Study | Recruitment period and number of participants | Trial design | Stent platform | Experimental and control treatment | Primary endpoints | Findings |
---|---|---|---|---|---|---|
GLOBAL LEADERS | 2013 to 2015 N = 15,968 18 countries | Multicentre, open-label, randomized superiority trial | BP-DES (Biolimus A9-eluting stent) | Experimental arm: 75–100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy Control arm: standard dual antiplatelet therapy with 75–100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months | A composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave MI at 2 years | Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by 12 months of aspirin alone in the prevention of all-cause mortality or new Q-wave MI 2 years after PCI |
MASTER DAPT | 2017 to 2019 N = 4434 30 countries | Multicentre, randomized, open-label, noninferiority trial with sequential superiority testing | BP-DES (Ultimaster, Terumo) | Experimental arm: discontinuation of DAPT after one month Median duration of DAPT: 34 days Control arm: Continue DAPT for at least 2 additional months Median duration of DAPT: 193 days | Net adverse clinical events (a composite of death from any cause, MI, stroke, or major bleeding) Major adverse cardiac or cerebral events (a composite of death from any cause, MI, or stroke) Major or clinically relevant nonmajor bleeding at 1 year | One month of DAPT was noninferior to the continuation of therapy for at least 2 additional months; abbreviated therapy also resulted in a lower incidence of major or clinically relevant non-major bleeding. |
STOPDAPT-2 | 2015 to 2017 N = 3009 Japan | Multicentre, open-label, adjudicator-blinded randomized controlled trial | DP-DES (Cobalt-chromium everolimus-eluting stent Xience Series, Abbott Vascular) | Experimental arm: 1-month DAPT followed by clopidogrel monotherapy Control arm: 12 months of DAPT with aspirin and clopidogrel | Composite of cardiovascular death, MI, ischemic or hemorrhagic stroke, definite stent thrombosis or major or minor bleeding at 12 months. | 1-month DAPT followed by clopidogrel monotherapy compared with 12 months of DAPT with aspirin and clopidogrel resulted in a significantly lower rate of a composite of cardiovascular and bleeding events |
One-month DAPT | 2015 to 2019 N = 3020 South Korea | Multicentre, randomized, open-label trial | Experimental arm: PF-DCS (Biofreedom) Control arm: BP-DES (predominantly Biomatrix and Ultimaster in 99% of cases) | Experimental arm: 1-month DAPT with aspirin and clopidogrel, then aspirin thereafter Median duration of DAPT: 1.1 months Control arm: 6–12 months of DAPT with aspirin and clopidogrel Median duration of DAPT: 12 months | 1 year composite of cardiac death, non-fatal MI, target vessel revascularisation, stroke, or major bleeding | 1-month DAPT followed by aspirin after PF-DCS was non-inferior to 6–12 months of DAPT after BP-DES for the 1-year composite endpoint. |