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Contemporary Antithrombotic Treatment in Patients with Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: Rationale and Design of the Greek AntiPlatElet Atrial Fibrillation (GRAPE-AF) Registry

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Abstract

Background

Approximately 5 to 7% of patients undergoing percutaneous coronary intervention (PCI) for the treatment of coronary artery disease require chronic oral anticoagulation (OAC) on top of aspirin and a P2Y12 receptor antagonist, mainly due to non-valvular atrial fibrillation (AF). The advent of non-vitamin K antagonist oral anticoagulants (NOACs) increased treatment options, while there is cumulative evidence that dual combination of a NOAC and a P2Y12 receptor antagonist attenuates risk of bleeding, compared to traditional triple therapy, consisting of a vitamin K antagonist (VKA), aspirin, and a P2Y12 receptor antagonist, without significantly compromising efficacy.

Study Design

Greek AntiPlatElet Atrial Fibrillation (GRAPE-AF, NCT 03362788) is an observational, nationwide study of non-valvular AF patients undergoing PCI, planning to enroll over 1-year period > 500 participants in 25 tertiary and non-tertiary PCI centers in Greece. Key data to be collected pre-discharge include demographics, detailed past medical history, and antithrombotic and concomitant treatment. Patients will be followed up at 1, 6, and 12 months post hospital discharge. Αt each follow-up visit, data on antithrombotic treatment, ischemic, bleeding, and adverse events will be collected. Study’s primary endpoint is clinically significant bleeding (Bleeding Academic Research Consortium, BARC ≥ 2) at 12 months, between VKAs and NOACs-treated patients, analyzed using Cox proportional hazards models, by an intention-to-treat principle. An independent endpoint committee will adjudicate all clinical events.

Conclusions

This study aims at providing “real-world” information on current antithrombotic treatment patterns and clinical outcome of patients with non-valvular AF undergoing PCI.

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Funding

This study has been funded by the Hellenic Cardiological Society.

Author information

Authors and Affiliations

  1. Cardiology Department, Patras University Hospital, Patras, Greece

    Ioanna Xanthopoulou & Periklis Davlouros

  2. 3rd Department of Internal Medicine, Red Cross Hospital, Athens, Greece

    Vasiliki-Maria Dragona

  3. 1st Department of Cardiology, Ippokration Hospital, National and Capodistrian University of Athens Medical School, Athens, Greece

    Costas Tsioufis

  4. 2nd Department of Cardiology, Attikon University Hospital, National and Capodistrian University of Athens Medical School, Athens, Greece

    Efstathios Iliodromitis & Dimitrios Alexopoulos

Authors
  1. Ioanna Xanthopoulou
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  2. Vasiliki-Maria Dragona
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  3. Periklis Davlouros
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  4. Costas Tsioufis
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  5. Efstathios Iliodromitis
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for the GRAPE-AF Investigators

Corresponding author

Correspondence to Ioanna Xanthopoulou.

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Conflict of Interest

Dr. Alexopoulos discloses lecturing honoraria from AstraZeneca, Bayer, and Boehringer Ingelheim and Advisory Board fees from AstraZeneca, Bayer, Boehringer Ingelheim, and Medtronic. Dr. Tsioufis has received consultancy fees, Research Grant and, honoraria fees from the following: Servier, Menarini, Medtronic, Bayer, Novartis, AstraZeneca, Boehringer Ingelheim, Pfizer, Chiesi, Recordati, Sanofi, and MSD. The rest of the authors have nothing to disclose.

Ethical Approval

This article does not contain any studies with animals performed by any of the authors. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Xanthopoulou, I., Dragona, VM., Davlouros, P. et al. Contemporary Antithrombotic Treatment in Patients with Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: Rationale and Design of the Greek AntiPlatElet Atrial Fibrillation (GRAPE-AF) Registry. Cardiovasc Drugs Ther 32, 191–196 (2018). https://doi.org/10.1007/s10557-018-6789-7

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