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Μηνύματα από τις σπουδαιότερες μελέτες στην Επεμβατική Καρδιολογία την τελευταία διετία. Χριστόδουλος Παπαδόπουλος MD, PhD, FESC Επίκουρος Καθηγητής Καρδιολογίας Ιατρικής Σχολής ΑΠΘ Γ' Πανεπιστημιακή Καρδιολογική Κλινική Γ.Ν. Ιπποκράτειο, Θεσσαλονίκη. Nothing to declare. TAVI.
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Μηνύματα από τις σπουδαιότερες μελέτες στην Επεμβατική Καρδιολογία την τελευταία διετία Χριστόδουλος Παπαδόπουλος MD, PhD, FESC Επίκουρος Καθηγητής Καρδιολογίας Ιατρικής Σχολής ΑΠΘ Γ' Πανεπιστημιακή Καρδιολογική Κλινική Γ.Ν. Ιπποκράτειο, Θεσσαλονίκη
Patients at Intermediate Surgical Risk SAPIEN XT and SAPIEN 3 CoreValve
Intermediate Risk NOTION | The CoreValve Platform Though the study was likely under-powered, NOTION showed all-cause mortality with TAVR with CoreValve to be non-inferior to SAVR in patients at lower surgical risk 1Sondergaard, presented at EuroPCR 2015
Medtronic Low Risk1 PARTNER 32 UK TAVI3 NOTION-24 N = ~1200 Up to 80 centers Evolut R, all routes Industry-sponsored 10-year follow-up N = 1228 Up to 64 centers SAPIEN 3, transfemoral Industry-sponsored 10-year follow-up N = 808 All UK TAVI centers All valves, all routes Publically funded 5-year follow-up N = 992 All Nordic countries All valves, transfemoral Physician and industry-sponsored 5-year follow-up Low Surgical Risk Active Trials Randomizing TAVR to SAVR Currently there is significant clinical investment in applying TAVR to younger patients at low surgical risk, both in North America and in Europe 1Popma, et al., presented at TCT 2016; 2Mack, et al., presented at TCT 2016; 3Moat, et al., presented at TCT 2016; 4Sondergaard, et al., presented at TCT 2016
Percutaneous coronary angioplasty versus coronary arterybypass grafting in treatment of unprotected left main stenosisNordic–Baltic–British left main revascularisation study (NOBLE)A prospective, randomised, open-label, non-inferiority trial NOBLE Evald Høj Christiansen Timo Mäkikallio, Niels R Holm, Mitchell Lindsay, Mark S Spence, Andrejs Erglis, Ian B A Menown, Thor Trovik, Markku Eskola, Hannu Romppanen, Thomas Kellerth, Jan Ravkilde, Lisette O Jensen, Gintaras Kalinauskas, Rikard B A Linder, Markku Pentikainen, Anders Hervold, Adrian Banning, Azfar Zaman, Jamen Cotton, Erlend Eriksen, Sulev Margus, Henrik T Sørensen, Per H Nielsen, Matti Niemelä, Kari Kervinen, Jens F Lassen, Michael Maeng, Keith Oldroyd, Geoff Berg, Simon J Walsh, Colm G Hanratty, Indulis Kumsars, Peteris Stradins, Terje K Steigen, Ole Fröbert, Alastair NJ Graham, Petter C Endresen, Matthias Corbascio, Olli A Kajander, Uday Trivedi, Juha Hartikainen, Vesa Anttila, David Hildick–Smith, Leif Thuesen, and Evald H Christiansen On behalf of the NOBLE investigators
Randomized (n= 1201) • Allocated to PCI (n=598) • Received PCI (n=585) • Did not receive PCI (n=13) • Died before PCI (n=1) • Patient declined PCI (n=4) • PCI operator declined (n=4) • LMCA lesion not significant (n=4) • Allocated to CABG (n=603) • Received CABG (n=570 ) • Did not receive CABG (n=33) • Died before CABG (n=1) • Patient declined CABG (n=15) • Not eligible for CABG (n=15) • Cross over by mistake (n=2) • Lost to follow-up (n=6) • Emigration (n=1) • Contact lost (n=2) • Withdrawal (n=3) • Lost to follow-up (n=11) • Emigration (n=0) • Contact lost (n=0) • Withdrawal (n=11) Patients allocated to PCI in analysis (n=592) 580 received PCI 7 received CABG Patients allocated to CABG in analysis (n=592) 567 received CABG 23 received PCI
Primary endpoint • A composite of major adverse cardiac and cerebrovascular events (MACCE) • Death from any cause • Non-procedural myocardial infarction • Repeat revascularization • Stroke
PCI did not show non-inferiority and CABG was superior to PCI ResultsPrimary endpoint: MACCE 28·9% HR 1·48 (1·11–1·96); p=0·0066 19·1%
Conclusions • PCI did not meet non-inferiority for the primary endpoint of 5-year MACCE compared to CABG • CABG was superior to PCI • PCI resulted in higher rates of non-procedural myocardial infarctions • Repeat revascularization was higher after PCI, primarily due to de novo lesions and non LMCA target lesion revascularization • All-cause mortality was similar for PCI and CABG
ΑΝΤΙΑΙΜΟΠΕΤΑΛΙΑΚΑ ΦΑΡΜΑΚΑ ΣΤΗΝ ΕΠΕΜΒΑΤΙΚΗ ΚΑΡΔΙΟΛΟΓΙΑ
ΑΝΤΙΘΡΟΜΒΩΤΙΚΗ ΑΓΩΓΗ ΣΕ ΑΣΘΕΝΕΙΣ ΜΕ AF ΚΑΙ ΑΓΓΕΙΟΠΛΑΣΤΙΚΗ
Enrollment Criteria RESPECT Trial Key Inclusion Criteria Key Exclusion Criteria Cryptogenic stroke within last 9 months TEE-confirmed PFO 18-60 years Patients > 60 at higher risk of recurrent stroke from non-PFO mechanisms Stroke due to identified cause such as: Large vessel atherosclerosis (e.g., carotid stenosis) Atrial fibrillation Intrinsic small vessel disease (lacunar infarcts) 11 other specific etiologies Inability to discontinue anticoagulation