Accepted Manuscript Benefits and Risks of Extended Duration Dual Antiplatelet Therapy after PCI in Patients With and Without Acute Myocardial Infarction Robert W. Yeh, MD MSc, Dean J. Kereiakes, MD, Philippe Gabriel Steg, MD, Stephan Windecker, MD, Michael J. Rinaldi, MD, Anthony H. Gershlick, MBBS, Donald E. Cutlip, MD, David J. Cohen, MD MSc, Jean Francois Tanguay, MD, Alice Jacobs, MD, Stephen D. Wiviott, MD, Joseph M. Massaro, PhD, Adrian C. Iancu, MD, Laura Mauri, MD MSc PII:
S0735-1097(15)00808-6
DOI:
10.1016/j.jacc.2015.03.003
Reference:
JAC 21053
To appear in:
Journal of the American College of Cardiology
Received Date: 23 February 2015 Revised Date:
2 March 2015
Accepted Date: 4 March 2015
Please cite this article as: Yeh RW, Kereiakes DJ, Steg PG, Windecker S, Rinaldi MJ, Gershlick AH, Cutlip DE, Cohen DJ, Tanguay JF, Jacobs A, Wiviott SD, Massaro JM, Iancu AC, Mauri L, on behalf of the DAPT Study Investigators, Benefits and Risks of Extended Duration Dual Antiplatelet Therapy after PCI in Patients With and Without Acute Myocardial Infarction, Journal of the American College of Cardiology (2015), doi: 10.1016/j.jacc.2015.03.003. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Benefits and Risks of Extended Duration Dual Antiplatelet Therapy after PCI in Patients With and Without Acute Myocardial Infarction
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Robert W. Yeh MD MSc, Dean J. Kereiakes MD, Philippe Gabriel Steg MD, Stephan Windecker MD, Michael J Rinaldi MD, Anthony H. Gershlick MBBS, Donald E. Cutlip MD, David J. Cohen MD MSc, Jean Francois Tanguay MD, Alice Jacobs MD, Stephen D. Wiviott MD, Joseph M. Massaro PhD, Adrian C. Iancu MD, and Laura Mauri MD MSc, on behalf of the DAPT Study Investigators. Massachusetts General Hospital (RWY); Beth Israel Deaconess Medical Center (DEC); Brigham and Women’s Hospital (SDW, LM); Boston Medical Center, Boston University (AJ); Harvard Clinical Research Institute (RWY, DEC, JMM, LM); Harvard Medical School (RWY, DEC, SDW, LM)—all in Boston, MA; The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati (DJK); Hôpital Bichat, Assistance Publique– Hôpitaux de Paris, Paris (PGS); Bern University Hospital, Bern (SW); The Sanger Heart and Vascular Institute, Charlotte, NC (MJR).; University Hospitals of Leicester, Leicester, UK (AHG); Saint Luke’s Mid-America Heart Institute, Kansas City, MO (DJC); Montreal Heart Institute, Universite de Montreal, Montreal (J-FT); Heart Institute, Cluj Napoca, Romania (ACI); Hospital Krakow, Poland (JT).
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Address for Correspondence: Laura Mauri, MD, MSc Division of Cardiovascular Medicine, Department of Medicine Brigham and Women’s Hospital 75 Francis Street; Boston, MA 02115 Email: [email protected]
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Sponsored by Harvard Clinical Research Institute. Funded by Abbott, Boston Scientific Corporation, Cordis Corporation, Medtronic, Inc., Bristol-Myers Squibb Company/Sanofi Pharmaceuticals Partnership, Eli Lilly and Company, and Daiichi Sankyo Company Limited and the US Department of Health and Human Services (1RO1FD003870-01).
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Relationships with Industry: Dr. Yeh: Advisory Board – Abbott Vascular; Consulting Fees – Gilead Sciences, Merck Dr. Kereiakes: None Dr. Steg: Personal fees from Amarin, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-MyersSquibb, Daiichi-Sankyo, GlaxoSmithKline, Eli Lilly, Merck-Sharpe-Dohme, Novartis, Otsuka, Pfizer, Roche, Medtronic, sanofi-aventis, Servier, Vivus, Janssn, The Medicines Company, and Orexigen; and grants from sanofi-aventis and Servier. Dr. Windecker: Research grants to the institution from Abbott, Biotronik, Boston Scientific, Edwards Lifesciences, Medtronic, Medicines Company and St Jude, and speaker fees from Astra Zeneca, Eli Lilly, Abbott, Biotronik, Boston Scientific, Bayer and Biosensors. Dr. Rinaldi: None Dr. Gershlick: Personal fees from Medtronic , personal fees from Abbott, grants from Medicines Company
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Dr. Cutlip: Other fees from Medtronic, other from Boston Scientific, other from Cordis Inc., other from Abbott Vascular, grants from NHLBI, during the conduct of the study. Dr. Cohen: Research grant support to institution – Eli Lilly, Astra Zeneca, Daiichi-Sankyo, Abbott Vascular, Boston Scientific, Medtronic; Consulting Fees – Eli Lilly, Astra Zeneca, Abbott Vascular, Medtronic Dr. Tanguay: Personal fees and other from Abbott Vascular, personal fees and other from AstraZeneca, personal fees from Bayer, personal fees and other from Bristol-Myers Squibb, personal fees and other from Eli Lilly, personal fees and other from GlaxoSmithKline, personal fees from Roche, personal fees and other from Sanofi-Aventis, personal fees from Servier, other from Ikaria, other from Merck Dr. Jacobs: None Dr. Wiviott: grants and personal fees from AstraZeneca, grants and personal fees from Bristol Myers Squibb, grants from Eisai, grants and personal fees from Arena, grants from Merck, personal fees from Aegerion, personal fees from Angelmed, personal fees from Janssen, personal fees from Xoma, personal fees from ICON Clinical, personal fees from Boston Clinical Research Institute, grants and personal fees from Eli Lilly/Daiichi Sankyo, grants from SanofiAventis, outside the submitted work. Dr. Massaro: Personal fees from Harvard Clinical Research Institute during the conduct of the study Dr. Iancu: None Dr. Mauri: Institutional research grants from Abbott, Boston Scientific, Cordis, Medtronic, Eli Lilly/Daiichi Sankyo, and sanofi Aventis/Bristol Myers Squibb; and personal fees from Medtronic, Recor, St. Jude Medical, and Biotronik.
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Acknowledgments: This research has been sponsored by Harvard Clinical Research Institute and funded by Abbott, Boston Scientific Corporation, Cordis Corporation, Medtronic, Inc., Bristol-Myers Squibb Company/Sanofi Pharmaceuticals Partnership, Eli Lilly and Company, and Daiichi Sankyo Company Limited and the US Department of Health and Human Services (1RO1FD003870-01).
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The authors wish to acknowledge Ms. Priscilla Driscoll-Schempp, Ms. Wen-Hua Hsieh, and Ms. Joanna Suomi for their important contributions to this study. GUEST EDITOR: P.K. Shah, M.D.
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Abstract Background: The benefits and risks of prolonged dual antiplatelet therapy may be different for patients with acute myocardial infarction (MI) compared with more stable presentations. Objective: To assess the benefits and risks of 30 versus 12 months of dual antiplatelet therapy among patients undergoing coronary stent implantation following presentation with and without MI. Methods: The DAPT Study was a randomized double-blind, placebo-controlled trial comparing 30 versus 12 months of dual antiplatelet therapy after coronary stenting. The effect of continued thienopyridine on ischemic and bleeding events among patients initially presenting with versus without MI was assessed. The co-primary endpoints were definite or probable stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE, a composite of death, myocardial infarction, or stroke). The primary safety endpoint was GUSTO moderate or severe bleeding. Results: Of 11,648 randomized patients (9961 treated with drug-eluting, 1687 with bare metal stents), 3,576 (30.7%) presented with MI. Between 12 and 30 months, continued thienopyridine reduced stent thrombosis compared with placebo in patients with and without MI at presentation (MI group 0.5% vs. 1.9%, hazard ratio [HR] 0.27, p
S0735-1097(15)00808-6
DOI:
10.1016/j.jacc.2015.03.003
Reference:
JAC 21053
To appear in:
Journal of the American College of Cardiology
Received Date: 23 February 2015 Revised Date:
2 March 2015
Accepted Date: 4 March 2015
Please cite this article as: Yeh RW, Kereiakes DJ, Steg PG, Windecker S, Rinaldi MJ, Gershlick AH, Cutlip DE, Cohen DJ, Tanguay JF, Jacobs A, Wiviott SD, Massaro JM, Iancu AC, Mauri L, on behalf of the DAPT Study Investigators, Benefits and Risks of Extended Duration Dual Antiplatelet Therapy after PCI in Patients With and Without Acute Myocardial Infarction, Journal of the American College of Cardiology (2015), doi: 10.1016/j.jacc.2015.03.003. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Benefits and Risks of Extended Duration Dual Antiplatelet Therapy after PCI in Patients With and Without Acute Myocardial Infarction
M AN U
SC
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Robert W. Yeh MD MSc, Dean J. Kereiakes MD, Philippe Gabriel Steg MD, Stephan Windecker MD, Michael J Rinaldi MD, Anthony H. Gershlick MBBS, Donald E. Cutlip MD, David J. Cohen MD MSc, Jean Francois Tanguay MD, Alice Jacobs MD, Stephen D. Wiviott MD, Joseph M. Massaro PhD, Adrian C. Iancu MD, and Laura Mauri MD MSc, on behalf of the DAPT Study Investigators. Massachusetts General Hospital (RWY); Beth Israel Deaconess Medical Center (DEC); Brigham and Women’s Hospital (SDW, LM); Boston Medical Center, Boston University (AJ); Harvard Clinical Research Institute (RWY, DEC, JMM, LM); Harvard Medical School (RWY, DEC, SDW, LM)—all in Boston, MA; The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati (DJK); Hôpital Bichat, Assistance Publique– Hôpitaux de Paris, Paris (PGS); Bern University Hospital, Bern (SW); The Sanger Heart and Vascular Institute, Charlotte, NC (MJR).; University Hospitals of Leicester, Leicester, UK (AHG); Saint Luke’s Mid-America Heart Institute, Kansas City, MO (DJC); Montreal Heart Institute, Universite de Montreal, Montreal (J-FT); Heart Institute, Cluj Napoca, Romania (ACI); Hospital Krakow, Poland (JT).
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Address for Correspondence: Laura Mauri, MD, MSc Division of Cardiovascular Medicine, Department of Medicine Brigham and Women’s Hospital 75 Francis Street; Boston, MA 02115 Email: [email protected]
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Sponsored by Harvard Clinical Research Institute. Funded by Abbott, Boston Scientific Corporation, Cordis Corporation, Medtronic, Inc., Bristol-Myers Squibb Company/Sanofi Pharmaceuticals Partnership, Eli Lilly and Company, and Daiichi Sankyo Company Limited and the US Department of Health and Human Services (1RO1FD003870-01).
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Relationships with Industry: Dr. Yeh: Advisory Board – Abbott Vascular; Consulting Fees – Gilead Sciences, Merck Dr. Kereiakes: None Dr. Steg: Personal fees from Amarin, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-MyersSquibb, Daiichi-Sankyo, GlaxoSmithKline, Eli Lilly, Merck-Sharpe-Dohme, Novartis, Otsuka, Pfizer, Roche, Medtronic, sanofi-aventis, Servier, Vivus, Janssn, The Medicines Company, and Orexigen; and grants from sanofi-aventis and Servier. Dr. Windecker: Research grants to the institution from Abbott, Biotronik, Boston Scientific, Edwards Lifesciences, Medtronic, Medicines Company and St Jude, and speaker fees from Astra Zeneca, Eli Lilly, Abbott, Biotronik, Boston Scientific, Bayer and Biosensors. Dr. Rinaldi: None Dr. Gershlick: Personal fees from Medtronic , personal fees from Abbott, grants from Medicines Company
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Dr. Cutlip: Other fees from Medtronic, other from Boston Scientific, other from Cordis Inc., other from Abbott Vascular, grants from NHLBI, during the conduct of the study. Dr. Cohen: Research grant support to institution – Eli Lilly, Astra Zeneca, Daiichi-Sankyo, Abbott Vascular, Boston Scientific, Medtronic; Consulting Fees – Eli Lilly, Astra Zeneca, Abbott Vascular, Medtronic Dr. Tanguay: Personal fees and other from Abbott Vascular, personal fees and other from AstraZeneca, personal fees from Bayer, personal fees and other from Bristol-Myers Squibb, personal fees and other from Eli Lilly, personal fees and other from GlaxoSmithKline, personal fees from Roche, personal fees and other from Sanofi-Aventis, personal fees from Servier, other from Ikaria, other from Merck Dr. Jacobs: None Dr. Wiviott: grants and personal fees from AstraZeneca, grants and personal fees from Bristol Myers Squibb, grants from Eisai, grants and personal fees from Arena, grants from Merck, personal fees from Aegerion, personal fees from Angelmed, personal fees from Janssen, personal fees from Xoma, personal fees from ICON Clinical, personal fees from Boston Clinical Research Institute, grants and personal fees from Eli Lilly/Daiichi Sankyo, grants from SanofiAventis, outside the submitted work. Dr. Massaro: Personal fees from Harvard Clinical Research Institute during the conduct of the study Dr. Iancu: None Dr. Mauri: Institutional research grants from Abbott, Boston Scientific, Cordis, Medtronic, Eli Lilly/Daiichi Sankyo, and sanofi Aventis/Bristol Myers Squibb; and personal fees from Medtronic, Recor, St. Jude Medical, and Biotronik.
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Acknowledgments: This research has been sponsored by Harvard Clinical Research Institute and funded by Abbott, Boston Scientific Corporation, Cordis Corporation, Medtronic, Inc., Bristol-Myers Squibb Company/Sanofi Pharmaceuticals Partnership, Eli Lilly and Company, and Daiichi Sankyo Company Limited and the US Department of Health and Human Services (1RO1FD003870-01).
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The authors wish to acknowledge Ms. Priscilla Driscoll-Schempp, Ms. Wen-Hua Hsieh, and Ms. Joanna Suomi for their important contributions to this study. GUEST EDITOR: P.K. Shah, M.D.
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Abstract Background: The benefits and risks of prolonged dual antiplatelet therapy may be different for patients with acute myocardial infarction (MI) compared with more stable presentations. Objective: To assess the benefits and risks of 30 versus 12 months of dual antiplatelet therapy among patients undergoing coronary stent implantation following presentation with and without MI. Methods: The DAPT Study was a randomized double-blind, placebo-controlled trial comparing 30 versus 12 months of dual antiplatelet therapy after coronary stenting. The effect of continued thienopyridine on ischemic and bleeding events among patients initially presenting with versus without MI was assessed. The co-primary endpoints were definite or probable stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE, a composite of death, myocardial infarction, or stroke). The primary safety endpoint was GUSTO moderate or severe bleeding. Results: Of 11,648 randomized patients (9961 treated with drug-eluting, 1687 with bare metal stents), 3,576 (30.7%) presented with MI. Between 12 and 30 months, continued thienopyridine reduced stent thrombosis compared with placebo in patients with and without MI at presentation (MI group 0.5% vs. 1.9%, hazard ratio [HR] 0.27, p
