In this section, we will highlight the key high-impact studies, updates, and analyses published in medicine during the past week.
A Trial of Intraoperative Low-Tidal-Volume Ventilation in Abdominal Surgery
In this randomized control trial, 400 patients with intermediate to high risk of pulmonary complications after major abdominal surgery were randomized to nonprotective (tidal volume 10-12ml/kg of predicted body weight, no PEEP) or lung-protective (tidal volume 6-8ml/kg predicted weight, PEEP of 6-8 cm H2O, and recruitment maneuvers every 30 minutes) mechanical ventilation. Major pulmonary and extrapulmonary complications occurred in 10.5% of the intervention group compared to 27.5% of patients in the control group (p=0.001). Those receiving lung-protective ventilation also required significantly less intervention for acute respiratory failure postoperatively (5% vs 17%, p=0.001), and had an average hospital stay that was 2.45 days shorter (13 vs. 11 days, p=0.006).
The SYNTAX trial randomly assigned 1800 patients with de-novo three-vessel disease or left main coronary disease to either percutaneous coronary intervention (PCI) with a paclitaxel-eluting stent or coronary artery bypass graft surgery (CABG). Incidence of major adverse cardiac and cerebrovascular events (MACCE) at 5 years was not significantly different in the CABG and PCI groups for those with less complex lesions (p=0.43) or left main coronary disease (p=0.12). However, for patients with complex lesions, MACCE was significantly increased for those receiving PCI compared to CABG (intermediate SYNTAX score, 25.8% of CABG vs 36.0% of PCI, p=0.008; high score, 26.8% vs 44.0%, p<0.0001). All-cause death at 5 years was 11.4% in the CABG group vs 13.9% in the PCI group (p=0.10).
In the Women’s Health Study, 39,000 female health professionals were randomized to vitamin E every other day or placebo and aspirin every other day or placebo in a 2×2 factorial design, with a primary endpoint of risk reduction of all significant vascular events and incidence of squamous cell cancers. At the end of the study, which ran from 1996 to 2004, 88.6% of survivors agreed to continue with post-trial follow up. During 18-year follow-up, there was a significant decrease in colorectal cancer incidence in the aspirin group (0.011) compared to the placebo group (0.014) (HR 0.80, CI 0.67 to 0.97, p=0.021), primarily due to a reduction in proximal colon cancer. Total cancer remained balanced between the 2 groups (16-year incidence, 0.127 and 0.132 in the aspirin and placebo groups, respectively; HR 0.97, 95% CI 0.92 to 1.03).
Lenalidomide plus Dexamethasone for High-Risk Smoldering Multiple Myeloma
Currently patients with smoldering (asymptomatic) multiple myeloma are not treated until symptoms develop. However, 40% of asymptomatic patients are in a high-risk subgroup (based on histologic and lab values) with progression to active disease of >50% within 2 years of diagnosis. In this multicenter phase 3 randomized trial, 125 patients with smoldering multiple myeloma were randomized to either early treatment (induction with lenalidomide and dexamethasone, and maintenance lenalidomide) or active surveillance. The primary outcome, median time to progression of symptomatic disease, was not reached in the treatment group at 40 months, compared to 21 months in the observation group (p<0.001). The HR for progression with treatment was 0.18, 95% CI 0.09 to 0.32), with symptomatic disease developing in 76% of the observation group and 13% of the treatment group.
In this multicenter RCT, two hundred and fifty-nine primary care practices in 6 European countries were randomized to usual care, online training in the use of CRP at point of care, enhanced communication skills, or both interventions to assess changes in management of upper and lower respiratory tract infections. The primary outcome, antibiotic prescribing rate, was significantly lower with CRP training (33% vs. 48%, adjusted risk ratio 0.54, 95% CI 0.42-0.69) and enhanced communication training (36% vs. 45%, adjusted risk ratio 0.69, 95% CI 0.54-0.87 ), and was lowest in the combined intervention group (combined RR 0.38, p<0.0001).
By Kathleen Li and David Ouyang
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