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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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.
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.
This study aims at providing “real-world” information on current antithrombotic treatment patterns and clinical outcome of patients with non-valvular AF undergoing PCI.
KeywordsAntithrombotic treatment Atrial fibrillation Percutaneous coronary intervention
This study has been funded by the Hellenic Cardiological Society.
Compliance with Ethical Standards
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.
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.
- 2.Rubboli A, Colletta M, Valencia J, Capecchi A, Franco N, Zanolla L, et al. Periprocedural management and in-hospital outcome of patients with indication for oral anticoagulation undergoing coronary artery stenting. J Interv Cardiol. Google Scholar
- 3.Choi HI, Ahn JM, Kang SH, Lee PH, Kang SJ, Lee SW, et al. Prevalence, management, and long-term (6-year) outcomes of atrial fibrillation among patients receiving drug-eluting coronary stents. JACC Cardiovasc Interv. Google Scholar
- 5.Rene AG, Genereux P, Ezekowitz M, Kirtane AJ, Xu K, Mehran R, et al. Impact of atrial fibrillation in patients with ST-elevation myocardial infarction treated with percutaneous coronary intervention (from the HORIZONS-AMI [harmonizing outcomes with revascularization and stents in acute myocardial infarction] trial). Am J Cardiol. 2014;113(2):236–42.CrossRefPubMedGoogle Scholar
- 20.Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, et al. 2016 ACC/AHA guideline focused update on duration of dual antiplatelet therapy in patients with coronary artery disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2016;68(10):1082–115.CrossRefPubMedGoogle Scholar
- 21.Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018;39(3):213–60.CrossRefPubMedGoogle Scholar
- 29.Dewilde WJ, Oirbans T, Verheugt FW, Kelder JC, De Smet BJ, Herrman JP, et al. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial. Lancet. 2013;381(9872):1107–15.CrossRefPubMedGoogle Scholar
- 30.Gao F, Shen H, Wang ZJ, Yang SW, Liu XL, Zhou YJ. Rationale and design of the RT-AF study: combination of rivaroxaban and ticagrelor in patients with atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention. Contemp Clin Trials. 2015;43:129–32.CrossRefPubMedGoogle Scholar
- 31.Lu W, Chen L, Wang Y, Yao Y, Fu C, Zuo P, et al. Rationale and design of MANJUSRI trial: a randomized, open-label, active-controlled multicenter study to evaluate the safety of combined therapy with ticagrelor and warfarin in AF subjects after PCI-eS. Contemp Clin Trials. 2015;40:166–71.CrossRefPubMedGoogle Scholar
- 33.Sarafoff N, Martischnig A, Wealer J, Mayer K, Mehilli J, Sibbing D, et al. Triple therapy with aspirin, prasugrel, and vitamin K antagonists in patients with drug-eluting stent implantation and an indication for oral anticoagulation. J Am Coll Cardiol. 2013;61(20):2060–6.CrossRefPubMedGoogle Scholar
- 34.Jackson LR 2nd, Ju C, Zettler M, Messenger JC, Cohen DJ, Stone GW, et al. Outcomes of patients with acute myocardial infarction undergoing percutaneous coronary intervention receiving an oral anticoagulant and dual antiplatelet therapy: a comparison of clopidogrel versus prasugrel from the TRANSLATE-ACS Study. JACC Cardiovasc Interv. 2015;8(14):1880–9.CrossRefPubMedGoogle Scholar