Trial Files: MTX for Knee OA, Dual Cardioversion for A Fib, and Tenecteplase at 4.5-24 hrs
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Pain Reduction With Oral Methotrexate in Knee Osteoarthritis: A Randomized, Placebo-Controlled Clinical Trial (PROMOTE)
Kingsbury S et al. Annals of Internal Medicine (July 2024)
Bottom line: This was a multicenter, randomized, double-blind, placebo-controlled trial conducted in 15 secondary care musculoskeletal clinics in the United Kingdom. A total of 155 participants with symptomatic, radiographic knee osteoarthritis (KOA) and knee pain on most days within the last 3 months were included in the study. Participants were randomly assigned to receive either oral methotrexate once weekly according to inflammatory arthritis dosing guidelines or a matched placebo over 12 months, in addition to their usual analgesia. The primary outcome was average knee pain at 6 months (according to a 0-10 numerical rating scale [NRS] assessing average overall knee pain severity over the previous week), with secondary outcomes including knee stiffness and function measured at 3, 6, 9, and 12 months. At 6 months, results showed a statistically significant reduction in knee pain of 0.79 NRS points in favour of methotrexate (95% CI, 0.08 to 1.51; P = 0.030). There was also a reduction in stiffness and function in the methotrexate group compared to the placebo group at 6 months. There were no significant differences in adverse events between the two groups. In conclusion, oral methotrexate added to usual medications showed promising results in reducing KOA symptoms.
Dual vs Single Cardioversion of Atrial Fibrillation in Patients With Obesity: A Randomized Clinical Trial
Aymond J et al. JAMA Cardiology (July 2024)
Bottom Line: This prospective, investigator-initiated, patient-blinded, randomized clinical trial compared dual direct-current cardioversion (DCCV) using 2 sets of pads with traditional single 200-J DCCV using 1 set of pads in patients with obesity (BMI of 35 or higher) undergoing planned, nonemergent electrical cardioversion for atrial fibrillation. The study spanned 3 years and included 3 sites in Louisiana. A total of 200 participants were randomized and the primary outcome was return to sinus rhythm immediately after the first cardioversion attempt. The results showed that dual DCCV was significantly more successful than single DCCV (97 of 99 patients [98%] vs 87 of 101 patients [86%]; P = 0.002), without any increase in complications or postprocedure chest discomfort. Patients in the single cardioversion cohort whose first attempt failed underwent dual cardioversion for up to 3 subsequent attempts, all of which were successful: 12 of 14 after second cardioversion and 2 of 14 after third cardioversion. This study provides evidence for the use of dual DCCV in patients with obesity undergoing electrical cardioversion for atrial fibrillation.
Tenecteplase for Ischemic Stroke at 4.5 to 24 Hours without Thrombectomy (TRACE-III)
Xiong Y et al. NEJM (June 2024)
Bottom Line: This randomized controlled trial evaluated the effectiveness and safety of tenecteplase in patients with ischemic stroke due to occlusion of the middle cerebral artery or internal carotid artery who had salvageable brain tissue on perfusion imaging and who did not have access to endovascular thrombectomy. Eligible patients were randomly assigned to receive either tenecteplase or standard medical treatment 4.5-24 hours after the patient was last known to be well. The primary outcome was the absence of disability at day 90, defined as a score of 0 or 1 on the modified Rankin scale (range, 0 to 6, with higher scores indicating greater disability), at day 90. A higher percentage of patients in the tenecteplase group achieved this outcome compared to the standard treatment group (33.0% vs. 24.2%; relative rate, 1.37; 95% confidence interval, 1.04 to 1.81; P=0.03). The incidence of symptomatic intracranial hemorrhage was higher in the tenecteplase group (3.0% compared to 0.8% in the standard treatment group). However, mortality was similar between the two groups (13.3% with tenecteplase and 13.1% with standard medical treatment). These results suggest that tenecteplase may be an effective treatment option for eligible patients with ischemic stroke beyond the traditional 4.5-hour window. However, caution should be taken due to the potential risk of intracranial hemorrhage.
Trial Files Issue #2024-16
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