New Science From NOTION-3, POPular PAUSE TAVI, RHEIA Add to Growing Evidence Surrounding TAVI

The benefit of PCI in patients with stable coronary artery disease and severe aortic stenosis who are undergoing transcatheter aortic valve implantation (TAVI) was the focus of the NOTION-3 trial presented at ESC Congress 2024 in London. Two other trials – POPular PAUSE TAVI and RHEIA – also addressed aspects of TAVI, including continuation vs. disruption of anticoagulants during the procedure, as well a comparison with surgical aortic valve implantation (SAVI) in women.

In the NOTION -3 trial, the results of which were also simultaneously published in the New England Journal of Medicine (NEJM), researchers found PCI was associated with a lower risk of a composite of death from any cause, myocardial infarction, or urgent revascularization at a median follow-up of two years compared with conservative treatment.

"NOTION-3 has answered an important clinical question, demonstrating that TAVI patients with CAD can derive considerable benefits from PCI, driven by reductions in MI and urgent revascularization," said Principal Investigator Jacob Thomsen Loenborg, MD. "We suggest that performing PCI should be the recommended treatment for patients undergoing TAVI that have CAD, but the final decision should be made based on the patient's age, comorbidities, life expectancy and their bleeding risk."

In patients undergoing TAVI with an indication for oral anticoagulation, results from the POPular PAUSE TAVI trial, also simultaneously published in NEJM, found that continuation of oral anticoagulation during the procedure was not noninferior to interruption of the medication. The trial's primary endpoint was a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days.

"We now have evidence from a randomized trial that continuing [oral anticoagulants] provides no apparent benefit in terms of thromboembolic events, said study investigator Dirk Jan van Ginkel, PhD. "Given the higher incidence of bleeding, our data support interrupting [oral anticoagulants] in patients undergoing TAVI."

In the RHEIA trial, which was dedicated to comparing TAVI vs. SAVI in women with severe aortic stenosis, researchers found TAVI to be superior to SAVI for reducing death, stroke or rehospitalization.

"In this first dedicated randomized TAVI trial in women, we were able to confirm its superiority over surgery, particularly with respect to reducing rehospitalizations, said Helene Eltchaninoff, PhD. "The added benefit of shorter index hospitalizations meant that TAVI treatment was able to reduce health care resource utilization. Although we acknowledge the short post-intervention interval and longer follow-up will be useful, our findings suggest that in women with severe symptomatic aortic stenosis, TAVI using balloon-expandable devices could be considered the preferred therapy."

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: ESC Congress, ESC24, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis


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