DIABETES trial P Jiménez-Quevedo, M Sabaté, DJ Angiolillo, JA Gómez-Hospital, R...
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Transcript of 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 trialDIABETES trial
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.
DIABETES trialDIABETES trial
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.
DIABETES trialDIABETES trial
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.
DIABETES trialDIABETES trial
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.
DIABETES trialDIABETES trial
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)
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
DIABETES trialDIABETES trial
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
DIABETES trialDIABETES trial
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
DIABETES trialDIABETES trial
% 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%
DIABETES trialDIABETES trial
CLINICAL ATHEROSCLEROSIS PROGRESSION at 2-year
%
0
2
4
6
8
10
12
7.7%10.0%
SESBMS
DIABETES trialDIABETES trial
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%
DIABETES trialDIABETES trial
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%)
DIABETES trialDIABETES trial
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.