McClure, J. D. , Ramsay, J. C. and Berry, C. (2020) Pooled analysis of bleeding and major adverse cardiovascular events in clinical trials of time-constrained dual-antiplatelet therapy after percutaneous coronary intervention. Journal of the American Heart Association, 9(16), e017109. (doi: 10.1161/JAHA.120.017109) (PMID:32779497) (PMCID:PMC7660822)
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Abstract
Background: The net clinical benefit of dual antiplatelet therapy (DAPT) reflects the paradoxical effects of an increased risk of bleeding and a reduced risk of major adverse cardiovascular events. A time‐constrained approach to DAPT has been recently investigated in 5 multicenter trials including GLOBAL LEADERS, STOPDAPT2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus‐Eluting Cobalt‐Chromium Stent‐2), SMART‐CHOICE, TWILIGHT (Ticagrelor With Aspirin or Alone in High‐Risk Patients After Coronary Intervention), and TICO (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome). Methods and Results: We undertook a pooled analysis of these trials to assess the overall associations between time‐constrained P2Y12 inhibitor monotherapy (aspirin‐free regimen) for bleeding events, major adverse cardiovascular events, and all‐cause mortality as compared to standard care with DAPT for at least 12 months post‐percutaneous coronary intervention. We implemented a DerSimonian and Laird random effects meta‐analysis using the metafor package in R. 32 361 randomized trial participants, including 16 898 (52.2%) who had a history of acute coronary syndrome, underwent percutaneous coronary intervention, and had outcome data available. P2Y12 inhibitor monotherapy from 1 to 3 months was associated with a reduced risk for bleeding (hazard ratio [HR] 0.60; 95% CI, 0.45‐0.81), including in the acute coronary syndrome group in which the magnitude of risk reduction was greatest (HR 0.50; 95% CI, 0.41‐0.61). The estimates of the effect of P2Y12 inhibitor monotherapy on the HR were also favorable for major adverse cardiovascular events (0.88; 95% CI, 0.77‐1.02) and all‐cause mortality (0.85; 95% CI, 0.71‐1.03). Conclusions: Compared with DAPT for 12 months post‐percutaneous coronary intervention, P2Y12 inhibitor monotherapy from 1 to 3 months substantially reduces the risk of major and fatal bleeding and, in addition, confers potentially protective effects, for major adverse cardiovascular events and all‐cause mortality. Considering patient safety, the results support a strategy of DAPT for 1 to 3 months followed by aspirin‐free P2Y12 inhibitor monotherapy.
| Item Type: | Articles |
|---|---|
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Berry, Professor Colin and McClure, Dr John |
| Authors: | McClure, J. D., Ramsay, J. C., and Berry, C. |
| College/School: | College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health |
| Journal Name: | Journal of the American Heart Association |
| Publisher: | American Heart Association |
| ISSN: | 2047-9980 |
| ISSN (Online): | 2047-9980 |
| Published Online: | 11 August 2020 |
| Copyright Holders: | Copyright © 2020 The Authors |
| First Published: | First published in Journal of the American Heart Association 9(16): e017109 |
| Publisher Policy: | Reproduced under a Creative Commons license |
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