PMID- 38401649 OWN - NLM STAT- MEDLINE DCOM- 20240424 LR - 20240502 IS - 1097-6744 (Electronic) IS - 0002-8703 (Linking) VI - 271 DP - 2024 May TI - Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial. PG - 68-75 LID - S0002-8703(24)00043-7 [pii] LID - 10.1016/j.ahj.2024.02.015 [doi] AB - BACKGROUND: Both transcatheter edge-to-edge repair (TEER) of mitral regurgitation or left atrial appendage closure (LAAC) require periprocedural anticoagulation with unfractionated heparin (UFH) that is administered either before or immediately after transseptal puncture (TSP). The optimal timing of UFH administration (before or after TSP) is unknown. The Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions trial (STOP CLOT Trial) was designed to determine if early anticoagulation is effective in reducing ischemic complications without increasing the risk of periprocedural bleeding. METHODS: The STOP CLOT trial is a multicenter, prospective, double-blind, placebo-controlled, randomized trial. A total of 410 patients scheduled for TEER or LAAC will be randomized 1:1 either early UFH administration (iv. bolus of 100 units/kg UFH or placebo, given after obtaining femoral vein access and at least 5 minutes prior to the start of the TSP) or late UFH administration (iv. bolus of 100 units/kg UFH or placebo given immediately after TSP). Prespecified preliminary statistical analysis will be performed after complete follow-up of the first 196 randomized subjects. To ensure blinding, a study nurse responsible for randomization and UFH/placebo preparation is not involved in the care of the patients enrolled into the study. The primary study endpoint is a composite of (1) major adverse cardiac and cerebrovascular events (death, stroke, TIA, myocardial infarction, or peripheral embolization) within 30 days post-procedure, (2) intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transesophageal echocardiography, or (3) occurrence of new ischemic lesions (diameter >/=4 mm) on brain magnetic resonance imaging performed 2 to 5 days after the procedure. The safety endpoint is the occurrence of moderate or severe bleeding complications during the index hospitalization. CONCLUSIONS: Protocols of periprocedural anticoagulation administration during structural interventions have never been tested in a randomized clinical trial. The Stop Clot trial may help reach consensus on the optimal timing of initiation of periprocedural anticoagulation. CLINICAL TRIALS REGISTRATION NUMBER: The study protocol is registered at ClinicalTrials.gov, identifier NCT05305612. CI - Copyright (c) 2024 Elsevier Inc. All rights reserved. FAU - Pregowski, Jerzy AU - Pregowski J AD - National Institute of Cardiology, Warsaw, Poland. Electronic address: jpregowski@ikard.pl. FAU - Pracon, Radoslaw AU - Pracon R AD - National Institute of Cardiology, Warsaw, Poland. FAU - Mioduszewska, Aleksandra AU - Mioduszewska A AD - National Institute of Cardiology, Warsaw, Poland. FAU - Skowronski, Jaroslaw AU - Skowronski J AD - National Institute of Cardiology, Warsaw, Poland. FAU - Sondergaard, Lars AU - Sondergaard L AD - Abbott, Santa Clara, CA. FAU - Mintz, Gary S AU - Mintz GS AD - Cardiovascular Research Foundation, New York, NY. FAU - Capodanno, Davide AU - Capodanno D AD - Policlinico "G. Rodolico-San Marco", University of Catania, Catania, Italy. FAU - Kim, Sang-Wook AU - Kim SW AD - Chung-Ang University Hospital, Seoul, Korea. FAU - De Baker, Ole AU - De Baker O AD - Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark. FAU - Wacinski, Piotr AU - Wacinski P AD - Samodzielny Publiczny Szpital Kliniczny 4 w Lublinie, Lublin, Poland. FAU - Wojakowski, Wojciech AU - Wojakowski W AD - Gornoslaskie Centrum Medyczne im prof. L. Gieca Slaskiego Uniwersytetu Medycznego, Katowice, Poland. FAU - Rdzanek, Adam AU - Rdzanek A AD - Uniwersyteckie Centrum Medyczne Warszawskiego Uniwersytetu Medycznego, Warsaw, Poland. FAU - Grygier, Marek AU - Grygier M AD - Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan, Poland. FAU - Chmielecki, Michal AU - Chmielecki M AD - Kliniczne Centrum Kardiologii, Uniwersyteckie, Centrum Kliniczne, Gdanski, Poland. FAU - Franco, Luis Nombela AU - Franco LN AD - Hospital Clinico San Carlos, Madrid, Spain. FAU - Stoklosa, Patrycjusz AU - Stoklosa P AD - National Institute of Cardiology, Warsaw, Poland. FAU - Firek, Bohdan AU - Firek B AD - National Institute of Cardiology, Warsaw, Poland. FAU - Marczak, Magdalena AU - Marczak M AD - National Institute of Cardiology, Warsaw, Poland. FAU - Milosz, Barbara AU - Milosz B AD - National Institute of Cardiology, Warsaw, Poland. FAU - Chmielak, Zbigniew AU - Chmielak Z AD - National Institute of Cardiology, Warsaw, Poland. FAU - Demkow, Marcin AU - Demkow M AD - National Institute of Cardiology, Warsaw, Poland. FAU - Witkowski, Adam AU - Witkowski A AD - National Institute of Cardiology, Warsaw, Poland. LA - eng SI - ClinicalTrials.gov/NCT05305612 PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20240222 PL - United States TA - Am Heart J JT - American heart journal JID - 0370465 RN - 0 (Anticoagulants) RN - 9005-49-6 (Heparin) SB - IM MH - Female MH - Humans MH - Male MH - *Anticoagulants/administration & dosage MH - *Atrial Appendage/surgery/diagnostic imaging MH - *Cardiac Catheterization/methods MH - Double-Blind Method MH - Heart Septum/surgery MH - *Heparin/administration & dosage MH - *Mitral Valve Insufficiency/surgery MH - Prospective Studies MH - Multicenter Studies as Topic MH - Randomized Controlled Trials as Topic COIS- Declaration of competing interest Dr Pregowski is a proctor for Abbott, Boston Scientific and Edwards LifeSciences; Dr Capodanno reports speaker's or consulting honoraria from Daiichi Sankyo, Sanofi Aventis, Terumo, Novo Nordisk (personal) and Medtronic (institutional); Dr Grygier is a proctor and reports speaker's or consulting honoraria from Abbott, Boston Scientific and Medtronic; Dr De Baker received institutional research grants and consulting fees from Abbott and Boston Scientific; Dr Wojakowski is a proctor for Abbott and reports speaker's fee from Edwards LifeSciences; Dr Witkowski is a proctor for Edwards LifeSciences; The other authors do not have relevant disclosures. EDAT- 2024/02/25 00:42 MHDA- 2024/04/25 00:54 CRDT- 2024/02/24 19:13 PHST- 2023/12/17 00:00 [received] PHST- 2024/02/17 00:00 [revised] PHST- 2024/02/19 00:00 [accepted] PHST- 2024/04/25 00:54 [medline] PHST- 2024/02/25 00:42 [pubmed] PHST- 2024/02/24 19:13 [entrez] AID - S0002-8703(24)00043-7 [pii] AID - 10.1016/j.ahj.2024.02.015 [doi] PST - ppublish SO - Am Heart J. 2024 May;271:68-75. doi: 10.1016/j.ahj.2024.02.015. Epub 2024 Feb 22.