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Table 1 Characteristics of RCTs included

From: Safety and efficacy of interrupting dual antiplatelet therapy one month following percutaneous coronary intervention: a meta-analysis of randomized controlled trials

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.

  1. BP-DES biodegradable-polymer drug eluting stent, DAPT dual antiplatelet therapy, DP-DES durable-polymer drug eluting stent, PF-DCS polymer-free drug coated stent, MI myocardial infarction