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Randomized Controlled Trial
. 2025 Sep 15;21(18):e1081-e1089.
doi: 10.4244/EIJ-D-24-01066.

VARC-HBR criteria validation in TAVI patients on oral anticoagulation

Daniël C Overduin  1 , Dirk Jan van Ginkel  1 , Willem L Bor  1 , Yusuke Kobari  2 , Hugo M Aarts  3   4 , Christophe Dubois  5 , Ole De Backer  2 , Maxim J P Rooijakkers  6 , Liesbeth Rosseel  7 , Leo Veenstra  8   9 , Frank van der Kley  10 , Kees H van Bergeijk  11 , Nicolas M van Mieghem  12 , Pierfrancesco Agostoni  13 , Michiel Voskuil  4 , Carl E Schotborgh  14 , Alexander J J Ijsselmuiden  8   9 , Jan A S Van Heyden  15 , Renicus S Hermanides  16 , Emanuele Barbato  17   18 , Darren Mylotte  19 , Enrico Fabris  20 , Peter Frambach  21 , Karl Dujardin  22 , Bert Ferdinande  23 , Joyce Peper  1 , Benno J W M Rensing  1 , Leo Timmers  1 , Martin J Swaans  1 , Jorn Brouwer  1 , Vincent J Nijenhuis  1   6 , Tom Adriaenssens  5 , Pieter A Vriesendorp  8   9 , Jose M Montero-Cabezas  10 , Hicham El Jattari  13 , Jonathan Halim  24 , Ben J L Van den Branden  25 , Remigio Leonora  16 , Marc Vanderheyden  7 , Michael Lauterbach  22 , Joanna J Wykrzykowska  11 , Arnoud W J van 't Hof  8   9 , Niels van Royen  6 , Jan G P Tijssen  3 , Ronak Delewi  3 , Jurriën M Ten Berg  1   8   9
Affiliations
Randomized Controlled Trial

VARC-HBR criteria validation in TAVI patients on oral anticoagulation

Daniël C Overduin et al. EuroIntervention. .

Abstract

Background: Bleeding remains a frequent complication after transcatheter aortic valve implantation (TAVI). Recently, the Valve Academic Research Consortium High Bleeding Risk (VARC-HBR) criteria were introduced to identify patients at (very) high risk of bleeding.

Aims: This study aimed to evaluate the validity of the VARC-HBR criteria for predicting bleeding risk in TAVI patients and to compare its performance with other existing criteria.

Methods: Data were obtained from the POPular PAUSE TAVI trial, a randomised clinical trial that evaluated the safety and efficacy of continuation versus interruption of oral anticoagulation during TAVI. Major and minor bleeding risk criteria were identified at baseline, and bleeding events were recorded up to 30 days after TAVI. Patients were classified into three groups: those with ≤1 minor criterion (moderate risk), those with 1 major or 2 minor criteria (high risk), and those with ≥2 major or ≥3 minor criteria (very high risk).

Results: A total of 856 patients were included: 332 (39%) were classified at moderate bleeding risk, 337 (39%) at high bleeding risk, and 187 (22%) at very high bleeding risk. Major bleeding occurred in 4.2% of moderate-risk patients, 9.5% in the high-risk group, and 15.0% in the very high-risk group (p<0.001). Receiver operating characteristic analysis showed moderate discriminative performance (area under the curve=0.64, 95% confidence interval: 0.58-0.70). Despite higher-than-expected event rates, the VARC-HBR criteria demonstrated good calibration with observed outcomes.

Conclusions: The VARC-HBR criteria effectively identified distinct subgroups with a stepwise increase in major bleeding post-TAVI. However, their predictive performance for individual risk was moderate.

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Conflict of interest statement

Y. Kobari has received consulting fees from Boston Scientific. O. De Backer has received institutional research grants and consulting fees from Abbott, Boston Scientific, and Medtronic. F. van der Kley has received consulting/lecturer fees from Edwards Lifesciences, Boston Scientific, and Abbott. N.M. Van Mieghem has received grants or contracts from Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Daiichi Sankyo, AstraZeneca, and Teleflex; and consulting/lecturer fees from Abbott, Boston Scientific, Medtronic, Daiichi Sankyo, PulseCath BV, Siemens, Teleflex, JenaValve, Anteris, and Amgen. M. Voskuil has received lecturer fees from Edwards Lifesciences, Medtronic, and Abbott. A.J.J. IJsselmuiden has received consulting/lecturer fees from Angiocare, Meril Life Sciences, and Medtronic. R.S. Hermanides has received lecturer fees from Abbott, Amgen, Edwards Lifesciences, and Novartis. E. Barbato has received lecturer fees from Abbott, Insight Lifetech, and Boston Scientific. D. Mylotte has received consulting fees from Boston Scientific, Medtronic, and MicroPort. M.J. Swaans has received consulting/lecturer fees from Abbott, Bioventrix Inc., Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, GE HealthCare, Medtronic, Philips Healthcare, and Siemens Healthineers. T. Adriaenssens has received consulting fees from Abbott. J.M. Montero-Cabezas has received lecturer fees from Penumbra, Inc.; and a research grant from Shockwave Medical. J.J. Wykrzykowska has received institutional research grants from Medtronic; lecturer fees from Boston Scientific, Meril Life Sciences, Abbott, SMT, Cordis, and Medis Medical Imaging; and participates on the advisory board of Medtronic and Novo Nordisk. A.W.J. van ’t Hof has received institutional research grants from Medtronic, AstraZeneca, and Boehringer Ingelheim; consulting fees from CeleCor Therapeutics; and participates in the Data Safety Monitoring Board for Diagram Research. N. van Royen has received institutional research grants from Abbott, Biotronik, Medtronic, and Philips; and lecturer fees from Abbott, Bayer, MicroPort, and Rainmed. R. Delewi has received institutional research grants and consulting fees from Abiomed, Amgen, Boston Scientific, Edwards Lifesciences, and Novartis. J.M. ten Berg has received institutional research grants from ZonMw, AstraZeneca, and Daiichi Sankyo; and consulting/lecturer fees from AstraZeneca, Daiichi Sankyo, CeleCor Therapeutics, and Boehringer Ingelheim. The other authors have no conflicts of interest relevant to the contents of this paper to declare.

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