www.metcardio.org Why are drug- Why are drug- eluting eluting stents safer than stents safer than bare-metal stents? bare-metal stents? Giuseppe Biondi Zoccai, MD Giuseppe Biondi Zoccai, MD Sapienza University of Rome, Rome, Italy Sapienza University of Rome, Rome, Italy METCARDIO, Ospedaletti, Italy METCARDIO, Ospedaletti, Italy [email protected][email protected]10 th International Cardiology Congress – Patras – 4-6 May 2012
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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 University of Rome , Rome , Italy METCARDIO, Ospedaletti , Italy [email protected]. 10 th International Cardiology Congress – Patras – 4-6 May 2012. LEARNING GOALS. - PowerPoint PPT Presentation
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Why are drug-eluting Why are drug-eluting stents safer than stents safer than
• 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
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END-POINTS• 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
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ANALYSIS
• 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
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ANALYSIS• 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.
Definite or probable thrombosisDirect estimateIndirect estimateTotal (95% CI)Test for overall effect Z=4.48 (p<0.00001)
-1.427-1.421
-0.968-1.122
0.5190.359
0.3770.304
32.4%67.6%
100.00%
39.4%60.6%
100.00%
0.24 (0.09-0.66)0.24 (0.12-0.49)0.24 (0.14-0.43)
0.38 (0.18-0.80)0.33 (0.18-0.53)0.35 (0.22-0.55)
Statistical inconsistency (I2): 0% for both comparisons
Palmerini, Biondi-Zoccai et al, Lancet 2012
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WHAT ABOUT DEATH OR MYOCARDIAL INFARCTION?
• 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
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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
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IMPLICATIONS• 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.
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IMPLICATIONS– 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.
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IS THIS A PARADIGM SHIFT?
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THE REPLY IS YOURS…
IF I NEEDED A STENT TODAY, WHICH STENT SHOULD I CHOOSE?
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Many thanks for your attention
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