Your browser doesn't support javascript.
loading
Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial.
Pregowski, Jerzy; Pracon, Radoslaw; Mioduszewska, Aleksandra; Skowronski, Jaroslaw; Sondergaard, Lars; Mintz, Gary S; Capodanno, Davide; Kim, Sang-Wook; De Baker, Ole; Wacinski, Piotr; Wojakowski, Wojciech; Rdzanek, Adam; Grygier, Marek; Chmielecki, Michal; Franco, Luis Nombela; Stoklosa, Patrycjusz; Firek, Bohdan; Marczak, Magdalena; Milosz, Barbara; Chmielak, Zbigniew; Demkow, Marcin; Witkowski, Adam.
Afiliação
  • Pregowski J; National Institute of Cardiology, Warsaw, Poland. Electronic address: jpregowski@ikard.pl.
  • Pracon R; National Institute of Cardiology, Warsaw, Poland.
  • Mioduszewska A; National Institute of Cardiology, Warsaw, Poland.
  • Skowronski 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.
  • Wacinski P; Samodzielny Publiczny Szpital Kliniczny 4 w Lublinie, Lublin, Poland.
  • Wojakowski W; Górnoslaskie Centrum Medyczne im prof. L. Gieca Slaskiego Uniwersytetu Medycznego, Katowice, Poland.
  • Rdzanek A; Uniwersyteckie Centrum Medyczne Warszawskiego Uniwersytetu Medycznego, Warsaw, Poland.
  • Grygier M; Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan, Poland.
  • Chmielecki M; Kliniczne Centrum Kardiologii, Uniwersyteckie, Centrum Kliniczne, Gdanski, Poland.
  • Franco LN; Hospital Clínico San Carlos, Madrid, Spain.
  • Stoklosa P; National Institute of Cardiology, Warsaw, Poland.
  • Firek B; National Institute of Cardiology, Warsaw, Poland.
  • Marczak M; National Institute of Cardiology, Warsaw, Poland.
  • Milosz 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.
Am Heart J ; 271: 68-75, 2024 05.
Article em En | MEDLINE | ID: mdl-38401649
ABSTRACT

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 11 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.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Cateterismo Cardíaco / Heparina / Apêndice Atrial / Insuficiência da Valva Mitral / Anticoagulantes Limite: Female / Humans / Male Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Cateterismo Cardíaco / Heparina / Apêndice Atrial / Insuficiência da Valva Mitral / Anticoagulantes Limite: Female / Humans / Male Idioma: En Ano de publicação: 2024 Tipo de documento: Article