1. Jose M. de la Torre Hernández … in behalf of the 3D investigators
New Drug-eluting stents in patients with Diabetes Mellitus and multivessel Disease (3D registry)
Rafael Romaguera
Hospital de Bellvitge – IDIBELL
Barcelona University, Spain
Jose M. de la Torre Hernández
Hospital M. de Valdecillas, Spain
MIT, MA, United States
… in behalf of the 3D investigators

2. Disclosures
None

3. Background (I)
Patients with Diabetes Mellitus (DM) and multivessel disease (MVD) remain at high risk for in-stent restenosis and adverse cardiovascular events despite the use of drug-eluting stents (DES).
There is an ongoing debate about the best DES for patients with DM. To date, there are no comparisons between everolimus-eluting stents (EES) and resolute zotarolimus-eluting stents (R-ZES) in patients with DM and MVD.

4. Background (II) DES is not a binary variable (Yes or not)
Total drug amount
Strut distance
Release kinetics
Polymer biocompatibility …
OBJECTIVE: To compare the clinical performance of EES vs R-ZES in patients with DM and MVD in the real-world practice

5. Design Nationwide registry of consecutive patients with DM and MVD.
Study conducted under the auspices of the Spanish Interventional Cardiology Society.
31 centers in Spain.

6. PRIMARY ENDPOINT: TLF at 24 months (Cardiac death, ST, MI, TLR)
Design
INCLUSION CRITERIA
Diabetes mellitus
(type 1 or 2, any treatment)
2 or 3 vessel disease (with/without LAD,
with/without LM disease)
PCI with 2nd / 3rd generation DES (any different to Cypher / Taxus / Endeavor)
EXCLUSION CRITERIA
Previous CABG
Use of BMS
Use of 1st gen DES
Cardiogenic shock (index)
PRIMARY ENDPOINT: TLF at 24 months (Cardiac death, ST, MI, TLR)

7. Statistical analysis
STEP 1: Cox regression model to evaluate EES vs R-ZES effect on time to TLF. Clustered by patient.
STEP 2: Competing event scenario. Fine and Gray model to evaluate EES vs R-ZES effect on time to TLF.
STEP 3: Propensity score matching. Then, Cox regression model (with matched population).
p value signficant < R for windows v

8. Results: Study flow-chart
1066 patients
2494 lesions
EES
1302 lesions
R-ZES
679 lesions
Other DES
393 lesions
Multiple DES
120 lesions (4.8%)
EES
519 matched
lesions
R-ZES
519 matched
lesions

9. Results: Baseline characteristics
Figure: Reason PCI instead of CABG

10. Results: Baseline characteristics

11. Results: TLF

12. Results: Stent thrombosis
HR %CI (0.10 – 0.90), p 0.032
1.3% R-ZES
0.4% EES
Days from stent

13. Results (Fine & Gray): TLF
10.1% TLF R-ZES
8.3% TLF EES
HR 0.81, 95%CI ( ), p 0.180
non-CV death R-ZES
non-CV death EES

14. propensity score matching
Results:
propensity score matching
p = 0.12
Adjusted rates of TLF in the matched cohort (519 pairs)
were not different.

15. Conclusions What is know?
2nd generation DES should be preferred in diabetes
EES and R-ZES perform similarly in the general population
What is new?
EES and R-ZES provide comparable results in patients with DM and MVD.
There is a signal (but very consistent with other studies) suggesting very low rate of ST with EES also in this population
What is next?
Large randomized clinical trials are warranted to find out the optimal DES in this high risk (and forgotten) population.