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, TAVI PCI Investigators
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.).
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.).