Abstract | OBJECTIVES: BACKGROUND: PCI in patients undergoing TAVR is not without risk, and there are no randomized data to inform clinical practice. METHODS: Patients with severe symptomatic aortic stenosis and significant coronary artery disease with Canadian Cardiovascular Society class ≤2 angina were randomly assigned to receive PCI or no PCI prior to TAVR. The primary endpoint was a composite of all-cause death or rehospitalization at 1 year. Noninferiority testing (prespecified margin of 7.5%) was performed in the intention-to-treat population. RESULTS:
At 17 centers, 235 patients underwent randomization. At 1 year, the primary composite endpoint occurred in 48 (41.5%) of the PCI arm and 47 (44.0%) of the no-PCI arm. The requirement for noninferiority was not met (difference: -2.5%; 1-sided upper 95% confidence limit: 8.5%; 1-sided noninferiority test P = 0.067). On analysis of the as-treated population, the difference was -3.7% (1-sided upper 95% confidence limit: 7.5%; P = 0.050). Mortality was 16 (13.4%) in the PCI arm and 14 (12.1%) in the no-PCI arm. At 1 year, there was no evidence of a difference in the rates of stroke, myocardial infarction, or acute kidney injury, with higher rates of any bleed in the PCI arm (P = 0.021). CONCLUSIONS:
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Authors | Tiffany Patterson, Tim Clayton, Matthew Dodd, Zeeshan Khawaja, Marie Claude Morice, Karen Wilson, Won-Keun Kim, Nicolas Meneveau, Rainer Hambrecht, Jonathan Byrne, Didier Carrié, Doug Fraser, David H Roberts, Sagar N Doshi, Azfar Zaman, Adrian P Banning, Hélène Eltchaninoff, Hervé Le Breton, David Smith, Ian Cox, Derk Frank, Anthony Gershlick, Mark de Belder, Martyn Thomas, David Hildick-Smith, Bernard Prendergast, Simon Redwood, ACTIVATION Trial Investigators |
Journal | JACC. Cardiovascular interventions
(JACC Cardiovasc Interv)
Vol. 14
Issue 18
Pg. 1965-1974
(09 27 2021)
ISSN: 1876-7605 [Electronic] United States |
PMID | 34556269
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
Topics |
- Aortic Valve Stenosis
(diagnostic imaging, surgery)
- Canada
- Humans
- Percutaneous Coronary Intervention
(adverse effects)
- Transcatheter Aortic Valve Replacement
(adverse effects)
- Treatment Outcome
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