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Impact of Optimal Medical Therapy in the Dual Antiplatelet Therapy Study
Charles D Resor1, Ashwin Nathan1, Dean J Kereiakes1
1From Division of Cardiology and Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (C.D.R., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., D.E.C., W.-H.H., L.M.); Harvard Medical School, Boston, MA (R.W.Y., L.M.); Division of Cardiology, University of Pennsylvania Medical Center, Philadelphia (A.N.); Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y., D.E.C.); Department of Biostatistics, Boston University School of Public Heath, MA (J.M.M.); The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique-Hôpitaux de Paris, Paris, France (P.G.S.); and National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, UK (P.G.S.).
Continued thienopyridine therapy significantly reduced myocardial infarction rates in patients with coronary heart disease, irrespective of their optimal medical therapy (OMT) status. This dual antiplatelet therapy strategy also consistently lowered major adverse cardiovascular events and increased bleeding risk.
Area of Science:
- Cardiovascular Medicine
- Clinical Trials
- Pharmacology
Background:
- Optimal medical therapy (OMT) and dual antiplatelet therapy (DAPT) improve outcomes in coronary heart disease.
- The impact of OMT on the effectiveness of DAPT remains unclear.
Purpose of the Study:
- To investigate whether optimal medical therapy (OMT) modifies the treatment effect of extended dual antiplatelet therapy (DAPT) in patients post-coronary stenting.
- To evaluate the efficacy and safety of continued thienopyridine therapy versus placebo in patients receiving or not receiving OMT.
Main Methods:
- The DAPT Study randomized 11,648 patients to 18 months of continued thienopyridine or placebo after an initial year of DAPT.
- OMT was defined as concurrent use of statin, beta-blocker, and ACE inhibitor/ARB.
- Outcomes included myocardial infarction, major adverse cardiovascular events, and bleeding.
Main Results:
- Continued thienopyridine reduced myocardial infarction regardless of OMT status (interaction P=0.103).
- Rates of major adverse cardiovascular and cerebrovascular events were reduced by continued thienopyridine, with a significant effect observed in patients not on OMT (HR, 0.63; P<0.001).
- Bleeding rates increased with continued thienopyridine in patients on OMT (HR, 2.13; P<0.001), but not significantly in those off OMT (HR, 1.30; P=0.189).
Conclusions:
- Continued thienopyridine therapy effectively reduces myocardial infarction rates in patients with coronary heart disease, irrespective of OMT.
- The benefits of extended DAPT on major adverse cardiovascular events and the associated bleeding risk should be considered in the context of OMT use.
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