1. Long-term follow-up of the DIABETES I (DIABETes and sirolimus Eluting Stent) 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)
No conflict of interest

2. (DIABETes and sirolimus Eluting Stent trial)
Multicenter, Prospective, Randomized. . 4 2 . 3 1
1 - Hospital San Carlos Madrid.
2 - Hospital de Bellvitge Barcelona.
3 - Hospital Clínico Valladolid
4 - Hospital do Meixoeiro Vigo

3. DIABETES TRIAL design PRIMARY ENDPOINT SECONDARY ENDPOINTS
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.

4. 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.

5. 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.

6. 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.

7. Definition: 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.

8. Flow Chart: 160 Pts Randomization 80 pts SES 80 pts BMS 111 lesions
Inclusion Criteria
Informed Consent
Rx Centralized
Sub Rx:
type of DM
80 pts SES
80 pts BMS
111 lesions
110 lesions
Abciximab + ASA mg/day + Clopidogrel 75 mg/day (at least 1 year)
1 cardiac death
2 non- cardiac death
2 missing
2 cardiac deaths
8 missing
9 Mo Angio FU (92%)
1-y clinical FU (100%)
2-y clinical U (97.5%)
9 Mo Angio FU (91%)
1-y clinical FU (100%)
2-y clinical U (100%)

9. QCA and IVUS analysis

10. Characteristics DIABETES Baseline SES BMS p= NS n=80 Age, y 66 ± 8.8
67 ± 9.6
Female, % 39
ID Diabetes, % 33 34
NID Diabetes, % 67 66
Hypertension, %
Current smoker, n % 45 50
Dyslipidemia, n % 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

11. Angiographic/Procedural characteristics
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
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
p= NS
*excluding CTO

12. 2-year results

13. 2-years Results SES BMS (n=80) p value Cardiac death, n (%) 2 (2.6)
3 (3.8) 1
MI, n (%)
Non-Q wave
Q-wave
1 (1.3)
7 (8.8)
6 (7.5)
0.3
0.1
0.6
TLR, n (%)
PCI
Bypass
6 (7.7)
0 (0)
28 (35.0)
27 (33.8)
<0.001
MACE, n (%)
10 (12.8)
33 (41.3)

14. % FREEDOM FROM TLR 92% 65% Event-free survival (%)
100
92% 80
65% 60
Event-free survival (%)
Sirolimus stent
Bare metal stent 40
Long rank test<0.0001 20
200
400
600
800
Time (days)

15. CLINICAL ATHEROSCLEROSIS PROGRESSION at 2-year%
10.0%
7.7%
BMS
SES

16. 85% 61% % FREEDOM FROM ANY REVASCULARIZATION Event-free survival (%)
200
400
600
800 20 40 60 80
100
85%
61%
Event-free survival (%)
Sirolimus stent
Bare metal stent
Test Long rank =0,0008
Time (days)
Time after initial procedure

17. Stent thromboses during dual antiplatelet treatment (<1-y)
Sirolimus Stent
Bare metal Stent 0%
1(1.3%)
<30 days
days

18. Stent thromboses after clopidogrel withdrawal (> 1 year)0%
3 (3.8%)
BMS
SES

19. 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.