-
Je něco špatně v tomto záznamu ?
TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and multivessel or advanced coronary disease: The transcatheter valve and vessels trial (TCW trial): Design and rationale
E. Kedhi, A. Rroku, RS. Hermanides, JH. Dambrink, S. Singh, JT. Berg, DJ. van Ginkel, M. Hudec, G. Amoroso, IJ. Amat-Santos, M. Andreas, RC. Teles, G. Bonnet, E. Van Belle, L. Conradi, L. van Garsse, W. Wojakowski, V. Voudris, J. Sacha, P....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu randomizované kontrolované studie, časopisecké články
NLK
ProQuest Central
od 2002-01-01 do Před 2 měsíci
Nursing & Allied Health Database (ProQuest)
od 2002-01-01 do Před 2 měsíci
Health & Medicine (ProQuest)
od 2002-01-01 do Před 2 měsíci
Health Management Database (ProQuest)
od 2002-01-01 do Před 2 měsíci
Public Health Database (ProQuest)
od 2002-01-01 do Před 2 měsíci
- MeSH
- aortální chlopeň chirurgie MeSH
- aortální stenóza * komplikace diagnóza chirurgie MeSH
- frakční průtoková rezerva myokardu * MeSH
- koronární angioplastika * škodlivé účinky MeSH
- koronární bypass MeSH
- lidé MeSH
- nemoci koronárních tepen * komplikace diagnóza chirurgie MeSH
- prospektivní studie MeSH
- transkatetrální implantace aortální chlopně * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: Patients with severe aortic stenosis (AS) frequently present with concomitant obstructive coronary artery disease (CAD). In those, current guidelines recommend combined coronary artery bypass grafting (CABG) and surgical aortic valve replacement (SAVR) as the preferred treatment option, although this surgical approach is associated with a high rate of clinical events. Combined transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) with or without FFR have evolved as a valid alternative for cardiac surgery in patients with AS and multivessel or advanced CAD. To date, no dedicated trial has prospectively evaluated the outcomes of a percutaneous versus surgical treatment for patients with both severe AS and CAD. AIMS: To investigate whether fractional-flow reserve (FFR)-guided PCI and TAVI is noninferior to combined CABG and SAVR for the treatment of severe AS and multivessel or advanced CAD. METHODS: The Transcatheter Valve and Vessels (TCW) trial (clinicaltrial.gov: NCT03424941) is a prospective, randomized, controlled, open label, international trial. Patients ≥ 70 years with severe AS and multivessel (≥ 2 vessels) or advanced CAD, deemed feasible by the heart team for both; a full percutaneous or surgical treatment, will be randomised in a 1:1 fashion to either FFR-guided PCI followed by TAVI (intervention arm) vs. CABG and SAVR (control arm). The primary endpoint is a patient-oriented composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve reintervention, and life threatening or disabling bleeding at 1 year. The TCW trial is powered for noninferiority, and if met, superiority will be tested. Assuming a primary endpoint rate of 30% in the CABG-SAVR arm, with a significance level α of 5%, a noninferiority limit delta of 15% and a loss to follow-up of 2%, a total of 328 patients are needed to obtain a power of 90%. The primary endpoint analysis is performed on an intention-to-treat basis. SUMMARY: The TCW Trial is the first prospective randomized trial that will study if a less invasive percutaneous treatment for severe AS and concomitant advanced CAD (i.e., FFR-guided PCI-TAVI) is noninferior to the guidelines recommended approach (CABG-SAVR).
Cardiovascular Institute Hospital Clínico San Carlos IdISSC Madrid Spain
Center for Digital Medicine and Robotics Jagiellonian University Medical College Kraków Poland
Centro de Investigación Biomdica en Red Enfermedades Cardiovasculares Madrid Spain
Department of Cardiac Surgery Medical University of Vienna Vienna Austria
Department of Cardiology and Structural Heart Disease Medical Univ Silesia Katowice Poland
Department of Cardiology and Structural Heart Disease Medical University of Silesia Katowice Poland
Department of Cardiology Haga Hospital The Hague The Netherlands
Department of Cardiology Onze Lieve Vrouwe Gasthuis Amsterdam The Netherlands
Department of Cardiothoracic Surgery Radboud University Medical Centre The Netherlands
Department of Cardiovascular Surgery University Heart and Vascular Center Hamburg Germany
Diagram Research Zwolle The Netherlands
Division of Clinical and Experimental Cardiology AOU Sassari University of Sassari Sassari Italy
Faculty of Physical Education and Physiotherapy Opole University of Technology Opole Poland
Hospital Clínico Universitario de Valladolid Valladolid Spain
Hospital de Santa Cruz Centro Hospitalar de Lisboa Ocidental Lisbon Portugal
Interventional Department of Cardiology Onassis Cardiac Surgery Center Athens Greece
Isala Heart Center Department of Cardiology Zwolle The Netherlands
Isala Heart Center Department of Thoracic Surgery Zwolle The Netherlands
McGill University Health Center Montreal Quebec Canada
Medico Surgical Department Hôpital Cardiologique de Haut Lévèque Bordeaux University Hospital France
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc24006562
- 003
- CZ-PrNML
- 005
- 20240423155345.0
- 007
- ta
- 008
- 240412e20240201xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1016/j.ahj.2024.01.010 $2 doi
- 035 __
- $a (PubMed)38309610
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Kedhi, Elvin $u McGill University Health Center, Montreal, Quebec, Canada; Department of Cardiology and Structural Heart Disease, Medical University of Silesia, Katowice, Poland. Electronic address: ekedhi@me.com
- 245 10
- $a TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and multivessel or advanced coronary disease: The transcatheter valve and vessels trial (TCW trial): Design and rationale / $c E. Kedhi, A. Rroku, RS. Hermanides, JH. Dambrink, S. Singh, JT. Berg, DJ. van Ginkel, M. Hudec, G. Amoroso, IJ. Amat-Santos, M. Andreas, RC. Teles, G. Bonnet, E. Van Belle, L. Conradi, L. van Garsse, W. Wojakowski, V. Voudris, J. Sacha, P. Cervinka, E. Lipsic, S. Somi, L. Nombela-Franco, S. Postma, K. Piayda, G. De Luca, K. Malinofski, T. Modine
- 520 9_
- $a BACKGROUND: Patients with severe aortic stenosis (AS) frequently present with concomitant obstructive coronary artery disease (CAD). In those, current guidelines recommend combined coronary artery bypass grafting (CABG) and surgical aortic valve replacement (SAVR) as the preferred treatment option, although this surgical approach is associated with a high rate of clinical events. Combined transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) with or without FFR have evolved as a valid alternative for cardiac surgery in patients with AS and multivessel or advanced CAD. To date, no dedicated trial has prospectively evaluated the outcomes of a percutaneous versus surgical treatment for patients with both severe AS and CAD. AIMS: To investigate whether fractional-flow reserve (FFR)-guided PCI and TAVI is noninferior to combined CABG and SAVR for the treatment of severe AS and multivessel or advanced CAD. METHODS: The Transcatheter Valve and Vessels (TCW) trial (clinicaltrial.gov: NCT03424941) is a prospective, randomized, controlled, open label, international trial. Patients ≥ 70 years with severe AS and multivessel (≥ 2 vessels) or advanced CAD, deemed feasible by the heart team for both; a full percutaneous or surgical treatment, will be randomised in a 1:1 fashion to either FFR-guided PCI followed by TAVI (intervention arm) vs. CABG and SAVR (control arm). The primary endpoint is a patient-oriented composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve reintervention, and life threatening or disabling bleeding at 1 year. The TCW trial is powered for noninferiority, and if met, superiority will be tested. Assuming a primary endpoint rate of 30% in the CABG-SAVR arm, with a significance level α of 5%, a noninferiority limit delta of 15% and a loss to follow-up of 2%, a total of 328 patients are needed to obtain a power of 90%. The primary endpoint analysis is performed on an intention-to-treat basis. SUMMARY: The TCW Trial is the first prospective randomized trial that will study if a less invasive percutaneous treatment for severe AS and concomitant advanced CAD (i.e., FFR-guided PCI-TAVI) is noninferior to the guidelines recommended approach (CABG-SAVR).
- 650 _2
- $a lidé $7 D006801
- 650 12
- $a nemoci koronárních tepen $x komplikace $x diagnóza $x chirurgie $7 D003324
- 650 _2
- $a aortální chlopeň $x chirurgie $7 D001021
- 650 12
- $a transkatetrální implantace aortální chlopně $7 D065467
- 650 12
- $a frakční průtoková rezerva myokardu $7 D053805
- 650 12
- $a koronární angioplastika $x škodlivé účinky $7 D062645
- 650 _2
- $a prospektivní studie $7 D011446
- 650 _2
- $a koronární bypass $7 D001026
- 650 12
- $a aortální stenóza $x komplikace $x diagnóza $x chirurgie $7 D001024
- 650 _2
- $a výsledek terapie $7 D016896
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 655 _2
- $a časopisecké články $7 D016428
- 700 1_
- $a Rroku, Andi $u Department of Cardiology, Deutsches Herzzentrum der Charité, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; DZHK (German Centre for Cardiovascular Research), Berlin, Germany
- 700 1_
- $a Hermanides, Rik S $u Isala Heart Center, Department of Cardiology, Zwolle, The Netherlands
- 700 1_
- $a Dambrink, Jan Henk $u Isala Heart Center, Department of Cardiology, Zwolle, The Netherlands
- 700 1_
- $a Singh, Sandeep $u Isala Heart Center, Department of Thoracic Surgery, Zwolle, The Netherlands
- 700 1_
- $a Berg, Jurriën Ten $u St.Antonius Ziekenhuis, Nieuwegein, The Netherlands and University Medical Center Maastricht, Maastricht, The Netherlands
- 700 1_
- $a van Ginkel, Dirk-Jan $u St.Antonius Ziekenhuis, Nieuwegein, The Netherlands and University Medical Center Maastricht, Maastricht, The Netherlands
- 700 1_
- $a Hudec, Martin $u SÚSCCH, A.S. Banská, Bystrica, Slovak Republic
- 700 1_
- $a Amoroso, Giovanni $u Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
- 700 1_
- $a Amat-Santos, Ignacio J $u Centro de Investigación Biomdica en Red, Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain; Hospital Clínico Universitario de Valladolid, Valladolid, Spain
- 700 1_
- $a Andreas, Martin $u Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria
- 700 1_
- $a Teles, Rui Campante $u Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal
- 700 1_
- $a Bonnet, Guillaume $u Medico-Surgical Department (Valvulopathies, Cardiac Surgery, Adult Interventional Cardiology), Hôpital Cardiologique de Haut-Lévèque, Bordeaux University Hospital, France
- 700 1_
- $a Van Belle, Eric $u CHU Lille, Department of Cardiology, Department of Interventional Cardiology for Coronary, Valves and Structural Heart Diseases, Institut Coeur Puomon, Inserm, U1011, Institut Pasteur de Lille, EGIG, Université de Lille, Lille, France
- 700 1_
- $a Conradi, Lenard $u Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Germany
- 700 1_
- $a van Garsse, Leen $u Department of Cardiothoracic Surgery, Radboud University Medical Centre, The Netherlands
- 700 1_
- $a Wojakowski, Wojtek $u Department of Cardiology and Structural Heart Disease, Medical Univ. Silesia, Katowice, Poland
- 700 1_
- $a Voudris, Vasileious $u Interventional Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece
- 700 1_
- $a Sacha, Jerzy $u Department of Cardiology, University Hospital, Institute of Medical Sciences, University of Opole, Opole, Poland; Faculty of Physical Education and Physiotherapy, Opole University of Technology, Opole, Poland
- 700 1_
- $a Cervinka, Pavel $u Department of Cardiology, Krajska Zdravotni A.S., Masaryk Hospital and UJEP Usti nad Labem, Czech Republic
- 700 1_
- $a Lipsic, Erik $u Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
- 700 1_
- $a Somi, Samer $u Department of Cardiology, Haga Hospital, The Hague, The Netherlands
- 700 1_
- $a Nombela-Franco, Luis $u Cardiovascular Institute, Hospital Clínico San Carlos IdISSC, Madrid, Spain
- 700 1_
- $a Postma, Sonja $u Diagram Research, Zwolle, The Netherlands
- 700 1_
- $a Piayda, Kerstin $u Department of Cardiology and Vascular Medicine, Medical Faculty, Justus-Liebig-University Giessen, Giessen, Germany
- 700 1_
- $a De Luca, Giuseppe $u Division of Clinical and Experimental Cardiology, AOU Sassari, University of Sassari, Sassari, Italy
- 700 1_
- $a Malinofski, Krzysztof $u Center for Digital Medicine and Robotics, Jagiellonian University Medical College, Kraków, Poland; Department of Bioinformatics and Telemedicine, Faculty of Medicine, Jagiellonian University Medical College, Kraków, Poland
- 700 1_
- $a Modine, Thomas $u Medico-Surgical Department (Valvulopathies, Cardiac Surgery, Adult Interventional Cardiology), Hôpital Cardiologique de Haut-Lévèque, Bordeaux University Hospital, France
- 773 0_
- $w MED00000228 $t The American heart journal $x 1097-6744 $g Roč. 270 (20240201), s. 86-94
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/38309610 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20240412 $b ABA008
- 991 __
- $a 20240423155342 $b ABA008
- 999 __
- $a ok $b bmc $g 2080889 $s 1216329
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2024 $b 270 $c - $d 86-94 $e 20240201 $i 1097-6744 $m The American heart journal $n Am Heart J $x MED00000228
- LZP __
- $a Pubmed-20240412
