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Pooled Analysis of Bleeding, Major Adverse Cardiovascular Events, and All‐Cause Mortality in Clinical Trials of Time‐Constrained Dual‐Antiplatelet Therapy After Percutaneous Coronary Intervention

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 G...

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Autores principales: McClure, John D., Ramsay, Jennifer C., Berry, Colin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7660822/
https://www.ncbi.nlm.nih.gov/pubmed/32779497
http://dx.doi.org/10.1161/JAHA.120.017109
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author McClure, John D.
Ramsay, Jennifer C.
Berry, Colin
author_facet McClure, John D.
Ramsay, Jennifer C.
Berry, Colin
author_sort McClure, John D.
collection PubMed
description 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.
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spelling pubmed-76608222020-11-17 Pooled Analysis of Bleeding, Major Adverse Cardiovascular Events, and All‐Cause Mortality in Clinical Trials of Time‐Constrained Dual‐Antiplatelet Therapy After Percutaneous Coronary Intervention McClure, John D. Ramsay, Jennifer C. Berry, Colin J Am Heart Assoc Brief Communication 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. John Wiley and Sons Inc. 2020-08-11 /pmc/articles/PMC7660822/ /pubmed/32779497 http://dx.doi.org/10.1161/JAHA.120.017109 Text en © 2020 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley. This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Brief Communication
McClure, John D.
Ramsay, Jennifer C.
Berry, Colin
Pooled Analysis of Bleeding, Major Adverse Cardiovascular Events, and All‐Cause Mortality in Clinical Trials of Time‐Constrained Dual‐Antiplatelet Therapy After Percutaneous Coronary Intervention
title Pooled Analysis of Bleeding, Major Adverse Cardiovascular Events, and All‐Cause Mortality in Clinical Trials of Time‐Constrained Dual‐Antiplatelet Therapy After Percutaneous Coronary Intervention
title_full Pooled Analysis of Bleeding, Major Adverse Cardiovascular Events, and All‐Cause Mortality in Clinical Trials of Time‐Constrained Dual‐Antiplatelet Therapy After Percutaneous Coronary Intervention
title_fullStr Pooled Analysis of Bleeding, Major Adverse Cardiovascular Events, and All‐Cause Mortality in Clinical Trials of Time‐Constrained Dual‐Antiplatelet Therapy After Percutaneous Coronary Intervention
title_full_unstemmed Pooled Analysis of Bleeding, Major Adverse Cardiovascular Events, and All‐Cause Mortality in Clinical Trials of Time‐Constrained Dual‐Antiplatelet Therapy After Percutaneous Coronary Intervention
title_short Pooled Analysis of Bleeding, Major Adverse Cardiovascular Events, and All‐Cause Mortality in Clinical Trials of Time‐Constrained Dual‐Antiplatelet Therapy After Percutaneous Coronary Intervention
title_sort pooled analysis of bleeding, major adverse cardiovascular events, and all‐cause mortality in clinical trials of time‐constrained dual‐antiplatelet therapy after percutaneous coronary intervention
topic Brief Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7660822/
https://www.ncbi.nlm.nih.gov/pubmed/32779497
http://dx.doi.org/10.1161/JAHA.120.017109
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