Continuation versus Interruption of Oral Anticoagulation during TAVI

Dirk Jan van Ginkel; Willem L Bor; Hugo M Aarts; Christophe Dubois; Ole De Backer; Maxim J P Rooijakkers; Liesbeth Rosseel; Leo Veenstra; Frank van der Kley; Kees H van Bergeijk; Nicolas M Van Mieghem; Pierfrancesco Agostoni; Michiel Voskuil; Carl E Schotborgh; Alexander J J IJsselmuiden; Jan A S Van Der Heyden; Renicus S Hermanides; Emanuele Barbato; Darren Mylotte; Enrico Fabris; Peter Frambach; Karl Dujardin; Bert Ferdinande; Joyce Peper; Benno J W M Rensing; Leo Timmers; Martin J Swaans; Jorn Brouwer; Vincent J Nijenhuis; Daniel C Overduin; Tom Adriaenssens; Yusuke Kobari; Pieter A Vriesendorp; Jose M Montero-Cabezas; Hicham El Jattari; Jonathan Halim; Ben J L Van den Branden; Remigio Leonora; Marc Vanderheyden; Michael Lauterbach; Joanna J Wykrzykowska; Arnoud W J van 't Hof; Niels van Royen; Jan G P Tijssen; Ronak Delewi; Jurriën M Ten Berg; POPular PAUSE TAVI Investigators.

doi:10.1056/NEJMoa2407794

Continuation versus Interruption of Oral Anticoagulation during TAVI

Dirk Jan van Ginkel, Willem L Bor, Hugo M Aarts, Christophe Dubois, Ole De Backer, Maxim J P Rooijakkers, Liesbeth Rosseel, Leo Veenstra, Frank van der Kley, Kees H van Bergeijk, Nicolas M Van Mieghem, Pierfrancesco Agostoni, Michiel Voskuil, Carl E Schotborgh, Alexander J J IJsselmuiden, Jan A S Van Der Heyden, Renicus S Hermanides, Emanuele Barbato, Darren Mylotte, Enrico FabrisPeter Frambach, Karl Dujardin, Bert Ferdinande, Joyce Peper, Benno J W M Rensing, Leo Timmers, Martin J Swaans, Jorn Brouwer, Vincent J Nijenhuis, Daniel C Overduin, Tom Adriaenssens, Yusuke Kobari, Pieter A Vriesendorp, Jose M Montero-Cabezas, Hicham El Jattari, Jonathan Halim, Ben J L Van den Branden, Remigio Leonora, Marc Vanderheyden, Michael Lauterbach, Joanna J Wykrzykowska, Arnoud W J van 't Hof, Niels van Royen, Jan G P Tijssen, Ronak Delewi, Jurriën M Ten Berg, POPular PAUSE TAVI Investigators.

Afdeling for Hjertesygdomme

Abstract

BACKGROUND: One third of patients undergoing transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation owing to concomitant diseases. Interruption of oral anticoagulation during TAVI may decrease the risk of bleeding, whereas continuation may decrease the risk of thromboembolism.

METHODS: We conducted an international, open-label, randomized, noninferiority trial involving patients who were receiving oral anticoagulants and were planning to undergo TAVI. Patients were randomly assigned in a 1:1 ratio to periprocedural continuation or interruption of oral anticoagulation. The primary outcome was a composite of death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI.

RESULTS: A total of 858 patients were included in the modified intention-to-treat population: 431 were assigned to continuation and 427 to interruption of oral anticoagulation. A primary-outcome event occurred in 71 patients (16.5%) in the continuation group and in 63 (14.8%) in the interruption group (risk difference, 1.7 percentage points; 95% confidence interval [CI], -3.1 to 6.6; P = 0.18 for noninferiority). Thromboembolic events occurred in 38 patients (8.8%) in the continuation group and in 35 (8.2%) in the interruption group (risk difference, 0.6 percentage points; 95% CI, -3.1 to 4.4). Bleeding occurred in 134 patients (31.1%) in the continuation group and in 91 (21.3%) in the interruption group (risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6).

CONCLUSIONS: In patients undergoing TAVI with a concomitant indication for oral anticoagulation, periprocedural continuation was not noninferior to interruption of oral anticoagulation during TAVI with respect to the incidence of a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days. (Funded by the Netherlands Organization for Health Research and Development and the St. Antonius Research Fund; POPular PAUSE TAVI ClinicalTrials.gov number, NCT04437303.).

Originalsprog	Engelsk
Tidsskrift	The New England journal of medicine
ISSN	0028-4793
DOI	https://doi.org/10.1056/NEJMoa2407794
Status	E-pub ahead of print - 31 aug. 2024

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10.1056/NEJMoa2407794

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van Ginkel, D. J., Bor, W. L., Aarts, H. M., Dubois, C., De Backer, O., Rooijakkers, M. J. P., Rosseel, L., Veenstra, L., van der Kley, F., van Bergeijk, K. H., Van Mieghem, N. M., Agostoni, P., Voskuil, M., Schotborgh, C. E., IJsselmuiden, A. J. J., Van Der Heyden, J. A. S., Hermanides, R. S., Barbato, E., Mylotte, D., ... POPular PAUSE TAVI Investigators. (2024). Continuation versus Interruption of Oral Anticoagulation during TAVI. The New England journal of medicine. Advance online publication. https://doi.org/10.1056/NEJMoa2407794

van Ginkel, DJ, Bor, WL, Aarts, HM, Dubois, C, De Backer, O, Rooijakkers, MJP, Rosseel, L, Veenstra, L, van der Kley, F, van Bergeijk, KH, Van Mieghem, NM, Agostoni, P, Voskuil, M, Schotborgh, CE, IJsselmuiden, AJJ, Van Der Heyden, JAS, Hermanides, RS, Barbato, E, Mylotte, D, Fabris, E, Frambach, P, Dujardin, K, Ferdinande, B, Peper, J, Rensing, BJWM, Timmers, L, Swaans, MJ, Brouwer, J, Nijenhuis, VJ, Overduin, DC, Adriaenssens, T, Kobari, Y, Vriesendorp, PA, Montero-Cabezas, JM, El Jattari, H, Halim, J, Van den Branden, BJL, Leonora, R, Vanderheyden, M, Lauterbach, M, Wykrzykowska, JJ, van 't Hof, AWJ, van Royen, N, Tijssen, JGP, Delewi, R, Ten Berg, JM & POPular PAUSE TAVI Investigators. 2024, 'Continuation versus Interruption of Oral Anticoagulation during TAVI', The New England journal of medicine. https://doi.org/10.1056/NEJMoa2407794

@article{2b13da15865f4228b476bc2dc02f65b7,

title = "Continuation versus Interruption of Oral Anticoagulation during TAVI",

abstract = "BACKGROUND: One third of patients undergoing transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation owing to concomitant diseases. Interruption of oral anticoagulation during TAVI may decrease the risk of bleeding, whereas continuation may decrease the risk of thromboembolism.METHODS: We conducted an international, open-label, randomized, noninferiority trial involving patients who were receiving oral anticoagulants and were planning to undergo TAVI. Patients were randomly assigned in a 1:1 ratio to periprocedural continuation or interruption of oral anticoagulation. The primary outcome was a composite of death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI.RESULTS: A total of 858 patients were included in the modified intention-to-treat population: 431 were assigned to continuation and 427 to interruption of oral anticoagulation. A primary-outcome event occurred in 71 patients (16.5%) in the continuation group and in 63 (14.8%) in the interruption group (risk difference, 1.7 percentage points; 95% confidence interval [CI], -3.1 to 6.6; P = 0.18 for noninferiority). Thromboembolic events occurred in 38 patients (8.8%) in the continuation group and in 35 (8.2%) in the interruption group (risk difference, 0.6 percentage points; 95% CI, -3.1 to 4.4). Bleeding occurred in 134 patients (31.1%) in the continuation group and in 91 (21.3%) in the interruption group (risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6).CONCLUSIONS: In patients undergoing TAVI with a concomitant indication for oral anticoagulation, periprocedural continuation was not noninferior to interruption of oral anticoagulation during TAVI with respect to the incidence of a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days. (Funded by the Netherlands Organization for Health Research and Development and the St. Antonius Research Fund; POPular PAUSE TAVI ClinicalTrials.gov number, NCT04437303.).",

author = "{van Ginkel}, {Dirk Jan} and Bor, {Willem L} and Aarts, {Hugo M} and Christophe Dubois and {De Backer}, Ole and Rooijakkers, {Maxim J P} and Liesbeth Rosseel and Leo Veenstra and {van der Kley}, Frank and {van Bergeijk}, {Kees H} and {Van Mieghem}, {Nicolas M} and Pierfrancesco Agostoni and Michiel Voskuil and Schotborgh, {Carl E} and IJsselmuiden, {Alexander J J} and {Van Der Heyden}, {Jan A S} and Hermanides, {Renicus S} and Emanuele Barbato and Darren Mylotte and Enrico Fabris and Peter Frambach and Karl Dujardin and Bert Ferdinande and Joyce Peper and Rensing, {Benno J W M} and Leo Timmers and Swaans, {Martin J} and Jorn Brouwer and Nijenhuis, {Vincent J} and Overduin, {Daniel C} and Tom Adriaenssens and Yusuke Kobari and Vriesendorp, {Pieter A} and Montero-Cabezas, {Jose M} and {El Jattari}, Hicham and Jonathan Halim and {Van den Branden}, {Ben J L} and Remigio Leonora and Marc Vanderheyden and Michael Lauterbach and Wykrzykowska, {Joanna J} and {van 't Hof}, {Arnoud W J} and {van Royen}, Niels and Tijssen, {Jan G P} and Ronak Delewi and {Ten Berg}, {Jurri{\"e}n M} and {POPular PAUSE TAVI Investigators.}",

note = "Copyright {\textcopyright} 2024 Massachusetts Medical Society.",

year = "2024",

month = aug,

day = "31",

doi = "10.1056/NEJMoa2407794",

language = "English",

journal = "The New England journal of medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

}

TY - JOUR

T1 - Continuation versus Interruption of Oral Anticoagulation during TAVI

AU - van Ginkel, Dirk Jan

AU - Bor, Willem L

AU - Aarts, Hugo M

AU - Dubois, Christophe

AU - De Backer, Ole

AU - Rooijakkers, Maxim J P

AU - Rosseel, Liesbeth

AU - Veenstra, Leo

AU - van der Kley, Frank

AU - van Bergeijk, Kees H

AU - Van Mieghem, Nicolas M

AU - Agostoni, Pierfrancesco

AU - Voskuil, Michiel

AU - Schotborgh, Carl E

AU - IJsselmuiden, Alexander J J

AU - Van Der Heyden, Jan A S

AU - Hermanides, Renicus S

AU - Barbato, Emanuele

AU - Mylotte, Darren

AU - Fabris, Enrico

AU - Frambach, Peter

AU - Dujardin, Karl

AU - Ferdinande, Bert

AU - Peper, Joyce

AU - Rensing, Benno J W M

AU - Timmers, Leo

AU - Swaans, Martin J

AU - Brouwer, Jorn

AU - Nijenhuis, Vincent J

AU - Overduin, Daniel C

AU - Adriaenssens, Tom

AU - Kobari, Yusuke

AU - Vriesendorp, Pieter A

AU - Montero-Cabezas, Jose M

AU - El Jattari, Hicham

AU - Halim, Jonathan

AU - Van den Branden, Ben J L

AU - Leonora, Remigio

AU - Vanderheyden, Marc

AU - Lauterbach, Michael

AU - Wykrzykowska, Joanna J

AU - van 't Hof, Arnoud W J

AU - van Royen, Niels

AU - Tijssen, Jan G P

AU - Delewi, Ronak

AU - Ten Berg, Jurriën M

AU - POPular PAUSE TAVI Investigators.

PY - 2024/8/31

Y1 - 2024/8/31

N2 - BACKGROUND: One third of patients undergoing transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation owing to concomitant diseases. Interruption of oral anticoagulation during TAVI may decrease the risk of bleeding, whereas continuation may decrease the risk of thromboembolism.METHODS: We conducted an international, open-label, randomized, noninferiority trial involving patients who were receiving oral anticoagulants and were planning to undergo TAVI. Patients were randomly assigned in a 1:1 ratio to periprocedural continuation or interruption of oral anticoagulation. The primary outcome was a composite of death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI.RESULTS: A total of 858 patients were included in the modified intention-to-treat population: 431 were assigned to continuation and 427 to interruption of oral anticoagulation. A primary-outcome event occurred in 71 patients (16.5%) in the continuation group and in 63 (14.8%) in the interruption group (risk difference, 1.7 percentage points; 95% confidence interval [CI], -3.1 to 6.6; P = 0.18 for noninferiority). Thromboembolic events occurred in 38 patients (8.8%) in the continuation group and in 35 (8.2%) in the interruption group (risk difference, 0.6 percentage points; 95% CI, -3.1 to 4.4). Bleeding occurred in 134 patients (31.1%) in the continuation group and in 91 (21.3%) in the interruption group (risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6).CONCLUSIONS: In patients undergoing TAVI with a concomitant indication for oral anticoagulation, periprocedural continuation was not noninferior to interruption of oral anticoagulation during TAVI with respect to the incidence of a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days. (Funded by the Netherlands Organization for Health Research and Development and the St. Antonius Research Fund; POPular PAUSE TAVI ClinicalTrials.gov number, NCT04437303.).

AB - BACKGROUND: One third of patients undergoing transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation owing to concomitant diseases. Interruption of oral anticoagulation during TAVI may decrease the risk of bleeding, whereas continuation may decrease the risk of thromboembolism.METHODS: We conducted an international, open-label, randomized, noninferiority trial involving patients who were receiving oral anticoagulants and were planning to undergo TAVI. Patients were randomly assigned in a 1:1 ratio to periprocedural continuation or interruption of oral anticoagulation. The primary outcome was a composite of death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI.RESULTS: A total of 858 patients were included in the modified intention-to-treat population: 431 were assigned to continuation and 427 to interruption of oral anticoagulation. A primary-outcome event occurred in 71 patients (16.5%) in the continuation group and in 63 (14.8%) in the interruption group (risk difference, 1.7 percentage points; 95% confidence interval [CI], -3.1 to 6.6; P = 0.18 for noninferiority). Thromboembolic events occurred in 38 patients (8.8%) in the continuation group and in 35 (8.2%) in the interruption group (risk difference, 0.6 percentage points; 95% CI, -3.1 to 4.4). Bleeding occurred in 134 patients (31.1%) in the continuation group and in 91 (21.3%) in the interruption group (risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6).CONCLUSIONS: In patients undergoing TAVI with a concomitant indication for oral anticoagulation, periprocedural continuation was not noninferior to interruption of oral anticoagulation during TAVI with respect to the incidence of a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days. (Funded by the Netherlands Organization for Health Research and Development and the St. Antonius Research Fund; POPular PAUSE TAVI ClinicalTrials.gov number, NCT04437303.).

U2 - 10.1056/NEJMoa2407794

DO - 10.1056/NEJMoa2407794

M3 - Journal article

C2 - 39216096

SN - 0028-4793

JO - The New England journal of medicine

JF - The New England journal of medicine

ER -

Continuation versus Interruption of Oral Anticoagulation during TAVI

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