{"id":"d148e27cf524","type":"article","url":"https://hartvaat.nl/2026/02/23/colchicine-en-spironolacton-bij-acuut-mi-voordeel-risico-analyse/","title":"Colchicine en spironolacton bij acuut MI: voordeel-risico analyse","title_en":"Benefit-risk of colchicine and spironolactone in acute myocardial infarction: a prespecified generalised pairwise comparisons analysis of the CLEAR trial.","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog","internist"],"tags":[],"journal":"Heart (British Cardiac Society)","doi":"10.1136/heartjnl-2025-326218","source_url":"https://doi.org/10.1136/heartjnl-2025-326218","authors":["Marc-André d'Entremont","Sanjit S Jolly","Faisal Alharthi","Binita Shah","David Austin","Quilong Yi","Robert F Storey","Matthias Bossard","Jan Cornel","Jeroen Jaspers Focks","Sasko Kedev","Valon Asani","Goran Stankovic","Michael Tsang","Nicholas Valettas","Jessica Tyrwhitt","Jackie Betz","Shun Fu Lee","Rajibul Mian","Johanne Silvain","Farzin Beygui","Andrew Czarnecki","Payam Dehghani","Warren Cantor","Shahar Lavi","James C Spratt","Emilie P Belley-Côté","John W Eikelboom"],"significance":7,"published":"2026-02-23","source_date":"2026-02-23","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/bloedsuikerdoelen-cardiovasculair/","https://hartvaat.nl/kennis/cardiometabool/inflammatie-en-atherosclerose/"],"congress":"","summary_en":"This prespecified generalized pairwise comparison analysis of CLEAR SYNERGY assessed the combined benefit-risk of colchicine and spironolactone after MI, providing a more nuanced evaluation than conventional composite endpoints.","created":"2026-07-03T10:32:12Z","updated":"2026-07-03T13:31:10Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gezamenlijke voordeel-risico analyse van colchicine en spironolacton na acuut MI. Colchicine biedt netto voordeel, spironolacton niet. Dit informeert de post-MI farmacotherapie.","abstract_original":"BACKGROUND: Composite outcomes in cardiovascular trials often group events of unequal clinical importance, and conventional analyses may obscure treatment trade-offs. Generalised pairwise comparisons (GPC), expressed as a win ratio (WR), allow for hierarchical ranking of events and incorporation of recurrent outcomes, providing a potentially more intuitive assessment of benefit-risk. METHODS: In a prespecified exploratory analysis of the 2×2 factorial, randomised CLEAR (Colchicine and Spironolactone in Patients with Myocardial Infarction) trial (7062 patients within 72 hours of acute myocardial infarction (MI) and percutaneous coronary intervention), we applied both time-to-first and recurrent-event GPC to reassess low-dose colchicine (0.5 mg daily) and spironolactone (25 mg daily) versus placebo. For the colchicine comparison, the hierarchical benefit-risk outcome included all-cause death, stroke, recurrent MI, unplanned ischaemia-driven revascularisation, serious infection or diarrhoea. For the spironolactone comparison, the outcome included all-cause death, stroke, MI, new or worsening heart failure, significant ventricular arrhythmia, hyperkalaemia or gynaecomastia/gynaecodynia. GPC results were compared with Cox, logistic and Andersen-Gill models. RESULTS: For colchicine, the time-to-first event GPC showed a 12% lower proportional win rate compared with placebo (WR 0.88, 95% CI 0.79 to 0.98; win difference -2.10%, 95% CI -3.84 to -0.37), driven largely by excess diarrhoea. For spironolactone, patients experienced a 14% lower win rate (WR 0.86, 95% CI 0.75 to 0.99; win difference -1.46%, 95% CI -2.84% to -0.08%), largely attributable to gynaecomastia and hyperkalaemia. Conventional statistical approaches yielded concordant results. Across both interventions, higher-order efficacy outcomes (death, MI, stroke, heart failure) showed no benefit. CONCLUSIONS: In patients with post-MI, both low-dose colchicine and spironolactone demonstrated disadvantageous benefit-risk profiles, reinforcing that neither agent should be used routinely. This prespecified application of GPC provided results consistent with traditional methods but offered a clinically intuitive framework for interpreting composite outcomes."}