Routine Protamine Use Enhances Hemostasis and Reduces Vascular Complications After TAVI: ACE-PROTAVI Trial

Transfemoral transcatheter aortic valve implantation is a minimally invasive procedure used to replace a damaged or diseased
aortic valve in the heart. Vascular complications following transfemoral TAVI continue to be a significant source of procedure-related complications. Routine
use of protamine to reverse anticoagulation at the end of transfemoral TAVI may
help decrease these complications, although there is limited data available.

To evaluate the efficacy and safety of routine protamine administration
after transfemoral TAVI, scientists conducted an ACE-PROTAV randomized clinical
trial.

For this trial, Pieter A. Vriesendorp, Heart Centre, The Alfred Hospital,
Melbourne, Australia, and the team recruited 410 patients from 3
Australian hospitals between December 2021 and June 2023 with a 1-year
follow-up period.

All patients accepted for transfemoral TAVI by a
multidisciplinary heart team were eligible for enrollment. Eligible
patients were randomized 1:1 between routine protamine administration and
placebo. Out of 410 patients, 199 patients were in the protamine group
and 211 in the placebo group. Measurements were done using odds
ratios(ORs)

The study results reveal:

• The
  median (IQR) patient age in the protamine group was 82 (77-85) years, and 68 of
  199 patients receiving protamine (34.2%) were female.
• The
  median (IQR) patient age in the placebo group was 80 (75-85) years, and 89 of
  211 patients receiving the placebo (42.2%) were female.
• Patients who received protamine
  administration at the start of the procedure experienced a higher rate of
  successful hemostasis (97.9% in 188 of 192 patients) compared to those who
  received a placebo (91.6% in 186 of 203 patients), with an absolute risk
  difference of 6.3%
• The median time to hemostasis (TTH) was
  shorter for those given protamine upfront, with a median of 181 seconds (IQR
  120-420) compared to 279 seconds (IQR 122-600) for the placebo group.
• Routine administration of protamine led to
  a lower risk of the composite outcome in the protamine group (5.2% in 10 of 192
  patients) compared to the placebo group (12.8% in 26 of 203 patients), with an
  odds ratio of 0.37.
• This reduction was mainly due to a lower
  rate of minor vascular complications in the protamine group. Additionally, no
  adverse events were linked to the use of protamine.

“The advantages of
protamine were evident in decreased minor vascular complications, shorter
procedural time, and reduced post-procedural hospital stay for patients who
received routine protamine compared to those who received a placebo,”
researchers concluded.

Reference: Vriesendorp PA, Nanayakkara S, Heuts S, et al. Routine Protamine Administration
for Bleeding in Transcatheter Aortic Valve Implantation: The ACE-PROTAVI
Randomized Clinical Trial. JAMA Cardiol. Published online August 14, 2024.
doi:10.1001/jamacardio.2024.2454