1 / 27

Presenter Disclosure Information

Presenter Disclosure Information. Intracoronary Compared with Intravenous Bolus Abciximab Application in Patients with ST-Elevation Myocardial Infarction Undergoing Primary Coronary Intervention.

gusty
Download Presentation

Presenter Disclosure Information

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Presenter Disclosure Information • Intracoronary Compared with Intravenous Bolus Abciximab Application • in Patients with ST-Elevation Myocardial Infarction Undergoing Primary Coronary Intervention The following relationships exist related to this presentation:Off-label use of intracoronary abciximab

  2. Intracoronary Compared with Intravenous Bolus Abciximab Application • in Patients with ST-Elevation Myocardial Infarction Undergoing Primary Coronary Intervention • The randomized Leipzig Immediate PercutaneouS Coronary Intervention Abciximab i.v. versus i.c. in ST-Elevation Myocardial Infarction Trial (LIPSIAbciximab-STEMI) Holger Thiele, Kathrin Schindler, Josef Friedenberger, Ingo Eitel, Georg Fürnau, Eigk Grebe, Dietmar Kivelitz, Gerhard Schuler

  3. Abciximab i.v. + PCI- Mortality 6 Months Meta-analysis - No. Deaths/No. Patients (%) Control better Abciximab better P-Value Control (n=1916) Abciximab (n=1996) 11/242 (4.5) 0.83 RAPPORT 10/241 (4.1) 12/201(6.0) 0.33 ISAR-2 17/200 (8.5) 5/149 (3.4) 0.13 ADMIRAL 11/151(7.3) 0.83 CADILLAC 44/1052 (4.2) 45/1030 (4.4) 0.15 Petronio et al 2/44 (4.5) 6/45 (13.3) 0.04 5/112 (4.5) Zorman et al 7/51 (13.7) 0.04 ACE 10/197 (5.0) 21/197 (10.5) Total 88/1996 (4.4) 118/1916 (6.2) 0.01 1,0 0,1 10,0 Odds Ratio (95% CI) De Luca et al. JAMA 2005;293:1759-1765

  4. Abciximab-Bolus i.c. versus i.v. Potential Benefits: • Higher concentration • Faster reduction thrombus burden • Improved TIMI-flow • No-Reflow  • Infarct size  • Outcome 

  5. Abciximab i.v. versus i.c. N=403; retrospective registry P<0.001 25 PCI Abciximab i.v 20.2 PCI Abciximab i.c. P=0.08 20 15.6 15 Events (%) 10.2 P<0.002 9.5 P<0.04 10 4.6 2.8 5 0.3 0.3 0 Death Re-MI MACE Urgent TVR Wöhrle et al. Circulation 2003;107:1840-1843

  6. Inclusion criteria • Clinical Symptoms: • AP < 12 hours • persistent angina > 30 minutes • ECG-Criteria: • ST  > 1mm in  2 extremity leads • ST  > 2mm in  2 anterior leads • Informed consent LIPSIAbciximab

  7. Endpoints • Primary study endpoint: - Infarct size delayed enhancement MRI (Days 1-4) - Extent microvascular obstruction • Secondary study endpoints: - ST-segment resolution 90 min. - TIMI-flow pre + post PCI - TMPG pre + post PCI - Infarct size [CK as AUC (2 days)] - Combined clinical endpoint: Death, Re-MI, New CHF, TVR Projection:Final infarct size of 2010% (54% MO) i.v. abciximab. Power 80%, 2-sided -value of 0.05 to detect absolute difference of 5% infarct size (2% MO) 2x 68 patients. LIPSIAbciximab

  8. Contrast-injection 2 mmol/kg/BW Bolus Gadobutrol i.v. MR – Image Acquisition 35 40 0 5 10 15 20 25 30 Time (min) 4CH+2 CH T2 3 x SA DE early SA Short axes DE late 4CH+2CH+SA 3D IR – GRE sequence (TR/TE/flip 2.8/1.1/15°) Survey SSFP sequence (TR/TE/flip = 3.2/1.2/60°) LIPSIAbciximab

  9. MR Image Analysis Blinded observers: Manual drawing of endocardial, epicardial, papillary, infarcted + MO contours % Infarct size = (Infarct volume/volume LV mass) % MO = (MO-volume/volume LV mass) Thiele et al; JACC 2006;47:1641-1645

  10. ECG Analysis +5.6 ECG 1. Sum ST-elevation +2.5 +1.3 +1.3 +5.6 +3.0 +4.7 2. Measurement Same leads 90 min. +7.4 +2.4 % Resolution=(ST Base - ST 90min.) / (ST Base) Categorization: Complete > 70%, intermediate 30-70%, no < 30% LIPSIAbciximab

  11. Study Profile Randomized (n=154) Abciximab i.v. (n=77) Abciximab i.c. (n=77) No MRI (n=6) Claustrophobia (n=2) Death (n=2) Refusal (n=1) PM (n=1) No MRI (n=10) Claustrophobia (n=1) Death (n=2) Refusal (n=2) PM (n=1) Obesity (n=2) Technical reasons (n=2) Lost to 30-day follow-up (n=0) Lost to 30-day follow-up (n=0) Primary endpoint analysis (n=71) Secondary endpoint analysis (n=77) Primary endpoint analysis (n=67) Secondary endpoint analysis (n=77) LIPSIAbciximab

  12. Patient Characteristics i.v. i.c. p (n=77) (n=77) Age 66 (54; 72) 64 (54; 70) 0.29 Male 58 (75%) 63 (82%) 0.43 TIMI-risk 4 (1; 6) 4 (1;6) 0.98 Previous MI 7 (9%) 8 (10%) 0.93 Anterior MI 40 (52%) 44 (57%) 0.63 Smoking 39 (51%) 38 (49%) 0.92 Hypertension 57 (74%) 54 (70%) 0.72 Hyperlipidemia 31 (40%) 27 (35%) 0.66 Diabetes mellitus 22 (29%) 24 (31%) 0.86 LIPSIAbciximab

  13. Reperfusion Times i.v. i.c. p (n=77) (n=77) Door-to-Balloon (min) 29 (21;49) 31 (22;40) 0.77 Symptom-Balloon (min) 218 (159;323) 244 (163;433) 0.47 LIPSIAbciximab

  14. Medication i.v. i.c. p (n=77) (n=77) ASA 77 (100%) 77 (100%) 1.0 Clopidogrel 77 (100%) 77 (100%) 1.0 ACE/AT-1 77 (100%) 76 (99%) 1.0 Beta-blocker 76 (99%) 76 (99%) 1.0 Statines 77 (100%) 76 (99%) 1.0 Aldosterone ant. 10 (13%) 10 (13%) 1.0 Abciximab pre PCI 53 (70%) 64 (83%) 0.14 Abciximab complete 72 (94%) 73 (95%) 0.94 LIPSIAbciximab

  15. p=0.51 TIMI-flow Pre-PCI Abciximab i.v. Abciximab i.c. N=51 N=44 N=18 N=15 N=9 N=5 N=6 N=4 LIPSIAbciximab

  16. p=0.91 TIMI-Flow Post-PCI Abciximab i.v. Abciximab i.c. N=64 N=65 N=8 N=10 N=1 N=2 N=1 N=1 LIPSIAbciximab

  17. p=0.67 TMPG Pre-PCI Abciximab i.v. Abciximab i.c. N=57 N=53 N=17 N=14 N=3 N=4 N=3 N=1 LIPSIAbciximab

  18. p=0.15 TMPG Post-PCI Abciximab i.v. Abciximab i.c. N=50 N=56 N=14 N=11 N=7 N=7 N=6 N=1 LIPSIAbciximab

  19. p=0.007 ST-Segment-Resolution (90 min) %Resolution=(ST Base - ST 90min.) / (ST Base) 77% (66.7; 100) 70% (45.2; 83.5) % i.v. i.c. LIPSIAbciximab

  20. p=0.03 ST-Segment-Resolution(90 min) i.v. i.c. 90 80 n=50 70 60 n=38 % 50 n=32 40 n=22 30 20 n=7 10 n=3 0 >70% 30-70% <30% >70% 30-70% <30% LIPSIAbciximab

  21. p=0.02 p=0.01 p=0.01 23.4 (13.6; 33.2) 15.1 (6.1; 25.2) 3.4 (0.1; 7.3) 1.1 (0.0; 3.7) 1.1 (0.0; 2.8) 0.1 (0.0; 1.6) MO early MO late IS IS MO early MO late Primary Study Endpoint DE-MRI i.v. i.c. % LV 30 25 20 15 10 5 0 LIPSIAbciximab

  22. Infarct Size -CK (Area Under the Curve) p=0.007 736 (416; 1304)mol/l/h mol/l 575 (359; 863)mol/l/h Time (h) LIPSIAbciximab

  23. Combined Clinical Endpoint (Death, Re-MI, new CHF, TVR) 20 p=0.06 15 i.v. % 10 5 i.c. 0 0 5 10 20 25 30 15 Days after randomization LIPSIAbciximab

  24. Predefined Subgroup Analysis – Primary Endpoint Early MO (% LV) Variable Late MO (% LV) % of patients Infarct size (% LV) Total 100 p=0.01 p=0.01 p=0.02 p=0.13 Non-anterior infarction 52 p=0.34 p=0.04 Anterior Infarction 48 p=0.06 p=0.04 p=0.04 Symptom –Reperfusion < 4 h p=0.22 54 p=0.22 p=0.26 Symptom – Reperfusion 4–8 h p=0.03 29 p<0.001 p=0.003 p=0.04 Symptom – Reperfusion > 8 h 17 p=0.02 p=0.004 TIMI = 3 post PCI 86 p=0.14 p=0.25 p=0.01 p=0.06 TIMI < 3 post PCI 14 p=0.01 p=0.009 TMPG = 3 post PCI p=0.31 70 p=0.55 p=0.10 TMPG < 3 post PCI p=0.001 30 p=0.005 p=0.01 5 10 2 15 10 5 0 6 3 5 4 0 1 2 3 4 5 6 60 50 40 30 20 10 0 10 20 30 40 50 60 15 1 Abciximab i.v. Abciximab i.c. Abciximab i.v. Abciximab i.c. Abciximab i.v. Abciximab i.c. LIPSIAbciximab

  25. Summary + Conclusions • Abciximab-bolus i.c. injection during primary PCI leads to • - improved perfusion (ECG) • - trend towards improved angiographic perfusion • - reduction microvascular obstruction • - reduction infarct size • - trend towards improved clinical outcome • Adequately powered trial necessary

  26. Study Design Abciximab i.v. vs. i.c.-STEMI Controlled, randomized, multicenter, open-label 1) Angina > 30 min, < 12 h; 2) 12-lead-ECG: STEMI; 3) Informed consent Randomization (n=1868) Abciximab i.v. (n=934) Abciximab i.c. (n=934) Primary PCI After wire passage abciximab-bolus i.v. Primary PCI After wire passage abciximab-bolus i.c. Abciximab i.v. continuously Abciximab i.v. continuously TIMI-flow pre + post PCI TIMI-flow pre + post PCI ECG 90 min + 24 h post PCI ECG 90 min + 24 h post PCI Core-Lab CK + CK-MB every 8 h for 48 h CK +CK-MB every 8 h for 48 h Díscharge or rehabilitation Discharge or rehabilitation 90 day follow-up: primary enpoint 90 day follow-up: primary endpoint 12 month follow-up (by telephone) 12 month follow-up (by telephone)

  27. Thank you for your attention thielh@medizin.uni-leipzig.de

More Related