Valvular & structural heart diseaseRandomised controlled trial
Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation
- Randomised controlled trial
Authors' conclusion
In patients undergoing TAVI who were receiving oral anticoagulation, the incidence of serious bleeding over a period of 1 month or 1 year was lower with oral anticoagulation alone than with oral anticoagulation plus clopidogrel.
Study context
- Population
- Patients undergoing transcatheter aortic-valve implantation (TAVI) receiving OAC for appropriate indications
- Participants
- 157 vs 156
- Comparison
- OAC alone vs OAC plus clopidogrel after TAVI
- oral anticoagulation alonen = 157
- oral anticoagulation plus clopidogreln = 156reference
- Primary endpoint
- All bleeding and non-procedure-related bleeding (two primary outcomes)
- Follow-up
- 12 months
Primary result
As reported in the abstract
All bleeding
oral anticoagulation alone vs oral anticoagulation plus clopidogrelRelative risk (95% CI)P value
all bleeding
0.63(0.43–0.90)
P = 0.01non-procedure-related bleeding: 34 (21.7%) vs 53 (34.0%)
0.64(0.44–0.92)
P = 0.02Secondary outcomes
| Outcome | oral anticoagulation alone | oral anticoagulation plus clopidogrel | difference (percentage points) (95% CI) | |
|---|---|---|---|---|
| Secondary composite 1 (CV death, non-procedure-related bleeding, stroke or MI) · 12 months · CI for noninferiority; margin 7.5 percentage points | 31.2% | 45.5% | −14.3 (−25.0 to −3.6) | |
| Secondary composite 2 (CV death, ischemic stroke or MI) · CI for noninferiority; margin 7.5 percentage points | 13.4% | 17.3% | −3.9 (−11.9 to 4.0) | |
| −30−20−10010Difference, percentage points (linear scale) |
| Outcome | RR (95% CI) | |
|---|---|---|
| Secondary composite 1 (CV death, non-procedure-related bleeding, stroke or MI) · 12 months · CI for superiority | 0.69 (0.51–0.92) | |
| Secondary composite 2 (CV death, ischemic stroke or MI) · CI for superiority | 0.77 (0.46–1.31) | |
| 0.512Relative risk (log scale) |
- Secondary composite 1 (CV death, non-procedure-related bleeding, stroke or MI): noninferiority margin 7.5 percentage points
- Secondary composite 2 (CV death, ischemic stroke or MI): noninferiority margin 7.5 percentage points
Original publication
Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation. N Engl J Med. Published 29 March 2020. doi:10.1056/nejmoa1915152
Summarised from the published abstract; every number is checked against it