Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial.

Autor: Pręgowski J; National Institute of Cardiology, Warsaw, Poland. Electronic address: jpregowski@ikard.pl., Pracoń R; National Institute of Cardiology, Warsaw, Poland., Mioduszewska A; National Institute of Cardiology, Warsaw, Poland., Skowroński J; National Institute of Cardiology, Warsaw, Poland., Sondergaard L; Abbott, Santa Clara, CA., Mintz GS; Cardiovascular Research Foundation, New York, NY., Capodanno D; Policlinico 'G. Rodolico-San Marco', University of Catania, Catania, Italy., Kim SW; Chung-Ang University Hospital, Seoul, Korea., De Baker O; Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark., Waciński P; Samodzielny Publiczny Szpital Kliniczny 4 w Lublinie, Lublin, Poland., Wojakowski W; Górnośląskie Centrum Medyczne im prof. L. Gieca Śląskiego Uniwersytetu Medycznego, Katowice, Poland., Rdzanek A; Uniwersyteckie Centrum Medyczne Warszawskiego Uniwersytetu Medycznego, Warsaw, Poland., Grygier M; Uniwersytecki Szpital Kliniczny w Poznaniu, Poznań, Poland., Chmielecki M; Kliniczne Centrum Kardiologii, Uniwersyteckie, Centrum Kliniczne, Gdański, Poland., Franco LN; Hospital Clínico San Carlos, Madrid, Spain., Stokłosa P; National Institute of Cardiology, Warsaw, Poland., Firek B; National Institute of Cardiology, Warsaw, Poland., Marczak M; National Institute of Cardiology, Warsaw, Poland., Miłosz B; National Institute of Cardiology, Warsaw, Poland., Chmielak Z; National Institute of Cardiology, Warsaw, Poland., Demkow M; National Institute of Cardiology, Warsaw, Poland., Witkowski A; National Institute of Cardiology, Warsaw, Poland.
Jazyk: angličtina
Zdroj: American heart journal [Am Heart J] 2024 May; Vol. 271, pp. 68-75. Date of Electronic Publication: 2024 Feb 22.
DOI: 10.1016/j.ahj.2024.02.015
Abstrakt: 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.
Competing Interests: Declaration of competing interest Dr Pręgowski 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.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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