Switching From Ticagrelor to Prasugrel in Patients With Acute Coronary Syndrome — a Stepped Wedge Cluster Randomized Evaluation in the SWEDEHEART-registry (SWITCH SWEDEHEART)

doi:10.1056/nejmoa2609057

SWITCH SWEDEHEART

Paziente / Popolazione Intervento / Esposizione Confronto Esito

In 17,095 patients with an acute coronary syndrome, prasugrel as the default P2Y12 inhibitor did not reduce death, myocardial infarction or stroke at 1 year compared with ticagrelor.

N

17.095pazienti

Disegno

Registry-based (SWEDEHEART), prospective, multicentre, open-label, stepped-wedge cluster-randomised trial; Swedish administrative regions form the clusters; all clusters start with ticagrelor as the default P2Y12 inhibitor and the order in which clusters switch to prasugrel as default is randomly assigned, one cluster switching every 9 months; outcomes captured through national registries with 1-year follow-up

Esito

Cumulative 1-year risk of the composite of death, myocardial infarction or stroke

Rilevanza

2Importante — uno dei diversi pilastri.

Risultato11.1% vs 11.8% at 1 year (adjusted OR 0.90, 95% CI 0.77-1.06); no difference in the individual components. Major bleeding 4.2% vs 4.4% (OR 0.80, 95% CI 0.64-0.99).

Omerovic E, et al. N Engl J Med. 2026; published online 29 August. 10.1056/nejmoa2609057

Discussione e critica

A stepped-wedge registry trial tests a regional default, not a drug in an individual patient, and that is its strength: 17,095 consecutive patients including the elderly, prior stroke and an indication for anticoagulation — the people conventional antiplatelet trials exclude. The ischaemic composite is neutral and its interval spans a 23% reduction to a 6% increase. The bleeding advantage is the finding people will quote, and its upper bound is 0.99 — one event either way and it disappears.