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Completed

NCT Number: NCT04437303

Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)

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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Key information

Conditions

Aortic Valve Disease Aortic Valve Stenosis Bleeding Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Heart Diseases Heart Valve Diseases Hemorrhage Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Thrombosis Embolism Vascular Complications Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

A.S.Z. Hospital, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Planned transfemoral or transsubclavian transcatheter aortic valve implantation procedure
  • Uses oral anticoagulation at screening
  • Provided written informed consent

Exclusion criteria

Patients at high risk for thromboembolism for whom interruption of oral anticoagulants is no option, i.e.:

  • Mechanical heart valve prosthesis
  • Intracardiac thrombus
  • < 3 months after venous thromboembolism
  • < 6 months after transient ischemic attack or stroke in patients with atrial fibrillation

Treatment and study plan

Continuation of oral anticoagulants

Drug

Oral anticoagulant treatment will not be interrupted before the procedure.

Interruption of oral anticoagulants

Drug

Peri-operative interruption of oral anticoagulants will be according to the Dutch guideline on antithrombotic therapy.

  • For direct oral anticoagulant users this will be in general 48 hours before the procedure, except for Dabigatran users with renal insufficiency: with estimated glomerular filtration rate 50-80 mL/min/1.73m^2 72 hours and with estimated glomerular filtration rate 30-50 mL/min/1.73m^2 96 hours before procedure.
  • For vitamin K antagonist users this will be 5 days for phenprocoumon and 3 days for acenocoumarol.
  • After the procedure oral anticoagulants will be resumed after 24 hours, if deemed safe by the treating physician.

Primary outcomes

  1. Net adverse clinical events

    Time frame: 30 days

    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

Secondary outcomes

  1. Procedure related primary endpoints

    Time frame: 30 days

    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

  2. Procedure related bleeding complications

    Time frame: 30 days

    Type 1-4 bleeding as defined by the VARC-3 criteria considered procedure related as adjudicated by the clinical event committee

  3. Procedure related thromboembolic complications

    Time frame: 30 days

    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

  4. Thromboembolic complications

    Time frame: 30 days

    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

  5. Neurologic events

    Time frame: 30 days

    Overt CNS injury, covert CNS injury, neurologic dysfunction (acutely symptomatic) without CNS injury as defined by the VARC-3 criteria

  6. Cerebrovascular events

    Time frame: 30 days

    All stroke and TIA as defined by the VARC-3 criteria.

  7. Stroke

    Time frame: 30 days

    All stroke as defined by the VARC-3 criteria

  8. Bleeding complications

    Time frame: 30 days

    Type 1-4 bleeding as defined by the VARC-3 criteria

  9. Early safety

    Time frame: 30 days

    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

  10. Clinical efficacy

    Time frame: 30 days

    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

  11. All-cause death

    Time frame: 30 days

  12. Cardiovascular death

    Time frame: 30 days

  13. Quality of Life

    Time frame: 30 days and 90 days

    Assessed by Short Form(SF)-12, Kansas City Cardiomyopathy Questionnaire (KCCQ), and Toronto aortic stenosis quality of life questionnaire (TASQ)

Other outcomes

  1. New York Heart Association class for heart failure

    Time frame: 30 days

  2. Rehospitalisation

    Time frame: 30 days

  3. Permanent pacemaker implantation

    Time frame: 30 days

  4. Bleeding

    Time frame: 30 days

    As classified by Bleeding Academic Research Consortium (BARC) criteria

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2020
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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