Φαρμακο’Εκλυουσεσ- Ενδοστεφανιαιεσ-Προθεσεις- · 0.06...
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ΦαρμακοΕκλυουσεσ Ενδοστεφανιαιεσ Προθεσεις ΚΑΡΔΙΟΛΟΓΙΚΟ ΤΜΗΜΑ, ΓΝΑ ΙΠΠΟΚΡΑΤΙΟ Δ. ΣΥΡΣΕΛΟΥΔΗΣ
Transcript of Φαρμακο’Εκλυουσεσ- Ενδοστεφανιαιεσ-Προθεσεις- · 0.06...
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.
