PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction (PREMIUM)

doi:10.1056/nejmoa2606997

PREMIUM

Patient / Population Intervention / Exposure Comparison Outcome

In 2,216 patients with STEMI undergoing primary PCI, aspirin-free prasugrel monotherapy was not non-inferior to 12 months of dual antiplatelet therapy for death, myocardial infarction or stroke at 12 months.

N

2,216patients

Design

Investigator-initiated, multicentre, open-label randomised controlled trial in Japan; 1:1 randomisation before primary PCI; all patients receive platinum-chromium everolimus-eluting stents (SYNERGY) with routine intravascular imaging guidance; non-inferiority design for the primary endpoint; 12-month follow-up

Endpoint

Composite of all-cause death, myocardial infarction or stroke at 12 months (non-inferiority)

Relevance

2Important — one of several pillars.

ResultDeath, stroke or myocardial infarction at 12 months 11.0% vs 8.5% (HR 1.34, 95% CI 1.02-1.75; P = 0.40 for non-inferiority) — non-inferiority not met. Major bleeding (BARC 3 or 5) 5.6% vs 8.4% (HR 0.66, 95% CI 0.47-0.91). Definite or probable stent thrombosis and serious adverse events were similar.

Takahashi K, Kozuma K, Morino Y, et al. N Engl J Med. 2026; published online 29 August. 10.1056/nejmoa2606997

Discussion & critique

Dropping aspirin from the start of primary PCI failed its non-inferiority test, and the confidence interval sits entirely above 1 — 2.5 percentage points more death, stroke or infarction, bought for 2.8 points less major bleeding. That is a trade, not a free lunch, and the trial was not designed to say which side a given patient should take. Japanese, open-label, and run with the low prasugrel dose used in Japan rather than the Western regimen, so the ischaemic arm of the trade may not transfer directly.