Protamine sulfate during transcatheter aortic valve implantation (PS TAVI) - a single-center, single-blind, randomized placebo-controlled trial

Abstract

Background: Bleeding complications after transcatheter aortic valve implantation (TAVI) negatively affect the post-procedural prognosis. Routine use of protamine sulfate (PS) to reverse unfractionated heparin after TAVI was never assessed in a randomized controlled trial.

Aims: The aim of this study was to assess the impact of PS on bleeding complications after TAVI.

Methods: Between December 2016 and July 2020 311 patients qualified to TAVI in one academic center were screened. Patients that met the inclusion criteria were randomized to either PS or normal saline administration at the moment of optimal valve deployment. Baseline, procedural, and follow-up data for up to 30 days were collected and analyzed. The primary endpoint (PE) was a composite of life-threatening and major bleeding according to Valve Academic Research Consortium within 48 hours after the procedure.

Results: Overall, 100 patients (48 males, median age 82 years) met the inclusion criteria and were included in the study. Forty-seven subjects (47%) were randomized to PS. The primary endpoint occurred in 29% of the study population. Despite numerically lower rates of PE in patients randomized to PS, a statistical significance was not reached (21% in the PS group and 36% in the placebo group; odds ratio [OR], 0.48; 95% confidence intervals [CI] 0.2-1.2; P = 0.11). There were no significant differences in secondary endpoints.

Conclusions: Routine protamine sulfate administration did not significantly decrease the rate of major and life-threatening bleeding complications after TAVI. Larger studies are required to assess the impact of routine PS use.

Trial registration: ClinicalTrials.gov NCT02974660.

Keywords: aortic; implantation; protamine; sulfate; transcatheter; valve.