A Randomized Comparison of CLOpidogrel Monotherapy Versus Extended Dual-antiplatelet Therapy Beyond 12 Months After Implantation of Drug-eluting StEnts in High-risk Lesions or Patients (A-CLOSE)

doi:10.1056/nejmoa2608533

A-CLOSE

Paziente / Popolazione Intervento / Esposizione Confronto Esito

In 3,203 high-risk patients after 12 months of DAPT following PCI, clopidogrel monotherapy was non-inferior to extended dual antiplatelet therapy for net adverse clinical events at 24 months.

N

3203pazienti

Disegno

Investigator-initiated, multicentre, open-label randomised controlled trial in South Korea (Yonsei University); 1:1 randomisation at 12 months (window −1 to +5 months) after drug-eluting stent implantation to clopidogrel monotherapy or continued aspirin plus clopidogrel; 24 months of assigned treatment and follow-up

Esito

Net adverse clinical events at 24 months — composite of all-cause death, myocardial infarction, stent thrombosis, stroke or BARC type 2, 3 or 5 bleeding

Rilevanza

2Importante — uno dei diversi pilastri.

RisultatoNet adverse clinical events 5.0% vs 5.1% at 24 months (P = 0.001 for non-inferiority). The composite hides a swap: ischaemic events 3.7% vs 1.6% (P < 0.001) and BARC 2, 3 or 5 bleeding 1.8% vs 4.1% (P < 0.001).

Lee YJ, et al. N Engl J Med. 2026; published online 29 August. 10.1056/nejmoa2608533

Discussione e critica

Non-inferior on the net endpoint, and the net endpoint is the problem: dropping aspirin at 12 months more than doubled ischaemic events (3.7% vs 1.6%) while more than halving bleeding (1.8% vs 4.1%), and the two cancel to within a tenth of a percentage point. Whether that trade is acceptable depends on which event the patient in front of you would survive, not on the composite. Open-label, a single country, and BARC type 2 — nuisance bleeding — counts inside the primary endpoint alongside death and stent thrombosis.