Trial Files Throwback: Aspirin after TAVI, lack of benefit of sodium bicarbonate for severe metabolic acidaemia, beta-lactams alone for CAP
Join us on July 17th, 2025, from 12-1 pm for a free crash course on antibiotics and updates in the management of bacteremia.
Speaker details: Dr. Mike Fralick is a Clinician Scientist who works in Toronto and Sault Ste. Marie. He was a site lead for the recently published BALANCE Trial, which identified 7 days of antibiotics was non-inferior to 14 days for non-Staph Aureus bacteremia.
Why do patients receive aspirin following TAVI?
Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation
Brouwer J et al. NEJM (August 2020)
Bottom Line: This randomized, controlled trial evaluated the effects of single versus dual antiplatelet treatment in patients undergoing transcatheter aortic valve implantation (TAVI) without an indication for long-term anticoagulation. A total of 665 patients were assigned to receive either aspirin alone or aspirin plus clopidogrel for 3 months. The primary outcomes included all bleeding and non-procedure-related bleeding over 12 months. Results showed that 50 patients (15.1%) of patients on aspirin alone experienced bleeding events compared to 89 (26.6%) on aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P=0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P=0.005). The study concluded that aspirin alone significantly reduced the incidence of bleeding compared to the dual therapy.
Why don’t we give bicarb to patients with metabolic acidemia?
Sodium bicarbonate therapy for patients with severe metabolic acidaemia in the intensive care unit (BICAR-ICU): a multicentre, open-label, randomised controlled, phase 3 trial
Jaber S et al. The Lancet (July 2018)
Bottom line: This multicentre, open-label, randomized controlled phase 3 trial evaluated the effects of 4.2% intravenous sodium bicarbonate infusion in 389 adult patients with severe acidaemia (pH ≤7·20, PaCO2 ≤45 mm Hg, and sodium bicarbonate concentration ≤20 mmol/L). The primary outcome was a composite of death from any cause by day 28 and at least one organ failure by day 7. Results showed that 66% of patients in the bicarbonate group and 71% in the control group experienced the primary outcome (absolute difference -5.5%, 95% CI -15.2 to 4.2; p=0.24). Safety outcomes indicated increased metabolic alkalosis, hypernatraemia, and hypocalcaemia in the bicarbonate group.
Why are most non-ICU patients with CAP treated with a beta-lactam alone?
Antibiotic Treatment Strategies for Community-Acquired Pneumonia in Adults CAP-START
Postma DF et al. NEJM (April 2015)
Bottom Line: This cluster-randomized, crossover trial evaluated the noninferiority of beta-lactam monotherapy compared to beta-lactam-macrolide combination therapy and fluoroquinolone monotherapy in patients with clinically suspected community-acquired pneumonia (CAP) admitted to non-ICU wards. The trial used an intention-to-treat analysis, using a noninferiority margin of 3 percentage points and a two-sided 90% confidence interval. A total of 656 patients were included in the beta-lactam strategy, 739 in the beta-lactam–macrolide strategy periods, and 888 in the fluoroquinolone strategy. The primary outcome of 90-day mortality showed 9.0% for beta-lactam, 11.1% for beta-lactam-macrolide, and 8.8% for fluoroquinolone. Among patients with clinically suspected CAP admitted to non-ICU wards, a strategy of preferred empirical treatment with beta-lactam monotherapy was noninferior to strategies with a beta-lactam–macrolide combination or fluoroquinolone monotherapy.
Trial Files Issue #2025-15
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