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