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Open Access Study protocol

Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial

Gérard Helft1*, Claude Le Feuvre1, Jean Louis Georges2, Didier Carrie3, Florence Leclercq4, Hélène Eltchaninoff5, Alain Furber6, Fabrice Prunier6, Laurent Sebagh7, Simon Cattan8, Guillaume Cayla9, Eric Vicaut10 and Jean-Philippe Metzger1

Author Affiliations

1 bd Vincent Auriol, Institut de Cardiologie, Hôpital Pitié-Salpétrière, Paris, France

2 rue de Versailles Hôpital Mignot, Versailles, France

3 avenue Jean Poulhes, CHU, Toulouse, France

4 avenue du Doyen Gaston Giraud Hôpital CHU, Montpellier, France

5 rue de Germont, CHU, Rouen, France

6 rue Larrey, CHU, Angers, France

7 rue de Turin Clinique Turin, Paris, France

8 10, rue du Général Leclerc, Hôpital Le Raincy, Le Raincy, France

9 place du Pr-Debré GHU, Carémeau, Nîmes, France

10 rue du Faubourg St Denis URC Hôpital, Lariboisière, Paris, France

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Trials 2013, 14:56  doi:10.1186/1745-6215-14-56

Published: 21 February 2013

Abstract

Background

Dual antiplatelet therapy with aspirin and thienopyridine is required after placement of coronary drug-eluting stents (DES) to prevent thrombotic complications. Current clinical guidelines recommend at least 6 to 12 months of treatment after a DES implantation, but it may be beneficial to apply dual antiplatelet therapy for a longer duration.

Methods/design

The optimal dual antiplatelet therapy (OPTIDUAL) study aims to compare the benefits and risks of dual antiplatelet therapy applied for either 12 or 48 months. We will examine the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) in patients undergoing percutaneous coronary intervention with DES for the treatment of coronary lesions. The OPTIDUAL study is an open-label multicenter, randomized, national trial that will include 1,966 patients treated with DES. All patients will be treated with dual antiplatelet therapy for 12 months (+/− 3). Then, patients with no MACCE or major bleeding will be randomized to receive either 36 additional months of clopidogrel plus aspirin or aspirin only. The primary end-point is the combination of death from all causes, myocardial infarction, stroke and major bleeding. The secondary end points include the individual components of the primary end-point, stent thrombosis, repeat revascularization of the treated vessel and minor bleeding.

Discussion

This randomized trial is designed to assess the benefits and safety of 12 versus 48 months of dual antiplatelet therapy in patients that receive a DES. We aim to determine whether substantial prolongation of clopidogrel (a thienopyridine) after DES implantation offers an advantage over its discontinuation.

Trial registration

ClinicalTrials.gov Identifier: NCT00822536

Keywords:
Drug-eluting stent; Clopidogrel; Coronary artery disease; Stent thrombosis; Randomized clinical trial