Φαρμακο-­‐Εκλυουσεσ  Ενδοστεφανιαιεσ  Προθεσεις  

ΚΑΡΔΙΟΛΟΓΙΚΟ  ΤΜΗΜΑ,  ΓΝΑ  ΙΠΠΟΚΡΑΤΙΟ  Δ.  ΣΥΡΣΕΛΟΥΔΗΣ  

1964   Dotter and Judkins.   Conceptual description of coronary angioplasty using an implantable prosthetic device  

May 1977   Gruntzig and Myler   First coronary angioplasty during coronary artery bypass graft  surgery  

September 1977   Andreas Gruntzig   First coronary angioplasty in an awake patient  

1979   Geoffrey Hartzler   First balloon angioplasty to treat AMI  

1986   Sigwart and Puel   The first implantation of a stent in human coronary arteries  

1991   Cannon and Roubin   First coronary stenting to treat AMI  

1994   Serruys et al. and Fischman et al   Publication of first two landmark (Benestent and STRESS) trials    

1994   FDA   FDA-approved use of stents to treat acute and threatened vessel closure after failed balloon angioplasty  

1999   Eduardo Sousa   The first drug (sirolimus) eluting stent implanted in human coronary artery  

2002–04   EME and FDA   Approvals of Cypher and Taxus stents in Europe and USA  

2011   EME   Approval of Absorb BVS in Europe  

Historical milestones in coronary artery stenting  

VASCULAR BIOLOGY  

Pathophysiological impact of angioplasty, stenting, DES  

Stefanini G, Holmes D. N Engl J Med 2013; 368:254-65  

DES  

Cook, Circulation 2007, 2009  

Räber, J Am Coll Card Intv 2012  

Nakazawa, J Am Coll Card 2011  

Guagliumi, Circulation 2011  

Pathological healing response to early generation DES  

Stefanini G, N Eng J Med 2013;368:254-65  

EFFICACY  

SES and PES vs BMS- angiographic efficacy  

SES and PES vs BMS- clinical efficacy  

SES vs PES – SIRTAX  

Windecker S. N Eng J Med 2005;353:653-62  

BETTER EFFICACY IN NEW DES  

 N = 11,167  

 N = 4,062  

Stefanini G, Eur Heart J 2012; 33, 1214–1222  

SAFETY  

ESC 2006- Barcelona Firestorm  

 Drug-Eluting Stents vs. Bare Metal Stents  

 Nationwide Registry: The SCAAR Experience  

Risk of Death With Sirolimus- and Paclitaxel-Eluting Stents versus Bare Metal Stents  

Kirtane AJ et al. Circulation 2009;119:3198-3206  

Stent thrombosis with EES and BMS  

 Palmerini T et al. Lancet 2012; 379:1393-402  

Stable CAD  

FAME II – 2nd generation DES  

De Bruyne B, N Eng J Med 2012  

FAME II  

De Bruyne B, N Eng J Med 2012  

STEMI  

Early generation DES vs BMS in STEMI  

New generation DES vs BMS in STEMI  

EES: TVR, ST   BES: C.DEATH, TVReinfarction, TVR (ischaemia driven)  

RISK OF ADVERSE EVENTS WITH NEW GENERATION DES (BES, EES vs BMS in STEMI pooled)  

Antiplatelet therapy  

SCAD  

2014 ESC/EACTS Guidelines on myocardial revascularization  

OPTIMIZE trial – ZES with DAPT x 3 vs x12 mo  

DEATH  

MI  

STROKE  

BLEEDING  

Primary endpoint

Months after the index procedure

Cum

ulat

ive

inci

denc

e (%

)

0 6 12

0.00

0.01

0.02

0.03

0.04

0.05

0.06

0.07

0.08

RESET TRIAL

No. at Risk E-ZES +3-month DAPT 1059 1049 1037 1027 945

Standard therapy 1058 1046 1032 1024 920

* Primary end-point; A composite of death from CV cause, MI, stent thrombosis, TVR or bleeding at 1 year

0

2

8

6

4

Cum

ulat

ive

even

t rat

e (%

)

0 6 12

Standard therapy E-ZES + 3-month DAPT

4.7%

p-value for non-inferiority < 0.01

Months

Difference = 0.0% 95% CI, -2.5 to 2.5; p = 0.84

4.7%

Individual component of primary endpoint (ITT) in RESET

Variables E-ZES+3-month DAPT (n=1,059)

Standard therapy (n=1,058)

Difference (95% CI) p

Death, n (%) From any cause 5 (0.5) 8 (1.0) -0.5% (-1.4 – 0.4) 0.39 From cardiovascular cause 2 (0.2) 4 (0.4) -0.2% (-0.6 – 0.3) 0.41 MI, n (%) 2 (0.2) 4 (0.4) -0.2% (-0.7 ~ 0.3) 0.41 TVR, n (%) 31 (3.9) 27 (3.7) 0.2% (-2.3 – 2.6) 0.70 Non-TVR, n (%) 15 (1.5) 11 (1.5) 0.0% (-1.3 – 1.4) 0.52 Stent thrombosis, n (%) 2 (0.2) 3 (0.3) -0.1% (-0.5 – 0.3) 0.65

< 1months 2 0 1-3 months 0 0 3-12 months 0 3

Bleeding, n (%) Major or minor 5 (0.5) 10 (1.0) -0.5% (-1.2 – 0.2) 0.20 Major 2 (0.2) 6 (0.6) -0.4% (-0.9 – 0.1) 0.16

CVA, n (%) 6 (0.6) 6 (0.7) 0.1% (-0.1 – 1.0) 0.96

Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents  

Mauri, NEJM 2014  

Increased Cardio- Cerebrovascular events, MI . Less moderate, severe bleeding.  

NST-ACS  

2014 ESC/EACTS Guidelines on myocardial revascularization  

STEMI  

2014 ESC/EACTS Guidelines on myocardial revascularization  

IMAGING GUIDANCE  

Imaging Guidance  

OCT  

!  Minimal lumen area, !  percentage lumen obstruction, !  percent neointimal hyperplasia (NIH), !  stent apposition, !  stent expansion, !  minimal stent cross section area, !  lumen gain, late lumen loss, and restenosis  

Ongoing and future developments  

Ongoing and future developments  

!  Novel anti-proliferative drugs !  Directional drug delivery !  Biodegradable polymers !  Polymer-free DES

!  YUKON CHOICE (Translumina) !  Biofreedom (Biosensors) !  VESTAsync (MIV) !  Nano (Lepu Medical) !  Bicare(Lepu Medical) !  Amazonia-Pax (Minvasys)

!  Bioresorbable scaffolds !  Pro-healing stents

!  Combo (OrbusNeich) (anti CD34 + sirolimus)

NOVOLIMUS – EXCELLA II  

BVS  

CONCLUSIONS  

!  Coronary artery stenting is the treatment of choice for patients requiring coronary angioplasty

!  Newer generation DES have almost negligible ISR

!  Newer generation DES when combined with DAPT and optimal deployment a low risk of ST

!  on-going studies to evaluate:

!  newer stent platforms,

!  anti-proliferative drugs,

!  novel polymers,

!  polymer-free stents

!  and bioresorbable stents

!  Probably there will not be one single stent suitable for all patients and lesions

!  Stent according to:

!  Genetic determinants,

!  risk profile (for restenosis, thrombosis and bleeding) and

!  lesion characteristics of individual patients.