Why are drug eluting stents safer than bare metal stents
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Why are drug-eluting stents safer than bare-metal stents?. Giuseppe Biondi Zoccai, MD Sapienza University of Rome , Rome , Italy METCARDIO, Ospedaletti , Italy [email protected] 10 th International Cardiology Congress – Patras – 4-6 May 2012. LEARNING GOALS.

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Why are drug eluting stents safer than bare metal stents

Why are drug-eluting stents safer than bare-metal stents?

Giuseppe Biondi Zoccai, MD

Sapienza UniversityofRome, Rome, Italy

METCARDIO, Ospedaletti, Italy

[email protected]

10th International Cardiology Congress – Patras – 4-6 May 2012


Learning goals
LEARNING GOALS

  • Current paradigm

  • Why could drug-eluting stents possibly be safer than bare-metal stents?

  • The case for network meta-analyses

  • Stent thrombosis with drug-eluting versus bare-metal stents: evidence from a network meta-analysis

  • Paradigm shift


Learning goals1
LEARNING GOALS

  • Current paradigm

  • Why could drug-eluting stents possibly be safer than bare-metal stents?

  • The case for network meta-analyses

  • Stent thrombosis with drug-eluting versus bare-metal stents: evidence from a network meta-analysis

  • Paradigm shift



Incidence of stent thrombosis
INCIDENCE OF STENT THROMBOSIS*

very late

total

acute

subacute

late

*at a median folllow-up of 18 months

D’Ascenzo et al, Int J Cardiol 2012


Predictors of stent thrombosis
PREDICTORS OF STENT THROMBOSIS*

*number of studies confirming the independent role of the predictor

D’Ascenzo et al, Int J Cardiol 2012


Impact of stent thrombosis
IMPACT OF STENT THROMBOSIS

Chechi et al, J Am Coll Cardiol 2008



2006 annus horribilis for drug eluting stents1
2006: ANNUS HORRIBILIS FOR DRUG-ELUTING STENTS

Nordmann et al, Eur Heart J 2006

Camenzind, ESC/WCC 2006

Bavry et al, Am J Med 2006


Learning goals2
LEARNING GOALS

  • Current paradigm

  • Why could drug-eluting stents possibly be safer than bare-metal stents?

  • The case for network meta-analyses

  • Stent thrombosis with drug-eluting versus bare-metal stents: evidence from a network meta-analysis

  • Paradigm shift


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


Risk of stent thrombosis with everolimus eluting versus bare metal stents
RISK OF STENT THROMBOSIS WITH EVEROLIMUS-ELUTING VERSUS BARE-METAL STENTS

Kaiser et al, New Engl J Med 2010

Sabate, ESC 2011


Potential of zotaroimus eluting stents
POTENTIAL OF ZOTAROIMUS-ELUTING STENTS BARE-METAL STENTS

Guagliumi et al, J Am Coll Cardiol Intv 2010


Learning goals3
LEARNING GOALS BARE-METAL STENTS

  • Current paradigm

  • Why could drug-eluting stents possibly be safer than bare-metal stents?

  • The case for network meta-analyses

  • Stent thrombosis with drug-eluting versus bare-metal stents: evidence from a network meta-analysis

  • Paradigm shift


Meta analyses
META-ANALYSES BARE-METAL STENTS

“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


Systematic review and meta analyses
SYSTEMATIC REVIEW AND META-ANALYSES BARE-METAL STENTS

  • 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


Arguably the most important meta analysis ever
ARGUABLY THE MOST IMPORTANT META-ANALYSIS EVER…. BARE-METAL STENTS

Antman et al, JAMA 1992



Standard pair wise meta analyses
STANDARD (PAIR-WISE) META-ANALYSES BARE-METAL STENTS

Point estimate

95% confidence interval

Inconsistency

P for effect

P for heterogeneity

Summary estimate

Hsia et al, Ann Surg 2008


Indirect and network meta analyses
INDIRECT AND NETWORK BARE-METAL STENTSMETA-ANALYSES

Biondi-Zoccai et al, HSR Proceedings 2011


Parallel hierarchy of clinical research
PARALLEL HIERARCHY BARE-METAL STENTSOF CLINICAL RESEARCH

Biondi-Zoccai et al, HSR Proceedings 2011


Learning goals4
LEARNING GOALS BARE-METAL STENTS

  • Current paradigm

  • Why could drug-eluting stents possibly be safer than bare-metal stents?

  • The case for network meta-analyses

  • Stent thrombosis with drug-eluting versus bare-metal stents: evidence from a network meta-analysis

  • Paradigm shift


Network meta analysis of stent thrombosis
NETWORK META-ANALYSIS OF STENT THROMBOSIS BARE-METAL STENTS

Palmerini, Biondi-Zoccai et al, Lancet 2012


GOAL BARE-METAL STENTS

  • We aimed to perform direct, indirect and combined (i.e. network) meta-analyses of the risk of stent thrombosis with all FDA approved coronary stents:

    • Bare-metal stents (BMS); Cobalt-chromium everolimus-eluting stents (CoCr-EES); Endeavor zotarolimus-eluting stents (End-ZES); Paclitaxel-eluting stents (PES); Platinum-chromium everolimus-eluting stents (PtCr-EES); Resolute zotarolimus-eluting stents (Res-ZES); Sirolimus-eluting stents (SES)

Palmerini, Biondi-Zoccai et al, Lancet 2012


Search and selection
SEARCH AND SELECTION BARE-METAL STENTS

  • Randomized trials of FDA approved coronary stents reporting on stent thrombosis according to the Academic Research Consortium (ARC) definitions were searched in multiple databases (including MEDLINE/PubMed).

  • Authors and experts were queried for additional data and insights on other potentially pertinent studies.

Palmerini, Biondi-Zoccai et al, Lancet 2012


End points
END-POINTS BARE-METAL STENTS

  • Primary end-point:

    • 1-year definite stent thrombosis

  • Secondary end-points:

    • Definite stent thrombosis occurring before 30 days, after 30 days, and within 2 years

    • Definite or probable stent thrombosis (at the above time points)

    • Death, cardiac death and myocardial infarction within 2 years

Palmerini, Biondi-Zoccai et al, Lancet 2012


Analysis
ANALYSIS BARE-METAL STENTS

  • Direct (pair-wise) meta-analyses were performed with a random-effect method computing odds ratios (OR) with 95% confidence intervals (95%CI).

  • Indirect and network meta-analyses were performed with a random-effect method within a Bayesian hierarchical framework, also computing OR and 95%CI.

Palmerini, Biondi-Zoccai et al, Lancet 2012


Analysis1
ANALYSIS BARE-METAL STENTS

  • Small study effects were appraised by funnel plot inspection.

  • Statistical consistency in pair-wise and network analyses was appraised with I2.

  • Sensitivity analyses were conducted using a fixed-effect method and restricted to several subgroups of interest.

  • RevMan and WinBUGS were used for computations.

Palmerini, Biondi-Zoccai et al, Lancet 2012


Review profile
REVIEW PROFILE BARE-METAL STENTS

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 RCTs meeting criteria

Palmerini, Biondi-Zoccai et al, Lancet 2012


Evidence network
EVIDENCE NETWORK BARE-METAL STENTS

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

PtCr-EES

Palmerini, Biondi-Zoccai et al, Lancet 2012


1 year definite stent thrombosis
1-YEAR DEFINITE STENT THROMBOSIS BARE-METAL STENTS

Odds Ratio

[95%]

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

Palmerini, Biondi-Zoccai et al, Lancet 2012


30 day definite stent thrombosis
30-DAY DEFINITE STENT THROMBOSIS BARE-METAL STENTS

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

Palmerini, Biondi-Zoccai et al, Lancet 2012


30 day to 1 year definite stent thrombosis
30-DAY TO 1-YEAR DEFINITE BARE-METAL STENTS STENT THROMBOSIS

Odds Ratio

[95%]

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 (1.11-18.5)

1

100

0.1

0.01

10

Favors Stent 1

Favors Stent 2

Palmerini, Biondi-Zoccai et al, Lancet 2012


2 year definite stent thrombosis
2-YEAR DEFINITE STENT THROMBOSIS BARE-METAL STENTS

Odds Ratio

[95%]

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

Palmerini, Biondi-Zoccai et al, Lancet 2012


Other results for definite stent thrombosis
OTHER RESULTS FOR BARE-METAL STENTSDEFINITE STENT THROMBOSIS

Palmerini, Biondi-Zoccai et al, Lancet 2012


OTHER RESULTS FOR BARE-METAL STENTSDEFINITE STENT THROMBOSIS

Palmerini, Biondi-Zoccai et al, Lancet 2012


Other results for definite or probable stent thrombosis
OTHER RESULTS FOR DEFINITE OR PROBABLE STENT THROMBOSIS BARE-METAL STENTS

Palmerini, Biondi-Zoccai et al, Lancet 2012


Statistical consistency
STATISTICAL CONSISTENCY BARE-METAL STENTS

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

Direct estimate

Indirect estimate

Total (95% CI)

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

39.4%

60.6%

100.00%

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

Palmerini, Biondi-Zoccai et al, Lancet 2012


What about death or myocardial infarction
WHAT ABOUT DEATH OR MYOCARDIAL INFARCTION? BARE-METAL STENTS

  • CoCr-EES were also associated with a significantly lower risk of myocardial infarction (OR=0.61 [0.47-0.79]).

  • These differences were supported by favorable trends for all cause death (OR=0.83 [0.65-1.03]) and cardiac death (OR=0.82 [0.58-1.13]).

Palmerini, Biondi-Zoccai et al, Lancet 2012


Learning goals5
LEARNING GOALS BARE-METAL STENTS

  • Current paradigm

  • Why could drug-eluting stents possibly be safer than bare-metal stents?

  • The case for network meta-analyses

  • Stent thrombosis with drug-eluting versus bare-metal stents: evidence from a network meta-analysis

  • Paradigm shift


Implications
IMPLICATIONS BARE-METAL STENTS

  • The largest and most comprehensive appraisal of the risk of stent thrombosis with different types of coronary stents 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 any other DES.


Implications1
IMPLICATIONS BARE-METAL STENTS

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

  • CoCr-EES were also associated with lower 1-year rates of definite stent thrombosis than were other 1st and 2nd generation DES, including PES, SES, PC-ZES, and Re-ZES.

  • These benefits were associated with lower rates of myocardial infarction.


Is this a paradigm shift
IS THIS A PARADIGM SHIFT? BARE-METAL STENTS


The reply is yours
THE REPLY IS YOURS… BARE-METAL STENTS

IF I NEEDED A STENT TODAY, WHICH STENT SHOULD I CHOOSE?


Many thanks for your attention BARE-METAL STENTSFor these and further slides on these topics please feel free to visit the metcardio.org website:http://www.metcardio.org/slides.html


Definitions of stent thrombosis
DEFINITIONS OF STENT THROMBOSIS BARE-METAL STENTS

Cutlip et al, Circulation 2007


Definitions of stent thrombosis1
DEFINITIONS OF STENT THROMBOSIS BARE-METAL STENTS

Cutlip et al, Circulation 2007


Definitions of stent thrombosis2
DEFINITIONS OF STENT THROMBOSIS BARE-METAL STENTS

Cutlip et al, Circulation 2007


Timing of stent thrombosis
TIMING OF STENT THROMBOSIS BARE-METAL STENTS

Cutlip et al, Circulation 2007


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