1. DEScover: One-Year Clinical Results
Presented at
Transcatheter Cardiovascular
Therapeutics 2006
Presented by Dr. David O. Williams and Dr. J. Dawn Abbott

2. DEScover One-Year Clinical Results: Study Design
Prospective/observational study
140 clinical sites in the US
Each site to enroll at least 60 consecutive patients undergoing PCI:
Target -7,500 patients
Enrollment period: December 2004 –June 2005
Exclusion criteria: refusal or inability to provide written informed consent and/or HIPAA authorization
Presented at TCT 2006

3. DEScover One-Year Clinical Results: Definitions
Death
All cause mortality
Myocardial infarction
Evolutionary ST-segment elevation, or
New Q-waves or LBBB, or
CK>2 ULN and elevated CK-MB or troponin
Stent thrombosis
Acute (0-24 hours), sub-acute (>24 hours – 30 days), or late (>30 days)
Classified as definite or probable (composite presented)
Adjudicated by an independent events committee
Angiographic characteristics were evaluated at the
clinical sites
Presented at TCT 2006

4. DEScover One-Year Clinical Results: Study Population
Enrolled patients n = 7752
> 1 stent attempted
n = 7420 (96%)
Balloon angioplasty
n = 325 (4%)
Bare-metal stent (BMS)
n = 397 (5%)
Drug-eluting stent (DES)
n = 7023 (95%)
SES only
n = 3873 (55%)
Combinations
n = 514 (7%)
PES only
n = 2636 (38%)
Presented at TCT 2006

5. DEScover One-Year Clinical Results: Baseline Characteristics
BMS Group
(n=397)
SES Group
(n=3873)
PES Group
(n=2636)
p-value BMS vs. DES
Mean Age, SD (years)
0.001
Prior coronary bypass (%)
26.6
18.3
20.0
0.0002
Prior angioplasty (%)
29.5
36.9
38.1
0.0017
Mean ejection fraction, SD
<0.0001
Ejection fraction <40% (%)
13.2
13.5
Patients in the BMS group were older (p=0.001), had a higher percentage of prior coronary bypass (p=0.0002), a lower percentage of prior angioplasty (p=0.0017), a lower ejection fraction (p<0.0001), and a greater percentage EF <40% (p=0.001) than patients in the DES group.
Presented at TCT 2006

6. DEScover One-Year Clinical Results: Baseline Characteristics
BMS Group (n=397)
SES Group (n=3873)
PES Group (n=2636)
p-value BMS vs. DES
Vessel Disease:
Single
Double
Triple
59.2
21.5
19.3
57.6
26.6
15.9
57.5
27.4
15.1
0.03
Indication for procedure (%)
Acute MI
Unstable Angina
Stable Angina
Objective Evidence of Ischemia
Other/Undetermined
31.8
26.3
9.6
23.7
8.6
21.0
31.6
14.4
25.0
8.0
20.8
34.2
14.5
23.3
7.1
<0.0001
Patients in the BMS group had greater multivessel disease (p=0.03) as well as a higher incidence of acute MI and unstable angina (p<0.0001) than patients in the DES group.
Presented at TCT 2006

7. DEScover One-Year Clinical Results: Procedural Characteristics
Patients in the BMS group had fewer attempted lesions (p<0.0001), a lower frequency of multi-lesion intervention (p=0.0005), fewer stents used (p<0.0001), less stent overlap (p=0.06) than DES patients
BMS patients had a higher incidence of total occlusions (p<0.0001) and de novo lesion intervention (p=0.01)
BMS Group (n=397)
SES Group (n=3873)
PES Group (n=2636)
p-value BMS vs. DES
Mean attempted lesions, SD
<0.0001
Multi-lesion intervention (%)
25.5
34.7
32.3
0.0005
Mean stents used, SD
Stent overlap (%)
13.2
17.5
15.1
0.06
Lesion type (%)
total occlusion
de novo lesion
19.1
96.5
11.2
93.7
9.9
94.1
0.01
Presented at TCT 2006

8. DEScover One-Year Clinical Results: Procedural Characteristics
Patients in the BMS group had a significantly larger maximum diameter of stent used (p<0.0001), but a shorter stent length (p=0.0002) than patients in the DES group
BMS patients had a significantly higher incidence of persistent flow reduction (p<0.0001) and a lower procedural success rate (p=0.005) than DES patients
BMS Group (n=397)
SES Group (n=3873)
PES Group (n= 2636)
p-value BMS vs. DES
Mean max. diam. of stent used, SD
<0.0001
Mean max. length of stent used, SD
0.0002
Persistent flow reduction (%)
2.3
0.3
0.7
Procedural Success
Complete
Partial
Failure
96.7
2.8
0.5
98.7
1.3
0.1
98.3
1.5
0.2
0.005
Presented at TCT 2006

9. DEScover One-Year Clinical Results: BMS vs. DES Adverse Events
Adverse Events (%) at one-year post-PCI for BMS (n=397) vs. DES (n=6509) patients
p=0.007
p=0.62
p=0.002
Death (p = 0.005), CABG (p = ), TVR (p = 0.007) and the composite of Death/MI
(p = 0.002) were significantly lower in DES group versus BMS group at one-year post-PCI on univariate analysis
p=0.005
p=0.19
p=0.0007
p=0.67
Presented at TCT 2006

10. DEScover In Hospital Results: SES vs. PES Adverse Events
Adverse Events (%) in-hospital post-PCI for SES (n=3873) vs. DES (n=2636) patients
p=0.18
There was no statistically significant difference in adverse events between SES and PES patients in-hospital post-PCI.
p=0.40
p=0.67
p=0.49
p=0.22
p=0.31
p=0.41
Presented at TCT 2006

11. DEScover One-Year Clinical Results: SES vs. PES Adverse Events
Adverse Events (%) at one-year post-PCI for SES (n=3873) vs. DES (n=2636) patients
p=0.37
There was no statistically significant difference in adverse events between SES and PES patients at one-year post-PCI.
p=0.20
p=0.64
p=0.45
p=0.20
p=0.53
p=0.06
Presented at TCT 2006

12. DEScover One-Year Clinical Results: BMS vs. DES
Patient selection
BMS placed more often in AMI, CABG
DES preferred for prior stent procedures
Clinical outcomes
Unadjusted data for death favored DES (3.1% vs. 5.9%, p=0.005) and Death/MI (5.2% vs. 9.0%, 0.002) but no difference following adjustment (HR 0.74, 95% CI )
Unadjusted data favored DES for TVR (6.0% vs. 9.5%, 0.007) as well as adjusted results (HR 0.58, 95% CI ).
Presented at TCT 2006

13. DEScover One-Year Clinical Results: SES vs. PES
Patient selection
Baseline clinical and angiographic features nearly identical
Clinical outcomes
Early, intermediate, and one-year clinical outcomes similar (p=ns) with rates of major adverse events low
Death %, 2.8%
MI %, 2.6%
Death/MI 5.2%, 5.3%
Stent thrombosis 0.5%, 0.8%
No significant differences in rates of any repeat PCI, CABG, or TVR (6.3%, 5.5%)
Presented at TCT 2006

14. DEScover One-Year Clinical Results: Limitations
Number of BMS patients relatively small in
comparison to DES group
Selection bias between BMS and DES patients (BMS put in STEMI pts, CABG pts etc)
Adjustment may not compensate for baseline differences
No information regarding antiplatelet therapy usage during follow-up
Follow-up beyond one-year desirable
Presented at TCT 2006