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 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.
Subject(s)
Anticoagulants , Atrial Appendage , Cardiac Catheterization , Heparin , Mitral Valve Insufficiency , Female , Humans , Male , Anticoagulants/administration & dosage , Atrial Appendage/surgery , Atrial Appendage/diagnostic imaging , Cardiac Catheterization/methods , Double-Blind Method , Heart Septum/surgery , Heparin/administration & dosage , Mitral Valve Insufficiency/surgery , Prospective Studies , Multicenter Studies as Topic , Randomized Controlled Trials as TopicABSTRACT
INTRODUCTION: Transfemoral access is a prevailing approach for transcatheter aortic valve implantation (TAVI) in contemporary practice, with a shift from surgical arteriotomy to a percutaneous arterial approach. OBJECTIVES: This study assessed long- and shortterm mortality, along with Valve Academic Research Consortium-2-defined complications in percutaneous transfemoral approach (PTA) TAVI. Furthermore, it explored the impact of a learning curve on procedural outcomes. PATIENTS AND METHODS: The study included 600 patients undergoing PTA TAVI at the National Institute of Cardiology, Warsaw, Poland, from January 2009 to September 2020. Retrospective data comparison involved 2 groups: early experience (first 200 patients) and late experience (next 400 patients). RESULTS: The primary end point (composite of lifethreatening bleeding, major vascular complication, or death at 30 days) occurred less often in the late experience group (28% vs 17.5%; P = 0.003). The late experience group also showed fewer cases of vascular complications (19% vs 10.7%; P = 0.005) and major bleeding (17.5% vs 8.5%; P = 0.001). Propensity matching yielded similar trends, including reduced frequency of pacemaker implantation (22.8% vs 10.9%; P = 0.03) and shorter median (interquartile range) hospitalization (11 [8-18] vs 7 [6-12] days; P <0.001) in the late experience group. CONCLUSIONS: The late experience group rated with PTA TAVI exhibited significantly reduced periprocedural complications, indicating a positive impact of accumulated expertise.