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P2Y12 inhibitor monotherapy or dual antiplatelet therapy after coronary revascularisation: individual patient level meta-analysis of randomised controlled trials

 Marco Valgimigli  ;  Felice Gragnano  ;  Mattia Branca  ;  Anna Franzone  ;  Usman Baber  ;  Yangsoo Jang  ;  Takeshi Kimura  ;  Joo-Yong Hahn  ;  Qiang Zhao  ;  Stephan Windecker  ;  Charles M Gibson  ;  Byeong-Keuk Kim  ;  Hirotoshi Watanabe  ;  Young Bin Song  ;  Yunpeng Zhu  ;  Pascal Vranckx  ;  Shamir Mehta  ;  Sung-Jin Hong  ;  Kenji Ando  ;  Hyeon-Cheol Gwon  ;  Patrick W Serruys  ;  George D Dangas  ;  Eùgene P McFadden  ;  Dominick J Angiolillo  ;  Dik Heg 5  ;  Peter Jüni  ;  Roxana Mehran 
 BMJ-BRITISH MEDICAL JOURNAL, Vol.373 : n1332, 2021-06 
Journal Title
Issue Date
Aged ; Coronary Artery Disease / drug therapy* ; Coronary Artery Disease / surgery ; Dual Anti-Platelet Therapy / adverse effects* ; Dual Anti-Platelet Therapy / methods ; Female ; Hemorrhage / chemically induced ; Hemorrhage / epidemiology ; Humans ; Male ; Middle Aged ; Mortality / trends ; Myocardial Infarction / epidemiology ; Myocardial Infarction / prevention & control ; Outcome Assessment, Health Care ; Percutaneous Coronary Intervention / adverse effects* ; Percutaneous Coronary Intervention / mortality ; Percutaneous Coronary Intervention / standards ; Purinergic P2Y Receptor Antagonists / adverse effects* ; Purinergic P2Y Receptor Antagonists / therapeutic use ; Randomized Controlled Trials as Topic ; Risk Assessment ; Stroke / epidemiology ; Stroke / prevention & control ; Thrombosis / drug therapy ; Thrombosis / prevention & control
Objective: To assess the risks and benefits of P2Y12 inhibitor monotherapy compared with dual antiplatelet therapy (DAPT) and whether these associations are modified by patients' characteristics.

Design: Individual patient level meta-analysis of randomised controlled trials.

Data sources: Searches were conducted in Ovid Medline, Embase, and three websites (www.tctmd.com, www.escardio.org, www.acc.org/cardiosourceplus) from inception to 16 July 2020. The primary authors provided individual participant data.

Eligibility criteria: Randomised controlled trials comparing effects of oral P2Y12 monotherapy and DAPT on centrally adjudicated endpoints after coronary revascularisation in patients without an indication for oral anticoagulation.

Main outcome measures: The primary outcome was a composite of all cause death, myocardial infarction, and stroke, tested for non-inferiority against a margin of 1.15 for the hazard ratio. The key safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding.

Results: The meta-analysis included data from six trials, including 24 096 patients. The primary outcome occurred in 283 (2.95%) patients with P2Y12 inhibitor monotherapy and 315 (3.27%) with DAPT in the per protocol population (hazard ratio 0.93, 95% confidence interval 0.79 to 1.09; P=0.005 for non-inferiority; P=0.38 for superiority; τ2=0.00) and in 303 (2.94%) with P2Y12 inhibitor monotherapy and 338 (3.36%) with DAPT in the intention to treat population (0.90, 0.77 to 1.05; P=0.18 for superiority; τ2=0.00). The treatment effect was consistent across all subgroups, except for sex (P for interaction=0.02), suggesting that P2Y12 inhibitor monotherapy lowers the risk of the primary ischaemic endpoint in women (hazard ratio 0.64, 0.46 to 0.89) but not in men (1.00, 0.83 to 1.19). The risk of bleeding was lower with P2Y12 inhibitor monotherapy than with DAPT (97 (0.89%) v 197 (1.83%); hazard ratio 0.49, 0.39 to 0.63; P<0.001; τ2=0.03), which was consistent across subgroups, except for type of P2Y12 inhibitor (P for interaction=0.02), suggesting greater benefit when a newer P2Y12 inhibitor rather than clopidogrel was part of the DAPT regimen.

Conclusions: P2Y12 inhibitor monotherapy was associated with a similar risk of death, myocardial infarction, or stroke, with evidence that this association may be modified by sex, and a lower bleeding risk compared with DAPT.

Registration: PROSPERO CRD42020176853.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Byeong Keuk(김병극) ORCID logo https://orcid.org/0000-0003-2493-066X
Jang, Yang Soo(장양수) ORCID logo https://orcid.org/0000-0002-2169-3112
Hong, Sung Jin(홍성진) ORCID logo https://orcid.org/0000-0003-4893-039X
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