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

Sponsor
St. Antonius Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04437303
Collaborator
(none)
858
1
2
45.2
19

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Continuation of oral anticoagulants
  • Drug: Interruption of oral anticoagulants
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
858 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)
Actual Study Start Date :
Nov 25, 2020
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Continuation of oral anticoagulants

Drug: Continuation of oral anticoagulants
Oral anticoagulant treatment will not be interrupted before the procedure.

Active Comparator: Interruption of oral anticoagulants

Drug: Interruption of oral anticoagulants
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.

Outcome Measures

Primary Outcome Measures

  1. Net clinical benefit [30 days]

    A composite of cardiovascular mortality, stroke, myocardial infarction, major vascular complications and major, disabling and life-threatening bleeding complications at 30 days post TAVI as defined by the VARC-2 criteria.

Secondary Outcome Measures

  1. Thromboembolic complications [30 days]

    Composite of stroke, transient ischemic attack, systemic embolism, distal embolization, myocardial infarction, and cardiovascular death not caused by bleeding

  2. Bleeding and vascular access site complications [30 days]

    Composite of bleeding and vascular access site and access-related complications (except distal embolization and systemic embolism)

  3. Early safety as defined by Valve Academic Research Consortium 2 criteria [30 days]

    Composite of all-cause mortality, all stroke, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction requiring intervention, major vascular complication, and valve-related dysfunction requiring repeat procedure (balloon valvuloplasty or valve replacement)

  4. Clinical efficacy as defined by Valve Academic Research Consortium 2 criteria [30 days]

    Composite of all-cause mortality, all stroke, hospitalizations for valve related symptoms or worsening congestive heart failure, New York Heart Association class for heart failure 3/4, and valve-related dysfunction (mean aortic valve gradient >=20 mmHg, effective orifice area (EOA) <=0.9-1.1 cm^2 and/or Doppler velocity index (DVI) <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)

  5. All-cause death [30 days]

  6. Quality of life assessed by Short Form-12 Questionnaire [3 months]

  7. Quality of life assessed by Toronto Aortic Stenosis Questionnaire [3 months]

  8. Quality of life assessed by Kansas City Cardiomyopathy Questionnaire [3 months]

  9. Stroke [30 days]

  10. Stroke and transient ischemic attack [30 days]

Other Outcome Measures

  1. Bleeding classification as defined by the International Society of Thrombosis and Haemostasis criteria [30 days]

  2. Bleeding classification as defined by Thrombolysis In Myocardial Infarction criteria [30 days]

  3. Bleeding classification as defined by Bleeding Academic Research Consortium criteria [30 days]

  4. Primary endpoints at discharge [Discharge]

  5. New York Heart Association class for heart failure [30 days]

  6. Device success as defined by Valve Academic Research Consortium 2 criteria [30 days]

    Absence or procedural mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical position AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)

  7. Time-related valve safety as defined by Valve Academic Research Consortium 2 criteria [30 days]

    Composite of: Structural valve deterioration (valve-related dysfunction (mean aortic valve gradient >=20 mmHg, effective orifice area (EOA) <=0.9-1.1 cm^2 and/or Doppler velocity index (DVI) <0.35 m/s, and/or moderate or severe prosthetic valve regurgitation) (requiring repeat procedure) Prosthetic valve endocarditis Prosthetic valve thrombosis Thrombo-embolic events (e.g. stroke) Bleeding (as defined by Valve Academic Research Consortium), unless clearly unrelated to valve therapy (e.g. trauma)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Planned transfemoral transcatheter aortic valve implantation procedure

  • Uses oral anticoagulation at screening

Exclusion Criteria:

Patients at high risk for thromboembolism for who 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Antonius Ziekenhuis Nieuwegein Utrecht Netherlands 3435CM

Sponsors and Collaborators

  • St. Antonius Hospital

Investigators

  • Principal Investigator: JurriĆ«n M ten Berg, MD PhD, St. Antonius Ziekenhuis Nieuwegein, The Netherlands

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
J.M. ten Berg, Professor dr., St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT04437303
Other Study ID Numbers:
  • NL73805.100.20
First Posted:
Jun 18, 2020
Last Update Posted:
Feb 9, 2022
Last Verified:
Feb 1, 2022

Study Results

No Results Posted as of Feb 9, 2022