ACE-PROTAVI
Trial question
What is the role of routine protamine administration for bleeding in patients after TAVI?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 410
410 patients (157 female, 253 male).
Inclusion criteria: patients after TAVI.
Key exclusion criteria: protamine allergy or anaphylaxis; planned arterial access via surgical cutdown; PCI with drug-eluting stent implantation within the past 3 months.
Interventions
N=199 routine protamine administration (intravenous administration of 10 mg/mL).
N=211 placebo (intravenous administration of 0.9% sodium chloride).
Primary outcome
Hemostasis success
97.9%
91.6%
97.9 %
73.4 %
49.0 %
24.5 %
0.0 %
Routine protamine
administration
Placebo
Significant
increase ▲
NNT = 15
Significant increase in hemostasis success (97.9% vs. 91.6%; OR 4.3, 95% CI 1.42 to 13.01).
Secondary outcomes
Significantly shorter median time to hemostasis (181 seconds vs. 279 seconds; MD -98, 95% CI -160 to -36).
Significant decrease in death, minor and major bleeding, or minor and major vascular complications (5.2% vs. 13%; OR 0.37, 95% CI 0.17 to 0.79).
Significant decrease in minor vascular complications (2.1% vs. 8.4%; OR 0.23, 95% CI 0.08 to 0.7).
Conclusion
In patients after TAVI, routine protamine administration was superior to placebo with respect to hemostasis success.
Reference
Pieter A Vriesendorp, Shane Nanayakkara, Samuel Heuts et al. Routine Protamine Administration for Bleeding in Transcatheter Aortic Valve Implantation: The ACE-PROTAVI Randomized Clinical Trial. JAMA Cardiol. 2024 Oct 1;9(10):901-908.
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