Near-infrared spectroscopy-intravascular ultrasound to improve assessment of coronary artery disease severity in patients referred for transcatheter aortic valve implantation (The IMPACTavi registry): Design and rationale.

BACKGROUND

Transcatheter aortic valve implantation (TAVI) was established as a standard treatment for high-operative risk patients with severe aortic stenosis (AS). Although coronary artery disease (CAD) often coexists with AS, clinical and angiographic evaluations of stenosis severity are unreliable in this specific setting. To provide precise risk stratification of coronary lesions, combined near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS) was developed to integrate morphological and molecular information on plaque composition. However, there is a lack of evidence on the association between NIRS-IVUS derived findings such as maximum 4mm lipid core burden index (maxLCBI

METHODS

The registry is designed as a non-randomized, prospective, observational, multicenter cohort registry. Patients referred for TAVI with angiographic evidence of CAD receive NIRS-IVUS imaging and are followed up to 24 months. Enrolled patients are classified as NIRS-IVUS positive and NIRS-IVUS negative, respectively, based on their maxLCBI

CONCLUSIONS

Identification of patients likely or unlikely to benefit from revascularization prior to TAVI represents an important unmet clinical need. This registry is designed to investigate whether NIRS-IVUS-derived atherosclerotic plaque characteristics can identify patients and lesions at risk for future adverse cardiovascular events after TAVI, in order to refine interventional decision-making in this challenging patient population.

Informations de copyright

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Déclaration de conflit d'intérêts

Disclosures T. Rheude received speaker fees from AstraZeneca and SIS Medical, and travel support from SIS Medical. C. Pellegrini has received the Else Kröner-Memorial grant from the Else Kröner-Fresenius-Stiftung. M. Hadamitzky reports a grant from Cleerly, New York. E. Xhepa reports lecture fees and honoraria from AstraZeneca, Boston Scientific and SIS Medical not related to the current work; proctor fees from Abbott Vascular and financial support for attending meetings and/or travel expenses from Abbott Vascular. A. Kastrati reports personal payments from CRF, New York, for participation on the DSMB Microport TARGET IV trial. H. Schunkert reports grants and personal fees from AstraZeneca; and personal fees from Vifor Pharma, Boehringer Ingelheim, Brahms, Medtronic, Sanofi-Aventis, MSD, Bristol-Meyers Squibb, Servier, Bayer Vital GmbH, Daiichi Sankyo, AMGEN, Novartis, Synlab, and Pfizer, outside the submitted work. M. Joner reports personal fees from Abbott, personal fees from Astra Zeneca, personal fees from Biotronik, grants and personal fees from Boston Scientific, personal fees and grants from Cardiac Dimensions, grants, and personal fees from Edwards, grant from Infraredx, a Nipro company, personal fees from Orbus Neich, personal fees from Recor, personal fees from Shockwave, outside the submitted work. The other authors have no relevant conflicts of interest to declare.