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ISAR-REACT 3

ClinicalTrials.gov Identifier NCT00262054. Bivalirudin Versus Unfractionated Heparin in Biomarker Negative Patients With Stable and Unstable Angina Undergoing PCI. ISAR-REACT 3.

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ISAR-REACT 3

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  1. ISAR REACT 3 ClinicalTrials.gov Identifier NCT00262054 Bivalirudin Versus Unfractionated Heparin in Biomarker Negative Patients With Stable and Unstable Angina Undergoing PCI ISAR-REACT 3 A. Kastrati, F.-J. Neumann, J. Mehilli, S. Schulz, G. Richardt, R. Iijima, R.A. Byrne, P.B. Berger, A. Schömig (Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment 3)

  2. ISAR REACT 3 Bivalirudin has not been compared with unfractionated heparin during PCI in the modern era, or in patients who have received optimal pretreatment with clopidogrel. Background

  3. ISAR REACT 3 Aim To compare bivalirudin alone to unfractionated heparin alone in biomarker negative pts undergoing PCI pretreated with clopidogrel 600 mg for >2 hours Hypothesis Bivalirudin is superior to UFH for biomarker negative patients undergoing PCI after optimal pretreatment with clopidogrel

  4. ISAR REACT 3 Acute coronary syndromes with positive biomarkers or ST-segment elevation on ECG Cardiogenic shock Active bleeding, bleeding diathesis Impaired renal function (creatinine >3 mg/dl) Exclusion Criteria

  5. ISAR REACT 3 Composite rate of: Death Myocardial infarction (defined as CK-MB ≥2x upper limit normal) Urgent target vessel revascularization Major bleeding (according to the REPLACE-2 criteria, JAMA ′03) Primary (Quadruple) Endpointat 30 Days • Intracranial, intraocular, or retroperitoneal bleeding, or • Clinically overt bleeding resulting in a decrease in Hb>3 g/dL, or • Any decrease in Hb>4 g/dL, or • Transfusion of >2 units of packed red blood cells or whole blood

  6. ISAR REACT 3 Composite rate of: Death Myocardial infarction Urgent target vessel revascularization Secondary (Triple) Endpointat 30 Days

  7. ISAR REACT 3 Study Population Double-blind randomization; double-dummy administration 4,570 Patients(600 mg clopidogrel) Bivalirudin UFH 2,289 Pts 2,281 Pts PCI 30-day Follow-up

  8. ISAR REACT 3 Type of PCI Bivalirudin UFH 6% BMS 7% DES 84% DES 82% 10% PTCA 11%

  9. ISAR REACT 3 Secondary (Triple) EndpointDeath, MI, UTVR Cumulative incidence (%) 10 8 Bivalirudin 5.9% 6 5.0% UFH 4 RR=1.16 [95% CI, 0.91-1.49], P=0.23 2 0 0 5 10 15 20 25 30 Days after randomization

  10. ISAR REACT 3 Bleeding Events Bivalirudin UFH Incidence (%) P=0.008 P=0.0001 P=0.15

  11. ISAR REACT 3 Primary (Quadruple) EndpointDeath, MI, UTVR, Major Bleeding Cumulative incidence (%) 10 UFH 8.7% 8.3% 8 Bivalirudin 6 4 RR=0.94 [95% CI, 0.77-1.15], P=0.57 2 0 0 5 10 15 20 25 30 Days after randomization

  12. ISAR REACT 3 In biomarker negative patients with stable and unstable angina undergoing PCI pretreated with clopidogrel 600 mg for >2 hours, bivalirudin does not improve “net clinical benefit” – the quadruple endpoint – at 30 days compared to UFH, although it significantly reduces bleeding Conclusion

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