late results from the paint trial percutaneous intervention with biodegradable-polymer based...
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Late Results from the PAINT trial
PercutAneous INTervention with biodegradable-polymer based paclitaxel-eluting, sirolimus-
eluting, or bare stents for the treatment of de novo coronary lesions
Pedro A. Lemos MD PhD,on behalf of the PAINT trial investigators
Heart Institute – InCorUniversity of Sao Paulo, Brazil
Potential conflicts of interestsPotential conflicts of interests
• Advisory Board:Advisory Board:• Speakers Board:Speakers Board:• Institutional Research Institutional Research
Grants:Grants:
Cordis, Boston Scientific, ScitechCordis, Boston Scientific, Scitech
Boston Scientific, Lilly, Scitech, Boston Scientific, Lilly, Scitech, AbbottAbbott
SMT, Boston Scientific, ScitechSMT, Boston Scientific, Scitech
To evaluate the late safety and
efficacy of 2 novel formulations
of DES with paclitaxel or
sirolimus, eluted in
biodegradable polymers, in
comparison to bare stents
LATE-PAINT trialMain Objective
274 patients treated with coronary stenting for:274 patients treated with coronary stenting for:- - De novo coronary lesion in a native vesselDe novo coronary lesion in a native vessel- Vessel size 2.5-3.5 mm- Vessel size 2.5-3.5 mm- Single stent per lesion up to 29-mm stent length- Single stent per lesion up to 29-mm stent length
Randomization Randomization (1:2:2)(1:2:2)
Infinnium Infinnium PESPES
(n=111 pts)
Supralimus Supralimus SESSES
(n=106 pts)
Matrix Matrix BMSBMS
(n=57 pts)(n=57 pts)
36-month clinical follow-36-month clinical follow-upup
Clopidogrel for 1 year
Study Design
9-month angiographic follow-up (96%)
Infinnium™ Paclitaxel-Eluting Stent
&Supralimus™ Sirolimus-Eluting
StentCumulative Paclitaxel Release
0
25
50
75
100
125
150
0 7 14 21 28 35 42 49 56
Time (days)
Am
ount
Pac
litax
el
Rel
ease
d (m
cg)
`
Slow drug release profile 50% release within 9 days 100% within 48 days
Drug released from the porous surface by diffusion
Polymers breaks into CO2 & H2O.
No residual polymer after 7 m.
Total drug content (µg)
Infinnium
19-mm 23-mm 29-mm
122 147 185
Supralimus125 151 191
Drug dose (µg)
Infinnium 2.5-3.5 x 19 mm122
Taxus 2.5-3.0 x 20 mm 135
Supralimus 2.5-3.5 x 19 mm125
Cypher 2.5-3.0 x 18 mm 153
Steering CommitteeSteering Committee- Pedro A. Lemos , Princ. - Pedro A. Lemos , Princ. InvestigatorInvestigator- Expedito E. Ribeiro- Expedito E. Ribeiro- Bruno M. Machado- Bruno M. Machado- Maurício de Rezende Barbosa- Maurício de Rezende Barbosa
- César R. Medeiros - César R. Medeiros - Itamar Ribeiro Oliveira- Itamar Ribeiro Oliveira- Eulógio E. Martinez- Eulógio E. Martinez- Valter C. Lima- Valter C. Lima- J. Airton Arruda- J. Airton Arruda- Fábio S. de Brito Jr. - Fábio S. de Brito Jr. - Paulo R. A. Caramori- Paulo R. A. Caramori
Data Safety and Adjudication Data Safety and Adjudication CommitteeCommittee
- Antonio Carlos Carvalho, - Antonio Carlos Carvalho, PresidentPresident- Luciano Drager- Luciano Drager- Carlos Augusto Campos- Carlos Augusto Campos
Contract Research Contract Research OrganizationOrganizationFundação Zerbini, São Fundação Zerbini, São Paulo, BrazilPaulo, Brazil
Database managementDatabase managementCoreware, São Paulo,Coreware, São Paulo,BrazilBrazil
Angiographic core labAngiographic core labCardialysis BV, Cardialysis BV, Rotterdam,Rotterdam,The NetherlandsThe Netherlands
Partial Corporate SponsoringPartial Corporate SponsoringSahajanand MT, Surat, Sahajanand MT, Surat, IndiaIndiaCMS Medical, Goiânia, CMS Medical, Goiânia, BrazilBrazil
Study Coordination
Multicenter in Brazil
Enrollment by Center
Pedro A. Lemos InCor
Bruno MoulinHUCAM
Marco PerinHosp. Sta Marcelina
Ludmilla de OliveiraNatal Hospital Center
Valter C. LimaUNIFESP
J. Airton de ArrudaIntercath Meridional
Antonio A. G. LimaHU Walter Cantidio
Paulo R. A. CaramoriPUCRS
Cesar R. MedeirosRede D’Or de Hospitais
Mauricio R. BarbosaBiocor
Fabio S. Brito Jr.Hospital São Camilo
103 pts
39 pts
32 pts
21 pts
18 pts
18 pts
15 pts
14 pts
8 pts
4 pts
2 pts
BMS(n=57 pts)
P
Male
Diabetes
61
29
67
26
0.6
0.5
SES(n=106 pts)
30 27 0.9ACS
Baseline Characteristics
67
35
PES(n=111 pts)
32
Age, y 60±10 59±10 0.660±11
LAD treated
MVD
44
37
58
42
0.1
0.9
57
35
St. diam., mm
St. length, mm
3.1±0.4 3.1±0.33.1±0.4
21.6±3.7 21.5±3.521.9±4.0
0.8
0.6
Cardiac Death 0.9 0 0.50.9
10.9 21.1Any event 8.6 <0.05
P
Myocardial infarction 6.4 5.35.7 0.8Target lesion revasc. 5.6 15.94.8 <0.01Target vessel revasc. 5.6 17.65.8 <0.01
12-Month Clinical Outcomes
BMS(n=57 pts)
SES(n=106 pts)
PES(n=111 pts)
Lemos et al. CCI 2009
33221100
20
15
10
5
0
BMS
SESPES
7.1%8.3%9.7%P=0.7
3-Year Death orNon-Fatal MI
YearsYears
Incid
en
ce (
%)
Incid
en
ce (
%)
3210
40
30
20
10
0
BMS
SES
PES
28.2%
11.3%
8.7%
P<0.01
YearsYears
Incid
en
ce (
%)
Incid
en
ce (
%)
3-Year Target Vessel Revascularization
P
Stent Thrombosis*
*Academic Research Consortium Criteria
BMS(n=57 pts)
SES(n=106 pts)
PES(n=111 pts)
1.9 0Definite 1.0 0.6
1.9 0Definite/probable 1.9 0.6
1 year
0Definite 0.5
0Definite/probable -
1 – 2 years
0Definite -
0Definite/probable -
2 – 3 years
0.9
0
0
0
0
0
0
0
Definite or Probable Definite or Probable Thrombosis in PAINT trialThrombosis in PAINT trial
Pooled DES dataPooled DES data
Compared to bare stents, implantation of biodegradable-polymer Infinnium paclitaxel- and Supralimus sirolimus-eluting stents resulted in:
• No late increase in hard events, with zero stent thrombosis after 24 months
• No loss in efficacy up to 36 months of follow-up
• Persistance of significantly better 36-m MACE rates
Conclusions
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