Original Investigation
Benefits and Risks of Extended Duration Dual Antiplatelet Therapy After PCI in Patients With and Without Acute Myocardial Infarction

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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.

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)

Key Words

acute coronary syndromes
antiplatelet therapy
myocardial infarction
percutaneous coronary intervention
randomized clinical trial

Abbreviations and Acronyms

BMS
bare-metal stent(s)
CI
confidence interval
DES
drug-eluting stent(s)
HR
hazard ratio
MACCE
major adverse cardiovascular and cerebrovascular events(s)
MI
myocardial infarction
PCI
percutaneous coronary intervention

Cited by (0)

This research is sponsored by the 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 U.S. Department of Health and Human Services (1RO1FD003870-01). Dr. Yeh is on the advisory board of Abbott Vascular; and has received consulting fees from Gilead Sciences and Merck. Dr. Kereiakes has served as a consultant for Boston Scientific and Abbott Vascular. Dr. Steg has received personal fees from Amarin, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Eli Lilly, Merck-Sharpe-Dohme, Novartis, Otsuka, Pfizer, Roche, Medtronic, Sanofi, Servier, Vivus, Janssen, The Medicines Company, and Orexigen; and has received grants from Sanofi and Servier. Dr. Windecker has received research grants to the institution from Abbott, Biotronik, Boston Scientific, Edwards Lifesciences, Medtronic, The Medicines Company, and St. Jude; and speaker fees from AstraZeneca, Eli Lilly, Abbott, Biotronik, Boston Scientific, Bayer, and Biosensors. Dr. Gershlick has received personal fees from Medtronic and Abbott; and grants from The Medicines Company. Dr. Cutlip has received other fees from Medtronic, Boston Scientific, Cordis Inc., and Abbott Vascular; and grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Dr. Cohen has received research grant support to the institution from Eli Lilly, AstraZeneca, Daiichi-Sankyo, Abbott Vascular, Boston Scientific, and Medtronic; and consulting fees from Eli Lilly, AstraZeneca, Abbott Vascular, and Medtronic. Dr. Tanguay has received personal fees and other from Abbott Vascular, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, and Sanofi; personal fees from Bayer, Roche, and Servier; and other fees from Ikaria and Merck. Dr. Wiviott has received grants and personal fees from AstraZeneca, Bristol-Myers Squibb, Arena, and Eli Lilly/Daiichi-Sankyo; grants from Eisai, Merck, and Sanofi; and personal fees from Aegerion, Angelmed, Janssen, Xoma, ICON Clinical, and the Boston Clinical Research Institute. Dr. Massaro has received personal fees from the Harvard Clinical Research Institute during the conduct of the study. Dr. Mauri has received institutional research grants from Abbott, Boston Scientific, Cordis, Medtronic, Eli Lilly/Daiichi-Sankyo, and Sanofi/Bristol-Myers Squibb; and personal fees from Medtronic, Recor, St. Jude Medical, and Biotronik. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

P. K. Shah, MD, served as Guest Editor for this paper.

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