2016 Large Clinical Studies in Interventional Cardiology

2016 Large Clinical Studies in Interventional Cardiology Kostopoulos Konstantinos CARDIOLOGIST 1st Cardiac Dpt. NIKEA GENERAL HOSPTAL Piraeus GREECE 37ο Π.Κ.Σ «Επεµβατική Καρδιολογία» 22/10/2016, Athens - Greece

PRAGUE-18: Pra vs Tica σε PPCI!έλεγχος αποτελεσµατικότητας & αιµορραγίας ANTARCTIC: Κανονική vs προσαρµοσµένης δόσης Pra σε ACS PCI, >75y.o PEGASUS TIMI 54: (Tica 60 vs 90) vs ASA: CV events σε high risk pts µε >12m x-acs CHAMPION PHOENIX: STEMI PPCI: off hours vs on hours DOCTORS: OCT use in ACS BBK II: Culotte vs T-stenting για διχασµικές βλάβες EROSION: Συµβολή OCT σε αποφυγή stenting ασθενών µε ACS NORSTENT: Real world σύγκριση BMS & DES CE-MARC II: Διάγνωση CAD: C. Cath - CMR vs UK NICE guidelines vs MPS-spect P2-S3i TAVR: TAVI σε διάµεσου κινδύνου ασθενείς µε σοβαρή AoS

PRAGUE-18 Study Randomized comparison of Ticagrelor vs Prasugrel in STEMI 1. Head-to-head comparison of PRASUGREL vs TICAGRELOR in STEMI patients treated by P.PCI 2. Safety of (economically motivated) postdischarge switch from PRASU/TICA to CLOPIDOGREL Circulation Sept 2016

PRAGUE-18 Study

PRAGUE-18 Study CONCLUSION No difference between TICA & PRASU in the early phase of AMI treated by PPCI 1y F.U results are expected by May 2017

ANTARCTIC Study Lancet Aug 2016

ANTARCTIC Study

CONCLUSION ANTARCTIC Study PLT function monitoring ATP therapy adjustment in stented for ACS elderly pts does not improve clinical outcome. This failure in clinical improvement is not related to the risk level of the population or type of P2Y 12 antagonist

PEGASUS TIMI 54 Study (ASA vs ASA+TICA) NEJM 2015

PEGASUS TIMI 54 Study (ASA vs ASA+TICA) 1. Stable pts w history of MI 2. Prior stroke pts excluded (primary stroke prevention population) 3. Long term placebo controlled trial w TICA 4. Long term FU (33m median duration)

PEGASUS TIMI 54 Study

PRAGUE-18 ANTARCTIC PEGASUS TIMI 54 CHAMPION PHOENIX DOCTORS BBK II EROSION NORSTENT CE-MARC II

STEMI PPCI: on-hours (07.00-19.00) off-hours (19.00-07.00, weekends, holidays) stent thrombosis, all-cause mortality, ischemia-driven revascularization at 48h

DOCTORS Study

OCT Angio DOCTORS Study

DOCTORS Study Post-OCT Pre-OCT Angio OCT Number of pts with post-pci FFR>0.90 77 (64.2%) 99 (82.5%) P=0.0001

DOCTORS Study

BBK II Study

EROSION Study

EROSION Study Inclusion criteria: -Men or non pregnant women >18yo. -Emergency PCI of pts w ACS -Culprit lesion in the native coronary artery -TIMI flow grade III & DS<70% on angiography -Plaque erosion detected by OCT

EROSION Study

NORSTENT STUDY

Study design NORSTENT STUDY -Multicenter pragmatic RCT in Norway -9013 pts (eligible: 73%) -Investigator initiated -Conducted in a real-world patient care setting -2008-2011, 5y F.U period -95% of pts in the DES arm received N.G-DES Enrollment criteria -Stable CAD or ACS -All lesions may be treated w DES or BMS only -No bifurcation lesion requiring 2-stent technique -No C.I to DAPT -No indication for (N)OAC

NORSTENT STUDY

CE-MARC II STUDY CMR: Cardiovascular Magnetic Resonance NICE: National Institute for health & Care Excellence MPS: Myocardial Perfusion Scintigraphy JAMA. 2016;316(10):1051-1060

CE-MARC II STUDY

TAVI in Intermediate-Risk Patients Lancet 2016;387:2218-25 N Engl J Med 2016;374:1609-20

The PARTNER 2A and S3i Trials Study Design Intermediate Risk Symptomatic Severe Aortic Stenosis Intermediate Risk ASSESSMENT by Heart Valve Team P2 S3i n = 1078 P2A n = 2032 ASSESSMENT: Optimal Valve Delivery Access Yes ASSESSMENT: Transfemoral Access No Transfemoral (TF) Transapical / Transaortic (TA/TAo) Transfemoral (TF) Transapical / TransAortic (TA/TAo) 1:1 Randomization 1:1 Randomization TF TAVR SAPIEN 3 TA/TAo TAVR SAPIEN 3 TF TAVR SAPIEN XT Surgical TA/Tao TAVR VS VS AVR SAPIEN 3 Surgical AVR Primary Endpoint: All-Cause Mortality, All Stroke, or Mod/Sev AR at One Year (Non-inferiority Propensity Score Analysis) P2=PARTNER 2A S3=SAPIEN 3 TAVR

Superiority Analysis Components of Primary Endpoint (VI) Mortality Favors TAVR Favors Surgery Weighted Difference -5.2% Upper 2-sided 95% CI -2.4% Superiority Testing p- value < 0.001-10 -8-6 -4-2 0 2 4 6 8 10 Stroke Weighted Difference -3.5% Upper 2-sided 95% CI -1.1% Superiority Testing p- value = 0.004-10 -8-6 -4-2 0 2 4 6 8 10 > Moderate Weighted Difference +1.2% Lower 2-sided 95% CI +0.2% Superiority Testing p- value = 0.0149-10 -8-6 -4-2 0 2 4 6 8 10 1-year rates of all-cause mortality (7.4%), all stroke (4.6%), and moderate or severe aortic regurgitation (1.5%)

PRAGUE-18: Παρόµοια αποτελεσµατικότητα & αιµορραγία για την PRASU vs TICA σε ασθενείς µε PPCI-AMI ANTARCTIC: Ισοδυναµία κανονικής vs προσαρµοσµένης δόσης PRASU σε ACS PCI, >75y.o PEGASUS TIMI 54: TICA 60 (vs 90, vs ASA) µειώνουν κίνδυνο ΑΕΕ σε ψηλού κινδύνου pts µε x-acs CHAMPION PHOENIX: off hours vs on hours STEMI PPCI: Ισοδύναµα αποτελέσµατα DOCTORS: OCT-guided PCI in ACS!ψηλότερο FFR έναντι angio µόνο BBK II: Culotte τεχνική καλύτερη της T-stenting για διχασµικές βλάβες EROSION: Συµβολή OCT σε ACS: αποφυγή stenting σε ¼ ασθενών NORSTENT: Παρόµοια αποτελέσµατα επιβίωσης BMS & DES CE-MARC II: Διάγνωση CAD: CMR(=MPS-spect) µειώνει µη αναγκαίους C. Cath - vs UK NICE guidelines P2-S3i TAVR: Διάµεσου κινδύνου ασθενείς µε σοβαρή AoS: TAVI τουλάχιστο ισοδύναµη µε Sx

TCT 2016 Late-breaking Trials First Reports ILUMIEN III (OPTIMIZE PCI) BIO-RESORT (TWENTE III) BIONICS ABSORB China ABSORB II LEADERS FREE EXCEL NOBLE REVELUTION FANTOM II MeRes-1 FORTITUDE FUTURE-I SENTINEL PARTNER II QUALITY OF LIFE PARTNER I FIVE-YEAR ECHO RESPECT COLOR PLATINUM DIVERSITY ReACT ILLUMENATE U.S WATCHMAN US POST-APPROVAL STUDY AMULET OBSERVATIONAL STUD PRISON IV TOSCA-5 TRANSFORM-OCT RIBS VI (Oct. 29 Nov. 2, 2016 - Washington, D.C)

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