Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE TAVI trial

Dirk Jan van Ginkel; Willem L. Bor; Christophe L.F. Dubois; Hugo M. Aarts; Maxim J.P. Rooijakkers; Kees H. van Bergeijk; Liesbeth Rosseel; Leo Veenstra; Ole De Backer; Nicolas M. Van Mieghem; Frank van der Kley; Adriaan Wilgenhof; Remigio Leonora; Jonathan Halim; Carl Schotborgh; Emanuele Barbato; Jan A.S. Van Der Heyden; Peter Frambach; Bert Ferdinande; Darren Mylotte; Enrico Fabris; Benno J.W.M. Rensing; Leo Timmers; Martin J. Swaans; Jorn Brouwer; Vincent J. Nijenhuis; Joyce Peper; Pieter A. Vriesendorp; Bas de Laat; Marisa Ninivaggi; Hendrik Stragier; Michiel Voskuil; Alexander J.J. IJsselmuiden; Renicus S. Hermanides; Pierfrancesco Agostoni; Arnoud W.J. van ‘t Hof; Joanna J. Wykrzykowska; Niels van Royen; Ronak Delewi; Jurrien M. ten Berg

doi:10.4244/EIJ-D-23-00206

Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE TAVI trial

Dirk Jan van Ginkel, Willem L. Bor, Christophe L.F. Dubois, Hugo M. Aarts, Maxim J.P. Rooijakkers, Kees H. van Bergeijk, Liesbeth Rosseel, Leo Veenstra, Ole De Backer, Nicolas M. Van Mieghem, Frank van der Kley, Adriaan Wilgenhof, Remigio Leonora, Jonathan Halim, Carl Schotborgh, Emanuele Barbato, Jan A.S. Van Der Heyden, Peter Frambach, Bert Ferdinande, Darren MylotteEnrico Fabris, Benno J.W.M. Rensing, Leo Timmers, Martin J. Swaans, Jorn Brouwer, Vincent J. Nijenhuis, Joyce Peper, Pieter A. Vriesendorp, Bas de Laat, Marisa Ninivaggi, Hendrik Stragier, Michiel Voskuil, Alexander J.J. IJsselmuiden, Renicus S. Hermanides, Pierfrancesco Agostoni, Arnoud W.J. van ‘t Hof, Joanna J. Wykrzykowska, Niels van Royen, Ronak Delewi, Jurrien M. ten Berg

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

3 Citationer (Scopus)

Abstract

About one-third of patients undergoing transcatheter aortic valve implantation (TAVI) use oral anticoagulants (OAC), mainly due to atrial fibrillation. General guidelines advise interrupting OAC in patients with a high risk of bleeding undergoing interventions. However, preliminary observational data suggest that the continuation of OAC during TAVI is safe and may reduce the risk of periprocedural thromboembolic events. The Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) is a multicentre, randomised clinical trial with open-label treatment and blinded endpoint assessment. Patients are randomised 1:1 to periprocedural continuation versus interruption of OAC and are stratified for vitamin K antagonist or direct oral anticoagulant use. The primary endpoint is a composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding within 30 days after TAVI, according to the Valve Academic Research Consortium-3 criteria. Secondary endpoints include separate individual and composite outcomes, quality of life and cost-effectiveness.

Originalsprog	Engelsk
Tidsskrift	EuroIntervention
Vol/bind	19
Udgave nummer	9
Sider (fra-til)	766-771
Antal sider	6
ISSN	1774-024X
DOI	https://doi.org/10.4244/EIJ-D-23-00206
Status	Udgivet - 2023
Udgivet eksternt	Ja

Bibliografisk note

Funding Information:
This investigator-initiated trial is funded by the St. Antonius Research Fund and by the Netherlands Organization for Health Research and Development. There is no industry involvement in the trial. The study is conducted according to the principles of the Declaration of Helsinki, amended by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013, and in accordance with the Medical Research Involving Human Subjects Act (WMO) and other guidelines, regulations, and acts. Ethics committees in each country and institutional review boards at each participating site authorised the clinical trial protocol. Monitoring is performed according to Good Clinical Practice (GCP) guidelines under the direction of the Research and Development Academy of St. Antonius Hospital. An independent Data Safety Monitoring Board (DSMB) was established to perform safety surveillance on the accruing study data to safeguard the interests of the trial participants. The board discusses the study protocol and (interim) outcomes and provides recommendations to the investigators on the further conduction of the trial. If the interim results are likely to convince a broad range of clinicians that one trial arm is clearly indicated or contraindicated, the DSMB will provide advice on whether recruitment should be terminated. A blinded clinical endpoint committee adjudicates all potential primary endpoints prior to presentation of the data to the DSMB. In addition, a yearly safety report is submitted to the accredited medical research ethics committees of the concerned member states.

Publisher Copyright:
© Europa Digital & Publishing 2023. All rights reserved.

Adgang til dokumentet

10.4244/EIJ-D-23-00206

Citationsformater

van Ginkel, D. J., Bor, W. L., Dubois, C. L. F., Aarts, H. M., Rooijakkers, M. J. P., van Bergeijk, K. H., Rosseel, L., Veenstra, L., De Backer, O., Van Mieghem, N. M., van der Kley, F., Wilgenhof, A., Leonora, R., Halim, J., Schotborgh, C., Barbato, E., Van Der Heyden, J. A. S., Frambach, P., Ferdinande, B., ... ten Berg, J. M. (2023). Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE TAVI trial. EuroIntervention, 19(9), 766-771. https://doi.org/10.4244/EIJ-D-23-00206

Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation : rationale and design of the POPular PAUSE TAVI trial. / van Ginkel, Dirk Jan; Bor, Willem L.; Dubois, Christophe L.F.; Aarts, Hugo M.; Rooijakkers, Maxim J.P.; van Bergeijk, Kees H.; Rosseel, Liesbeth; Veenstra, Leo; De Backer, Ole; Van Mieghem, Nicolas M.; van der Kley, Frank; Wilgenhof, Adriaan; Leonora, Remigio; Halim, Jonathan; Schotborgh, Carl; Barbato, Emanuele; Van Der Heyden, Jan A.S.; Frambach, Peter; Ferdinande, Bert; Mylotte, Darren; Fabris, Enrico; Rensing, Benno J.W.M.; Timmers, Leo; Swaans, Martin J.; Brouwer, Jorn; Nijenhuis, Vincent J.; Peper, Joyce; Vriesendorp, Pieter A.; de Laat, Bas; Ninivaggi, Marisa; Stragier, Hendrik; Voskuil, Michiel; IJsselmuiden, Alexander J.J.; Hermanides, Renicus S.; Agostoni, Pierfrancesco; van ‘t Hof, Arnoud W.J.; Wykrzykowska, Joanna J.; van Royen, Niels; Delewi, Ronak; ten Berg, Jurrien M.

I: EuroIntervention, Bind 19, Nr. 9, 2023, s. 766-771.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

van Ginkel, DJ, Bor, WL, Dubois, CLF, Aarts, HM, Rooijakkers, MJP, van Bergeijk, KH, Rosseel, L, Veenstra, L, De Backer, O, Van Mieghem, NM, van der Kley, F, Wilgenhof, A, Leonora, R, Halim, J, Schotborgh, C, Barbato, E, Van Der Heyden, JAS, Frambach, P, Ferdinande, B, Mylotte, D, Fabris, E, Rensing, BJWM, Timmers, L, Swaans, MJ, Brouwer, J, Nijenhuis, VJ, Peper, J, Vriesendorp, PA, de Laat, B, Ninivaggi, M, Stragier, H, Voskuil, M, IJsselmuiden, AJJ, Hermanides, RS, Agostoni, P, van ‘t Hof, AWJ, Wykrzykowska, JJ, van Royen, N, Delewi, R & ten Berg, JM 2023, 'Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE TAVI trial', EuroIntervention, bind 19, nr. 9, s. 766-771. https://doi.org/10.4244/EIJ-D-23-00206

van Ginkel, Dirk Jan ; Bor, Willem L. ; Dubois, Christophe L.F. ; Aarts, Hugo M. ; Rooijakkers, Maxim J.P. ; van Bergeijk, Kees H. ; Rosseel, Liesbeth ; Veenstra, Leo ; De Backer, Ole ; Van Mieghem, Nicolas M. ; van der Kley, Frank ; Wilgenhof, Adriaan ; Leonora, Remigio ; Halim, Jonathan ; Schotborgh, Carl ; Barbato, Emanuele ; Van Der Heyden, Jan A.S. ; Frambach, Peter ; Ferdinande, Bert ; Mylotte, Darren ; Fabris, Enrico ; Rensing, Benno J.W.M. ; Timmers, Leo ; Swaans, Martin J. ; Brouwer, Jorn ; Nijenhuis, Vincent J. ; Peper, Joyce ; Vriesendorp, Pieter A. ; de Laat, Bas ; Ninivaggi, Marisa ; Stragier, Hendrik ; Voskuil, Michiel ; IJsselmuiden, Alexander J.J. ; Hermanides, Renicus S. ; Agostoni, Pierfrancesco ; van ‘t Hof, Arnoud W.J. ; Wykrzykowska, Joanna J. ; van Royen, Niels ; Delewi, Ronak ; ten Berg, Jurrien M. / Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation : rationale and design of the POPular PAUSE TAVI trial. I: EuroIntervention. 2023 ; Bind 19, Nr. 9. s. 766-771.

@article{67c675ba651849238f15b1e73cb449bc,

title = "Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE TAVI trial",

abstract = "About one-third of patients undergoing transcatheter aortic valve implantation (TAVI) use oral anticoagulants (OAC), mainly due to atrial fibrillation. General guidelines advise interrupting OAC in patients with a high risk of bleeding undergoing interventions. However, preliminary observational data suggest that the continuation of OAC during TAVI is safe and may reduce the risk of periprocedural thromboembolic events. The Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) is a multicentre, randomised clinical trial with open-label treatment and blinded endpoint assessment. Patients are randomised 1:1 to periprocedural continuation versus interruption of OAC and are stratified for vitamin K antagonist or direct oral anticoagulant use. The primary endpoint is a composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding within 30 days after TAVI, according to the Valve Academic Research Consortium-3 criteria. Secondary endpoints include separate individual and composite outcomes, quality of life and cost-effectiveness. Since continuation of OAC is associated with the ancillary benefit that it simplifies periprocedural management, the primary outcome is first analysed for non-inferiority; if non-inferiority is proven, superiority will be tested. Recruitment started in November 2020, and the trial will continue until a total of 858 patients have been included and followed for 90 days. In summary, POPular PAUSE TAVI is the first randomised clinical trial to assess the safety and efficacy of periprocedural continuation versus interruption of OAC in patients undergoing TAVI.",

keywords = "bleeding, stroke, TAVI",

author = "{van Ginkel}, {Dirk Jan} and Bor, {Willem L.} and Dubois, {Christophe L.F.} and Aarts, {Hugo M.} and Rooijakkers, {Maxim J.P.} and {van Bergeijk}, {Kees H.} and Liesbeth Rosseel and Leo Veenstra and {De Backer}, Ole and {Van Mieghem}, {Nicolas M.} and {van der Kley}, Frank and Adriaan Wilgenhof and Remigio Leonora and Jonathan Halim and Carl Schotborgh and Emanuele Barbato and {Van Der Heyden}, {Jan A.S.} and Peter Frambach and Bert Ferdinande and Darren Mylotte and Enrico Fabris and Rensing, {Benno J.W.M.} and Leo Timmers and Swaans, {Martin J.} and Jorn Brouwer and Nijenhuis, {Vincent J.} and Joyce Peper and Vriesendorp, {Pieter A.} and {de Laat}, Bas and Marisa Ninivaggi and Hendrik Stragier and Michiel Voskuil and IJsselmuiden, {Alexander J.J.} and Hermanides, {Renicus S.} and Pierfrancesco Agostoni and {van {\textquoteleft}t Hof}, {Arnoud W.J.} and Wykrzykowska, {Joanna J.} and {van Royen}, Niels and Ronak Delewi and {ten Berg}, {Jurrien M.}",

year = "2023",

doi = "10.4244/EIJ-D-23-00206",

language = "English",

volume = "19",

pages = "766--771",

journal = "EuroIntervention",

issn = "1774-024X",

publisher = "Europa Digital & Publishing",

number = "9",

}

TY - JOUR

T1 - Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation

T2 - rationale and design of the POPular PAUSE TAVI trial

AU - van Ginkel, Dirk Jan

AU - Bor, Willem L.

AU - Dubois, Christophe L.F.

AU - Aarts, Hugo M.

AU - Rooijakkers, Maxim J.P.

AU - van Bergeijk, Kees H.

AU - Rosseel, Liesbeth

AU - Veenstra, Leo

AU - De Backer, Ole

AU - Van Mieghem, Nicolas M.

AU - van der Kley, Frank

AU - Wilgenhof, Adriaan

AU - Leonora, Remigio

AU - Halim, Jonathan

AU - Schotborgh, Carl

AU - Barbato, Emanuele

AU - Van Der Heyden, Jan A.S.

AU - Frambach, Peter

AU - Ferdinande, Bert

AU - Mylotte, Darren

AU - Fabris, Enrico

AU - Rensing, Benno J.W.M.

AU - Timmers, Leo

AU - Swaans, Martin J.

AU - Brouwer, Jorn

AU - Nijenhuis, Vincent J.

AU - Peper, Joyce

AU - Vriesendorp, Pieter A.

AU - de Laat, Bas

AU - Ninivaggi, Marisa

AU - Stragier, Hendrik

AU - Voskuil, Michiel

AU - IJsselmuiden, Alexander J.J.

AU - Hermanides, Renicus S.

AU - Agostoni, Pierfrancesco

AU - van ‘t Hof, Arnoud W.J.

AU - Wykrzykowska, Joanna J.

AU - van Royen, Niels

AU - Delewi, Ronak

AU - ten Berg, Jurrien M.

PY - 2023

Y1 - 2023

N2 - About one-third of patients undergoing transcatheter aortic valve implantation (TAVI) use oral anticoagulants (OAC), mainly due to atrial fibrillation. General guidelines advise interrupting OAC in patients with a high risk of bleeding undergoing interventions. However, preliminary observational data suggest that the continuation of OAC during TAVI is safe and may reduce the risk of periprocedural thromboembolic events. The Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) is a multicentre, randomised clinical trial with open-label treatment and blinded endpoint assessment. Patients are randomised 1:1 to periprocedural continuation versus interruption of OAC and are stratified for vitamin K antagonist or direct oral anticoagulant use. The primary endpoint is a composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding within 30 days after TAVI, according to the Valve Academic Research Consortium-3 criteria. Secondary endpoints include separate individual and composite outcomes, quality of life and cost-effectiveness. Since continuation of OAC is associated with the ancillary benefit that it simplifies periprocedural management, the primary outcome is first analysed for non-inferiority; if non-inferiority is proven, superiority will be tested. Recruitment started in November 2020, and the trial will continue until a total of 858 patients have been included and followed for 90 days. In summary, POPular PAUSE TAVI is the first randomised clinical trial to assess the safety and efficacy of periprocedural continuation versus interruption of OAC in patients undergoing TAVI.

AB - About one-third of patients undergoing transcatheter aortic valve implantation (TAVI) use oral anticoagulants (OAC), mainly due to atrial fibrillation. General guidelines advise interrupting OAC in patients with a high risk of bleeding undergoing interventions. However, preliminary observational data suggest that the continuation of OAC during TAVI is safe and may reduce the risk of periprocedural thromboembolic events. The Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) is a multicentre, randomised clinical trial with open-label treatment and blinded endpoint assessment. Patients are randomised 1:1 to periprocedural continuation versus interruption of OAC and are stratified for vitamin K antagonist or direct oral anticoagulant use. The primary endpoint is a composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding within 30 days after TAVI, according to the Valve Academic Research Consortium-3 criteria. Secondary endpoints include separate individual and composite outcomes, quality of life and cost-effectiveness. Since continuation of OAC is associated with the ancillary benefit that it simplifies periprocedural management, the primary outcome is first analysed for non-inferiority; if non-inferiority is proven, superiority will be tested. Recruitment started in November 2020, and the trial will continue until a total of 858 patients have been included and followed for 90 days. In summary, POPular PAUSE TAVI is the first randomised clinical trial to assess the safety and efficacy of periprocedural continuation versus interruption of OAC in patients undergoing TAVI.

KW - bleeding

KW - stroke

KW - TAVI

U2 - 10.4244/EIJ-D-23-00206

DO - 10.4244/EIJ-D-23-00206

M3 - Journal article

C2 - 37605804

AN - SCOPUS:85176860494

VL - 19

SP - 766

EP - 771

JO - EuroIntervention

JF - EuroIntervention

SN - 1774-024X

IS - 9

ER -