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Why has rate control traditionally been preferred over rhythm control for atrial fibrillation?
A Comparison of Rate Control and Rhythm Control in Patients with Atrial Fibrillation (AFFIRM)
The AFFIRM Investigators. NEJM (December 2002)
Bottom Line: This randomized, multicenter trial compared rhythm- and rate-control strategies in 4060 patients with atrial fibrillation at high risk for stroke or death. Participants were randomized to rate control or cardioversion and subsequent treatment with anti-arrhythmic drugs. The primary outcome was overall mortality, evaluated over five years. Results showed 356 deaths (23.8%) in the rhythm-control group and 310 deaths (21.3%) in the rate-control group, with a hazard ratio of 1.15 (95% CI, 0.99 to 1.34; P=0.08). Safety outcomes indicated more hospitalizations and adverse drug effects in the rhythm-control group. The study concluded that rhythm-control offers no survival advantage compared to rate control.
What is the evidence for tPA in acute ischemic stroke?
Tissue Plasminogen Activator for Acute Ischemic Stroke (NINDS)
The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. NEJM (December 1995)
Bottom Line: This randomized, double-blind trial evaluated the efficacy of intravenous recombinant tissue plasminogen activator (t-PA) for acute ischemic stroke in a total of 624 patients. Patients were randomized to receive either t-PA at a dose of 0.9 mg/kg within 0 to 90 minutes or 91 to 180 minutes of onset of stroke or placebo. The study had two parts. Part 1 enrolled 291 patients and tested whether t-PA had clinical activity, as indicated by an improvement of 4 points over base-line values in the score of the National Institutes of Health Stroke Scale (NIHSS) or the resolution of the neurologic deficit within 24 hours of the onset of stroke. Part 2, in which 333 patients were enrolled, evaluated clinical outcomes at three months using various assessment scales. Part 1 demonstrated no significant difference in neurologic improvement at 24 hours in the t-PA group, although a benefit was observed at three months for all outcome measures. Compared to placebo, the t-PA group was at least 30% more likely to have minimal or no disability at 3 months based on the assessment scales. Symptomatic intracerebral hemorrhage within 36 hours after the onset of stroke occurred in 6.4% of patients given t-PA but only 0.6% of patients given placebo (P<0.001). Mortality at three months was 17% in the t-PA group and 21% in the placebo group (P = 0.30). The study concluded that t-PA improved clinical outcomes despite safety concerns.
What is the evidence for peripartum antiretroviral treatment to reduce vertical transmission of HIV?
Reduction of Maternal-Infant Transmission of Human Immunodeficiency Virus Type 1 with Zidovudine Treatment
Connor EM et al. NEJM (November 1994)
Bottom Line: This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of zidovudine in reducing maternal-infant HIV transmission. The study enrolled 477 HIV-infected pregnant patients with CD4+ counts above 200 cells/mm³ and who had not received antiretroviral therapy during the current pregnancy. The intervention group received zidovudine antepartum (100 mg orally five times daily), intrapartum (2 mg/kg IV over one hour and then 1 mg/kg until delivery), and for the newborn (2 mg/kg orally every 6 hours for 6 weeks), while the comparator group received placebo. At 18 months, 8.3% of infants in the zidovudine group were HIV-infected compared to 25.5% in the placebo group, representing a 67.5% relative reduction in risk (95% CI, 40.7-82.1%, P = 0.00006). Minimal toxic effects were noted. Hemoglobin levels at birth in infants in the zidovudine group were significantly lower than in the placebo group, however, by 12 weeks of age, hemoglobin values were similar between both groups. In conclusion, zidovudine reduced the risk of maternal-infant HIV transmission by approximately two thirds.
Trial Files Issue #2025-06