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Transcatheter aortic valve implantation (TAVI) is a rapidly growing treatment option for patients with aortic valve stenosis. Stroke is a feared complication of TAVI, with an incidence of around 4-5% in the first 30 days. Up to 50% of patients undergoing TAVI have an indication for oral anticoagulants (OAC) mostly for atrial fibrillation. OAC use during TAVI could increase bleeding complications, but interruption during TAVI may increase the risk for thromboembolic events (i.e. stroke, systemic embolism, myocardial infarction). Recent observational data suggest that periprocedural continuation of OAC is safe and might decrease the risk of stroke. Beside the potential reduction of thromboembolic events, continuation of OAC is associated with an evident clinical ancillary benefit for patients and staff. Since periprocedural OAC interruption not infrequently leads to misunderstanding and potentially dangerous situations, when patients are not properly informed before hospital admission or may experience difficulties with the interruption regimen.
Hypothesis:
Periprocedural continuation of oral anticoagulants is safe and might decrease thromboembolic complications without an increase in bleeding complications at 30 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuation of oral anticoagulants | Active Comparator |
| |
| Interruption of oral anticoagulants | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuation of oral anticoagulants | Drug | Oral anticoagulant treatment will not be interrupted before the procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Net adverse clinical events | A composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding complications at 30 days post TAVI as defined by the VARC-3 criteria | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure related primary endpoints | Cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding complications as defined by the VARC-3 criteria considered procedure related as adjudicated by the clinical event committee | 30 days |
| Procedure related bleeding complications |
| Measure | Description | Time Frame |
|---|---|---|
| New York Heart Association class for heart failure | 30 days | |
| Rehospitalisation | 30 days | |
| Permanent pacemaker implantation |
Inclusion Criteria:
Exclusion Criteria:
Patients at high risk for thromboembolism for whom interruption of oral anticoagulants is no option, i.e.:
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| Name | Affiliation | Role |
|---|---|---|
| Jurriën M ten Berg, MD PhD | St. Antonius Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.S.Z. Hospital | Aalst | Belgium | ||||
| O.L.V. Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41128170 | Derived | van Bergeijk KH, Overduin DC, Venema CS, van Ginkel DJ, van der Werf HW, van den Heuvel AFM, Voors AA, Wykrzykowska JJ, Ten Berg JM. Sex Differences in Transcatheter Aortic Valve Implantation Outcomes in Patients on Oral Anticoagulants: A Popular PAUSE TAVI SubAnalysis. J Am Heart Assoc. 2025 Nov 4;14(21):e043448. doi: 10.1161/JAHA.125.043448. Epub 2025 Oct 23. | |
| 39216096 |
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| Interruption of oral anticoagulants | Drug | Peri-operative interruption of oral anticoagulants will be according to the Dutch guideline on antithrombotic therapy.
|
|
Type 1-4 bleeding as defined by the VARC-3 criteria considered procedure related as adjudicated by the clinical event committee |
| 30 days |
| Procedure related thromboembolic complications | All stroke (except haemorrhagic), TIA, myocardial infarction, systemic embolism (vascular complications: distal embolization (non-cerebral) from a vascular source) as defined by the VARC-3 criteria considered procedure related as adjudicated by the clinical event committee | 30 days |
| Thromboembolic complications | All stroke (except haemorrhagic), TIA, myocardial infarction and systemic embolism (vascular complications: distal embolization (non-cerebral) from a vascular source) as defined by the VARC-3 criteria | 30 days |
| Neurologic events | Overt CNS injury, covert CNS injury, neurologic dysfunction (acutely symptomatic) without CNS injury as defined by the VARC-3 criteria | 30 days |
| Cerebrovascular events | All stroke and TIA as defined by the VARC-3 criteria. | 30 days |
| Stroke | All stroke as defined by the VARC-3 criteria | 30 days |
| Bleeding complications | Type 1-4 bleeding as defined by the VARC-3 criteria | 30 days |
| Early safety | Freedom from all-cause mortality, all stroke, VARC type 2-4 bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure related conduction abnormalities, surgery or intervention related to the device as defined by the VARC-3 criteria | 30 days |
| Clinical efficacy | Freedom from: all-cause mortality, all stroke, hospitalization for procedure- or valve-related causes, KCCQ Overall Summary Score <45 or decline from baseline of >10 point as defined by the VARC-3 criteria | 30 days |
| All-cause death | 30 days |
| Cardiovascular death | 30 days |
| Quality of Life | Assessed by Short Form(SF)-12, Kansas City Cardiomyopathy Questionnaire (KCCQ), and Toronto aortic stenosis quality of life questionnaire (TASQ) | 30 days and 90 days |
| 30 days |
| Bleeding | As classified by Bleeding Academic Research Consortium (BARC) criteria | 30 days |
| Aalst |
| Belgium |
| ZNA Middelheim | Antwerp | Belgium |
| AZ Sint-Jan | Bruges | Belgium |
| East Limburg Hospital | Genk | Belgium |
| University Hospital Leuven | Leuven | Belgium |
| AZ Delta | Roeselare | 8800 | Belgium |
| Rigshospitalet Copenhagen | Copenhagen | Denmark |
| University Hospital Galway | Galway | Ireland |
| Azienda Sanitaria Universitaria Integrata di Trieste | Trieste | Italy |
| National Institute of Cardiac Surgery and Interventional Cardiology | Luxembourg | Luxembourg |
| St. Antonius Ziekenhuis | Nieuwegein | Utrecht | 3435CM | Netherlands |
| Amsterdam UMC | Amsterdam | Netherlands |
| Amphia Hospital | Breda | Netherlands |
| UMC Groningen | Groningen | Netherlands |
| Leiden University Medical Center | Leiden | Netherlands |
| Maastricht UMC+ | Maastricht | Netherlands |
| Radboud UMC | Nijmegen | Netherlands |
| Erasmus MC | Rotterdam | Netherlands |
| Haga Hospital | The Hague | Netherlands |
| UMC Utrecht | Utrecht | Netherlands |
| Isala | Zwolle | Netherlands |
| 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.; POPular PAUSE TAVI Investigators. Continuation versus Interruption of Oral Anticoagulation during TAVI. N Engl J Med. 2025 Jan 30;392(5):438-449. doi: 10.1056/NEJMoa2407794. Epub 2024 Aug 31. |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| D020521 | Stroke |
| D006470 | Hemorrhage |
| D009203 | Myocardial Infarction |
| D016769 | Embolism and Thrombosis |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
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