DIABETES trial P Jiménez-Quevedo, M Sabaté, DJ Angiolillo, JA Gómez-Hospital, R...

DIABETES trialDIABETES trial

P Jiménez-Quevedo, M Sabaté, DJ Angiolillo, JA Gómez-Hospital, R Hernández-Antolín, J Goicolea, F Alfonso, C Bañuelos, J Escaned, R Moreno,

F Fernández-Avilés, C Macaya

(On behalf of the DIABETES Investigators)

P Jiménez-Quevedo, M Sabaté, DJ Angiolillo, JA Gómez-Hospital, R Hernández-Antolín, J Goicolea, F Alfonso, C Bañuelos, J Escaned, R Moreno,

F Fernández-Avilés, C Macaya

(On behalf of the DIABETES Investigators)

No conflict of interestNo conflict of interest

Long-term follow-up of the DIABETES I (DIABETes and sirolimus Eluting Stent) trial:

Long-term follow-up of the DIABETES I (DIABETes and sirolimus Eluting Stent) trial:

DIABETES trialDIABETES trialDIABETES

(DIABETes and sirolimus Eluting Stent trial)DIABETES

(DIABETes and sirolimus Eluting Stent trial)

...

.2

1

3

4

1 - Hospital San Carlos Madrid. 2 - Hospital de Bellvitge Barcelona. 3 - Hospital Clínico Valladolid4 - Hospital do Meixoeiro Vigo

Multicenter, Prospective, Randomized.


DIABETES TRIAL designPRIMARY ENDPOINT

Late lumen loss (in-stent and in-segment) as assessed by QCA at 9-month angiographic follow-up. SECONDARY ENDPOINTS

Other QCA parameters (restenosis, MLD) at FU.

Mean neointimal hyperplasia and % volume obstruction by

IVUS at 9-month follow-up.

MACE (Cardiac death, MI and TLR) at 30 d, 9,12, 13 and 24 months.

Development of complications: aneurysm formation, late thrombosis, edge effect, late stent malapposition.


Inclusion criteria:

Diabetic patient (non-insulin dependent or insulin dependent) according to WHO 1999 Report. Coronary lesions in native coronary arteries and symptoms or objective evidence of ischemia. Lesion favourable for PTCA + stent implantation. Informed consent.


Exclusion criteria: Diabetic patient without pharmacological treatment (on diet). Stenoses located in true bifurcations, SVG, LIMA or unprotected left main. In-stent restenosis. Chronic renal or hepatic insufficiency. Previous brachytherapy or DES implantation. Recent AMI (<72h) with CPK (x 2). Malignancy.


Objectives:

To present the Long-term clinical follow-up of patients included in the DIABETES trial:

Need for repeated TLR.

Need for non-TLR (atherosclerosis progression).

Safety after clopidogrel withdrawal at

1-year.


Clinical atherosclerosis progression:

the need for revascularization secondary to development of new significant coronary stenoses, not present in previous angiograms, accompanied by symptoms or evidence of ischemia.

Definition:

DIABETES trialDIABETES trialFlow Chart:Flow Chart:

160 Pts 160 Pts RandomizationRandomization

Inclusion CriteriaInformed ConsentInclusion CriteriaInformed Consent

Rx CentralizedSub Rx: type of DM

Rx CentralizedSub Rx: type of DM

80 pts SES 80 pts BMS110 lesions

9 Mo Angio FU (92%)1-y clinical FU (100%)2-y clinical U (97.5%)

111 lesions

2 cardiac deaths8 missing2 cardiac deaths8 missing

1 cardiac death2 non- cardiac death2 missing

1 cardiac death2 non- cardiac death2 missing

9 Mo Angio FU (91%)1-y clinical FU (100%)2-y clinical U (100%)

Abciximab + ASA 100-300 mg/day + Clopidogrel 75 mg/day (at least 1 year)


QCA and IVUS analysisQCA and IVUS analysis

DIABETES trialDIABETES trial BaselineBaseline CharacteristicsCharacteristics

SES n=80

BMS n=80

Age, y 66 ± 8.8 67 ± 9.6

Female, % 39 39

ID Diabetes, % 33 34

NID Diabetes, % 67 66

Hypertension, % 66 66

Current smoker, n % 45 50

Dyslipidemia, n % 61 61

Previous MI, n % 31 43

Previous revascularization % 20 18

Ejection Fraction, % 67 ±13 63 ±14

HbA1c, % 7.4 ±1.5 7.3 ±1.4

LDL-cholesterol, mg/dl 104 ±31 104 ±28

Creatine clearance, ml/min 71 ±23 75 ±30

p= NS

DIABETES


p= NS

SES n=111

BMS n=110

Treated artery, % LAD/LCX/RCA 39/21/40 44/23/33

Lesion length*, mm 14.5±8.2 15.3±7.6

Reference diam, mm 2.3±0.5 2.3±0.5

Total occl, % 13 14

Multivessel stent, % 23 24

N. stenosis / patient 1.4±0.6 1.4±0.5

N. stent / patient 1.6±0.8 1.7±0.9

Stent length, mm 22±10 23±13

IIb/IIIa inhibitors, % 64 54

Angiographic/Procedural characteristics

*excluding CTO


2-year results


2-years Results SES(n=80)

BMS(n=80)

p value

Cardiac death, n (%) 2 (2.6) 3 (3.8) 1

MI, n (%) Non-Q wave Q-wave

3 (3.8)1 (1.3)2 (2.6)

7 (8.8)6 (7.5)1 (1.3)

0.30.10.6

TLR, n (%) PCI Bypass

6 (7.7)6 (7.7)0 (0)

28 (35.0)27 (33.8)1 (1.3)

<0.001<0.0011

MACE, n (%) 10 (12.8) 33 (41.3) <0.001


% FREEDOM FROM TLRE

vent

-fre

e su

rviv

al (

%)

Time (days)

0 200 400 600 800

0

20

40

60

80

100

Long rank test<0.0001

Sirolimus stentBare metal stent

92%

65%


CLINICAL ATHEROSCLEROSIS PROGRESSION at 2-year

%

0

2

4

6

8

10

12

7.7%10.0%

SESBMS


Time (days)

Sirolimus stentBare metal stent

% FREEDOM FROM ANY REVASCULARIZATION

Time after initial procedure

0 200 400 600 800

0

20

40

60

80

100

Test Long rank =0,0008Eve

nt-f

ree

surv

ival

(%

)

85%

61%


Stent thromboses during dual antiplatelet treatment (<1-y)

<30 days 30-365 days

0

1

2

3

4

5

Sirolimus StentBare metal Stent

0%

1(1.3%)

0%

1(1.3%)


Stent thromboses after clopidogrel withdrawal (> 1 year)

0

1

2

3

4

5

0%

3 (3.8%)

BMS SES

DIABETES trialDIABETES trialConclusions (I):Conclusions (I):

DIABETES trial demonstrated that the significant reduction in clinical restenosis and major cardiac events observed in the Sirolimus group persisted up to 2 years.

This benefitial effect of sirolimus stent implantation may be tarnished by long term incidence of late stent thrombosis after clopidogrel withdrawal.

DIABETES trial demonstrated that the significant reduction in clinical restenosis and major cardiac events observed in the Sirolimus group persisted up to 2 years.

This benefitial effect of sirolimus stent implantation may be tarnished by long term incidence of late stent thrombosis after clopidogrel withdrawal.

DIABETES trial P Jiménez-Quevedo, M Sabaté, DJ Angiolillo, JA Gómez-Hospital, R...

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