Valvular & structural heart diseaseRandomised controlled trial
A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement
- Randomised controlled trial
- terminated prematurely by the DSMB for safety concerns
- Terminated prematurely by the data and safety monitoring board because of safety concerns
Authors' conclusion
In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy.
Study context
- Population
- Patients without an established indication for OAC after successful transcatheter aortic-valve replacement (TAVR)
- Participants
- 1,644 patients
- Comparison
- Rivaroxaban-based vs antiplatelet-based strategy after TAVR
- Primary endpoint
- Composite of:
- Death
- Thromboembolic events
Primary result
Death or first thromboembolic event · median 17 months
Hazard ratio
1.35
95% CI 1.01–1.81
P = 0.04
Events by treatment group
Rivaroxaban
9.8 per 100 person-years
105 events
Antiplatelet
7.2 per 100 person-years
78 events
Rivaroxaban vs Antiplatelet
HR 1.35 (95% CI 1.01–1.81); P = 0.04
As reported in the abstract
Further findings
per 100 person-years
| Outcome | Rivaroxaban | Antiplatelet | HR (95% CI) | |
|---|---|---|---|---|
| All-cause death | 5.8 | 3.4 | 1.69 (1.13–2.53) | |
| 0.20.5125Hazard ratio (log scale) |
Safety
per 100 person-years
| Outcome | Rivaroxaban | Antiplatelet | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Major, disabling or life-threatening bleeding (primary safety outcome) · intention-to-treat analysis | 4.3 | 2.8 | 1.50 (0.95–2.37) | P = 0.08 | |
| 0.512Hazard ratio (log scale) |
Original publication
A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement. N Engl J Med. Published 16 November 2019. doi:10.1056/nejmoa1911425
Summarised from the published abstract; every number is checked against it