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Long-Term Outcomes in Patients Undergoing
Coronary Stenting on Dual Oral Antiplatelet
Treatment Requiring Oral Anticoagulant Therapy
R. Rossini, G. Musumeci, C. Lettieri, M.
Molfese, L. Mihalcsik, P. Mantovani, V.
Sirbu, T. A. Bass, F. Della Rovere,
A. Gavazzi, D. J Angiolillo
Dipartimento Cardiovascolare, Ospedali Riuniti
di Bergamo Ospedale Carlo Poma,
Mantova Ospedale Galliera, Genova
University of Florida, Jacksonville, US
American Journal of Cardiology 2008 102
1618-1623
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Background
In patients undergoing coronary stenting,
long-term dual antiplatelet therapy with aspirin
and clopidogrel reduces atherothrombotic events
but also increases the risk of bleeding. The
potential for developing bleeding complications
is further enhanced in patients also requiring
oral anticoagulant treatment (triple therapy).
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Aim
To assess long-term outcomes associated with the
use of triple-therapy in patients undergoing
coronary stenting and evaluate how these may be
affected by targeting international normalized
ratio (INR) values to the lower therapeutic
range.
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Methods

• We analyzed 102 consecutive patients undergoing
  coronary stenting treated with dual antiplatelet
  therapy also requiring oral anticoagulation. The
  target international normalized ratio (INR) value
  was 2-2.5
• An age and sex-matched control group (n102)
  with similar disease presentation and procedure
  type was selected from the study period
• 18 months Follow-up
• TIMI major and minor bleedings
• MACE death, myocardial infarction, stent
  thrombosis, stroke and target vessel
  revascularization

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Baseline Characteristics
Triple
Controls
P value
( n 102 )
( n 102 )
68.2 ? 8.1
0.2 81 (79.4 ) 0.8
46 (45 )
0.6 35 (34.3 ) 0.9
1.50.9 0.8
49 (48) 0.4

• Age (y) 67.9 ? 9.3
• Male 82 (80.4)
• UA/NSTEMI 45 (44.1 )
• STEMI 35 (34.3 )
• Stent/Pt 1.50.7
• Pt with DES 48 (47)
• Target INR value 2-2.5

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Main Indications for Warfarin use
Mean duration of triple therapy was 158 days
(range 30-540)

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Results 18-month Major and Minor Bleeding

P0.1
P0.6
Mean INR at the time of bleeding was 3.10.7
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(No Transcript)
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Specificity

• The optimal ROC-defined INR value cut point
  between sensitivity and specificity for all
  bleeding was 2.6.
• This cut-off value had a specificity of 89, a
  sensitivity of 66, a negative predicted value of
  95, and a positive predictive value of 44.

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All bleeding cumulative distribution
100

95.1
90
89.2
P0.13
80
Bleeding event free survival
70
Double therapy
60
Triple therapy
50
0
200
300
450
600
Days
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All bleeding cumulative distribution by INR
100

95.1
95.1
90
80
Bleeding event free survival

70
Double therapy
66.7

60
Triple therapy with INR lt 2.6
Triple therapy with INR 2.6
50
0
200
300
450
600
Days
Plt0.0001 vs Double therapy
Plt0.0001 vs Triple with INR lt2.6
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• In the triple therapy group, use of GPIIb/IIIa
  blocker (OR 2.7, P 0.03), value of INR gt 2.6
  (OR 9.8, P 0.0007), female gender (OR 2.0, P
  0.04), and smoking (OR 2.9, P 0.02), were
  significant predictors of any bleeding at 18
  months in univariate analyses
• Multivariable analysis showed that only an INR gt
  2.6 predicted overall bleeding (OR 19.2, 95 CI
  4.3-44.6 P0.0003).

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18-month MACE

P0.7
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Conclusions

• In high risk patients implanted with coronary
  stent,
• long term triple therapy seems to be safe and
  effective.
• Careful monitoring and low target of INR must be
  provided in these patients