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Completeness of Follow

Completeness of Follow. -. up. (20,078 patients). Hospital Discharge rec’d. 100%. 30 day rec’d. 99.98%. Lost to Follow. -. -Up at 9d. 12 patients (< 0.1%). Coordinating Center:. Population Health Research Institute,. McMaster University. Hamilton, Canada. Baseline Characteristics.

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Completeness of Follow

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  1. Completeness of Follow - up (20,078 patients) Hospital Discharge rec’d 100% 30 day rec’d 99.98% Lost to Follow - -Up at 9d 12 patients (< 0.1%) Coordinating Center: Population Health Research Institute, McMaster University Hamilton, Canada

  2. Baseline Characteristics Outcome Enox (%) Fonda (%) No. Rand. 10021 10057 Troponin or CKMB > ULN 70.5 70.3 ECG with ischemia 79.8 80.6 > 50.3 51.7 ST depression 1mm T wave inversion (>3 mm) 25.1 24.6 Male 61.4 62.0 Suspected MI w/o ST elevation 54.9 54.4 Prior Heart Failure 13.8 13.9 Prior MI 25.7 25.7 Hypertension 67.1 67.4 Diabetic 25.0 25.6 Current or Former Smoker 54.6 54.1

  3. Therapies During Initial Hospitalization Enox (%) Fonda (%) No. Rand. 10021 10057 ASA 97.5 97.5 GPIIb/IIIa Inhib 17.6 18.6 During PCI 41.0 41.7 Clopididogrel/Ticlopidine 67.2 67.6 Beta - blockers 87.7 87.2 Calcium Channel Blockers 26.8 26.9 ACE Inhibitors/ARB 76.1 74.9 Statins 77.5 78.5 70% of patients recruited from centers with cath labs

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

  5. Primary Efficacy Outcome Death/MI/RI at Day 9 Non - inferiority Margin=1.185 1.01 1.13 0.90 P - Value for Non - Inferiority=0.007 0.8 1 1.2 Fonda Better Enox Better Hazard Ratio

  6. Efficacy Outcomes at Day 9 Non - inferiority Margin=1.185 Enox Fonda Death/MI/RI 5.7% 5.8% Death/MI 4.1% 4.1% Death 1.9% 1.8% MI 2.7% 2.6% Refract 1.9% 1.9% Isch 0.8 1 1.2 Fonda Better Enox Better Hazard Ratio

  7. Major Bleeding: 9 Days Enoxaparin 0.04 HR 0.52 95% CI 0.44 - 0.61 0.03 P<0.001 Cumulative Hazard 0.02 Fondaparinux 0.01 0.0 0 1 2 3 4 5 6 7 8 9 Days

  8. Categories of Major Bleeds at 9 Days Enox Fonda P (No. Pts) (No. Pts) No. Rand. 10021 10057 Total Bleeding 412 (4.1%) 217 (2.2%) <0.001 Intracranial 7 7 Surgery req’d to stop bleed 73 40 Retroperitoneal 36 9 ¯ ³ 315 152 Hb 3 g/dL ³ 282 164 Transfusion 2 units

  9. No. of Patients Receiving Transfusions Enox Fonda No. (%) No. (%) No. Randomized 10021 10057 1 Unit 24 (0.2%) 14 (0.1%) 2 Units 183 (1.9%) 133 (1.3%) 3 Units 56 (0.6%) 57 (0.6%) 4+ Units 166 (1.7%) 134 (1.3%) Any transfusion 433 (4.3%) 338 (3.4%)

  10. Efficacy - Safety Balance Death/MI/RI/ Maj Bleed: Day 9 Enoxaparin 0.08 0.06 Fondaparinux Cumulative Hazard 0.04 HR 0.81 HR 0.82 95% CI 0.73 - 0.89 95% CI 0.74 - 0.90 P<0.001 0.02 0.0 0 1 2 3 4 5 6 7 8 9 Days

  11. Efficacy Outcomes at Day 30 Enox Fonda Death/MI/RI 8.6% 8.0% P=0.07 Death/MI 6.8% 6.2% Death 3.5% 2.9% P=0.02 MI 4.1% 3.9% RI 2.2% 2.2% Strokes P=0.002 Death/MI/Stroke 0.8 1 1.2

  12. Mortality: Day 30 Enoxaparin 0.03 Fondaparinux 0.02 Cumulative Hazard HR 0.83 HR 0.83 95% CI 0.71 - 0.97 95% CI 0.71 - 0.97 0.01 P=0.02 0.0 0 3 6 9 12 15 18 21 24 27 30 Days

  13. Major Bleeding: Day 30 0.05 Enoxaparin 0.04 0.03 Cumulative Hazard Fondaparinux 0.02 HR 0.62 HR 0.63 95% CI 0.54 - 0.72 95% CI 0.55 - 0.73 0.01 P<0.001 0.0 0 3 6 9 12 15 18 21 24 27 30 Days

  14. Death/MI/RI/Major Bleeds: Day 30 0.12 Enoxaparin 0.10 Fondaparinux 0.08 Cumulative Hazard 0.06 HR 0.82 HR 0.83 0.04 95% CI 0.75 - 0.89 95% CI 0.76 - 0.90 P<0.001 0.02 0.0 0 3 6 9 12 15 18 21 24 27 30 Days

  15. Efficacy at 6 Months Enox Fonda P value 0.06 Death/MI/RI 13.2% 12.3% 0.05 Death/MI 11.4% 10.5% 0.05 Death 6.5% 5.8% MI 6.6% 6.3% 0.04 Strokes 1.7% 1.3% 0.007 Death/MI/Stroke 12.5% 11.1% 0.8 1 1.2

  16. Death or MI: 6 Months 0.12 Enoxaparin 0.10 Fondaparinux 0.08 Cumulative Hazard 0.06 HR 0.92 HR 0.91 95% CI 0.84 -1.00 95% CI 0.84 - 0.04 P=0.05 0.02 0.0 0 20 40 60 80 100 120 140 160 180 Days

  17. Mortality at 6 Months Enoxaparin 0.06 Fondaparinux 0.04 Cumulative Hazard HR 0.89 HR 0.89 95% CI 0.80 - 95% CI 0.79 - 1.00 0.02 P=0.05 0.0 0 20 40 60 80 100 120 140 160 180 Days

  18. Major Bleeding: 6 Months 0.06 Enoxaparin 0.05 0.04 Fondaparinux 0.03 Cumulative Hazard HR 0.72 HR 0.72 0.02 95% CI 0.64 - 0.82 - 0.82 P<0.001 0.01 0.0 0 20 40 60 80 100 120 140 160 180 Days

  19. Death, MI, RI, Maj or B leeding at 6 Months Enoxaparin 0.15 Fondaparinux 0.10 Cumulative Hazard HR 0.86 HR 0.87 95% CI 0.81 - 0.93 95% CI 0.81 - 0.93 0.05 P<0.001 0.0 0 20 40 60 80 100 120 140 160 180 Days

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

  21. Patients Undergoing PCI within Patients Undergoing PCI within the First 8 Days of Randomization the First 8 Days of Randomization Enoxaparin Relative Risk Fondaparinux P Value (n=3135) (n=3104) (95% CI) Complications involving No. of events (% of patients) the vascular access site Any complication 251 (8.1%) 103 (3.3%) 0.41 (0.33 - 0.51) <0.001 Pseudoaneurysm 49 (1.6%) 31 (1.0%) 0.63 (0.40 - 0.98) Large hematoma 138 (4.4%) 50 (1.6%) 0.36 (0.26 - 0.49) PCI - related coronary complication Any complication 268 (8.6%) 299 (9.5%) 1.11 (0.94 - 1.29) 0.21 Abrupt closure, new thrombus 161 (5.2%) 188 (6.0%) 1.16 (0.94 - 1.42) with reduced flow, dissection, or no reflow Catheter - related thrombus not 3 (0.1%) 9 (0.3%) 2.99 (0.81 - 11.04) 0.08 resulting in clinical complications All catheter - related thrombi 8 (0.4%) 29 (0.9%) 3.59 (1.64 - 7.84) 0.001

  22. Patients Undergoing PCI within Patients Undergoing PCI within the First 8 Days of Randomization the First 8 Days of Randomization Enoxaparin Relative Risk Fondaparinux P Value (n=3135) (n=3104) (95% CI) Clinical Events at 9 days No. of events (% of patients) Death 38 (1.2%) 37 (1.2%) 0.96 (0.62 - 1.51) MI 154 (5.0%) 161 (5.1%) 1.04 (0.84 - 1.28) Stroke 13 (0.4%) 13 (0.4%) 0.99 (0.46 - 2.13) Major Bleeding 158 (5.1%) 72 (2.3%) 0.45 (0.34 - 0.59) Death, MI or stroke 190 (6.1%) 198 (6.3%) 1.03 (0.87 - 1.25) Death, MI, stroke or major 321 (10.3%) 255 (8.2%) 0.79 (0.67 - 0.92) 0.003 bleeding Any procedural complication, major bleeding, death, MI or 638 (20.6%) 521 (16.6%) 0.81 (0.73 - 0.90) <0.001 stroke

  23. Patients Undergoing PCI within Patients Undergoing PCI within the First 8 Days of Randomization the First 8 Days of Randomization Enoxaparin Relative Risk Fondaparinux P Value (n=3135) (n=3104) (95% CI) Clinical Events at 30 days No. of events (% of patients) Death 65 (2.1%) 62 (2.0%) 0.94 (0.67 - 1.33) MI 169 (5.4%) 179 (5.7%) 1.05 (0.86 - 1.29) Stroke 22 (0.7%) 18 (0.6%) 0.81 (0.44 - 1.51) Major Bleeding 169 (5.4%) 87 (2.8%) 0.51 (0.40 - 0.66) Death, MI or stroke 228 (7.3%) 231 (7.4%) 1.00 (0.84 - 1.20) Death, MI, stroke or major 364 (11.7%) 297 (9.5%) 0.81 (0.70 - 0.93) 0.004 bleeding

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

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