Routine revascularization with percutaneous coronary intervention in patients with coronary artery disease undergoing transcatheter aortic valve implantation – the third nordic aortic valve intervention trial – NOTION-3 - 08/12/22

Doi : 10.1016/j.ahj.2022.10.009

Muhammad Sabbah, MD ^a, Karsten Veien, MD ^b, Matti Niemela, MD ^c, Phillip Freeman, MD, PhD ^d, Rickard Linder, MD, PhD, FESC ^e,^f, Dan Ioanes, MD ^g, Christian Juhl Terkelsen, MD, DMSc ^h,ⁱ, Olli A. Kajander, MD, PhD ^j, Sasha Koul, MD ^k, Mikko Savontaus, MD ^l, Pasi Karjalainen, MD, PhD ^j, Andrejs Erglis, MD ^m, Mikko Minkkinen, MD ^j, Troels Jørgensen, MD, PhD ^a, Lars Sondergaard, MD, PhD, DMSc ^a,ⁿ, Ole De Backer, MD, PhD ^a, Thomas Engstrøm, MD, PhD, DMSc ^a,ⁿ, Jacob Lønborg, MD, PhD, DMSc ^a,^⁎
^a Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Denmark
^b Department of Cardiology, Odense University Hospital, Odense, Denmark
^c Department of Cardiology, Oulu University Hospital, University of Oulu, Finland
^d Department of Cardiology, Aalborg University Hospital, Denmark
^e Department of Medicine, Karolinska Institutet, Stockholm, Sweden
^f Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden
^g Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
^h The Danish Heart Foundation
ⁱ Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark
^j Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki, Finland
^k Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden
^l Heart Center, Turku University Hospital, Finland
^m University of Latvia, Riga, Latvia
ⁿ Department of Clinical Medicine, University of Copenhagen, Denmark

^⁎Reprint requests: Jacob Lønborg, Inge Lehmanns Vej 7, 2100 Copenhagen, Denmark.Inge Lehmanns Vej 7Copenhagen2100Denmark

Résumé

Background

Coronary artery disease (CAD) frequently coexists with severe aortic valve stenosis (AS) in patients planned for transcatheter aortic valve implantation (TAVI). How to manage CAD in this patient population is still an unresolved question. In particular, it is still not known whether fractional flow reserve (FFR) guided revascularization with percutaneous coronary intervention (PCI) is superior to medical treatment for CAD in terms of clinical outcomes.

Study design

The third Nordic Aortic Valve Intervention (NOTION-3) Trial is an open-label investigator-initiated, multicenter multinational trial planned to randomize 452 patients with severe AS and significant CAD to either FFR-guided PCI or medical treatment, in addition to TAVI. Patients are eligible for the study in the presence of at least 1 significant PCI-eligible coronary stenosis. A significant stenosis is defined as either FFR ≤0.80 and/or diameter stenosis >90%. The primary end point is a composite of first occurring all-cause mortality, myocardial infarction, or urgent revascularization (PCI or coronary artery bypass graft performed during unplanned hospital admission) until the last included patient have been followed for 1 year after the TAVI.

Summary

NOTION-3 is a multicenter, multinational randomized trial aiming at comparing FFR-guided revascularization vs medical treatment of CAD in patients with severe AS planned for TAVI.

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Vol 255

P. 39-51 - janvier 2023 Retour au numéro

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Routine revascularization with percutaneous coronary intervention in patients with coronary artery disease undergoing transcatheter aortic valve implantation – the third nordic aortic valve intervention trial – NOTION-3 - 08/12/22

Résumé

Background

Study design

Summary

Plan

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