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Roxana Mehran, on behalf of the ACUITY investigators

Long-term Outcomes of Patients with ACS and Chronic Renal Insufficiency Undergoing PCI and being treated with Bivalirudin vs UFH/Enoxaparin plus a GP IIb/IIIa Inhibitor: Results from the Randomized ACUITY Trial. Roxana Mehran, on behalf of the ACUITY investigators. Disclosures. Medical

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Roxana Mehran, on behalf of the ACUITY investigators

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  1. Long-term Outcomes of Patients with ACS and Chronic Renal Insufficiency Undergoing PCI and being treated with Bivalirudin vs UFH/Enoxaparin plus a GP IIb/IIIa Inhibitor: Results from the Randomized ACUITY Trial Roxana Mehran, on behalf of the ACUITY investigators

  2. Disclosures

  3. Medical management UFH or Enoxaparin + GP IIb/IIIa PCI Bivalirudin + GP IIb/IIIa Angiography within 72h R* Bivalirudin Alone CABG ACUITY Study Design Moderate-high risk unstable angina or NSTEMI undergoing an invasive strategy (N = 13,819) Moderate- high risk ACS Aspirin in all Clopidogrel dosing and timing per local practice *Stratified by pre-angiography thienopyridine use or administration ACUITY Design. Stone GW et al. AHJ 2004;148:764–75

  4. Study Medications • Anti-thrombin agents (started pre-angiography) 1 Target aPTT 50-75 seconds 2 If last enoxaparin dose ≥8h - <16h before PCI; 3 If maintenance dose discontinued or ≥16h from last dose 4 Discontinued at end of PCI with option to continue at 0.25mg/kg for 4-12h if GPIIb/IIIa inhibitor not used ACUITY Design. Stone GW et al. AHJ 2004;148:764–75

  5. Primary Endpoints • Net Clinical Outcomes • Death, MI, unplanned revascularization for ischemia or non-CABG major bleeding • Composite Ischemia • Death, MI or unplanned revascularization for ischemia • Major Bleeding (Non-CABG) • Intracranial, intraocular, or retroperitoneal bleeding • Access site bleed requiring intervention/surgery • Hematoma ≥5 cm • Hgb ≥4g/dL w/o overt source • Hgb ≥3g/dL with an overt source • Reoperation for bleeding • Any blood transfusion ACUITY Design. Stone GW et al. AHJ 2004;148:764–75

  6. Background and Objectives of the Current Analysis • Background • Patients with ACS and chronic renal insufficiency have increased ischemic and bleeding complications after PCI • Objectives • Evaluate the impact of renal insufficiency and antithrombin strategy on the outcomes in patients presenting with ACS and undergoing PCI

  7. CrCl ≥60 mL/min N=5994 CrCl <60 mL/min N=1352 Management Strategy (N=13,819) CABG (n=1,539) 32.5% Medical Rx (n=4,491) 11.1% 56.4% PCI (n=7,789)

  8. Baseline Characteristics by Renal Function in PCI Patients

  9. Baseline Characteristics by Renal Function in PCI Patients

  10. 30-Day Outcomes by Renal Function in PCI Patients P<0.0001 P<0.0001 P<0.0001 30 Day Events (%)

  11. P=0.27 P=0.85 P=0.02 30 day Outcomes in Renally Impaired PCI Patients UFH/Enox + GP IIb/IIIa vs. Bivalirudin + GP IIb/IIIa vs. Bivalirudin Alone 30 Day Events (%)

  12. 30-Day Major Bleeding (non-CABG) – Renally Impaired PCI pts *P value for bivalirudin alone vs. heparin + IIb/IIIa inhibitor

  13. 1-Year Outcomes by Renal Function in PCI Patients P<0.0001 1 Year Events (%) P<0.0001

  14. 1-Year Outcomes in Renally Impaired PCI Patients by Treatment Group Hazard Ratio ±95% CI HR (95% CI) Bivalirudin Better UFH/Enox+ IIb/IIIa Better

  15. Study Limitations • Subgroup analysis, results should be considered hypothesis generating • Treatment was open label and not randomized based upon renal function

  16. Conclusions • In patients with ACS who undergo invasive management, the presence of renal insufficiency is associated with higher rates of composite ischemia and mortality at 1 year • Bivalirudin monotherapy improved early clinical outcomes compared to UFH/Enox + GP IIb/IIIa inhibitors by reducing 30-day major bleeding, and resulted in similar rates of one year composite ischemia and mortality

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