Valvular & structural heart diseaseRandomised controlled trial
Routine Protamine Administration for Bleeding in Transcatheter Aortic Valve Implantation
- Randomised controlled trial
- investigator-initiated
- double-blind
- placebo-controlled
- 3 Australian hospitals
Authors' conclusion
In the ACE-PROTAVI randomized clinical trial, routine administration of protamine increased the rate of hemostasis success and decreased TTH.
Study context
- Population
- Patients accepted for transfemoral transcatheter aortic valve implantation (TAVI) by a multidisciplinary heart team
- Participants
- 410 patients
- Comparison
- Routine protamine vs placebo after transfemoral TAVI
- Protaminen = 199
- Placebon = 211reference
- Primary endpoint
- Coprimary: hemostasis success rate and time to hemostasis (TTH)
Primary result
As reported in the abstract
Absolute risk difference
6.3%
95% CI 2.0%–10.6%
P = 0.006
Events by treatment group
Protamine vs Placebo
absolute risk difference 6.3% (95% CI 2.0%–10.6%); P = 0.006
Secondary outcomes
| Outcome | Protamine | Placebo | OR (95% CI) | P value | |
|---|---|---|---|---|---|
| Composite of all-cause death, major/minor bleeding and major/minor vascular complications (major secondary) · 30 days · driven predominantly by minor vascular complications | 5.2% | 12.8% | 0.37 (0.1–0.8) | P = 0.01 | |
| 0.10.31310Odds ratio (log scale) |
Safety
- Adverse events associated with protamine
- 0 · events
Original publication
Routine Protamine Administration for Bleeding in Transcatheter Aortic Valve Implantation. JAMA Cardiol. Published 1 October 2024. doi:10.1001/jamacardio.2024.2454
Summarised from the published abstract; every number is checked against it