To evaluate the efficacy and safety of peri-procedurally continued versus interrupted oral anticoagulants in patients undergoing transcatheter aortic valve implantation.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary endpoints:
- Procedure related primary endpoints at 30 days.
- Procedure related bleeding complications (type 1-4 bleeding ) at 30 days as
defined by the VARC-3 criteria.
- Procedure related thromboembolic complications (all stroke (except
haemorrhagic), TIA, myocardial infarction, systemic embolism (vascular
complications: distal embolization (non-cerebral) from a vascular source)) at
30 days as defined by the VARC-3 criteria.
- Thromboembolic complications (all stroke (except haemorrhagic), TIA,
myocardial infarction and systemic embolism (vascular complications: distal
embolization (non-cerebral) from a vascular source)) at discharge and 30 days
as defined by the VARC-3 criteria.
- Neurologic events (overt CNS injury, covert CNS injury, neurologic
dysfunction (acutely symptomatic) without CNS injury) at discharge and 30 days
as defined by the VARC-3 criteria.
- Cerebrovascular events (all stroke, TIA) at discharge and 30 days as defined
by the VARC-3 criteria.
- All stroke at discharge and 30 days as defined by the VARC-3 criteria.
- Bleeding complications (type 1-4 bleeding) at discharge and 30 days as
defined by the VARC-3 criteria.
- Early safety at 30 days as defined by VARC-3 criteria, 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
- Clinical efficacy at 30 days as defined by VARC-3 criteria, 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
- All-cause death at discharge and 30 days.
- Cardiovascular death at discharge and 30 days.
- Quality of life (assessed by SF-12, KCCQ, and TASQ) at 30 days and 90 days.
Other endpoints:
- NYHA classification for heart failure.
- Rehospitalisation.
- Permanent pacemaker implantation.
- Cost-effectiveness.
- Separate and combined components (e.g. thromboembolic, neurologic, vascular
and bleeding complications) of primary and secondary endpoints, both at 30 days
and hospital discharge.
- Bleeding as classified by and BARC at 30 days and hospital discharge.
- Other composite endpoints as proposed by VARC-3 definitions and its separate
components.
Background summary
Transcatheter aortic valve implantation (TAVI) is a rapidly growing treatment
option for patients with aortic valve stenosis. Nowadays, also patients with
low risk undergo TAVI. Stroke is a feared and frequently occurring 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;
vitamin-k-antagonist or NOAC) 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 shows a lower risk of stroke
in patients continuing OAC during TAVI compared to in patients interrupting
OAC, without an increase in bleeding. We hypothesize that periprocedural
continuation of OAC is safe and might decrease thromboembolic complications
without an increase in bleeding complications at 30 days.
Study objective
To evaluate the efficacy and safety of peri-procedurally continued versus
interrupted oral anticoagulants in patients undergoing transcatheter aortic
valve implantation.
Study design
Randomised controlled open-label multicentre trial
Intervention
Continuation versus interruption of OAC during TAVI
Study burden and risks
At this moment no clear evidence or guidance exists regarding continuation or
interruption of oral anticoagulants during TAVI. There is a variety in clinical
practise. Some hospitals advise their patients to interrupt OAC up to 7 days
before and after TAVI, with or without bridging, some advise their patients to
continue OAC. So we do not know what is best for the patient, and what
advantage the patient might have from one of the two strategies. The burden for
the patient will be limited to an instruction regarding periprocedural OAC use,
and questionnaires at baseline, after 30 days and after 3 months.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
• Planned transfemoral or transsubclavian TAVI procedure
• Uses oral anticoagulation at screening
• Provided written informed consent
Exclusion criteria
Patients at high risk for thromboembolism for who interruption of oral
anticoagulants is no option, i.e.:
- Mechanical heart valve
- Intracardiac thrombus
- < 3 months after venous thromboembolism
- < 6 months after TIA/stroke in patients with atrial fibrillation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-001817-20-NL |
| ClinicalTrials.gov | NCT04437303 |
| CCMO | NL73805.100.20 |