Robert W Yeh1, Dean J Kereiakes2, Philippe Gabriel Steg3, Stephan Windecker4, Michael J Rinaldi5, Anthony H Gershlick6, Donald E Cutlip7, David J Cohen8, Jean-Francois Tanguay9, Alice Jacobs10, Stephen D Wiviott11, Joseph M Massaro12, Adrian C Iancu13, Laura Mauri14. 1. Massachusetts General Hospital, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts. 2. The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, Ohio. 3. Université Paris-Diderot, Paris, France, INSERM U-1148, Paris, France; Hôpital Bichat, Département Hospitalo-Universitaire FIRE, Assistance Publique-Hôpitaux de Paris, Paris, France; NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom. 4. Bern University Hospital, Bern, Switzerland. 5. The Sanger Heart and Vascular Institute, Carolinas HealthCare System, Charlotte, North Carolina. 6. Department of Cardiovascular Sciences, University of Leicester and National Institute of Health Research Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester, Leicester, United Kingdom. 7. Harvard Clinical Research Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Boston, Massachusetts. 8. Saint Luke's Mid-America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri. 9. Montreal Heart Institute, Université de Montréal, Montreal, Canada. 10. Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts. 11. Harvard Medical School, Boston, Massachusetts; Brigham and Women's Hospital, Boston, Massachusetts. 12. Harvard Clinical Research Institute, Boston, Massachusetts; Boston University School of Public Health, Boston, Massachusetts. 13. Heart Institute, University of Medicine Iuliu Hatieganu, Cluj Napoca, Romania. 14. Harvard Clinical Research Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: lmauri1@partners.org.
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. OBJECTIVES: This study sought to assess the benefits and risks of 30 versus 12 months of dual antiplatelet therapy among patients undergoing coronary stent implantation with and without MI. METHODS: The Dual Antiplatelet Therapy Study, a randomized double-blind, placebo-controlled trial, compared 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 coprimary endpoints were definite or probable stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE). The primary safety endpoint was GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries) moderate or severe bleeding. RESULTS: Of 11,648 randomized patients (9,961 treated with drug-eluting stents, 1,687 with bare-metal stents), 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%, p < 0.001; no MI group, 0.4% vs. 1.1%, p < 0.001; interaction p = 0.69). The reduction in MACCE for continued thienopyridine was greater for patients with MI (3.9% vs. 6.8%; p < 0.001) compared with those with no MI (4.4% vs. 5.3%; p = 0.08; interaction p = 0.03). In both groups, continued thienopyridine reduced MI (2.2% vs. 5.2%, p < 0.001 for MI; 2.1% vs. 3.5%, p < 0.001 for no MI; interaction p = 0.15) but increased bleeding (1.9% vs. 0.8%, p = 0.005 for MI; 2.6% vs. 1.7%, p = 0.007 for no MI; interaction p = 0.21). CONCLUSIONS: Compared with 12 months of therapy, 30 months of dual antiplatelet therapy reduced the risk of stent thrombosis and MI in patients with and without MI, and increased bleeding. (The Dual Antiplatelet Therapy Study [The DAPT Study]; NCT00977938).
RCT Entities:
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. OBJECTIVES: This study sought to assess the benefits and risks of 30 versus 12 months of dual antiplatelet therapy among patients undergoing coronary stent implantation with and without MI. METHODS: The Dual Antiplatelet Therapy Study, a randomized double-blind, placebo-controlled trial, compared 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 coprimary endpoints were definite or probable stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE). The primary safety endpoint was GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries) moderate or severe bleeding. RESULTS: Of 11,648 randomized patients (9,961 treated with drug-eluting stents, 1,687 with bare-metal stents), 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%, p < 0.001; no MI group, 0.4% vs. 1.1%, p < 0.001; interaction p = 0.69). The reduction in MACCE for continued thienopyridine was greater for patients with MI (3.9% vs. 6.8%; p < 0.001) compared with those with no MI (4.4% vs. 5.3%; p = 0.08; interaction p = 0.03). In both groups, continued thienopyridine reduced MI (2.2% vs. 5.2%, p < 0.001 for MI; 2.1% vs. 3.5%, p < 0.001 for no MI; interaction p = 0.15) but increased bleeding (1.9% vs. 0.8%, p = 0.005 for MI; 2.6% vs. 1.7%, p = 0.007 for no MI; interaction p = 0.21). CONCLUSIONS: Compared with 12 months of therapy, 30 months of dual antiplatelet therapy reduced the risk of stent thrombosis and MI in patients with and without MI, and increased bleeding. (The Dual Antiplatelet Therapy Study [The DAPT Study]; NCT00977938).
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