Valvular & structural heart diseaseRandomised controlled trial
Continuation versus Interruption of Oral Anticoagulation during transcatheter aortic-valve implantation (TAVI)
- Randomised controlled trial
- international
- open-label
- non-inferiority
Authors' conclusion
In patients undergoing TAVI with a concomitant indication for oral anticoagulation, periprocedural continuation was not noninferior to interruption of oral anticoagulation during TAVI with respect to the incidence of a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days.
Study context
- Population
- Patients receiving OAC and planning to undergo TAVImodified ITT population
- Participants
- 858 patients
- Comparison
- Periprocedural continuation vs interruption of OAC during TAVI
- Continuationn = 431
- Interruptionn = 427reference
- Primary endpoint
- Composite of:
- CV death
- Stroke from any cause
- MI
- Major vascular complications
- Major bleeding
- Follow-up
- 30 days after TAVI
Primary result
As reported in the abstract
Risk difference
1.7 percentage points
95% CI −3.1 to 6.6
P = 0.18 for non-inferiority
Events by treatment group
Continuation vs Interruption
risk difference 1.7 percentage points (95% CI −3.1 to 6.6); P for non-inferiority = 0.18
Further findings
| Outcome | Continuation | Interruption | risk difference (percentage points) (95% CI) | |
|---|---|---|---|---|
| Thromboembolic events | 8.8% | 8.2% | 0.6 (−3.1 to 4.4) | |
| −4−20246Difference, percentage points (linear scale) |
Safety
| Outcome | Continuation | Interruption | risk difference (percentage points) (95% CI) | |
|---|---|---|---|---|
| Bleeding | 31.1% | 21.3% | 9.8 (3.9–15.6) | |
| −1001020Difference, percentage points (linear scale) |
Original publication
Continuation versus Interruption of Oral Anticoagulation during TAVI. N Engl J Med. Published 31 August 2024. doi:10.1056/nejmoa2407794
Summarised from the published abstract; every number is checked against it