Stent thrombosis evidence from a network meta analysis
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Stent thrombosis: evidence from a network meta-analysis. Giuseppe Biondi Zoccai, MD Department of Medico-Surgical Sciences and Biotechnologies Sapienza University of Rome [email protected] LEARNING GOALS. What is stent thrombosis (ST)? What are network meta-analyses (NMA)?

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Stent thrombosis: evidence from a network meta-analysis

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Stent thrombosis evidence from a network meta analysis

Stent thrombosis: evidence from a network meta-analysis

Giuseppe Biondi Zoccai, MD

DepartmentofMedico-SurgicalSciences and Biotechnologies

Sapienza UniversityofRome

[email protected]


Learning goals

LEARNING GOALS

  • What is stent thrombosis (ST)?

  • What are network meta-analyses (NMA)?

  • NMA of ST

    • Goals

    • Methods

    • Results

    • Implications


Learning goals1

LEARNING GOALS

  • What is stent thrombosis (ST)?

  • What are network meta-analyses (NMA)?

  • NMA of ST

    • Goals

    • Methods

    • Results

    • Implications


What is stent thrombosis

WHAT IS STENT THROMBOSIS

D’Ascenzo et al, submitted


Definitions of stent thrombosis

DEFINITIONS OF STENT THROMBOSIS

Cutlip et al, Circulation 2007


Definitions of stent thrombosis1

DEFINITIONS OF STENT THROMBOSIS

Cutlip et al, Circulation 2007


Definitions of stent thrombosis2

DEFINITIONS OF STENT THROMBOSIS

Cutlip et al, Circulation 2007


Timing of stent thrombosis

TIMING OF STENT THROMBOSIS

Cutlip et al, Circulation 2007


Incidence of des thrombosis

INCIDENCE OF DES THROMBOSIS

very late

total

acute

subacute

late

D’Ascenzo et al, Int J Cardiol 2012


Predictors of stent thrombosis

PREDICTORS OF STENT THROMBOSIS

D’Ascenzo et al, Int J Cardiol 2011


Impact of stent thrombosis

IMPACT OF STENT THROMBOSIS

Chechi et al, J Am Coll Cardiol 2008


Learning goals2

LEARNING GOALS

  • What is stent thrombosis (ST)?

  • What are network meta-analyses (NMA)?

  • NMA of ST

    • Goals

    • Methods

    • Results

    • Implications


Famous quotes

FAMOUS QUOTES

“If I have seen further it is by standing on the shoulders of giants” Isaac Newton

“The great advances in science usually result from new tools rather than from new doctrines”

Freeman Dyson


Famous quotes1

FAMOUS QUOTES

“I like to think of the meta-analytic process as similar to being in a helicopter.

On the ground individual trees are visible with high resolution.

This resolution diminishes as the helicopter rises, and in its place we begin to see patterns not visible from the ground” Ingram Olkin


Baby steps of meta analysis

BABY STEPS OF META-ANALYSIS

  • 1904 - Karl Pearson (UK): correlation between inoculation of vaccine for typhoid fever and mortality across apparently conflicting studies

  • 1931 – Leonard Tippet (UK): comparison of differences between and within farming techniques on agricultural yield adjusting for sample size across several studies

  • 1937 – William Cochran (UK): combination of effect sizes across different studies of medical treatments

  • 1970s – Robert Rosenthal and Gene Glass (USA), Archie Cochrane (UK): combination of effect sizes across different studies of, respectively, educational and psychological treatments

  • 1980s– exponential development/use of meta-analytic methods


Minimal glossary

MINIMAL GLOSSARY

  • Review: viewpoint on a subject quoting different primary authors

  • Overview: as above

  • Qualitative review: deliberately avoids a systematic approach

  • Systematic review: deliberately uses a systematic approach to study search, selection, abstraction, appraisal and pooling

  • Quantitative review: uses quantitative methods to appraise or synthesize data

  • Meta-analysis: uses specific statistical methods for data pooling and/or exploratory analysis

  • Individual patient data meta-analysis: uses specific stastistical methods for data pooling or subgroup exploration exploiting individual patient data

    →Our focus:systematic review + meta-analysis


Systematic review and meta analyses

SYSTEMATIC REVIEW AND META-ANALYSES

  • What is a systematic review?

    • A systematic appraisal of the methodological quality, clinical relevance and consistency of published evidence on a specific clinical topic in order to provide clear suggestions for a specific healthcare problem

  • What is a meta-analysis?

    • A quantitative synthesis that, preserving the identity of individual studies, tries to provide an estimate of the overall effect of an intervention, exposure, or diagnostic strategy


Ebm hierarchy of evidence

EBM HIERARCHY OF EVIDENCE

  • N of 1 randomized controlled trial

  • Systematic reviews of homogeneous randomized trials

  • Single (large) randomized trial

  • Systematic review of homogeneous observational studies addressing patient-important outcomes

  • Single observational study addressing patient-important outcomes

  • Physiologic studies (eg blood pressure, cardiac output, exercise capacity, bone density, and so forth)

  • Unsystematic clinical observations

Guyatt and Rennie, Users’ guide to the medical literature, 2002


Stent thrombosis evidence from a network meta analysis

PROS

  • Application to any clinical research question

  • Systematic searches for clinical evidence

  • Explicit and standardized methods for search and selection of evidence sources

  • Thorough appraisal of the internal validity of primary studies

  • Quantitative synthesis with increased statistical power

  • Increased external validity by appraising the effect of an intervention (exposure) across different settings

  • Test subgroup hypotheses (eg with patient-level reviews)

  • Explore clinical and statistical heterogeneity

Lau et al, Lancet 1998


Reasons for meta analysis failure

REASONS FOR META-ANALYSIS FAILURE

  • Duplicate efforts may lead to discordant results

  • Funding or conflicts of interest may bias

  • Studies/events might not be found

  • Studies may be of low quality/internal validity

  • Studies may be heterogeneous/inconsistent, ie “mixing apples with oranges” provides unreal fruits

  • Studies may not be relevant to current individual practice

  • Selection based on publication may bias

  • Analysis with highly sensitive but unrobust tests may bias

LeLorier et al, New Engl J Med 1997; Lau et al, Lancet 1998; Rosen, BMC BMC Health Services Research 2009


Arguably the most important meta analysis ever

ARGUABLY THE MOST IMPORTANT META-ANALYSIS EVER….

Antman et al, JAMA 1992


Showing discrepancies among evidence and experts

…SHOWING DISCREPANCIES AMONG EVIDENCE AND EXPERTS


Standard pair wise meta analyses

STANDARD (PAIR-WISE) META-ANALYSES

Incosistency

P for effect

P for heterogeneity

Hsia et al, Ann Surg 2008


Indirect and network meta analyses

INDIRECT AND NETWORKMETA-ANALYSES

Biondi-Zoccai et al, HSR Proceedings 2011


Parallel hierarchy of clinical research

PARALLEL HIERARCHY OF CLINICAL RESEARCH


Learning goals3

LEARNING GOALS

  • What is stent thrombosis (ST)?

  • What are network meta-analyses (NMA)?

  • NMA of ST

    • Goals

    • Methods

    • Results

    • Implications


Network meta analysis nma of stent thrombosis st

NETWORK META-ANALYSIS (NMA) OF STENT THROMBOSIS (ST)


Nma of st background

NMA OF ST: BACKGROUND


Nma of st goals

NMA OF ST: GOALS


Learning goals4

LEARNING GOALS

  • What is stent thrombosis (ST)?

  • What are network meta-analyses (NMA)?

  • NMA of ST

    • Goals

    • Methods

    • Results

    • Implications


Nma of st design

NMA OF ST: DESIGN


Nma of st design1

NMA OF ST: DESIGN


Nma of st search and selection

NMA OF ST: SEARCH AND SELECTION


Nma of st analysis

NMA OF ST: ANALYSIS


Nma of st analysis1

NMA OF ST: ANALYSIS


Learning goals5

LEARNING GOALS

  • What is stent thrombosis (ST)?

  • What are network meta-analyses (NMA)?

  • NMA of ST

    • Goals

    • Methods

    • Results

    • Implications


Nma of st profile

NMA OF ST: PROFILE

2602 potentially relevant articles

FDA

approved

stents

(BMS, SES, PES, End-ZES, Res-ZES, CoCr-EES, PtCr-EES)

49 RCTs

50,844 pts

2441 excluded

2117 not a comparison of DES

324 post-hoc, subgroup,

follow-up, or pooled analyses

Review of title

and abstract

161 articles needing full review

112 excluded

84 not an RCT

13 DES not FDA approved

11 no ARC definition

4 DES pooled

Full-text

review

49 articles meeting criteria


Nma of st network

NMA OF ST: NETWORK

9 studies

PES

BMS

9 studies

4 studies

8 studies

1 study

5 studies

2 studies

6 studies

End-ZES

SES

6 studies

CoCr-EES

2 studies

1 study

Res-ZES

Pt-Cr-EES


Nma of st results

NMA OF ST: RESULTS

30-day definite stent thrombosis

Odds Ratio [95%]

CoCr-EES vs BMS

CoCr-EES vs PES

CoCr-EES vs SESCoCr-EES vs End-ZES

CoCr-EES vs Res-ZES

PtCr-EES vs BMS

PtCr-EES vs PES

PtCr-EES vs End-ZES

PtCr-EES vs Res-ZES

SES vs BMS

0.21 (0.11-0.42)

0.27 (0.14-0.51)

0.40 (0.21-0.79)

0.22 (0.09-0.54)

0.07 (0.00-0.46)

0.06 (0.00-0.68)

0.07 (0.00-0.83)

0.06 (0.00-0.73)

0.02 (0.00-0.43)

0.54 (0.30-0.90)

1

10

0.1

0.01

Favors Stent 2

Favors Stent 1


Nma of st results1

NMA OF ST: RESULTS

Odds Ratio

[95%]

30d – 1yr definite stent thrombosis

CoCr-EES vs BMS

CoCr-EES vs PES

CoCr-EES vs End-ZES

End-ZES vs SES

0.27 (0.08-0.74)

0.24 (0.08-0.62)

0.13 (0.02-0.56)

4.06 (1.11-18.54)

1

100

0.1

0.01

10

Favors Stent 1

Favors Stent 2


Nma of st results2

NMA OF ST: RESULTS

Odds Ratio

[95%]

1-year definite stent thrombosis

CoCr-EES vs BMS

CoCr-EES vs PES

CoCr-EES vs SESCoCr-EES vs Res-ZES

CoCr-EES vs End-ZES

SES vs BMS

End-ZES vs SES

0.23 (0.13-0.41)

0.28 (0.16-0.48)

0.41 (0.24-0.70)

0.14 (0.03-0.47)

0.21 (0.10-0.44)

0.57 (0.36-0.88)

1.92 (1.07-3.90)

1

10

0.1

0.01

Favors Stent 1

Favors Stent 2


Nma of st results3

NMA OF ST: RESULTS

Odds Ratio

[95%]

2-year definite stent thrombosis

CoCr-EES vs BMS

CoCr-EES vs PES

0.35 (0.17-0.69)

0.34 (0.19-0.62)

1

10

0.1

0.01

Favors Stent 1

Favors Stent 2


Nma of st results4

NMA OF ST: RESULTS


Nma of st results5

NMA OF ST: RESULTS


Nma of st results6

NMA OF ST: RESULTS


Nma of st results7

NMA OF ST: RESULTS

Odds Ratio IV

Random, 95% CI

Log (odds ratio)

SE

Weight

Definite stent thrombosis

32.4%

67.6%

100.00%

0.24 (0.09-0.66)

0.24 (0.12-0.49)

0.24 (0.14-0.43)

Direct estimate

Indirect estimate

Total (95% CI)

Test for overall effect Z=4.82 (p<0.00001)

-1.427

-1.421

0.519

0.359

Definite or probable thrombosis

39.4%

60.6%

100.00%

Direct estimate

Indirect estimate

Total (95% CI)

Test for overall effect Z=4.48 (p<0.00001)

0.38 (0.18-0.80)

0.33 (0.18-0.53)

0.35 (0.22-0.55)

-0.968

-1.122

0.377

0.304

Statistical inconsistency (I2):

0% for both comparisons

1

10

0.001

0.1

IV = inverse variance

SE = standard error

Favors CoCr-EES

Favors BMS


Potential of everolimus eluting stents

POTENTIAL OF EVEROLIMUS-ELUTING STENTS

Verheye et al, J Am Coll Cardiol 2007


Potential of everolimus eluting stents1

POTENTIAL OF EVEROLIMUS-ELUTING STENTS

Kolandaivelu et al, Circulation 2011


Learning goals6

LEARNING GOALS

  • What is stent thrombosis (ST)?

  • What are network meta-analyses (NMA)?

  • NMA of ST

    • Goals

    • Methods

    • Results

    • Implications


Implications

IMPLICATIONS

  • The largest and most comprehensive study comparing the rates of ARC definite and definite or probable stent thrombosis between different types of DES and between DES and BMS has the following implications:

    • CoCr-EES were associated with significantly lower rates of 1-year and 2-year definite stent thrombosis than were BMS, a result not present with other DES.


Implications1

IMPLICATIONS

  • The reduction in stent thrombosis with CoCr-EES compared with BMS was apparent both early and late (occurring before 30 days and between 31 days and 1 year).

  • CoCr-EES were also associated with significantly lower 1-year rates of definite stent thrombosis than were other first and second generation DES, including PES, SES, PC-ZES, and Re-ZES.


Is this a paradigm shift

IS THIS A PARADIGM SHIFT?


The reply is yours

THE REPLY IS YOURS…

IF YOU NEEDED A STENT TODAY, WHICH STENT WOULD YOU CHOOSE?


Stent thrombosis evidence from a network meta analysis

For these and further slides on these topics please feel free to visit the metcardio.org website:http://www.metcardio.org/slides.html


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