POET-II
Accelerated Treatment of Endocarditis (POET II)
Doente / População Intervenção / Exposição Comparação Desfecho
In 508 patients with left-sided infective endocarditis, a tailored 2–4-week antibiotic course was non-inferior to the standard 4–6-week course for death, unplanned cardiac surgery, relapse or embolisation at 6 months.
N
508doentes
Desenho
International, multicentre, open-label RCT (POET II, NCT03851575), 1:1 after ≥2–4 weeks of antibiotic therapy and met criteria for clinical stabilisation; dual primary design — superiority for the efficacy end point, non-inferiority (margin 7.5 percentage points) for the safety end point; 6-month follow-up; 13 sites in Denmark, Sweden and the United States
Desfecho
Dual primary: (1) efficacy — days alive without antibiotic treatment for infective endocarditis or bacteraemia within 6 months after randomisation (superiority); (2) safety — composite of death from any cause, unplanned cardiac surgery or symptomatic embolic events within 6 months (non-inferiority, margin 7.5 percentage points). Relapse of bacteraemia or infective endocarditis was a key secondary end point.
Relevância
2Importante — um de vários pilares.
ResultadoMedian time alive without antibiotic treatment 183 days (IQR 181–183) vs 169 days (IQR 166–171); Hodges-Lehmann difference 13 days (95% CI 12 to 13), P < 0.001 for superiority. Primary safety composite 21/255 (8.2%) vs 27/253 (10.7%); absolute difference −2.4 percentage points (95% CI −7.7 to 2.7), P < 0.001 for non-inferiority. Relapse 13 (5.1%) vs 4 (1.6%), P = 0.04. Median antibiotic duration 26 vs 41 days.
Bundgaard H, Pries-Heje M, Hjulmand J, et al. Response-Tailored or Standard-Duration Antibiotic Treatment for Infective Endocarditis. N Engl J Med. 2026; published online 28 August 2026. 10.1056/nejmoa2607887
Discussão e crítica
Two weeks less antibiotic in stabilised left-sided endocarditis, with the composite of death, valve surgery and embolism holding non-inferior. The cost sits in the relapse rate, which tripled — 5.1% vs 1.6%, P = 0.04 — and relapse in endocarditis is not a soft endpoint. The primary measure, days alive without antibiotic treatment, favours the shorter arm by construction; the safety composite is the one that decides whether to shorten a course, and the trial is open-label.