Baseline Characteristics

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Baseline Characteristics. Baseline High Risk Features. Invasive Management. *In patients receiving study antithrombin pre angiography. median (IQR). Primary Endpoint Measures (ITT). UFH/Enoxaparin + GPI vs. Bivalirudin + GPI. P NI

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  • Baseline Characteristics

    UFH/Enoxaparin + GP IIb/IIIa(N=4,603)Bivalirudin + GP IIb/IIIa(N=4,604)Bivalirudin alone(N=4,612)Age (median [range], yrs)63 [23-91]63 [21-95]63 [20-92]Male70.6%69.9%69.3%Diabetes28.4%27.7%28.1% - Insulin requiring8.5%8.6%8.8%Hypertension66.8%67.2%67.1%Hyperlipidemia57.2%57.4%57.0%Current smoker29.0%29.3%29.0%Prior MI31.6%30.5%31.8%Prior PCI39.0%37.8%39.9%Prior CABG18.2%17.4%18.1%Renal insufficiency5.7%6.0%5.7%

  • Baseline High Risk Features

    UFH/Enoxaparin + GP IIb/IIIa(N=4,603)Bivalirudin + GP IIb/IIIa(N=4,604)Bivalirudin alone(N=4,612)Biomarker or ST 71.3%70.1%70.9% - Biomarker +58.1%56.9%58.5% - ST-segment 35.2%35.4%34.3%Biomarker + ST 21.9%22.2%21.9%TIMI Risk Score - Low (0-2)16.1%15.4%15.6% - Intermediate (3-4)53.7%55.5%54.5% - High (5-7)30.3%29.1%29.9%

  • Invasive Management*In patients receiving study antithrombin pre angiographymedian (IQR)

    UFH/Enoxaparin + GP IIb/IIIa(N=4,603)Bivalirudin + GP IIb/IIIa(N=4,604)Bivalirudin alone(N=4,612)Angiography99.2%98.8%98.9%Adm. to angio (h)19.7 (7.0-29.3)19.5 (7.0-28.2)19.8 (7.3-29.0)Drug* to angio/interv (h)5.6 (1.6-22.5)5.0 (1.4-21.4)5.2 (1.5-22.5)Actual procedurePCI55.6%56.7%56.8%CABG11.9%10.8%10.6%Medical therapy32.4%32.5%32.6%

  • Primary Endpoint Measures (ITT)UFH/Enoxaparin + GPI vs. Bivalirudin + GPIPNI
  • Primary Endpoint Measures (ITT)11.7%11.8%1.01 (0.90-1.12)
  • Primary Endpoint Measures (ITT)UFH/Enoxaparin + GPI vs. Bivalirudin AlonePNI
  • Primary Endpoint Measures (ITT)Bivalirudin alone betterUFH/Enox + IIb/IIIa betterRisk ratio95% CIPrimaryendpointBivalaloneUFH/Enox+ IIb/IIIaRR (95% CI)Net clinical outcomeIschemic compositeMajor bleedingUpper boundary non-inferiority11.7%10.1%0.86 (0.77-0.97)
  • Components of the Ischemic CompositeUFH/Enoxaparin + GPI vs. Bivalirudin + GPI vs. Bivalirudin Alone

  • Major Bleeding EndpointsUFH/Enoxaparin + GPI vs. Bivalirudin + GPI vs. Bivalirudin AlonePSup=0.38PSup
  • Major Bleeding (Primary Endpoint)Values in yellow = P
  • Minor Bleeding (Non CABG)Values in yellow = P
  • Bleeding Endpoints (Non-CABG)P1 = Bivalirudin+GPI vs. UFH/Enox+GPI; P2 = Bivalirudin alone vs. UFH/Enox+GPI

    UFH/Enoxaparin + GP IIb/IIIa(N=4,603)Bivalirudin + GP IIb/IIIa(N=4,604)Bivalirudin alone(N=4,612)P1ValueP2ValueACUITY Scale - Any23.9%23.7%14.2%0.88

  • Net Clinical Outcome CompositeUFH/Enoxaparin + IIb/IIIa vs. Bivalirudin AloneMen (n=6444)Women (n=2771)Diabetes (n=2585)No diabetes (n=6630)CrCl 60 (n=6993) CrCl
  • Net Clinical Outcome CompositeUFH/Enoxaparin + IIb/IIIa vs. Bivalirudin AloneYes (n=3197)No (n=6008)Low (0-2) (n=1291)Intermed (3-4) (n=4407)High (5-7) (n=2449)Elevated (n=5368)Normal (n=3841)Risk ratio95% CIBivalAloneUFH/Enox+ IIb/IIIaPPint0.350.020.180.42Biomarkers (CK/Trop)ST DeviationTIMI Risk ScorePre ThienopyridineYes (n=5192)No (n=4023)RR (95% CI)Bivalirudin alone betterUFH/Enox + IIb/IIIa better

  • Net Clinical Outcome CompositeUFH/Enoxaparin + IIb/IIIa vs. Bivalirudin AloneBivalirudin alone betterUFH/Enox + IIb/IIIa betterBivalAloneUFH/Enox+ IIb/IIIaPPint0.590.620.569.1%10.0%0.91 (0.73-1.12)0.366.7%7.1%0.94 (0.80-1.10)0.4610.6%12.6%0.84 (0.65-1.10)0.21RR (95% CI)PCI (n=5170)CABG (n=1048)Medical (n=2989)No prior AT (n=3290)Consistent Rx (n=5519)Crossover (n=3211)A-thrombin crossoverEarly (
  • Net Clinical Outcome Composite Endpoint05101505101520253035Cumulative Events (%)Days from RandomizationUFH/Enoxaparin + GPI vs. Bivalirudin + GPI vs. Bivalirudin Alone

  • Ischemic Composite Endpoint05101505101520253035Cumulative Events (%)Days from RandomizationEstimateP(log rank)7.3%UFH/Enoxaparin + IIb/IIIa (N=4603)Bivalirudin + IIb/IIIa (N=4604)0.377.7%Bivalirudin alone (N=4612)0.307.8%UFH/Enoxaparin + GPI vs. Bivalirudin + GPI vs. Bivalirudin Alone

  • Major Bleeding EndpointCumulative Events (%)Days from RandomizationEstimateP(log rank)Bivalirudin + IIb/IIIa (N=4604)0.415.3%Bivalirudin alone (N=4612)
  • Event Rates and Power CalculationsNI = non-inferiority; Sup = superiority

    UFH/Enox + GP IIb/IIIaBivalirudin +GP IIb/IIIaBivalirudinalonePredictedRateRatePowerRatePowerEndpointNISupNISupNet clinical outcome12.4%10.3%99%88%10.5%99%81%Ischemic events6.5%5.3%99%67%6.5%87%-Major bleeding9.0%7.5%99%73%6.0%99%99%

  • Summary Conclusions: Primary ResultsNI = non-inferiority; Sup = superiority

    EndpointNet clinical outcomeIschemic eventsMajor bleeding

    UFH/Enox + GP IIb/IIIaBivalirudin +GP IIb/IIIaBivalirudinalone

  • Summary Conclusions: Primary ResultsNI = non-inferiority; Sup = superiority

    UFH/Enox + GP IIb/IIIaObservedRateEndpointNet clinical outcome11.7%Ischemic events7.3%Major bleeding5.7%

    UFH/Enox + GP IIb/IIIaBivalirudin +GP IIb/IIIaBivalirudinalone

  • Summary Conclusions: Primary ResultsNI = non-inferiority; Sup = superiority

    UFH/Enox + GP IIb/IIIaBivalirudin +GP IIb/IIIaObservedRateRatePValueEndpointNet clinical outcome11.7%11.8%

  • Conclusions: Primary ResultsNI = non-inferiority; Sup = superiority

    UFH/Enox + GP IIb/IIIaBivalirudin +GP IIb/IIIaBivalirudinaloneObservedRateRatePValueRatePValueEndpointNet clinical outcome11.7%11.8%

  • Clinical ImplicationsIn patients with moderate-high risk ACS undergoing an early invasive strategy with use of GP IIb/IIIa inhibitors Bivalirudin is an acceptable substitute for either unfractionated heparin or enoxaparinHowever, compared to either UFH/enoxaparin with GP IIb/IIIa inhibition or bivalirudin with GP IIb/IIIa inhibition A bivalirudin alone strategy results in significantly greater net clinical benefit and enhanced survival free from adverse events at 30 days

    Angiomax was also found superior to heparin and as effective as the combination of heparin plus GP IIb/IIIa with respect to the triple endpoint of death, MI, urgent revascularization

    Angiomax was also found superior to heparin and as effective as the combination of heparin plus GP IIb/IIIa with respect to the triple endpoint of death, MI, urgent revascularization

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