Columbia / CRF DES vs. BMS Meta-Analysis

Columbia / CRFColumbia / CRFDES vs. BMS Meta-AnalysisDES vs. BMS Meta-Analysis

Kirtane et al, Circ 2009;119: 3198-3206

DES Studies: Data SynthesisDES Studies: Data Synthesis

• In order to synthesize the existing data, we In order to synthesize the existing data, we performed a systematic review and meta-performed a systematic review and meta-analysis of all DES vs. BMS studies through analysis of all DES vs. BMS studies through 2/082/08 To derive summary estimates of all-cause To derive summary estimates of all-cause

mortality, MI, and TVR in studies with ≥1 year of mortality, MI, and TVR in studies with ≥1 year of follow-upfollow-up

To specifically assess differences between on-To specifically assess differences between on-label / off-label use, and between RCT and label / off-label use, and between RCT and observational dataobservational data


Methods: Inclusion CriteriaMethods: Inclusion Criteria

• English language RCTs or registries which English language RCTs or registries which reported a reported a direct comparison direct comparison of DES of DES (commercialized formulations of SES and PES (commercialized formulations of SES and PES only) vs. BMS up through February 2008only) vs. BMS up through February 2008

• Criteria for each study: Criteria for each study:

≥≥100 patients total100 patients total

Mortality reported (± MI and/or TVR)Mortality reported (± MI and/or TVR)

≥≥1 year of 1 year of cumulativecumulative follow-up reported, follow-up reported, with the outcome assessed at the same time with the outcome assessed at the same time point in both comparator armspoint in both comparator arms


Study Flow DiagramStudy Flow DiagramPubmed search thru 2/08: stent AND bare AND (eluting OR sirolimus OR paclitaxel)

834 articles

221 review articles or editorials115 no/unclear clinical outcomes described 104 sub-studies/more recent papers

81 no BMS/DES comparison100 basic science or non-approved device

84 with <1 year f/u or <100 pts 92 case reports, meta-analyses, non-coronary studies, or other

56 studies EuroIntervention search (146 articles)

3 articles

met criteria

AHA (3/246), TCT (9/206), ESC (4/243), ACC (0/468) abstracts and

reference searches

16 abstracts

met criteria

RCT studies: 22 (9,470 patients)

Registry studies: 34 (182,901 patients)

37 articles


All-Cause Mortality: All RCTsAll-Cause Mortality: All RCTs

I-V Overall (I-squared = 0.0%, p = 0.918)

BASKET (SES only)

TAXUS II

HAAMU-STENTSeville

Ortolani et al

TAXUS IV

E-SIRIUS

Study ID

DIABETES

PRISON II

STRATEGY

RAVEL

SES-SMART

TAXUS V

Typhoon

MISSION!

SCORPIUSSESAMI

D+L Overall

Passion

C-SIRIUS

Pache et al

SIRIUS

0.97 (0.81, 1.15)

0.82 (0.37, 1.84)

1.61 (0.57, 4.53)

2.00 (0.63, 6.38)1.35 (0.23, 7.78)

2.00 (0.19, 21.38)

0.89 (0.63, 1.25)

1.08 (0.25, 2.24)

ES (95% CI)

1.44 (0.48, 4.33)

0.50 (0.09, 2.67)

0.84 (0.36, 1.96)

1.75 (0.73, 4.16)

0.21 (0.02, 1.71)

0.97 (0.57, 1.65)

1.01 (0.38, 2.65)

0.48 (0.09, 2.59)

1.28 (0.35, 4.61)0.43 (0.11, 1.63)

0.97 (0.81, 1.15)

0.70 (0.36, 1.36)

0.68 (0.11, 4.04)

1.40 (0.45, 4.35)

1.02 (0.67, 1.54)

100.00

4.80

2.87

2.301.00

0.55

26.29

2.57

(I-V)

2.55

1.07

4.30

4.08

0.62

10.92

3.27

1.09

Weight

1.861.70

6.99

0.95

2.40

17.82

%

0.97 (0.81, 1.15)

0.82 (0.37, 1.84)

1.61 (0.57, 4.53)

2.00 (0.63, 6.38)1.35 (0.23, 7.78)

2.00 (0.19, 21.38)

0.89 (0.63, 1.25)

1.08 (0.25, 2.24)

ES (95% CI)

1.44 (0.48, 4.33)

0.50 (0.09, 2.67)

0.84 (0.36, 1.96)

1.75 (0.73, 4.16)

0.21 (0.02, 1.71)

0.97 (0.57, 1.65)

1.01 (0.38, 2.65)

0.48 (0.09, 2.59)

1.28 (0.35, 4.61)0.43 (0.11, 1.63)

0.97 (0.81, 1.15)

0.70 (0.36, 1.36)

0.68 (0.11, 4.04)

1.40 (0.45, 4.35)

1.02 (0.67, 1.54)

100.00

4.80

2.87

2.301.00

0.55

26.29

2.57

(I-V)

2.55

1.07

4.30

4.08

0.62

10.92

3.27

1.09

Weight

1.861.70

6.99

0.95

2.40

17.82

%

1.1 1 10

8,867 patients, 21 trials, mean F/U 2.9 years8,867 patients, 21 trials, mean F/U 2.9 years

Favors BMS

Estimate (95% CI) Weight (%)

0.97 (0.81,1.15)0.97 (0.81,1.15), p=0.72

Random Effects*Fixed Effects (I2=0.0%)

Favors DES


All-Cause Mortality: RCT’s (Off-Label)All-Cause Mortality: RCT’s (Off-Label)


HAAMU-STENT

Passion

PRISON II

MISSION!

DIABETES

BASKET (SES only)

Seville

D+L Overall

SES-SMART

STRATEGY

TAXUS V - complex

Study ID

SESAMI

Typhoon

0.84 (0.62, 1.13)

2.00 (0.63, 6.38)

0.70 (0.36, 1.36)

0.50 (0.09, 2.67)

0.48 (0.09, 2.59)

1.44 (0.48, 4.33)

0.82 (0.37, 1.84)

1.35 (0.23, 7.78)

0.84 (0.62, 1.13)

0.21 (0.02, 1.71)

0.84 (0.36, 1.96)

0.84 (0.38, 1.84)

ES (95% CI)

0.43 (0.11, 1.63)

1.01 (0.38, 2.65)

100.00

6.64

20.16

Weight

3.10

3.16

7.36

13.84

%

2.87

1.80

12.40

14.32

(I-V)

4.90

9.44

1.1 1 10

4,049 patients, 12 trials, mean F/U 1.5 years4,049 patients, 12 trials, mean F/U 1.5 years

Favors DES Favors BMS


0.84 (0.62,1.13)

0.84 (0.62,1.13), p=0.24

Random Effects

*Fixed Effects (I2=0.0%)


MI: All RCTsMI: All RCTs8,850 patients, 20 trials , mean F/U 2.9 years8,850 patients, 20 trials , mean F/U 2.9 years

D+L Overall (I-squared = 3.0%, p = 0.420)I-V Overall

SCORPIUS

TAXUS II

PRISON II

TAXUS V

Passion

STRATEGY

MISSION!

Typhoon

SIRIUS

TAXUS IV

BASKET (All)

RAVEL

Ortolani et alDIABETES

HAAMU-STENT

Study ID

E-SIRIUS

SES-SMART

SCANDSTENT

SESAMI

C-SIRIUS

1.1 1 10


SESAMI

Passion

C-SIRIUS

RAVEL

TAXUS IV

TAXUS V

SCORPIUS

SIRIUS

DIABETES

MISSION!

E-SIRIUS

SCANDSTENT

Study ID

Ortolani et al

SES-SMARTSTRATEGY

HAAMU-STENT

BASKET (All)

Typhoon

TAXUS II

PRISON II

D+L Overall

0.94 (0.79, 1.13)

1.00 (0.20, 4.88)

0.83 (0.26, 2.69)

0.59 (0.14, 2.47)

1.24 (0.49, 3.14)

0.99 (0.66, 1.48)

1.27 (0.79, 2.04)

0.82 (0.23, 2.95)

0.96 (0.59, 1.55)

0.60 (0.20, 1.50)

0.62 (0.28, 1.39)

1.94 (0.93, 4.02)

0.33 (0.09, 1.18)

ES (95% CI)

1.50 (0.26, 8.61)

0.16 (0.04, 0.67)0.82 (0.31, 2.40)

0.25 (0.03, 2.19)

1.15 (0.64, 2.08)

0.80 (0.22, 2.97)

0.63 (0.23, 1.72)

0.83 (0.26, 2.64)

0.94 (0.78, 1.13)

100.00

1.29

2.40

1.59

3.80

20.13

Weight

14.59

2.02

14.07

3.23

5.11

6.13

%

1.98

(I-V)

1.07

1.653.13

0.71

9.45

1.94

3.24

2.44

1.1 1 10


0.94 (0.78,1.13)0.95 (0.79,1.13), p=0.54


Random Effects*Fixed Effects (I2=3.0%)


MI: RCT’s (Off Label)MI: RCT’s (Off Label)4,532 patients, 12 trials , mean F/U 1.5 years4,532 patients, 12 trials , mean F/U 1.5 years

1.1 1 10


SCANDSTENT

HAAMU-STENT

Typhoon

D+L Overall

SES-SMART

PRISON II

TAXUS V - complex

Passion

Study ID

STRATEGY

MISSION!

SESAMI

BASKET (All)

DIABETES

0.83 (0.62, 1.10)

0.33 (0.09, 1.18)

0.25 (0.03, 2.19)

0.80 (0.22, 2.97)

0.77 (0.54, 1.10)

0.16 (0.04, 0.67)

0.83 (0.26, 2.64)

1.84 (0.86, 3.94)

0.83 (0.26, 2.69)

ES (95% CI)

0.82 (0.31, 2.40)

0.62 (0.28, 1.39)

1.00 (0.20, 4.88)

1.15 (0.64, 2.08)

0.60 (0.20, 1.50)

100.00

5.08

1.83

4.97

4.24

Weight

6.26

%

14.52

6.16

(I-V)

8.03

13.11

3.30

24.22

8.29

1.1 1 10



SCANDSTENT

HAAMU-STENT

Typhoon

D+L Overall

SES-SMART

PRISON II

TAXUS V - complex

Passion

Study ID

STRATEGY

MISSION!

SESAMI

BASKET (All)

DIABETES

0.83 (0.62, 1.10)

0.33 (0.09, 1.18)

0.25 (0.03, 2.19)

0.80 (0.22, 2.97)

0.77 (0.54, 1.10)

0.16 (0.04, 0.67)

0.83 (0.26, 2.64)

1.84 (0.86, 3.94)

0.83 (0.26, 2.69)

ES (95% CI)

0.82 (0.31, 2.40)

0.62 (0.28, 1.39)

1.00 (0.20, 4.88)

1.15 (0.64, 2.08)

0.60 (0.20, 1.50)

100.00

5.08

1.83

4.97

4.24

Weight

6.26

%

14.52

6.16

(I-V)

8.03

13.11

3.30

24.22

8.29

1.1 1 10Favors DES Favors BMS

0.77 (0.54,1.10)

0.83 (0.62,1.10), p=0.19

Random Effects

*Fixed Effects (I2=25.5%)


TVR: All RCTsTVR: All RCTs

NOTE: Weights are from random effects analysis

D+L Overall (I-squared = 53.2%, p = 0.006)

Pache et al

Study ID

HAAMU-STENT

C-SIRIUS

Typhoon

STRATEGY

SIRIUS

SCANDSTENT

TAXUS II

PRISON II

TAXUS IV

E-SIRIUS

MISSION!

Ortolani et al

SESAMI

I-V Overall

TAXUS V

RAVEL

0.45 (0.37, 0.54)

0.38 (0.23, 0.64)

ES (95% CI)

0.33 (0.09, 1.19)

0.30 (0.10, 0.93)

0.42 (0.25, 0.69)

0.34 (0.16, 0.77)

0.48 (0.37, 0.62)

0.17 (0.09, 0.33)

0.61 (0.35, 1.08)

0.37 (0.19, 0.69)

0.57 (0.45, 0.72)

0.35 (0.21, 0.56)

0.38 (0.17, 0.85)

0.58 (0.25, 1.36)

0.36 (0.17, 0.79)

0.51 (0.45, 0.57)

0.77 (0.60, 0.98)

0.51 (0.25, 1.04)

100.00

7.14

(D+L)

1.91

2.45

7.20

4.22

11.51

5.44

%

6.44

5.49

11.94

Weight

7.45

4.08

3.78

4.36

11.75

4.83

1.1 1 10

7,291 patients, 16 trials , mean F/U 3.2 years7,291 patients, 16 trials , mean F/U 3.2 years



0.45 (0.37,0.54), p<0.0010.51 (0.45,0.57)

*Random Effects (I2=53.2%)Fixed Effects


TVR: RCTs (Off Label)TVR: RCTs (Off Label)



Typhoon

Study ID

STRATEGY

SCANDSTENT

TAXUS V - complex

I-V Overall

HAAMU-STENT

SESAMI

MISSION!

PRISON II

0.38 (0.27, 0.52)

0.42 (0.25, 0.69)

ES (95% CI)

0.34 (0.16, 0.77)

0.17 (0.09, 0.33)

0.62 (0.44, 0.86)

0.42 (0.34, 0.52)

0.33 (0.09, 1.19)

0.36 (0.17, 0.79)

0.38 (0.17, 0.85)

0.37 (0.19, 0.69)

100.00

16.43

(D+L)

10.35

12.95

21.55

%

4.98

10.65

10.04

Weight

13.06

1.1 1 10

2,673 patients, 8 trials , mean F/U 1.6 years2,673 patients, 8 trials , mean F/U 1.6 years



0.38 (0.27,0.52), p<0.001

0.42 (0.34,0.52)

*Random Effects (I2=47.8%)

Fixed Effects


TVR: RCTsTVR: RCTsMeta-Regression on Percent Angiographic F/UMeta-Regression on Percent Angiographic F/U

*log(HR) regressed on percentage of pts with angiographic *log(HR) regressed on percentage of pts with angiographic f/u; figure displayed on exponentiated scalef/u; figure displayed on exponentiated scale

.2.4

.6.8

20 40 60 80 100perangfu

tvr_hr Fitted values

p=0.73

*Haz

ard

Rat

io

Percentage of Patients with Angiographic F/U



Asan Korea (adjusted)

SMART

Melbourne

Massachusetts (matched)

Washington Hosp Center (matched)

Multicenter SVG (adjusted)

I-V Overall

Rotterdam Off-Label

STENT (adjusted)

ACUITY (from RCT)

REAL (adjusted)

Liverpool (matched)

Wake Forest (adjusted)

Mayo FFR Substudy

Cedars Acute MI

GHOST (adjusted)

Sussex ElderlyERACI III (from RCT)

NY State (adjusted, unmatched)

Ontario (matched)

Study ID

MIDAS (adjusted)

RESTEM

McMaster STEMI (adjusted)

Germany Metabolic Syndrome

Western Denmark (adjusted)

ARTS II (from RCT)

DEScover (unadjusted)

Northern New England (adjusted)

SCAAR (adjusted)

Italian Diabetic Multivessel (adjusted)

NHLBI (off label, adjusted)NHLBI (on label, adjusted)

0.78 (0.71, 0.86)

0.60 (0.46, 0.79)

0.59 (0.48, 0.71)

0.67 (0.23, 1.94)

0.79 (0.71, 0.89)

1.16 (0.78, 1.75)

1.33 (0.47, 3.76)

0.81 (0.78, 0.85)

0.98 (0.85, 1.13)

0.69 (0.55, 0.87)

0.63 (0.49, 0.82)

0.83 (0.70, 0.98)

0.45 (0.24, 0.84)

0.72 (0.55, 0.95)

1.00 (0.21, 4.75)

0.82 (0.37, 1.83)

0.55 (0.36, 0.83)

0.72 (0.30, 1.72)1.18 (0.54, 2.58)

0.84 (0.72, 0.97)

0.71 (0.59, 0.84)

ES (95% CI)

0.66 (0.59, 0.74)

0.73 (0.51, 1.05)

0.17 (0.03, 0.97)

1.47 (0.65, 3.35)

1.00 (0.86, 1.17)

0.74 (0.41, 1.35)

0.53 (0.35, 0.80)

0.51 (0.26, 1.00)

1.03 (0.94, 1.14)

1.22 (0.36, 4.10)

0.94 (0.64, 1.38)1.47 (0.87, 2.48)

100.00

Weight

4.35

5.23

0.71

6.15

3.02

0.74

5.85

4.83

4.50

5.55

1.70

%

4.31

0.35

1.16

2.91

1.001.20

5.77

5.46

(D+L)

6.14

3.40

0.28

1.11

5.72

1.83

2.95

1.53

6.30

0.56

3.192.20

0.78 (0.71, 0.86)

0.60 (0.46, 0.79)

0.59 (0.48, 0.71)

0.67 (0.23, 1.94)

0.79 (0.71, 0.89)

1.16 (0.78, 1.75)

1.33 (0.47, 3.76)

0.81 (0.78, 0.85)

0.98 (0.85, 1.13)

0.69 (0.55, 0.87)

0.63 (0.49, 0.82)

0.83 (0.70, 0.98)

0.45 (0.24, 0.84)

0.72 (0.55, 0.95)

1.00 (0.21, 4.75)

0.82 (0.37, 1.83)

0.55 (0.36, 0.83)

0.72 (0.30, 1.72)1.18 (0.54, 2.58)

0.84 (0.72, 0.97)

0.71 (0.59, 0.84)

ES (95% CI)

0.66 (0.59, 0.74)

0.73 (0.51, 1.05)

0.17 (0.03, 0.97)

1.47 (0.65, 3.35)

1.00 (0.86, 1.17)

0.74 (0.41, 1.35)

0.53 (0.35, 0.80)

0.51 (0.26, 1.00)

1.03 (0.94, 1.14)

1.22 (0.36, 4.10)

0.94 (0.64, 1.38)1.47 (0.87, 2.48)

100.00

Weight

4.35

5.23

0.71

6.15

3.02

0.74

5.85

4.83

4.50

5.55

1.70

%

4.31

0.35

1.16

2.91

1.001.20

5.77

5.46

(D+L)

6.14

3.40

0.28

1.11

5.72

1.83

2.95

1.53

6.30

0.56

3.192.20

1.1 1 10

All-Cause Mortality: All RegistriesAll-Cause Mortality: All Registries169,595 patients, 31 registries, mean F/U 2.5 years169,595 patients, 31 registries, mean F/U 2.5 years

Favors BMS


0.78 (0.71,0.86), p<0.0010.81 (0.78,0.85)

Favors DES

*Random Effects (I2=71%)Fixed Effects




Northern New England (adjusted)

GHOST (adjusted)

I-V Overall



STENT (adjusted)


Liverpool (matched)


REAL (adjusted)

Study ID



MIDAS (adjusted)


NHLBI (on label, adjusted)


Ontario (matched)


NHLBI (off label, adjusted)

SCAAR (adjusted)

0.79 (0.71, 0.89)

0.51 (0.26, 1.00)

0.55 (0.36, 0.83)

0.82 (0.79, 0.86)

1.33 (0.47, 3.76)

0.84 (0.72, 0.97)

0.69 (0.55, 0.87)

1.00 (0.86, 1.17)

0.45 (0.24, 0.84)

0.72 (0.55, 0.95)

0.83 (0.70, 0.98)

ES (95% CI)

0.79 (0.71, 0.89)

1.22 (0.36, 4.10)

0.66 (0.59, 0.74)

0.60 (0.46, 0.79)

1.47 (0.87, 2.48)

0.17 (0.03, 0.97)

0.71 (0.59, 0.84)

1.16 (0.78, 1.75)

0.94 (0.64, 1.38)

1.03 (0.94, 1.14)

100.00

2.15

4.11

1.04

8.18

%

6.83

8.10

2.40

6.09

7.86

(D+L)

8.71

0.78

8.71

6.14

3.10

0.40

Weight

7.72

4.26

4.50

8.93

0.79 (0.71, 0.89)

0.51 (0.26, 1.00)

0.55 (0.36, 0.83)

0.82 (0.79, 0.86)

1.33 (0.47, 3.76)

0.84 (0.72, 0.97)

0.69 (0.55, 0.87)

1.00 (0.86, 1.17)

0.45 (0.24, 0.84)

0.72 (0.55, 0.95)

0.83 (0.70, 0.98)

ES (95% CI)

0.79 (0.71, 0.89)

1.22 (0.36, 4.10)

0.66 (0.59, 0.74)

0.60 (0.46, 0.79)

1.47 (0.87, 2.48)

0.17 (0.03, 0.97)

0.71 (0.59, 0.84)

1.16 (0.78, 1.75)

0.94 (0.64, 1.38)

1.03 (0.94, 1.14)

100.00

2.15

4.11

1.04

8.18

%

6.83

8.10

2.40

6.09

7.86

(D+L)

8.71

0.78

8.71

6.14

3.10

0.40

Weight

7.72

4.26

4.50

8.93

1.1 1 10

All-Cause Mortality: Adjusted RegistriesAll-Cause Mortality: Adjusted Registries136,558 patients, 19 registries , mean F/U 2.7 years136,558 patients, 19 registries , mean F/U 2.7 years

Favors BMS


0.79 (0.71,0.89), p<0.0010.82 (0.79,0.86)

Favors DES





RESTEM

Ontario (matched)



Study ID


GHOST (adjusted)

REAL (adjusted)

Brazil Large Vessels

Melbourne

ACUITY (from RCT)

Cedars Acute MI

I-V Overall

NHLBI (on label, adjusted)

Mayo FFR Substudy

Harbor AMI


STENT (adjusted)

ARTS II (from RCT)

ERACI III (from RCT)

SCAAR (adjusted)


DEScover (unadjusted)


Germany Metabolic Syndrome


NHLBI (off label, adjusted)

0.87 (0.78, 0.97)

0.80 (0.52, 1.23)

1.10 (0.91, 1.32)

1.29 (1.06, 1.57)

1.02 (0.46, 2.25)

ES (95% CI)

0.28 (0.04, 1.71)

1.12 (0.74, 1.70)

0.92 (0.76, 1.11)

1.50 (0.25, 8.90)

1.00 (0.39, 2.58)

1.07 (0.91, 1.25)

0.25 (0.06, 1.16)

0.95 (0.91, 1.00)

0.71 (0.47, 1.05)

0.67 (0.12, 3.84)

0.19 (0.05, 0.69)

0.84 (0.60, 1.18)

0.69 (0.52, 0.92)

0.53 (0.32, 0.88)

2.30 (0.91, 5.96)

1.01 (0.91, 1.11)

0.66 (0.42, 1.05)

0.69 (0.40, 1.18)

0.51 (0.29, 0.88)

0.23 (0.07, 0.78)

0.92 (0.83, 1.02)

0.71 (0.50, 1.00)

100.00

3.96

8.04

Weight

7.83

1.59

(D+L)

0.32

4.14

7.97

0.36

1.17

8.59

0.51

4.31

0.38

0.64

5.21

6.09

3.20

1.18

9.67

3.66

2.91

2.81

0.75

9.61

5.08

%

0.87 (0.78, 0.97)

0.80 (0.52, 1.23)

1.10 (0.91, 1.32)

1.29 (1.06, 1.57)

1.02 (0.46, 2.25)

ES (95% CI)

0.28 (0.04, 1.71)

1.12 (0.74, 1.70)

0.92 (0.76, 1.11)

1.50 (0.25, 8.90)

1.00 (0.39, 2.58)

1.07 (0.91, 1.25)

0.25 (0.06, 1.16)

0.95 (0.91, 1.00)

0.71 (0.47, 1.05)

0.67 (0.12, 3.84)

0.19 (0.05, 0.69)

0.84 (0.60, 1.18)

0.69 (0.52, 0.92)

0.53 (0.32, 0.88)

2.30 (0.91, 5.96)

1.01 (0.91, 1.11)

0.66 (0.42, 1.05)

0.69 (0.40, 1.18)

0.51 (0.29, 0.88)

0.23 (0.07, 0.78)

0.92 (0.83, 1.02)

0.71 (0.50, 1.00)

100.00

3.96

8.04

Weight

7.83

1.59

(D+L)

0.32

4.14

7.97

0.36

1.17

8.59

0.51

4.31

0.38

0.64

5.21

6.09

3.20

1.18

9.67

3.66

2.91

2.81

0.75

9.61

5.08

%

1.1 1 10

MI: All RegistriesMI: All Registries130,191 patients, 25 registries , mean F/U 2.5 years130,191 patients, 25 registries , mean F/U 2.5 years



0.87 (0.78,0.97), p=0.01 0.95 (0.91,1.00)


*MI is QWMI in Washington Hospital Center, RESTEMKirtane et al, Circ 2009;119: 3198-3206



REAL (adjusted)


STENT (adjusted)

ERACI III (from RCT)

GHOST (adjusted)

Study ID

I-V Overall



Sussex Elderly

Montevergine

DEScover (adjusted)




Ontario (matched)

Brazil Large Vessels

Cedars Acute MI

RESTEM

Mayo FFR Substudy

0.54 (0.47, 0.61)

0.67 (0.59, 0.76)

0.58 (0.28, 1.18)

0.58 (0.47, 0.71)

0.58 (0.39, 0.86)

0.28 (0.20, 0.39)

ES (95% CI)

0.57 (0.54, 0.60)

0.32 (0.24, 0.43)

0.65 (0.49, 0.85)

0.84 (0.28, 2.54)

0.51 (0.39, 0.68)

0.58 (0.40, 0.83)

0.54 (0.50, 0.60)

0.32 (0.05, 1.92)

0.63 (0.48, 0.83)

0.69 (0.60, 0.80)

0.43 (0.17, 1.10)

0.22 (0.08, 0.62)

0.62 (0.47, 0.80)

0.18 (0.04, 0.78)

100.00

10.09

2.37

8.61

5.27

6.22

(D+L)

6.97

Weight

7.26

1.15

7.22

5.73

10.63

0.45

7.29

9.80

1.54

1.31

7.44

0.66

%

0.54 (0.47, 0.61)

0.67 (0.59, 0.76)

0.58 (0.28, 1.18)

0.58 (0.47, 0.71)

0.58 (0.39, 0.86)

0.28 (0.20, 0.39)

ES (95% CI)

0.57 (0.54, 0.60)

0.32 (0.24, 0.43)

0.65 (0.49, 0.85)

0.84 (0.28, 2.54)

0.51 (0.39, 0.68)

0.58 (0.40, 0.83)

0.54 (0.50, 0.60)

0.32 (0.05, 1.92)

0.63 (0.48, 0.83)

0.69 (0.60, 0.80)

0.43 (0.17, 1.10)

0.22 (0.08, 0.62)

0.62 (0.47, 0.80)

0.18 (0.04, 0.78)

100.00

10.09

2.37

8.61

5.27

6.22

(D+L)

6.97

Weight

7.26

1.15

7.22

5.73

10.63

0.45

7.29

9.80

1.54

1.31

7.44

0.66

%

1.1 1 10

TVR: All RegistriesTVR: All Registries74,154 pts, 18 registries , mean F/U 2.2 years74,154 pts, 18 registries , mean F/U 2.2 years



0.54 (0.48,0.61), p<0.001 0.57 (0.54,0.60)



Summary: DES vs. BMSSummary: DES vs. BMS Treatment Effect EstimatesTreatment Effect Estimates

MortalityMortality MIMI TVRTVR

RCTsRCTs 8,867 pts, 8,867 pts, 21 trials 21 trials

8,850 pts, 8,850 pts, 20 trials 20 trials

7,291 pts, 7,291 pts, 16 trials 16 trials

- Fixed effectsFixed effects- Random effectsRandom effects

0.970.970.970.97

0.950.950.940.94

0.510.510.450.45

RegistriesRegistries 169,595 pts, 169,595 pts, 31 studies 31 studies

130,191 pts, 130,191 pts, 25 studies 25 studies

74,154 pts, 74,154 pts, 18 studies 18 studies

- Fixed effectsFixed effects- Random effectsRandom effects

0.810.810.780.78

0.950.950.870.87

0.570.570.540.54

<1.0 <1.0 DES better DES better


First AuthorFirst Author JournalJournal DES ptsDES pts BMS ptsBMS pts F/U F/U YearsYears

DES DES MortalityMortality

BMS BMS MortalityMortality pp

GroeneveldGroeneveld JACCJACC 71,96571,965 71,96571,965 22 10.7%10.7% 13.5%13.5% <0.001<0.001

Shishebor Shishebor JACCJACC 6,0536,053 1,9831,983 4.54.5 8.0%8.0% 17.0%17.0% <0.001<0.001

WangWang CCICCI 3,4173,417 4,1494,149 11 6.0%6.0% 11.4%11.4% <0.0001<0.0001

AnstromAnstrom Arch Int MedArch Int Med 1,5011,501 3,1653,165 22 8.6%8.6% 8.6%8.6% 0.940.94

AustinAustin Circ InterventionsCirc Interventions 1,1051,105 6,3946,394 22 6.6%6.6% 7.7%7.7% 0.040.04

Vlaar Vlaar CCICCI 536536 557557 22 6.4%6.4% 6.4%6.4% 0.930.93

YanYan IJCIJC 239239 433433 11 0.5%0.5% 2.9%2.9% 0.070.07

AlidoostiAlidoosti Hellen J CardHellen J Card 228228 15681568 1.51.5 5.3%5.3% 4.7%4.7% 0.100.10

Dominguez FrancoDominguez Franco Clin CardiologyClin Cardiology 205205 215215 1.51.5 6.3%6.3% 8.4%8.4% NSNS

RamanaRamana CCICCI 141141 170170 33 6.0%6.0% 12.0%12.0% 0.050.05

NuscaNusca AJCAJC 121121 113113 33 12.0%12.0% 21.0%21.0% <0.05<0.05

GarroGarro EurointerventionEurointervention 117117 128128 22 4.4%4.4% 4.1%4.1% 1.01.0

OkadaOkada Circ JCirc J 8080 124124 11 16.3%16.3% 19.8%19.8% 0.490.49

AssaliAssali EurointerventionEurointervention 6868 4343 22 2.9%2.9% 4.7%4.7% 0.600.60

Malenka et al (JAMA) excluded for DES era/BMS era comparison; 4 additional studies reported cardiac death onlyMalenka et al (JAMA) excluded for DES era/BMS era comparison; 4 additional studies reported cardiac death only

14 Subsequent DES vs. BMS Registries14 Subsequent DES vs. BMS RegistriesPublished 2/08-9/08 (N=176,777 pts)*Published 2/08-9/08 (N=176,777 pts)*

*Studies already included in meta-analysis*Studies already included in meta-analysisin unpublished format not listedin unpublished format not listed

Documents

Columbia / CRF DES vs. BMS Meta-Analysis