6/9/2008 comparative effectiveness reviews: methodological observations david b. matchar, md...
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6/9/20086/9/2008
Comparative effectiveness Comparative effectiveness reviews: methodological reviews: methodological observationsobservations
David B. Matchar, MDDavid B. Matchar, MDProfessor of Medicine and Director, Professor of Medicine and Director,
Center for Clinical Health Policy ResearchCenter for Clinical Health Policy ResearchDuke University Medical CenterDuke University Medical Center
I. Drug-Eluting vs. Bare Metal Stents: I. Drug-Eluting vs. Bare Metal Stents: Results from a Practice-Based RegistryResults from a Practice-Based RegistryI. Drug-Eluting vs. Bare Metal Stents: I. Drug-Eluting vs. Bare Metal Stents:
Results from a Practice-Based RegistryResults from a Practice-Based Registry
Eric L. Eisenstein, DBA; Kevin J. Anstrom, PhD; David F. Kong, MD, AM;Eric L. Eisenstein, DBA; Kevin J. Anstrom, PhD; David F. Kong, MD, AM;
Linda K. Shaw, MS; Robert H. Tuttle, MSPH; Daniel B. Mark, MD, MPH;Linda K. Shaw, MS; Robert H. Tuttle, MSPH; Daniel B. Mark, MD, MPH;
Judith M. Kramer, MD, MS; Robert A. Harrington, MD; Judith M. Kramer, MD, MS; Robert A. Harrington, MD;
David B. Matchar, MD; David E. Kandzari, MD; David B. Matchar, MD; David E. Kandzari, MD;
Eric D. Peterson, MD, MPH; Kevin A. Schulman, MD; Robert M. Califf, MDEric D. Peterson, MD, MPH; Kevin A. Schulman, MD; Robert M. Califf, MD
Division of Cardiology, Department of Medicine, Duke University Medical Center, Division of Cardiology, Department of Medicine, Duke University Medical Center, Duke Clinical Research Institute, Duke Clinical Research Institute,
Duke Translational Medicine Institute, Duke DECIDE Network, andDuke Translational Medicine Institute, Duke DECIDE Network, and
Duke Center for Clinical Health Policy Research, Durham, NCDuke Center for Clinical Health Policy Research, Durham, NC
Eric L. Eisenstein, DBA; Kevin J. Anstrom, PhD; David F. Kong, MD, AM;Eric L. Eisenstein, DBA; Kevin J. Anstrom, PhD; David F. Kong, MD, AM;
Linda K. Shaw, MS; Robert H. Tuttle, MSPH; Daniel B. Mark, MD, MPH;Linda K. Shaw, MS; Robert H. Tuttle, MSPH; Daniel B. Mark, MD, MPH;
Judith M. Kramer, MD, MS; Robert A. Harrington, MD; Judith M. Kramer, MD, MS; Robert A. Harrington, MD;
David B. Matchar, MD; David E. Kandzari, MD; David B. Matchar, MD; David E. Kandzari, MD;
Eric D. Peterson, MD, MPH; Kevin A. Schulman, MD; Robert M. Califf, MDEric D. Peterson, MD, MPH; Kevin A. Schulman, MD; Robert M. Califf, MD
Division of Cardiology, Department of Medicine, Duke University Medical Center, Division of Cardiology, Department of Medicine, Duke University Medical Center, Duke Clinical Research Institute, Duke Clinical Research Institute,
Duke Translational Medicine Institute, Duke DECIDE Network, andDuke Translational Medicine Institute, Duke DECIDE Network, and
Duke Center for Clinical Health Policy Research, Durham, NCDuke Center for Clinical Health Policy Research, Durham, NC
Supported by the Agency for Healthcare Research & QualityContract No. 290-05-0032
Duke University Medical Center Institutional Review Board ApprovalRegistry Number 8223-06-2R0ER
Supported by the Agency for Healthcare Research & QualityContract No. 290-05-0032
Duke University Medical Center Institutional Review Board ApprovalRegistry Number 8223-06-2R0ER
Background and ObjectivesBackground and ObjectivesBackground and ObjectivesBackground and Objectives
Extrapolating drug eluting stent (DES) clinical Extrapolating drug eluting stent (DES) clinical trial results onto clinical practice may be trial results onto clinical practice may be unreliable. unreliable.
Current antiplatelet regimens may not be Current antiplatelet regimens may not be sufficient to prevent late adverse events. sufficient to prevent late adverse events.
This analysis examined outcomes for:This analysis examined outcomes for:
DES and bare metal stent (BMS), andDES and bare metal stent (BMS), and
Clopidogrel use beyond 6 months.Clopidogrel use beyond 6 months.
Extrapolating drug eluting stent (DES) clinical Extrapolating drug eluting stent (DES) clinical trial results onto clinical practice may be trial results onto clinical practice may be unreliable. unreliable.
Current antiplatelet regimens may not be Current antiplatelet regimens may not be sufficient to prevent late adverse events. sufficient to prevent late adverse events.
This analysis examined outcomes for:This analysis examined outcomes for:
DES and bare metal stent (BMS), andDES and bare metal stent (BMS), and
Clopidogrel use beyond 6 months.Clopidogrel use beyond 6 months.
Duke Databank for Cardiovascular Disease Duke Databank for Cardiovascular Disease Patients receiving:Patients receiving:
BMS, January 2000 - July 2005BMS, January 2000 - July 2005
DES, April 2003 - July 2005DES, April 2003 - July 2005
Exclusion criteriaExclusion criteria Congenital heart diseaseCongenital heart disease Valvular heart diseaseValvular heart disease Prior CABG or PCIPrior CABG or PCI Left main coronary diseaseLeft main coronary disease
Duke Databank for Cardiovascular Disease Duke Databank for Cardiovascular Disease Patients receiving:Patients receiving:
BMS, January 2000 - July 2005BMS, January 2000 - July 2005
DES, April 2003 - July 2005DES, April 2003 - July 2005
Exclusion criteriaExclusion criteria Congenital heart diseaseCongenital heart disease Valvular heart diseaseValvular heart disease Prior CABG or PCIPrior CABG or PCI Left main coronary diseaseLeft main coronary disease
Study PopulationStudy PopulationStudy PopulationStudy Population
InitialInitial: Demographic, medical history, physical : Demographic, medical history, physical examination and catheterization dataexamination and catheterization data
Follow-upFollow-up (at 6 months, 1 year, and then annually) (at 6 months, 1 year, and then annually)
Medication use (Clopidogrel, aspirin)Medication use (Clopidogrel, aspirin)
Events up to 24 months (through September 7, Events up to 24 months (through September 7, 2006) 2006)
Censored at time of last contact Censored at time of last contact
98% follow-up completion rate 98% follow-up completion rate
Median follow-up 3.1 years Median follow-up 3.1 years
InitialInitial: Demographic, medical history, physical : Demographic, medical history, physical examination and catheterization dataexamination and catheterization data
Follow-upFollow-up (at 6 months, 1 year, and then annually) (at 6 months, 1 year, and then annually)
Medication use (Clopidogrel, aspirin)Medication use (Clopidogrel, aspirin)
Events up to 24 months (through September 7, Events up to 24 months (through September 7, 2006) 2006)
Censored at time of last contact Censored at time of last contact
98% follow-up completion rate 98% follow-up completion rate
Median follow-up 3.1 years Median follow-up 3.1 years
Data CollectionData CollectionData CollectionData Collection
Baseline Patient CharacteristicsBaseline Patient CharacteristicsBaseline Patient CharacteristicsBaseline Patient Characteristics
0.420.420.420.4261 (53, 70)61 (53, 70)61 (53, 70)61 (53, 70)60 (52, 70)60 (52, 70)60 (52, 70)60 (52, 70)Age Median (Q1,Q3) Age Median (Q1,Q3) Age Median (Q1,Q3) Age Median (Q1,Q3)
<0.001<0.001<0.001<0.001 2.8 (2.5, 3.0)2.8 (2.5, 3.0)
2.8 (2.5, 3.0)2.8 (2.5, 3.0)3.0 (2.8, 3.3)3.0 (2.8, 3.3)3.0 (2.8, 3.3)3.0 (2.8, 3.3)
Stent Diameter mm Stent Diameter mm Median (Q1,Q3)Median (Q1,Q3)Stent Diameter mm Stent Diameter mm Median (Q1,Q3)Median (Q1,Q3)
12121212 88 88 33 33
3131313128282828 22 22
5757575764646464 11 11
<0.001<0.001<0.001<0.001Number of Diseased Vessels (%)Number of Diseased Vessels (%)Number of Diseased Vessels (%)Number of Diseased Vessels (%)
<0.001<0.001<0.001<0.0014242424248484848Previous MI (%)Previous MI (%)Previous MI (%)Previous MI (%)
0.470.470.470.471212121211111111CHF (%)CHF (%)CHF (%)CHF (%)
0.0450.0450.0450.0452828282825252525Diabetes (%)Diabetes (%)Diabetes (%)Diabetes (%)
0.850.850.850.856363636363636363Male Gender (%)Male Gender (%)Male Gender (%)Male Gender (%)
0.370.370.370.376969696970707070White Race (%)White Race (%)White Race (%)White Race (%)
15011501150115013165316531653165Number of PatientsNumber of PatientsNumber of PatientsNumber of Patients
P- valueP- valueP- valueP- valueDESDESDESDESBMSBMSBMSBMS
0.00
0.05
0.10
0.15
0.20
0.25
1 7 13 19 25
0.00
0.05
0.10
0.15
0.20
0.25
1 7 13 19 250.00
0.05
0.10
0.15
0.20
0.25
1 7 13 19 25
0.00
0.05
0.10
0.15
0.20
0.25
1 7 13 19 25
0.00
0.05
0.10
0.15
0.20
0.25
1 7 13 19 25
0.00
0.05
0.10
0.15
0.20
0.25
1 7 13 19 250.00
0.05
0.10
0.15
0.20
0.25
1 7 13 19 25
0.00
0.05
0.10
0.15
0.20
0.25
1 7 13 19 25
0 6 12 18 2400 66 1212 1818 242400 66 1212 1818 2424
00 66 1212 1818 24 2400 66 1212 1818 24 24
00 66 1212 1818 24 2400 66 1212 1818 24 24 00 66 1212 1818 24 2400 66 1212 1818 24 24
DeathDeath Nonfatal MINonfatal MI
TVRTVR MACEMACE
MonthsMonthsMonthsMonths MonthsMonthsMonthsMonths
p=0.94p=0.94
p=0.022p=0.022
p<0.001p<0.001p<0.001p<0.001
-9.7 (-11.7, -7.7)-9.7 (-11.7, -7.7)
-9.4 (-12.2, -6.6)-9.4 (-12.2, -6.6)
0.1 (-2.0, 2.1)0.1 (-2.0, 2.1)
-1.5 (-2.8, -2.0)-1.5 (-2.8, -2.0)
DES DES BMS BMS DES DES BMS BMS
Cumulative Incidence RatesCumulative Incidence RatesCumulative Incidence RatesCumulative Incidence Rates
DES-BMS (95% CI)DES-BMS (95% CI)
00
55
1010
1515
2020
2525
00
55
1010
1515
2020
2525
00
55
1010
1515
00
55
1010
1515
Landmark AnalysisLandmark AnalysisLandmark AnalysisLandmark Analysis
A form of survival analysisA form of survival analysis
The cohort consists of patients without The cohort consists of patients without death, MI, or revascularization at a specific death, MI, or revascularization at a specific time after initial stent placement (the time after initial stent placement (the “landmark” time point)“landmark” time point)
Outcomes evaluated from this landmark Outcomes evaluated from this landmark time point forwardtime point forward
A form of survival analysisA form of survival analysis
The cohort consists of patients without The cohort consists of patients without death, MI, or revascularization at a specific death, MI, or revascularization at a specific time after initial stent placement (the time after initial stent placement (the “landmark” time point)“landmark” time point)
Outcomes evaluated from this landmark Outcomes evaluated from this landmark time point forwardtime point forward
Landmark AnalysisLandmark AnalysisLandmark AnalysisLandmark Analysis Patients categorized into one of 4 groups: Patients categorized into one of 4 groups:
DES with clopidogrel (DES+C)DES with clopidogrel (DES+C)
DES without clopidogrel (DES-C)DES without clopidogrel (DES-C)
BMS with clopidogrel (BMS+C) BMS with clopidogrel (BMS+C)
BMS without clopidogrel (BMS-C) BMS without clopidogrel (BMS-C)
Patients categorized into one of 4 groups: Patients categorized into one of 4 groups:
DES with clopidogrel (DES+C)DES with clopidogrel (DES+C)
DES without clopidogrel (DES-C)DES without clopidogrel (DES-C)
BMS with clopidogrel (BMS+C) BMS with clopidogrel (BMS+C)
BMS without clopidogrel (BMS-C) BMS without clopidogrel (BMS-C)
DES-CDES-C(n=579)(n=579)
BMS-CBMS-C(n=1976)(n=1976)
BMS+CBMS+C(n=417)(n=417)
DES+CDES+C(n=637)(n=637)
66 66 88 88 88 8813131313 33 33
27272727262626263131313129292929 22 22
67676767666666666262626258585858 11 11
<0.001<0.001<0.001<0.001Number of diseased vessels (%)Number of diseased vessels (%)Number of diseased vessels (%)Number of diseased vessels (%)
<0.001<0.001<0.001<0.00146464646515151513838383839393939Hx MI (%)Hx MI (%)Hx MI (%)Hx MI (%)
0.0260.0260.0260.02611111111 99 991515151510101010Hx CHF (%)Hx CHF (%)Hx CHF (%)Hx CHF (%)
0.0010.0010.0010.00123232323292929293030303027272727Hx Diabetes (%)Hx Diabetes (%)Hx Diabetes (%)Hx Diabetes (%)
0.930.930.930.9363636363646464646464646463636363Male (%)Male (%)Male (%)Male (%)
0.180.180.180.1820202020202020202424242419191919Black race (%)Black race (%)Black race (%)Black race (%)
0.730.730.730.7361 (52, 71)61 (52, 71)61 (52, 71)61 (52, 71)61 (53, 70)61 (53, 70)61 (53, 70)61 (53, 70)60 (53, 70)60 (53, 70)60 (53, 70)60 (53, 70)61 (53, 71)61 (53, 71)61 (53, 71)61 (53, 71)Age, yearsAge, yearsAge, yearsAge, years
p-valuep-valuep-valuep-value
6-Month Landmark Patient Characteristics6-Month Landmark Patient Characteristics6-Month Landmark Patient Characteristics6-Month Landmark Patient Characteristics
6-Month Landmark Analysis 6-Month Landmark Analysis Adjusted Cumulative Mortality Rates Adjusted Cumulative Mortality Rates6-Month Landmark Analysis 6-Month Landmark Analysis Adjusted Cumulative Mortality Rates Adjusted Cumulative Mortality Rates
DES-CDES-C
DES+CDES+C
00
22
44
66
88
Per
cen
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um
ula
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Inci
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Rat
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1212 1818 242466MonthsMonths
0.0310.031-3.3 (-6.3, -0.3)-3.3 (-6.3, -0.3)DES+C – DES-CDES+C – DES-C
pp% (95% CI)% (95% CI)
5.35.3
2.02.0
6-Month Landmark Analysis 6-Month Landmark Analysis Adjusted Cumulative Mortality Rates Adjusted Cumulative Mortality Rates6-Month Landmark Analysis 6-Month Landmark Analysis Adjusted Cumulative Mortality Rates Adjusted Cumulative Mortality Rates
DES-CDES-C
DES+CDES+C
00
22
44
66
88
Per
cen
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um
ula
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Inci
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Rat
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1212 1818 242466
0.0110.011-2.5 (-4.4, -0.6)-2.5 (-4.4, -0.6)DES+C – BMS-CDES+C – BMS-C
0.0310.031-3.3 (-6.3, -0.3)-3.3 (-6.3, -0.3)DES+C – DES-CDES+C – DES-C
pp% (95% CI)% (95% CI)
5.35.3
2.02.0
BMS-CBMS-C4.54.5
MonthsMonths
6-Month Landmark Analysis 6-Month Landmark Analysis Adjusted Cumulative Mortality Rates Adjusted Cumulative Mortality Rates6-Month Landmark Analysis 6-Month Landmark Analysis Adjusted Cumulative Mortality Rates Adjusted Cumulative Mortality Rates
DES-CDES-C
BMS-CBMS-C
DES+CDES+C
BMS+CBMS+C
00
22
44
66
88
Per
cen
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um
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Inci
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1212 1818 242466
0.500.50-0.7 (-2.9, 1.4)-0.7 (-2.9, 1.4)BMS+C – BMS-CBMS+C – BMS-C
0.550.550.8 (-1.8, 3.5)0.8 (-1.8, 3.5)DES-C – BMS-CDES-C – BMS-C
0.0110.011-2.5 (-4.4, -0.6)-2.5 (-4.4, -0.6)DES+C – BMS-CDES+C – BMS-C
0.180.18-1.7 (-4.2, 0.8)-1.7 (-4.2, 0.8)DES+C – BMS+CDES+C – BMS+C
0.0310.031-3.3 (-6.3, -0.3)-3.3 (-6.3, -0.3)DES+C – DES-CDES+C – DES-C
pp% (95% CI)% (95% CI)
5.35.3
3.73.7
4.54.5
2.02.0
MonthsMonths
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II. ACE vs. ARB for long-term II. ACE vs. ARB for long-term treatment of essential hypertensiontreatment of essential hypertension
Rx A
Rx B Rx C
Indirect comparison
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Criteria for considering Criteria for considering performing an indirect comparisonperforming an indirect comparison Common comparator (amlodipine, atenolol, or pbo)Common comparator (amlodipine, atenolol, or pbo) Study populations comparable with regard to key Study populations comparable with regard to key
characteristics relevant to the assessed outcomecharacteristics relevant to the assessed outcome For event rates (death, stroke, or MI) For event rates (death, stroke, or MI) → → mean age mean age For studies of laboratory measures (HbA1c, For studies of laboratory measures (HbA1c,
glucose, creatinine, GFR, or proteinuria) glucose, creatinine, GFR, or proteinuria) → → mean mean lab at baselinelab at baseline
Comparable = Comparable = ∆ ≤ ∆ ≤ 10% (e.g., mean aged 70 years 10% (e.g., mean aged 70 years vs. 63 years vs. 63 years
More than 1 study of an ACE inhibitor versus the More than 1 study of an ACE inhibitor versus the comparator and more than 1 study of an ARB versus comparator and more than 1 study of an ARB versus the comparator. the comparator.
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Despite these relatively liberal Despite these relatively liberal criteria…criteria…
we did not identify any appropriate we did not identify any appropriate candidate studies related to an candidate studies related to an outcome of special interest, and thus outcome of special interest, and thus we did not attempt to use indirect we did not attempt to use indirect evidence to infer relative effect of evidence to infer relative effect of ACE inhibitors versus ARBs.ACE inhibitors versus ARBs.
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III. Requisite analysisIII. Requisite analysis
Stupid Perfect
Requisite
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Item/servicepresented
for consideration
Clinical/policy question(s) formulated
Current evidence reviewed
List of alternative designs constructed
Evidence development strategy implemented
Decision made
“Value of Information”exercise performed
“Adequate data”defined
Data deemed adequate for decision making
Figure 1: Deciding When To Develop a Registry: the “Value of Information” Exercise.
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6-Month Landmark View6-Month Landmark View6-Month Landmark View6-Month Landmark View
BaselineBaselineBaselineBaseline 6 Months6 Months6 Months6 Months 24 Months24 Months24 Months24 Months
BMSBMSn=3165n=3165BMSBMSn=3165n=3165
DESDESn=1501n=1501DESDESn=1501n=1501
Exclusions:Exclusions: Death: Death: 123123 Nonfatal MI: Nonfatal MI: 94 94 Revascularization: Revascularization: 289289 Meds not reported: Meds not reported: 266266
Exclusions:Exclusions: Death: Death: 123123 Nonfatal MI: Nonfatal MI: 94 94 Revascularization: Revascularization: 289289 Meds not reported: Meds not reported: 266266
BMS+CBMS+Cn=417n=417BMS+CBMS+Cn=417n=417
BMS-CBMS-Cn=1976n=1976BMS-CBMS-Cn=1976n=1976
DES+CDES+Cn=637 n=637 DES+CDES+Cn=637 n=637
DES-CDES-Cn=579 n=579 DES-CDES-Cn=579 n=579
Exclusions:Exclusions: Death: Death: 62 62 Nonfatal MI: Nonfatal MI: 18 18 Revascularization: Revascularization: 76 76 Meds not reported: Meds not reported: 129129
Exclusions:Exclusions: Death: Death: 62 62 Nonfatal MI: Nonfatal MI: 18 18 Revascularization: Revascularization: 76 76 Meds not reported: Meds not reported: 129129
6-Month Landmark Analysis 6-Month Landmark Analysis Adjusted Cumulative Rates of Death or Nonfatal MI Adjusted Cumulative Rates of Death or Nonfatal MI 6-Month Landmark Analysis 6-Month Landmark Analysis Adjusted Cumulative Rates of Death or Nonfatal MI Adjusted Cumulative Rates of Death or Nonfatal MI
DES-CDES-C
DES+CDES+C
00
22
44
66
88
Per
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1212 1818 242466
0.0210.021-4.1 (-7.6, -0.6)-4.1 (-7.6, -0.6)DES+C – DES-CDES+C – DES-C
pp% (95% CI)% (95% CI)7.27.2
3.13.1
MonthsMonths
6-Month Landmark Analysis 6-Month Landmark Analysis Adjusted Cumulative Rates of Death or Nonfatal MI Adjusted Cumulative Rates of Death or Nonfatal MI 6-Month Landmark Analysis 6-Month Landmark Analysis Adjusted Cumulative Rates of Death or Nonfatal MI Adjusted Cumulative Rates of Death or Nonfatal MI
DES-CDES-C
BMS-CBMS-C
DES+CDES+C
00
22
44
66
88
Per
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1212 1818 242466
0.0170.017-2.9 (-5.3, -0.5)-2.9 (-5.3, -0.5)DES+C – BMS-CDES+C – BMS-C
0.0210.021-4.1 (-7.6, -0.6)-4.1 (-7.6, -0.6)DES+C – DES-CDES+C – DES-C
pp% (95% CI)% (95% CI)7.27.2
6.06.0
3.13.1
MonthsMonths
DES-CDES-C
BMS-CBMS-C
DES+CDES+C
BMS+CBMS+C
00
22
44
66
88
Per
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1212 1818 242466
0.700.70-0.5 (-3.2, 2.2)-0.5 (-3.2, 2.2)BMS+C – BMS-CBMS+C – BMS-C
0.440.441.2 (-1.8, 4.2)1.2 (-1.8, 4.2)DES-C – BMS-CDES-C – BMS-C
0.0170.017-2.9 (-5.3, -0.5)-2.9 (-5.3, -0.5)DES+C – BMS-CDES+C – BMS-C
0.160.16-2.4 (-5.6, 0.9)-2.4 (-5.6, 0.9)DES+C – BMS+CDES+C – BMS+C
0.0210.021-4.1 (-7.6, -0.6)-4.1 (-7.6, -0.6)DES+C – DES-CDES+C – DES-C
pp% (95% CI)% (95% CI)7.27.2
5.55.5
6.06.0
3.13.1
MonthsMonths
6-Month Landmark Analysis6-Month Landmark Analysis Adjusted Cumulative Rates of Death or Nonfatal MI Adjusted Cumulative Rates of Death or Nonfatal MI 6-Month Landmark Analysis6-Month Landmark Analysis Adjusted Cumulative Rates of Death or Nonfatal MI Adjusted Cumulative Rates of Death or Nonfatal MI
DES+CDES+C(n=637)(n=637)
p-valuep-valuep-valuep-valueBMS-CBMS-C
(n=1976)(n=1976)BMS+CBMS+C(n=417)(n=417)
DES-CDES-C(n=579)(n=579)
6-Month Landmark Medication Use6-Month Landmark Medication Use6-Month Landmark Medication Use6-Month Landmark Medication Use
Clopidogrel use at: Clopidogrel use at:
<0.001<0.001 0 0100100 0 0100100 6 Months (%)(%) 6 Months (%)(%)
<0.001<0.001 5 5777715157373 12 Months (%)(%) 12 Months (%)(%)
<0.001<0.001 8 8626215155555 24 Months (%)(%) 24 Months (%)(%)
Aspirin use at: Aspirin use at:
0.0030.0038787828286869393 24 Months (%)(%) 24 Months (%)(%)
0.0030.0038585848486869191 12 Months (%)(%) 12 Months (%)(%)
<0.001<0.0018080868674749494 6 Months (%)(%) 6 Months (%)(%)
LimitationsLimitationsLimitationsLimitations
Clopidogrel and DES use not randomizedClopidogrel and DES use not randomized
Unmeasured prognostic factorsUnmeasured prognostic factors
Clopidogrel use identified by patient self-Clopidogrel use identified by patient self-report report
90-day window used to determine follow-90-day window used to determine follow-up contact and medication use up contact and medication use
Clopidogrel and DES use not randomizedClopidogrel and DES use not randomized
Unmeasured prognostic factorsUnmeasured prognostic factors
Clopidogrel use identified by patient self-Clopidogrel use identified by patient self-report report
90-day window used to determine follow-90-day window used to determine follow-up contact and medication use up contact and medication use
ConclusionsConclusionsConclusionsConclusions
Compared to BMS, DES is associated with Compared to BMS, DES is associated with reduced rates of TVRreduced rates of TVR
Death and MI higher for DES patients Death and MI higher for DES patients stopping clopidogrel therapy at 6 monthsstopping clopidogrel therapy at 6 months
Results consistent with CREDO, BASKET-Results consistent with CREDO, BASKET-LATE, and PREMIERLATE, and PREMIER
Need rigorous clinical trials to assess Need rigorous clinical trials to assess optimal duration of clopidogrel therapyoptimal duration of clopidogrel therapy
Compared to BMS, DES is associated with Compared to BMS, DES is associated with reduced rates of TVRreduced rates of TVR
Death and MI higher for DES patients Death and MI higher for DES patients stopping clopidogrel therapy at 6 monthsstopping clopidogrel therapy at 6 months
Results consistent with CREDO, BASKET-Results consistent with CREDO, BASKET-LATE, and PREMIERLATE, and PREMIER
Need rigorous clinical trials to assess Need rigorous clinical trials to assess optimal duration of clopidogrel therapyoptimal duration of clopidogrel therapy