INTERVENCIONISMO CARDIACO

Manel SabatéH. Clínic, Barcelona

Intervencionismo Cardiaco 2008-09

- Tratamiento de la enfermedad multivaso y/o TCI:- ICP vs. Cirugía en enfermedad de 3 v y/o TCI:

Syntax 2 años- ICP en TCI: ISAR-Left Main; Main Compare;

LeMans Registry- Stent farmacoactivos de 2ª generación:

- SPIRIT IV, COMPARE trials.- NEVO II

Intervencionismo Cardiaco 2008-09

- Tratamiento de la enfermedad multivaso y/o TCI:- ICP vs. Cirugía en enfermedad de 3 v y/o TCI:

Syntax 2 años- ICP en TCI: ISAR-Left Main; Main Compare;

LeMans Registry- Stent farmacoactivos de 2ª generación:

- SPIRIT IV, COMPARE trials.- NEVO II

71% enrolled

(N=3,075)

All Pts with de novo 3VD and/or LM disease (N=4,337)

Treatment preference (9.4%) Referring MD or pts. refused

informed consent (7.0%) Inclusion/exclusion (4.7%) Withdrew before consent (4.3%) Other (1.8%) Medical treatment (1.2%)TAXUS

n=903PCI

n=198CABG

n=1077CABGn=897

no f/un=428

5yr f/un=649

PCIall captured w/

follow up

CABG2500

750 w/ f/uvsvs

Total enrollment N=3075

Stratification: LM and Diabetes

Two Registry ArmsRandomized Armsn=1800

Two Registry ArmsN=1275

Randomized ArmsN=1800

Heart Team (surgeon & interventionalist)

PCIN=198

CABGN=1077

Amenable for only one treatment approach

TAXUS*

N=903 CABG

N=897 vsvs

Amenable for bothtreatment options

Stratification: LM and Diabetes

LM33.7%

3VD66.3%

LM34.6%

3VD65.4%

23 US Sites62 EU Sites +SYNTAX Trial DesignSYNTAX Trial Design

**TAXUS ExpressTAXUS Express

Patient Characteristics (II)Patient Characteristics (II)Randomized CohortRandomized Cohort

Patient-basedCABGN=897

TAXUSN=903 P value

Total SYNTAX Score 29.1 ±11.4 28.4 ±11.5 0.19Diffuse disease or small vessels, % 10.7 11.3 0.69No. lesions, mean ± SD 4.4 ±1.8 4.3 ±1.8 0.443VD only, % 66.3 65.4 0.70Left main, any, % 33.7 34.6 0.70 Left Main only 3.1 3.8 0.46 Left Main + 1 vessel 5.1 5.4 0.78 Left Main + 2 vessel 12.0 11.5 0.72 Left Main + 3 vessel 13.5 13.9 0.78Total occlusion, % 22.2 24.2 0.33Bifurcation, % 73.3 72.4 0.67Trifurcation, % 10.6 10.7 0.92

Average Number of Stents Implanted per Patient

0

1

2

3

4

5

Avg

. # s

tent

s or

lesi

ons

treat

ed

4.6

3.5 3.7

Average Total Stented Length

0

20

40

60

80

100

71

Ave

rage

tota

l ste

nt le

ngth

(mm

) 86.1

73

MAIN-COMPARE trialn=858 (n=660-SES; n=189 PES)

Lee JY et al. J Am Coll Cardiol 2009; 54:853–9

ISAR-LEFT MAIN trial

Mehili J et al. J Am Coll Cardiol 2009;53:1760–8

Le Mans Registry

Buszman PE et al. J Am Coll Cardiol 2009;54:1500–11

Intervencionismo Cardiaco 2008-09

- Tratamiento de la enfermedad multivaso y/o TCI:- ICP vs. Cirugía en enfermedad de 3 v y/o TCI:

Syntax 2 años- ICP en TCI: ISAR-Left Main; Main Compare;

LeMans Registry- Stent farmacoactivos de 2ª generación:

- SPIRIT IV, COMPARE trials.- NEVO II

SPIRIT IV trial

SPIRIT IV trial

SPIRIT IV trial

SPIRIT IV trial

Eligible Patients for PCI

Guide-wire passage± Predilatation

Operator blinded1:1 Randomisation

Taxus Liberte Xience V

Expected MACE 9% versus 14 % (delta 5%)Power 85%1800 patients

Eligible Patients for PCI

Guide-wire passage± Predilatation

Operator blinded1:1 Randomisation

Taxus Liberte Xience V

Expected MACE 9% versus 14 % (delta 5%)Power 85%1800 patients

Study Outline: COMPARE trial

Clinical events were adjudicated by an independent CECTarget vessel revascularizations were analysed by an independent QCA core lab.

Primary Endpoint Result MACE (all death, non-fatal MI and TVR)

# Patients at Risk

Taxus

Xience P = 0.023 (log-rank test)

RR = 0.69 (0.50-0.95) 9.1 %

6.2 %

Taxus 903 868 865 860 853 849 842 838 833 825 823 822 819Xience 897 872 870 867 865 864 858 854 851 849 844 842 840

Δ 1.1%

Δ 2.9 %

Secondary Endpoint Result Stent Thrombosis

(Definite & probable according to ARC)

2.6 %

0.7 %

Taxus

Xience P = 0.002 (log-rank test)

RR = 0.26 (0.11-0.64)

The NEVO™ stent provides:

CoCr stent platform- Flexible, conformable, thin

struts, maximized vesselcoverage, open cell design

Reservoir Technology (RES-TECHNOLOGY™)

- Reduced contact between vessel wall

and polymer

Biodegradable polymer - Rapid endothelialization

- Inflammation scores on par with BMS- Tailored sirolimus release achieving

CYPHER®-like tissue levels

Sirolimus - Largest body of clinical evidence

NEVO™ Sirolimus-Eluting Stent : Cordis’ 1st RES TECHNOLOGY™ Stent

Bridge elements

Reservoirs

Ductile Hinges

Reservoirs minimize tissue/polymer contact areaby more than 75%

0

20

40

60

80

100

Surface Coated Stent NEVO™ Stent

75%Reduction

NEVO™: Reduced Relative Polymer Exposure

NEVO RES-I Study Overview

40 sites worldwideEurope, South America, Australia and New Zealand

394 subjects, stratified by diabetic status, and randomized 1:1

Single De Novo Native Coronary Artery LesionsReference Vessel Diameter: 2.5 - 3.5 mm

Lesion Length: ≤ 28 mm

Primary Endpoint: 6-month in-stent late lossSub-Study: IVUS subset (50 patients per arm)

Dual antiplatelet therapy for ≥ 6 months

NEVO™ Sirolimus-eluting Stent

(n = 202)

TAXUS® Liberté™ Paclitaxel-eluting Stent

(n = 192)

30 Day 6Months 1Year 2Year 3Year 4ear

Angiographic/ IVUS

5Year

Clinical/ MACE

87% Angiographic follow up; 97% 180 day clinical follow up

P<0.001 for superiority

P<0.001

Primary Endpoint

Late

Los

s (m

m)

±0.31

±0.48

±0.32

±0.42

n=185 n=166 n=166 n=166

Primary Endpoint: Late Lumen Loss at 6 Months

NEVO™

Taxus® Liberte™

TCT 09, Oral presentation, J. Ormiston

P = 0.19

P = 0.37

P = 0.75

No reports of Emergent CABG

% o

f pat

ient

s

8/198 13/189 1/198 3/189 4/198 5/189 5/198 8/189 3/198 6/187

P = 0.354

P = 0.33

6-Month MACE and Components

10

8

6

4

2

0

MACE Death MI Death or MI TLR

4.0

7.4

0.5

1.62.0

2.6 2.5

4.2

1.5

3.2

NEVO™

Taxus® Liberte™

EuroPCR 09, Oral presentation, Chr. Spaulding

Diabetic Subgroup Analysis:In-Stent Late Lumen Loss at 6 Months

Diabeticsn = 65

Non-Diabeticsn = 277

0.5

0.3

0.4

0.1

0.2

0.0

P = 0.03 P < 0.001

0.17

± 0.42

0.42

± 0.46

0.12

± 0.28

0.34

± 0.46

Late

loss

(mm

)

NEVO™

Taxus® Liberté™

EuroPCR 09, Oral presentation, Chr. Spaulding

Intervencionismo Cardiaco 2008-09CONCLUSIONES

- La cirugía presenta mejores resultados que la ICP en pacientes con enfermedad de 3 v y/o TCI a los 2 años de seguimiento a expensas de una mayor necesidad de nueva revascularización con ICP.

- Los pacientes con Syntax score bajo evolucionan de forma parecida entre ICP y cirugía coronaria.

- Los pacientes con enfermedad de tronco pueden beneficiarse de la ICP. Se requieren estudios multicéntricos diseñados a este objetivo.

- Los stent farmacoactivos de 2ª generación son más eficaces y más seguros que los de 1ª generación (Taxus™)