Drug-eluting stents HCS Working Group Seminars Macedonia Pallas Hotel, Friday 21 st February 2014 Drug-eluting stents Are they all equal? Vassilis Vassilis Spanos Spanos Interventional Cardiologist, As. Director 3 Interventional Cardiologist, As. Director 3 rd rd Cardiology Clinic Cardiology Clinic Euroclinic Hospital, Athens Euroclinic Hospital, Athens
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Drug -eluting stents Are they all equal? · Kandzari D.Kandzari D.et.al. “ et.al. “Comparison of zotarolimusComparison of zotarolimus--eluting and sirolimuseluting and sirolimus--eluting
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Drug-eluting stents
HCS Working Group Seminars
Macedonia Pallas Hotel, Friday 21st February 2014
Drug-eluting stents
Are they all equal?
VassilisVassilis SpanosSpanosInterventional Cardiologist, As. Director 3Interventional Cardiologist, As. Director 3rdrd Cardiology ClinicCardiology Clinic
Sousa JE et al. Lack of Neointimal Proliferation After Implantation of Sirolimus-Coated Stents in Human
Coronary Arteries : A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound
Study ( Circulation. 2001;103:192-195 )
An unsuccessful trial - QuaDDS stent
F. Liistro, A. Colombo: Late acute thrombosis after paclitaxel eluting stent implantation
(Heart 2001;86:262-264 )
““CONCLUSIONCONCLUSION: : This single case report highlights the problem that late coronary thrombosis following paclitaxel This single case report highlights the problem that late coronary thrombosis following paclitaxel
eluting stent implantation may be an important limitation of restenosis prevention by some drug eluting stents. eluting stent implantation may be an important limitation of restenosis prevention by some drug eluting stents.
In the absence of other data, we think that combined antiplatelet treatment should be continued in the long term, In the absence of other data, we think that combined antiplatelet treatment should be continued in the long term,
unless it is contraindicatedunless it is contraindicated””
DES proven superior to BMS and DES proven superior to BMS and
used extensively in everyday practice used extensively in everyday practice
in USA & Europein USA & Europe
Cypher stentCypher stent
Taxus stentTaxus stent
DES proven superior to BMSDES proven superior to BMS
DES proven nonDES proven non--inferior to either inferior to either
Cypher or Taxus Cypher or Taxus
DES tested in clinical studies and/or DES tested in clinical studies and/or
used in everyday practice in Europeused in everyday practice in Europe
The Endeavor stent: ENDEAVOR II Study
TVFTVF at 9 months was at 9 months was
reduced from 15.1% to reduced from 15.1% to
7.9% with the Endeavor 7.9% with the Endeavor
((pp=0.0001)=0.0001)
FajadetFajadet J.J. et.al. “et.al. “Randomized, doubleRandomized, double--blind, multicenter study of the Endeavor blind, multicenter study of the Endeavor zotarolimuszotarolimus--eluting eluting
phosphorylcholinephosphorylcholine--encapsulated stent for treatment of native coronary artery lesions: clinical and encapsulated stent for treatment of native coronary artery lesions: clinical and
angiographic results of the ENDEAVOR II trial” Circulation 2006; 114angiographic results of the ENDEAVOR II trial” Circulation 2006; 114: 798: 798--806806
((pp=0.0001)=0.0001)
The rate of inThe rate of in--segment segment
restenosis was reduced from restenosis was reduced from
35.0% to 13.2% with 35.0% to 13.2% with
Endeavor (Endeavor (pp<0.0001)<0.0001)
End points Endeavor
(n=282)
Cypher
(n=94)
p
In-stent mean lumen diameter (mm) 2.08 2.52 <0.001
In-segment mean lumen diameter (mm) 1.92 2.16 <0.001
In-stent diameter stenosis (%) 24.3 11.0 <0.001
The Endeavor stent: ENDEAVOR III Study
In-stent diameter stenosis (%) 24.3 11.0 <0.001
In-segment diameter stenosis (%) 29.9 23.9 <0.001
In-stent binary restenosis (%) 9.2 2.1 0.02
In-segment binary restenosis (%) 11.7 4.3 0.04
In-stent late loss (mm) 0.60 0.15 <0.001
In-segment late loss (mm) 0.34 0.13 <0.001
Kandzari D.Kandzari D. et.al. “et.al. “Comparison of zotarolimusComparison of zotarolimus--eluting and sirolimuseluting and sirolimus--eluting stents in patients with eluting stents in patients with
RasmunsenRasmunsen K.K. et.al. “et.al. “Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents
in routine clinical care (SORT OUT III): a randomised controlled superiority trial” JACC 2006; 46” JACC 2006; 46: :
24402440--4747
Biolimus vs Sirolimus eluting stents
5 years follow up of the LEADERS Trial5 years follow up of the LEADERS Trial857 857 ptspts with BES vs. 850 with SESwith BES vs. 850 with SES
P. P. SerruysSerruys, TCT 2012, TCT 2012
Biolimus vs Sirolimus eluting stents
5 years follow up of the LEADERS Trial5 years follow up of the LEADERS Trial857 857 ptspts with BES vs. 850 with SESwith BES vs. 850 with SES
P. P. SerruysSerruys, TCT 2012, TCT 2012
Biolimus vs Sirolimus eluting stents
5 years follow up of the LEADERS Trial5 years follow up of the LEADERS Trial857 857 ptspts with BES vs. 850 with SESwith BES vs. 850 with SES
P. P. SerruysSerruys, TCT 2012, TCT 2012
DES: Different approaches
Αντίδραση υπερευαισθησίας
J. Nebeker et al. (JACC. 2006;47:175-181)
Paclitaxel vs. Everolimus eluting stents2 years follow up of the SPIRIT IV Trial2 years follow up of the SPIRIT IV Trial
2458 2458 ptspts with EES vs. 1229 with PESwith EES vs. 1229 with PES
Stone G. et Stone G. et al “2 year follow up from the SPIRIT IV al “2 year follow up from the SPIRIT IV Trial”Trial”J Am Coll Cardiol 2011:28;58(1):19-25
EES vs. SES: SORT OUT IV Trial1390 1390 ptspts (1805 lesions) with EES vs. 1384pts (1779 lesions) with SES(1805 lesions) with EES vs. 1384pts (1779 lesions) with SES
Jensen L. et Jensen L. et al al Circulation.2012; 125: 1246-1255
Less ST with Everolimus
eluting stents
4 years Registry, 12339 4 years Registry, 12339 ptspts::
4212 4212 lsnslsns EES EES -- 4308 PES 4308 PES -- 3819 SES 3819 SES
RaberRaber L. et L. et al “al “Very Late Coronary Stent Thrombosis of a Newer-Generation Everolimus-Eluting
Stent Compared With Early-Generation Drug-Eluting Stents” Circulation.2012; 125: 1110-1121
Lower risk of cardiac death/MI with Lower risk of cardiac death/MI with
EES compared with PES (hazard EES compared with PES (hazard
13 months follow up of the RESOLUTE All 13 months follow up of the RESOLUTE All ComersTrialComersTrial1140 1140 ptspts with ZES vs. 1152 with EESwith ZES vs. 1152 with EES
0.15mm
0.06mm
SerruysSerruys P. et P. et al “al “Comparison of Zotarolimus-Eluting and Everolimus-Eluting Coronary Stents” ”
N Engl J Med 2010; 363:136-146
0.06mm
New DES have to present convincing data
S. Windecker et al. (PCR 2013)
The CoStar stent: PISCES Study
P. Serruys et al. ( JACC 2005;46:253-260 )
Lowest in-stent late loss (0.38 mm, and 0.30 mm, p <0.01) and volume
obstruction (8% and 5%, p <0.01) in the 30-day release groups (10µg, 30µg).
8.6% MACE for DES: death 0.5%, myocardial infarction 2.7%, and TLR 5.3%.
•DES are complex devices with different characteristics and
should be judged from their results as regards efficacy and
safety
CONCLUSIONS
•There are second generation DES that have shown superiority
compared to first generation (Cypher or Taxus) stents
•DES technology will continue to evolve aiming to devices with
higher efficacy and safety
Thank you for your attention!Thank you for your attention!
www.mathetinkardiasou.grwww.mathetinkardiasou.gr
The Endeavor stent: More safe?
ZES SES PES
1 year follow up of the ZEST Trial1 year follow up of the ZEST Trial2645 2645 ptspts randomized to ZES, SES, PESrandomized to ZES, SES, PES
Park D.Park D. et.al. “et.al. “Comparison of Zotarolimus-Eluting Stents With Sirolimus- and Paclitaxel-Eluting
Stents for Coronary Revascularization : The ZEST (Comparison of the Efficacy and Safety of
Zotarolimus-Eluting Stent with Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary
2 years follow up of the COMPARE Trial2 years follow up of the COMPARE Trial897pts (1286 lesions) with EES vs. 903pts (1294 897pts (1286 lesions) with EES vs. 903pts (1294 lsnslsns) with PES) with PES
Smits P. et Smits P. et al “2 year follow up al “2 year follow up of a Randomized Controlled Trial of EES and PES for Coronary
Revascularization in Daily Practice” J Am Coll Cardiol. 2011;58(1):11-18
Paclitaxel vs. Everolimus eluting stents
2 years follow up of the SPIRIT III Trial2 years follow up of the SPIRIT III Trial669 lesions with EES vs. 333 with PES669 lesions with EES vs. 333 with PES
0.28mm
Stone G. et Stone G. et al Randomized Comparison of al Randomized Comparison of EverolimusEverolimus--Eluting and Eluting and PaclitaxelPaclitaxel--Eluting Eluting
Serruys P. American College of Cardiology 2007 Scientific Sessions; March 24, 2007.
In-stent restenosis (%) 11.5
A stent A stent made from a polylactic acid (PLA) backbone, with an everolimus/PLA made from a polylactic acid (PLA) backbone, with an everolimus/PLA
coating coating expected toexpected to dissolve dissolve completely completely after 12after 12--18 month18 monthss
LLate loss and restenosis were greater than with current ate loss and restenosis were greater than with current DESDES, , probably due toprobably due to the the
15% shrinkage seen with the new stent15% shrinkage seen with the new stent
DES: a lot of different devices
DES proven superior to BMS and DES proven superior to BMS and
used extensively in everyday practice used extensively in everyday practice
in USA & Europein USA & Europe
Cypher stentCypher stent
Taxus stentTaxus stent
DES proven superior to BMSDES proven superior to BMS
DES proven nonDES proven non--inferior to either inferior to either
Cypher or Taxus Cypher or Taxus
DES tested in clinical studies and/or DES tested in clinical studies and/or
used in everyday practice in Europeused in everyday practice in Europe