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American Journal of Cardiology 2008; 102: 1618-1623

Long-Term Outcomes in Patients Undergoing Coronary Stenting on Dual Oral Antiplatelet Treatment Requiring Oral Anticoagulant Therapy

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American Journal of Cardiology 2008; 102: 1618-1623

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  1. 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

  2. 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”).

  3. 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.

  4. 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 (n=102) 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

  5. 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 1.5±0.9 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 1.5±0.7 • Pt with DES 48 (47%) • Target INR value 2-2.5

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

  7. Results: 18-month Major and Minor Bleeding % P=0.1 P=0.6 Mean INR at the time of bleeding was 3.1±0.7

  8. 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%.

  9. All bleeding cumulative distribution % 100 95.1 % 90 89.2 % P=0.13 80 Bleeding event free survival 70 Double therapy 60 Triple therapy 50 0 200 300 450 600 Days

  10. 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 < 2.6 Triple therapy with INR ≥ 2.6 50 0 200 300 450 600 Days † P<0.0001 vs Double therapy ‡ P<0.0001 vs Triple with INR <2.6

  11. In the triple therapy group, use of GPIIb/IIIa blocker (OR 2.7, P = 0.03), value of INR > 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 > 2.6 predicted overall bleeding (OR 19.2, 95% CI 4.3-44.6; P=0.0003).

  12. 18-month MACE % P=0.7

  13. 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 Conclusions

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