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Cardiopatia Ischemica: Ruolo del Cardiologo Interventista
Prof. Carlo Di MarioCardiologia Interventistica Strutturale
AOU Careggi, Firenze
1977 Univ. Zurich 2017
Trial Design
ORBITA: Clinical Characteristics
Medical Opimization Therapy
LAD: 69%;QCA %AS: 84%; FFR:0.69
ORBITA Primary Endpoint: Not Met
No Significant Differences in Secondary Endpoint
UPDATE on FAME 2 Results: 3 Years
FAME 2 Baseline Characteristics
FAME 2 Three Years Outcome
First Presentation by FEARON at TCT 2017 in Denver
Driver of Difference: Urgent Revascularization
First Presentation by FEARON at TCT 2017 in Denver
Persistence of Angina
First Presentation by FEARON at TCT 2017 in Denver
FAME @: Cost @ 3 Years
First Presentation by FEARON at TCT 2017 in Denver
European Heart Journal (2013)34, 2949–3003
European Heart Journal (2013)34, 2949–3003
Indication for Revascularization
b. With documented ischaemia or FFR , 0.80 for angiographic diameter stenoses 50–90%.
Presented by Escaned at ESC Congress 2017, Barcellona
Patients with 3-vessel disease in 22 countries (454 pts)
Syntax Study II
Syntax Study II
Presented by Escaned at ESC Congress 2017, Barcelona
SYNTAX 2Presented ESC Barcelona Dr Javier Escaned
MATRIX: Radial Approach
Coprimary composite outcomes at 30 daysA) All-cause mortality, myocardial infarction, or stroke. B) all-cause mortality, myocardial infarction, stroke, or 3 or 5 BARC type bleeding
Valgimigli et al: Lancet. 2015 Jun 20;385(9986):2465-76
All-cause mortality, myocardial infarction, or stroke.
All-cause mortality, myocardial infarction, stroke, or 3-5 BARC type bleeding
Byrne RA, Serruys PW, European Heart Journal (2015) 36, 2608–2620
A systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013.
158 randomized clinical trials were included; >15000 patients
Long-Term Results Second Generation DES
Byrne RA, Serruys PW, EHJ (2015) 36, 2608–2620
Presented by Escaned at ESC Congress 2017, Barcelona
I V U S
PaPd
0 100 200 300 400 500 600 700 800 900
70
120
Pressure (
mm
Hg)
Time (ms)
Wave-freePeriod
i F R/F F R
Cut-Off as Simple as FFR but Less Prone to Inaccuracies
4486 Patients
J Escaned et al EHJ 2017 0, 1-11
Syntax II Study -CTO Recanalisation
Angiographic Success
%
0
20
40
60
80
100
2015 2016
84.8 91.3
78.181.2
Full Members
Associated Members
0
20
40
60
80
100
2008 2009 2010 2011 2012 2013 2014 2015 2016
85.5 86.5 88.1 87.6 87.8 90.387 89 89
73.6
64.2
77.1 76.5 77.879.5 82.2 83.3 81.2
Antegrade Retrograde
Syntax Study II-1 year result
Presented by Escaned at ESC Congress 2017, Barcellona
J Escaned et al EHJ 2017 0, 1-11
Syntax II Study –MACCE
Excel trial (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization)
905 eligible patients with left main coronary artery disease and low or intermediate
SYNTAX score randomized to PCI or CABG
Primary endpoint: composite of death from any cause, stroke, or MI at 3 years
PCI:
Xience (second generation DES)
IVUS performed in 77.6%
CABG:
off-pump 29.4%
bilateral artery graft in 28.8%
Peri-procedural (within 72 h CK>5-10x URL) and spontaneous
stroke disability of modified
Rankin Scale (mRS) ≥1
Stone GW, Sabik JF et al N Engl J Med. 2016;375(23):2223-2235.
Third Generation SYNERGY Stent
1 Month Stable/6 Months ACS
Efficacy Primary Endpoint
Safety Primary Endpoints
AIDA Trial: 30 Months Follow-Up ABSORB in Allcomers (>30% PPCI)
From Wykrzykowska et al, NEJM 2017
AIDA Trial: 30 Months Follow-Up ABSORB in Allcomers (>30% PPCI)
From Wykrzykowska et al, NEJM 2017
Expansion 3.0 mm ABSORB with ostial LAD underexpansion with3.0x8 mm NC balloon at 16 Atm (A) and 3.5x10 mm Schwager
balloon at 26 Atm (B)
No Scaffold Fracture @ 28.0+3.4 Atm
A
B
A
B
A
B
Fabris, Mattesini, Di Mario et al, CCI 2015
SubGroup Analysis RE-DUAL PCI
Main Results: Presented ESC 2017
Main Efficacy Results: Presented ESC 2017
ACS SubGroup Analysis RE-DUAL PCI
Stent SubGroup Analysis RE-DUAL PCI
Ticagrelor SubGroup Analysis
Has in 40 Yrs Interventional Cardiology Reached Maturity?
..or in other words, has it really become a boring subject?
Titian, The Man’s Three Ages , National Gallery of Scotland , Edinburgh