A randomized prospective multicenter trial for stroke prevention by prophylactic surgical closure of the left atrial appendage in patients undergoing bioprosthetic aortic valve surgery––LAA-CLOSURE trial protocol - 26/05/21
, Juan Bustamante-Munguira, MD, PhD 3, Christian Olsson, MD, PhD 4, Anders Jeppsson, MD, PhD 5, Frank R. Halfwerk, MD 6, Juha Hartikainen, MD, PhD 7, Piotr Suwalski, MD, PhD 8, Igor Zindovic, MD, PhD 9, Guillermo Reyes Copa, MD, PhD 10, F.R.N. van Schaagen, MD 12, Thorsten Hanke, MD, PhD 13, Sergei Cebotari, MD 14, Markus Malmberg, MD, PhD 1, Mireia Fernandez-Gutierrez, MD 3, Markus Bjurbom, MD 4, Henrik Schersten, MD, PhD 5, Ron Speekenbrink, MD, PhD 6, Teemu Riekkinen, MD, PhD 7, Danyal Ek, MD 9, Tuija Vasankari, MSc 1, Gregory Y.H. Lip, MD 15, K.E. Juhani Airaksinen, MD, PhD 1, Bart van Putte, MD, PhD 11for the LAA-CLOSURE Investigators
Riassunto |
Patients undergoing surgical aortic valve replacement (SAVR) are at high risk for atrial fibrillation (AF) and stroke after surgery. There is an unmet clinical need to improve stroke prevention in this patient population. The LAA-CLOSURE trial aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing bioprosthetic SAVR. This randomized, open-label, prospective multicenter trial will enroll 1,040 patients at 13 European sites. The primary endpoint is a composite of cardiovascular mortality, stroke and systemic embolism at 5 years. Secondary endpoints include cardiovascular mortality, stroke, systemic embolism, bleed fulfilling academic research consortium (BARC) criteria, hospitalization for decompensated heart failure and health economic evaluation. Sample size is based on 30% risk reduction in time to event analysis of primary endpoint. Prespecified reports include 30-day safety analysis focusing on AF occurrence and short-term outcomes and interim analyses at 1 and 3 years for primary and secondary outcomes. Additionally, substudies will be performed on the completeness of the closure using transesophageal echocardiography/cardiac computed tomography and long-term ECG recording at one year after the operation.
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| Funding: This work was supported by The Finnish Medical Foundation, Helsinki, Finland; the Finnish Foundation for Cardiovascular Research, Helsinki, Finland; State Clinical Research Fund (EVO) of Turku University Hospital, Turku, Finland; and with an unrestricted research grant Atricure ltd (Mason, OH, USA). |
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| Author Disclosures: Tuomas Kiviniemi: lectures for Bayer, Boehringer Ingelheim, AstraZeneca and St. Jude Medical, Bristol-Myers Squibb-Pfizer, MSD; received research grants from The Finnish Medical Foundation, Helsinki, Finland; the Finnish Foundation for Cardiovascular Research; Clinical Research Fund (VTR) of Turku University Hospital, Turku, Finland, Finnish Cardiac Society. Member of advisory board for Boehringer Ingelheim, MSD. Anders Jeppsson: Lectures for Boehringer-Ingelheim, Consultancy fees from Xvivo Perfusion, Werfen, Boehringer-Ingelheim, Portola and LFB France. Research grants from the Swedish State (ALF), Swedish Heart Lung Foundation, Region Västra Götaland, Swedish Research Council. |
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| Frank Halfwerk: No conflict of interest related to the present study. Outside this trial, Thoraxcentrum Twente has received institutional research grants from Abbott Vascular, Biotronik, Boston Scientific and Medtronic. Juha Hartikainen: research grants from EU 2020 Horizon, the Finnish Foundation for Cardiovascular Research, Clinical Research Fund (VTR) of Kuopio University Hospital, Kuopio, Finland; Lectures for; Cardiome AG, MSD and AstraZeneca. Member of the advisory boards for Amgen, Pfizer, MSD, AstraZeneca, Bayer and BMS. Markus Malmberg: travel grants and congress sponsorship (Abbott, Boston Lifesciences, Medtronic). Juhani Airaksinen: research grants from the Finnish Foundation for Cardiovascular Research, Clinical Research Fund (VTR) of Turku University Hospital, Turku, Finland; Lectures for Bayer, Cardiome AG and Boehringer Ingelheim, Member in the advisory boards for Bayer, Astra Zeneca, Bristol-Myers Squibb-Pfizer and Boston Scientific. |
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| Gregory Lip: Consultant and speaker for BMS/Pfizer, Boehringer Ingelheim and Daiichi-Sankyo. No fees are received personally. |
Vol 237
P. 127-134 - luglio 2021 Ritorno al numero
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