Baseline Characteristics 54.154.6Current or Former Smoker 25.625.0Diabetic 67.467.1Hypertension 25.7 Prior MI 13.913.8Prior Heart Failure.

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Presentation transcript:

Baseline Characteristics Current or Former Smoker Diabetic Hypertension 25.7 Prior MI Prior Heart Failure Suspected MI w/o ST elevation Male No. Rand ECG with ischemia T wave inversion (>3 mm) ST depression  1mm Troponinor CKMB > ULN Fonda (%)Enox(%)Outcome

Therapies During Initial Hospitalization During PCI Statins ACE Inhibitors/ARB Calcium Channel Blockers Beta-blockers Clopididogrel/Ticlopidine GPIIb/IIIaInhib 97.5 ASA No. Rand. Fonda (%)Enox(%) 70% of patients recruited from centers withcathlabs

Days of Study Treatment Compliance and Duration 5.4 (2.4)5.2 (2.3) FondaEnox Mean No. of days of therapy (SD) % who received > 1 dose of drug 99.2%99.4%

Primary Efficacy Outcome Death/MI/RI at Day P-Value for Non-Inferiority=0.007 Non-inferiority Margin=1.185 Hazard Ratio Fonda BetterEnoxBetter

Efficacy Outcomes at Day 9 5.8%5.7% Death/MI/RI 1.9% Refract Isch 2.6%2.7% MI 1.8%1.9% Death 4.1% Death/MI FondaEnox Non-inferiority Margin=1.185 Hazard Ratio Fonda BetterEnoxBetter

Major Bleeding: 9 Days Days Cumulative Hazard HR % CI P<0.001 Enoxaparin Fondaparinux

Categories of Major Bleeds at 9 Days Transfusion  2 units  Hb  3g/dL <0.001 P 217 (2.2%)412 (4.1%)Total Bleeding 936Retroperitoneal No. Rand. 4073Surgeryreq’dto stop bleed 77Intracranial Fonda (No. Pts) Enox (No. Pts)

No. of Patients Receiving Transfusions No. Randomized 338 (3.4%) 134 (1.3%) 57 (0.6%) 133 (1.3%) 14 (0.1%) Fonda No. (%) 433 (4.3%)Any transfusion 166 (1.7%)4+ Units 56 (0.6%)3 Units 183 (1.9%)2 Units 24 (0.2%)1 Unit Enox No. (%)

Efficacy-Safety Balance Death/MI/RI/MajBleed: Day 9 Days Cumulative Hazard HR 0.82 HR % CI % CI P<0.001 Enoxaparin Fondaparinux

Efficacy Outcomes at Day 30 Death/MI/Stroke Strokes 8.0%8.6%Death/MI/RI 2.2% RI 3.9%4.1%MI 2.9%3.5%Death 6.2%6.8%Death/MI FondaEnox P=0.02 P= P=0.002

Mortality: Day 30 Days Cumulative Hazard HR % CI P=0.02 Enoxaparin Fondaparinux

Major Bleeding: Day 30 Days Cumulative Hazard HR 0.63 HR % CI % CI P<0.001 Enoxaparin Fondaparinux

Death/MI/RI/Major Bleeds: Day 30 Days Cumulative Hazard HR 0.83 HR % CI % CI P<0.001 Enoxaparin Fondaparinux

Efficacy at 6 Months %12.5% Death/MI/Stroke 12.3%13.2% Death/MI/RI 1.3%1.7% Strokes 6.3%6.6% MI 5.8%6.5% Death 10.5%11.4% Death/MI FondaEnox P value

Death or MI: 6 Months Days Cumulative Hazard HR 0.91 HR % CI P=0.05 Enoxaparin Fondaparinux

Mortality at 6 Months Days Cumulative Hazard HR % CI % CI P=0.05 Enoxaparin Fondaparinux

Major Bleeding: 6 Months Days Cumulative Hazard HR % CI P<0.001 Enoxaparin Fondaparinux

Death, MI, RI,MajorBleeding at 6 Months Days Cumulative Hazard Enoxaparin Fondaparinux HR 0.87 HR % CI P<0.001

Patients Undergoing PCI within the First 8 Days of Randomization 2348 (74.9%)2317 (74.6%)Thienopyridines 1308 (41.7%)1273 (41.0%)GP Iib/IIIa inhibitor 651 (20.8%)1724 (55.5%)Unfractionated heparin No. of events (% of patients) Concomitant antithrombotic drugs Fondaparinux (n=3135) Enoxaparin (n=3104)

Patients Undergoing PCI within the First 8 Days of Randomization ( )29 (0.9%)8 (0.4%) All catheter-related thrombi ( )9 (0.3%)3 (0.1%) Catheter-related thrombus not resulting in clinical complications 1.16 ( )188 (6.0%)161 (5.2%) Abrupt closure, new thrombus with reduced flow, dissection, or no reflow ( )299 (9.5%)268 (8.6%) Any complication PCI-related coronary complication 0.36 ( )50 (1.6%)138 (4.4%) Large hematoma 0.63 ( )31 (1.0%)49 (1.6%) Pseudoaneurysm < ( )103 (3.3%)251 (8.1%) Any complication No. of events (% of patients) Complications involving the vascular access site P Value Relative Risk (95% CI) Fondaparinux (n=3135) Enoxaparin (n=3104)

Patients Undergoing PCI within the First 8 Days of Randomization ( )255 (8.2%)321 (10.3%) Death, MI, stroke or major bleeding 1.03 ( )198 (6.3%)190 (6.1%)Death, MI or stroke 0.99 ( )13 (0.4%) Stroke 0.45 ( )72 (2.3%)158 (5.1%)Major Bleeding < ( )521 (16.6%)638 (20.6%) Any procedural complication, major bleeding, death, MI or stroke 1.04 ( )161 (5.1%)154 (5.0%)MI 0.96 ( )37 (1.2%)38 (1.2%)Death No. of events (% of patients) Clinical Events at 9 days P Value Relative Risk (95% CI) Fondaparinux (n=3135) Enoxaparin (n=3104)

Patients Undergoing PCI within the First 8 Days of Randomization ( )297 (9.5%)364 (11.7%) Death, MI, stroke or major bleeding 1.00 ( )231 (7.4%)228 (7.3%)Death, MI or stroke 0.51 ( )87 (2.8%)169 (5.4%)Major Bleeding 0.81 ( )18 (0.6%)22 (0.7%)Stroke 1.05 ( )179 (5.7%)169 (5.4%)MI 0.94 ( )62 (2.0%)65 (2.1%)Death No. of events (% of patients) Clinical Events at 30 days P Value Relative Risk (95% CI) Fondaparinux (n=3135) Enoxaparin (n=3104)

Clinical Implications THE OASIS 5 TRIAL CLEARLY DEMONSTRATES THAT FONDAPARINUX IS THE PREFERRED ANTICOAGULANT FOR TREATMENT OF ACS