome of composite of death from cardiac causes, nonfatal MI, and refractory angina. The study was stopped early after enrollment of 465 out of a planned 600 patients due to a highly significant (p<0.001) difference in the incidence of the primary outcome favoring preventive PCI. There was an absolute risk reduction of 14% in the preventive PCI group (HR 0.35, 95% CI 0.21-0.58) over 23 months, which became evident within 6 months post-procedure. There was a similar HR of 0.36 when limiting analysis to only cardiac death and nonfatal MI. In patients undergoing PCI for acute STEMI, preventive PCI reduced risk of subsequent adverse cardiovascular events compared with PCI limited to the infarct artery. The value of immediate vs delayed preventive PCI is still unknown, as is the utility of preventive PCI in NSTEMI.
The standard treatment for venous thromboembolism is currently low molecular weight heparin followed by vitamin K antagonists, though new oral agents such as factor Xa inhibitors and direct thrombin inhibitors have been shown to be similarly effective. The major disadvantage of these agents is that they are not easily reversible in the case of bleeding events. In this double-blind RCT, 8292 patients with acute symptomatic DVT or PE were randomized to heparin followed by edoxaban (a factor Xa inhibitor) along with placebo warfarin, or heparin with concurrent warfarin initiation and placebo edoxaban for a period of 3 to 12 months to study the incidence of recurrent VTE (efficacy) and clinically relevant bleeding (safety). Recurrent VTE occurred in 3.2% of the edoxaban group vs 3.5% of the warfarin group (HR 0.89, 95% CI -1.16 to 0.39, p<0.001 for noninferiority). Among patients with PE and evidence of RV dysfunction, VTE recurred in 3.3% of the edoxaban group vs 6.2% in the control group (HR 0.52, 95% CI 0.28 to 0.98). The edoxaban group also had significantly lower rates of clinically relevant bleeding (8.5% vs 10.3% of the warfarin group, HR 0.81, 95% CI 0.71 to 0.94, p=0.004 for superiority), though there were similar rates of major bleeding (1.4% vs 1.5% in the warfarin group). In patients with renal impairment, the dose of edoxaban was halved with similar efficacy and significantly less clinically relevant bleeding compared to patients in the warfarin group.
High doses of oral fluconazole in the first trimester has been linked to birth defects in some case reports, prompting the FDA to increase the pregnancy category for fluconazole from C to D in 2011, however the effect of more common lower therapeutic doses of oral fluconazole is unclear. In this retrospective nation-wide cohort study, data from all infants born in Denmark in the Medical Birth Registry were reviewed for exposure to fluconazole and incidence of 15 major birth defects previously associated with azole agents. No significantly increased risk of overall birth defects was found among 7352 pregnancies with fluconazole exposure regardless of cumulative dose compared to 900,000+ unexposed pregnancies. Looking at specific defects, the risk of tetralogy of Fallot was significantly higher in exposed vs. unexposed pregnancies. This persisted after controlling for factors such as exposure time window, cumulative fluconazole dose, and treatment with other category D and X drugs. The absolute increased risk was calculated to be 6.5 (95% CI 1.5-17) excess cases of tetralogy of Fallot per 10,000 pregnancies exposed.
There is a lack of consensus about the routine use of intraoperative cholangiography (IOC) in the prevention of CBD injury during cholecystectomy. In this retrospective cohort study, investigators analyzed data from over 92,000 Texas Medicare beneficiaries who underwent cholecystectomy for various reasons between 2000 and 2009. Overall, IOC was used in 40% of patients, with a common duct injury rate of 0.21%, compared to 0.36% among patients who did not receive IOC, which was statistically significant when analyzed using descriptive statistics and multivariable logistic regression taking into account surgeon and hospital characteristics that were statistically significant in bivariate analyses with CBD injury. However, instrumental variable analysis, which better controls for unmeasured confounding variables, using the percentage of hospital IOC use eliminated the significant association between IOC and CBD injury (OR 1.26, 95% CI 0.81-1.96), as did using the percentage of surgeon IOC use (OR 1.31, 95% CI 0.91-1.89). Therefore the investigators concluded that routine IOC should not be advocated as a means of preventing CBD injury.
By Kathleen Li and David Ouyang
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