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