1. Comprehensive Meta-Analysis of DES vs
Comprehensive Meta-Analysis of DES vs. BMS Randomized Trials and Registries
Ajay J. Kirtane, M.D., S.M.
Gregg W. Stone, M.D.

2. Conflict of Interest Disclosure
Ajay J. Kirtane
Past honorarium from Boston Scientific Corporation (modest)
Consultant/Speaker: Medtronic Vascular, Abbott Vascular (modest)
Gregg W. Stone
Research grants from Boston Scientific and Abbott Vascular

3. Background: DES vs. BMS RCTs
In most individual RCTs, DES have reduced the rates of TLR and TVR compared to BMS, with no significant differences in death or MI
However, individual RCTs are underpowered to assess low frequency endpoints
RCTs, particularly the pivotal RCTs leading to regulatory approval, have been criticized for not reflecting “real-world” DES use
RCT outcomes may vary based upon differences in enrollment criteria (e.g. “on-label” vs. “off- label”), the amount of routine angiographic FU, and with the duration of clinical FU

4. Background: DES vs. BMS Registries
In order to address issues of both sample size as well as generalizability to the “real-world”, numerous observational and registry comparisons of DES vs. BMS have been undertaken
The outcomes from these studies have varied
While more generalizable than RCTs, the DES vs. BMS registries are heterogeneous, with differences in design and analysis methodology (e.g. adjusted vs. unadjusted, type of adjustment)
Registry outcomes may also vary based upon the types of patients enrolled (e.g. all comers vs. just ACS or high risk), and the duration of clinical FU

5. Persistent Questions: DES vs. BMS
While some of the alarm generated after ESC has been mitigated by analyses of patient-level data from the “on-label” RCTs*, there remains concern regarding DES outcomes in “off-label” patients and lesions, and with uncontrolled use
Are DES safe in higher risk off-label pts and in the unregulated environment of real-world use?
Are the benefits of DES in reducing TVR as robust in the real-world as in the RCTs, given the impact of routine angio FU and the oculostenotic reflex in many RCTs?
*Stone et al, Kastrati et al, Spaulding et al, Mauri et al
N Engl J Med 2007; 356(10).

6. Methods: Goals and Objectives (1)
We therefore sought to perform a systematic review and meta-analysis of DES vs. BMS studies
To derive summary estimates of all-cause mortality, MI, and TVR in studies with ≥1 year of follow-up
To specifically assess differences between RCT and registry safety and effiacy with regard to these endpoints

7. Methods: Goals and Objectives (2)
Randomized Trials
To assess differences between RCTs according to “on-label” vs. “off-label” use, duration of FU, and baseline risk
Registries / Observational Analyses
To assess differences in the estimates derived from registries using unadjusted and adjusted analyses (and according to the types of adjustment)
To assess differences between registries according to duration of FU, and baseline risk
To assess differences in effect size estimates between the RCTs and registries for each endpoint

8. Methods: Inclusion Criteria
English language RCTs or registries which reported a direct comparison of DES (commercialized formulations of SES and PES only) vs. BMS.
Criteria for each study:
≥100 patients total
Mortality reported (± MI and/or TVR)
≥1 year of cumulative follow-up reported, with the outcome assessed at the same time point in both comparator arms

9. Methods: Exclusion Criteria
“DES era” vs. pure “BMS era” studies in which the DES era group did not exclude BMS pts
Excepting intent-to-treat RCTs
Study used a control group from another study already in the meta-analysis
Study was itself a meta-analysis (although data abstracted from individual studies in a published meta-analysis could be used)

10. Methods: Search Strategy (1)
2 PUBMED searches
Focused: (eluting stent OR DES OR drug-eluting stent) AND (bare OR uncoated OR standard OR BMS) AND (("2002"[PDat] : "2008"[PDat]) AND (Humans[Mesh]) AND (English[lang])) AND (coronary) NOT (cost-effectiveness) NOT review[pt] NOT case reports[pt] NOT editorial[pt] NOT comment[pt]
Broad: stent AND bare AND (eluting OR sirolimus OR paclitaxel)
Cochrane database
Eurointervention journal

11. Methods: Search Strategy (2)
Abstracts/presentations from 2007 meetings:
ACC SCAI/I2 Summit
ESC
TCT
AHA
Data requested from study PI’s for large registries
For most updated data
Where not publicly available or to clarify methodology

12. Methods: Analysis
Pre-specified separate analysis of RCTs and Registries performed given clinical heterogeneity
RCTs: Direct randomization to DES vs. BMS
Registries: Non-rand comparison of DES vs. BMS (including non-rand comparisons within a RCT)
All analyses cumulative
No landmarks
Single time point estimate for each study assuming constant hazard of DES vs. BMS through study period (hence use of HR or RR as the estimate)
Higher quality estimate picked for primary analyses (adjusted > unadjusted)

13. Methods: Statistical Analysis
All analyses were performed at The Cardiovascular Research Foundation/Columbia University
Models (both reported):
Fixed effects (Inverse-Variance weighted)
Random effects (DerSimonian and Laird)*
Fixed effects model was considered the primary model if significant heterogeneity was not present; otherwise random effects was considered primary
Formal heterogeneity testing was performed using the I2 statistic; heterogeneity was defined as I2 ≥ 25%
*Weights displayed in figures are based upon the primary model used

14. Selected Excluded Studies
GRACE
Non-landmark data not available (PI contacted as well)
Unequal follow-up in comparator arms (data not presented at fixed timepoint)
RRISC
Less than 100 patients
Medicare Data
Comparison of pre-DES era with post-DES rather than DES vs. BMS
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15. All-Cause Mortality: All RCTs
8,867 patients, 21 trials
Estimate (95% CI)
Weight (%)
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Random Effects
*Fixed Effects (I2=0.0%)
0.97 (0.81,1.15)
0.97 (0.81,1.15), p=0.72
Favors DES
Favors BMS
Mean f/u 2.9 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 15

16. All-Cause Mortality: RCTs (On-Label)
4,818 patients, 10 trials
Estimate (95% CI)
Weight (%)
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Random Effects
*Fixed Effects (I2=0.0%)
1.05 (0.84,1.30)
1.05 (0.84,1.30), p=0.69
Favors DES
Favors BMS
Mean f/u 4.0 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 16

17. All-Cause Mortality: RCT’s (Off-Label)
4,049 patients, 12 trials
Estimate (95% CI)
Weight (%)
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Random Effects
*Fixed Effects (I2=0.0%)
0.84 (0.62,1.13)
0.84 (0.62,1.13), p=0.24
Favors DES
Favors BMS
Mean f/u 1.5 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 17

18. All-Cause Mortality: All Registries
161,232 patients, 28 registries
Estimate (95% CI)
Weight (%)
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*Random Effects (I2=70.1%)
Fixed Effects
0.80 (0.72,0.88), p<0.001
0.83 (0.79,0.86)
Favors DES
Favors BMS
Mean f/u 2.5 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 18

19. All-Cause Mortality: Unadjusted Registries
122,989 patients, 22 registries
Estimate (95% CI)
Weight (%)
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*Random Effects (I2=75.3%)
Fixed Effects
0.70 (0.63,0.78), p<0.001
0.69 (0.66,0.72)
Favors DES
Favors BMS
Mean f/u 2.1 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 19

20. All-Cause Mortality: Adjusted Registries
134,534 patients, 18 registries
Estimate (95% CI)
Weight (%)
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*Random Effects (I2=76.6%)
Fixed Effects
0.80 (0.72,0.90), p<0.001
0.82 (0.79,0.86)
Favors DES
Favors BMS
Mean f/u 2.7 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 20

21. All-Cause Mortality: Registries
Begg’s Funnel Plot
p=0.92
log(Hazard Ratio)
Standard Error of log(Hazard Ratio)
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Ajay J. Kirtane and Gregg W. Stone, 2008 21

22. Ajay J. Kirtane and Gregg W. Stone, 2008
MI: All RCTs
8,850 patients, 20 trials
Estimate (95% CI)
Weight (%)
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Random Effects
*Fixed Effects (I2=3.0%)
0.94 (0.78,1.13)
0.94 (0.79,1.13), p=0.54
Favors DES
Favors BMS
Mean f/u 2.9 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 22

23. Ajay J. Kirtane and Gregg W. Stone, 2008
MI: RCTs (On Label)
4,318 patients, 9 trials
Estimate (95% CI)
Weight (%)
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Random Effects
*Fixed Effects (I2=0.0%)
1.03 (0.81,1.30)
1.03 (0.81,1.30), p=0.82
Favors DES
Favors BMS
Mean f/u 4.4 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 23

24. Ajay J. Kirtane and Gregg W. Stone, 2008
MI: RCT’s (Off Label)
4,532 patients, 12 trials
Estimate (95% CI)
Weight (%)
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Random Effects
*Fixed Effects (I2=25.5%)
0.77 (0.54,1.10)
0.83 (0.62,1.10), p=0.19
Favors DES
Favors BMS
Mean f/u 1.5 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 24

25. Ajay J. Kirtane and Gregg W. Stone, 2008
MI: All Registries
129,955 patients, 24 registries
Estimate (95% CI)
Weight (%)
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*Random Effects (I2=57.9%)
Fixed Effects
0.89 (0.80,0.98), p=0.023
0.96 (0.91,1.01)
*MI is QWMI in Washington Hospital Center, RESTEM
Favors DES
Favors BMS
Mean f/u 2.5 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 25

26. MI: Unadjusted Registries
88,221 patients, 18 registries
Estimate (95% CI)
Weight (%)
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*Random Effects (I2=77.8%)
Fixed Effects
0.83 (0.70,0.97), p=0.023
0.88 (0.83,0.93)
*MI is QWMI in Washington Hospital Center, RESTEM
Favors DES
Favors BMS
Mean f/u 2.0 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 26

27. MI: Adjusted Registries
107,294 patients, 14 registries
Estimate (95% CI)
Weight (%)
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*Random Effects (I2=60.8%)
Fixed Effects
0.91 (0.81,1.01), p=0.083
0.96 (0.91,1.01)
*MI is QWMI in Washington Hospital Center
Favors DES
Favors BMS
Mean f/u 2.8 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 27

28. Ajay J. Kirtane and Gregg W. Stone, 2008
TVR: All RCTs
7,291 patients, 16 trials
Estimate (95% CI)
Weight (%)
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*Random Effects (I2=53.2%)
Fixed Effects
0.45 (0.37,0.54), p<0.001
0.51 (0.45,0.57)
Favors DES
Favors BMS
Mean f/u 3.2 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 28

29. TVR: RCTs Meta-Regression on Percent Angiographic F/U p=0.73
*Hazard Ratio
p=0.73
Percentage of Patients with Angiographic F/U
*log(HR) regressed on percentage of pts with angiographic f/u; figure displayed on exponentiated scale
Ajay J. Kirtane and Gregg W. Stone, 2008

30. Ajay J. Kirtane and Gregg W. Stone, 2008
TVR: All Registries
73,819 patients, 17 registries
Estimate (95% CI)
Weight (%)
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*Random Effects (I2=71.2%)
Fixed Effects
0.53 (0.47,0.61), p<0.001
0.57 (0.54,0.60)
Favors DES
Favors BMS
Mean f/u 2.2 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 30

31. TVR: Unadjusted Registries
55,531 patients, 12 registries
Estimate (95% CI)
Weight (%)
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*Random Effects (I2=88.9%)
Fixed Effects
0.60 (0.48,0.74), p<0.001
0.73 (0.69,0.77)
Favors DES
Favors BMS
Mean f/u 2.2 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 31

32. TVR: Adjusted Registries
63,456 patients, 11 registries
Estimate (95% CI)
Weight (%)
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*Random Effects (I2=79.4%)
Fixed Effects
0.54 (0.46,0.63), p<0.001
0.58 (0.54,0.61)
Favors DES
Favors BMS
Mean f/u 2.2 yrs
Ajay J. Kirtane and Gregg W. Stone, 2008 32

33. Summary: DES vs. BMS Treatment Effect Estimates
Mortality MI
TVR
RCTs
8,867 pts, trials
8,850 pts, trials
7,291 pts, trials
Fixed effects
Random effects
0.97
0.94
0.51
0.45*
Registries
161,232 pts, studies
129,955 pts, studies
73,819 pts, studies
0.83
0.80*
0.96
0.89*
0.57
0.53*
<1.0  DES better

34. Study Limitations
Randomized trial analyses are still underpowered to assess these clinical endpoints
Registry analyses are based upon observational, non-randomized analyses
Potential for residual confounding
Significant heterogeneity, despite attempts to address this through random effects models, meta-regression and sensitivity analyses
Analysis was primarily of summary-level data and included unpublished studies
Use of hazard ratio / relative risk assumes constant hazards throughout the FU period

35. Conclusions (1)
In 22 RCTs in which 9,470 pts were randomized to DES or BMS and followed for ≥1 yr, DES resulted in:
Non significant 3% and 6% reductions in mortality and MI respectively
A highly significant 55% reduction in TVR
In 30 registries in which 174,302 pts were treated with either DES or BMS (non-randomized) and followed for ≥1 yr, DES was associated with:
A highly significant 20% reduction in mortality
A significant 11% reduction in MI
A highly significant 47% reduction in TVR

36. Conclusions (2)
The favorable results of DES from the RCT and registry analysis populations were robust and consistent for both on-label and off-label use, and for clinical f/u extending to 3-4 years
These findings, derived from more than 180,000 pts treated in 52 studies, strongly suggest that DES are safe for both on-label and off-label use, and have comparable efficacy in both RCTs and in the “real-world”