6/9/2008 Comparative effectiveness reviews: methodological observations David B. Matchar, MD Professor of Medicine and Director, Center for Clinical Health

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

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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


DES-CDES-C

DES+CDES+C

00

22

44

66

88

Per

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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


pp% (95% CI)% (95% CI)

5.35.3

2.02.0

BMS-CBMS-C4.54.5

MonthsMonths


DES-CDES-C

BMS-CBMS-C

DES+CDES+C

BMS+CBMS+C

00

22

44

66

88

Per

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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


0.180.18-1.7 (-4.2, 0.8)-1.7 (-4.2, 0.8)DES+C – BMS+CDES+C – BMS+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

6/9/20086/9/2008

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.

6/9/20086/9/2008

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.

6/9/20086/9/2008

III. Requisite analysisIII. Requisite analysis

Stupid Perfect

Requisite

6/9/20086/9/2008

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.

6/9/20086/9/2008

6/9/20086/9/2008

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

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1212 1818 242466


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

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1212 1818 242466



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

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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


0.160.16-2.4 (-5.6, 0.9)-2.4 (-5.6, 0.9)DES+C – BMS+CDES+C – BMS+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

Documents

6/9/2008 Comparative effectiveness reviews: methodological observations David B. Matchar, MD Professor of Medicine and Director, Center for Clinical Health