{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T23:54:00Z","timestamp":1787615640609,"version":"build-2736575974"},"reference-count":30,"publisher":"American Medical Association (AMA)","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Cardiol"],"published-print":{"date-parts":[[2024,10,1]]},"abstract":"Importance<\/jats:title>Vascular complications after transfemoral transcatheter aortic valve implantation (TAVI) remain an important cause of procedure-related morbidity. Routine reversal of anticoagulation with protamine at the conclusion of transfemoral TAVI could reduce complications, but data remain scarce.<\/jats:p><\/jats:sec>Objective<\/jats:title>To evaluate the efficacy and safety of routine protamine administration after transfemoral TAVI.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>The ACE-PROTAVI trial was an investigator-initiated, double-blind, placebo-controlled randomized clinical trial performed at 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.<\/jats:p><\/jats:sec>Interventions<\/jats:title>Eligible patients were randomized 1:1 between routine protamine administration and placebo.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>The coprimary outcomes were the rate of hemostasis success and time to hemostasis (TTH), presented as categorical variables and compared with a \u03c72<\/jats:sup> test or as continuous variables as mean (SD) or median (IQR), depending on distribution. The major secondary outcome was a composite of all-cause death, major and minor bleeding complications, and major and minor vascular complications after 30 days, reported in odds ratios (ORs) with 95% CIs and P<\/jats:italic> values.<\/jats:p><\/jats:sec>Results<\/jats:title>The study population consisted of 410 patients: 199 patients in the protamine group and 211 in the placebo group. 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 receiving up-front protamine administration had a higher rate of hemostasis success (188 of 192 patients [97.9%]) than patients in the placebo group (186 of 203 patients [91.6%]; absolute risk difference, 6.3%; 95% CI, 2.0%-10.6%; P<\/jats:italic>\u2009=\u2009.006); in addition, patients receiving up-front protamine had a shorter median (IQR) TTH (181 [120-420] seconds vs 279 [122-600] seconds; P<\/jats:italic>\u2009=\u2009.002). Routine protamine administration resulted in a reduced risk of the composite outcome in the protamine group (10 of 192 [5.2%]) vs the placebo group (26 of 203 [12.8%]; OR, 0.37; 95% CI, 0.1-0.8; P<\/jats:italic>\u2009=\u2009.01). This difference was predominantly driven by the difference in the prevalence of minor vascular complications. There were no adverse events associated with protamine use.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>In the ACE-PROTAVI randomized clinical trial, routine administration of protamine increased the rate of hemostasis success and decreased TTH. The beneficial effect of protamine was reflected in a reduction in minor vascular complications, procedural time, and postprocedural hospital stay duration in patients receiving routine protamine compared with patients receiving placebo.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>anzctr.org.au Identifier: ACTRN12621001261808<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamacardio.2024.2454","type":"journal-article","created":{"date-parts":[[2024,8,14]],"date-time":"2024-08-14T15:02:04Z","timestamp":1723647724000},"page":"901","source":"Crossref","is-referenced-by-count":24,"title":["Routine Protamine Administration for Bleeding in Transcatheter Aortic Valve Implantation"],"prefix":"10.1001","volume":"9","author":[{"given":"Pieter A.","family":"Vriesendorp","sequence":"first","affiliation":[{"name":"Heart Centre, The Alfred Hospital, Melbourne, Australia"},{"name":"Heart+Vascular Center, Department of Cardiology, Maastricht University Medical Center, Maastricht, the 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