System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Publications

Journal Article Ahead of print 4 citations

PubMed: 42670987 DOI: 10.1056/NEJMoa2606924

Timing of PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation.

N Engl J Med

Authors: Barbara E Stähli, Frank Ruschitzka, Dirk Westermann, Axel Linke, Norman Mangner, Nicolas M Van Mieghem, Rahel Kesterke, Laura Oberholzer, Jürgen Rothe, Constantin von Zur Mühlen, Tobias Zeus, Won-Keun Kim, Philipp Lauten, Nikos Werner, Christof Burgdorf, Hannes Alber, P Christian Schulze, Michael Joner, Jonathan Michel, Alessandro Candreva, Philipp Jakob, Michael Würdinger, Julia Stehli, Alexander Gotschy, Christian Templin, Omer Dzemali, Luise Gaede, Steffen Massberg, Alexander Lauten, Frank van der Kley, Aydan Ewers, Thomas Nestelberger, Mohamed Abdel-Wahab, Giuseppe Musumeci, Sebastian Barth, Michael Hansen, Andreas Mügge, Moritz Seiffert, David M Leistner, Thomas Cuisset, Steffen Schneider, Adnan Kastrati, Ian Ford, Markus A Kasel

Affiliations

  • Department of Cardiology, University Heart Center, University Hospital Zurich, Center for Translational and Experimental Cardiology (CTEC), and University of Zurich, Zurich, Switzerland.
  • Department of Cardiology and Angiology, Faculty of Medicine, University Heart Center Freiburg-Bad Krozingen, and University of Freiburg, Freiburg, Germany.
  • Department of Internal Medicine and Cardiology, Herzzentrum Dresden, University Clinic, Technische Universität Dresden, Dresden, Germany.
  • Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands, and Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.
  • Department of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty of the Heinrich Heine University, Düsseldorf, Germany.
  • Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany.
  • Department of Cardiology, Heart Center, Zentralklinik Bad Berka, Bad Berka, Germany.
  • Department of Internal Medicine III, Heart Center Trier, Krankenhaus der Barmherzigen Brüder, Trier, Germany.
  • Heart and Vascular Center Bad Bevensen, Bad Bevensen, Germany.
  • Department of Cardiology, Klinikum Klagenfurt am Wörthersee, Klagenfurt am Wörthersee, Austria.
  • Department of Internal Medicine I, Division of Cardiology, University Hospital Jena, Jena, Germany.
  • Department of Cardiology, Technical University of Munich (TUM) University Hospital, German Heart Center Munich, Munich, Germany.
  • German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Munich, Germany.
  • Department of Internal Medicine B, University Medicine Greifswald, Greifswald, Germany.
  • DZHK partner site Greifswald, Greifswald, Germany.
  • Department of Cardiac Surgery, University Heart Center, University Hospital Zurich, City Hospital Zurich-Triemli, Zurich, Switzerland.
  • CTEC, University of Zurich, Zurich, Switzerland.
  • Klinikum Herrsching, Starnberger Kliniken, Herrsching, Germany.
  • Department of Medicine I, Ludwig-Maximilians-Universität München (LMU Munich), Munich, Germany.
  • Department of General and Interventional Cardiology and Rhythmology, Helios Medical Center, Health and Medical University Erfurt, Erfurt, Germany.
  • Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.
  • Department of Cardiology and Angiology, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Ruhr-University Bochum, Bochum, Germany.
  • Department of Cardiology, Cardiovascular Research Institute Basel, University Hospital Basel, University of Basel, Basel, Switzerland.
  • Heart Center Leipzig at Leipzig University, Leipzig, Germany.
  • Cardiology Department, Azienda Ospedaliera Ordine Mauriziano di Torino, Turin, Italy.
  • Department of Cardiology, Cardiovascular Center Bad Neustadt-Saale, Bad Neustadt an der Saale, Germany.
  • Division of Cardiology, Center of Internal Medicine, University Hospital Magdeburg, Otto-von-Guericke University, Magdeburg, Germany.
  • Ruhr-University Bochum, Medical Faculty, Institute of Physiology, Department of Cellular and Translational Physiology, Bochum, Germany.
  • Department of Cardiology, University Heart Center Frankfurt, University Hospital Frankfurt, Frankfurt am Main, Germany.
  • DZHK partner site Rhine-Main, Frankfurt am Main, Germany.
  • Department of Cardiology, Centre Hospitalier Universitaire Timone and INSERM, INRAE, Center for Cardiovascular and Nutrition Research, Aix-Marseille University, Marseille, France.
  • Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany.
  • Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.

Abstract

BACKGROUND

Approximately one half of patients undergoing transcatheter aortic-valve implantation (TAVI) have concomitant coronary artery disease. Although percutaneous coronary intervention (PCI) is often performed before TAVI, the preferred treatment strategy has not been established.

METHODS

We conducted an international, open-label, randomized, noninferiority trial at 48 centers in Europe. Patients with severe aortic stenosis and coronary artery disease were randomly assigned in a 1:1 ratio to a strategy of either TAVI before PCI (TAVI-first group) or PCI before TAVI (PCI-first group). The primary end point was a composite of death from any cause; nonfatal myocardial infarction; ischemia-driven revascularization; rehospitalization related to the valve, procedure, or heart failure; or life-threatening, disabling, or major bleeding at 1 year after randomization. The noninferiority margin was 6.6 percentage points, with testing for noninferiority of TAVI first as compared with PCI first.

RESULTS

A total of 986 patients underwent randomization: 498 were assigned to the TAVI-first group and 488 to the PCI-first group. A primary end-point event occurred in 105 patients (22.2%) in the TAVI-first group and in 112 patients (24.2%) in the PCI-first group (risk difference, -2.0 percentage points; 95% confidence interval, -7.4 to 3.4; P<0.001 for noninferiority). Serious adverse events occurred in 264 patients in the TAVI-first group and in 273 patients in the PCI-first group.

CONCLUSIONS

Among patients with severe aortic stenosis and coronary artery disease, a strategy of TAVI before PCI was noninferior to a strategy of PCI before TAVI with respect to the primary end point at 1 year. (Funded by University Hospital Zurich and others; TAVI PCI ClinicalTrials.gov number, NCT04310046.).

MeSH

Constriction, Pathologic, Aortic Valve Stenosis, Coronary Artery Disease, Arteries, Aortic Valve, Transcatheter Aortic Valve Replacement, Random Allocation