A Randomized Trial of Same-Day Home Discharge and Abciximab Bolus-Only Compared to Overnight Hospitalization and Abciximab Bolus + Infusion after Trans-Radial Coronary Stenting. 12-Months Results of the EASY Trial. OF Bertrand, R R Delarochellière Delarochellière, , J J Rodés-Cabau Rodés-Cabau, G , G Proulx Proulx, , OF Bertrand, O Gleeton Gleeton, CM Nguyen, JP , CM Nguyen, JP Déry Déry, , G G Barbeau Barbeau, B No , B Noël, ël, O E Larose, J Rouleau Rouleau, JR , JR Boudreault Boudreault, , P P Poirier Poirier, , L L Roy Roy E Larose, J Quebec Heart-Lung Institute / Laval Hospital, Quebec, Canada Quebec Heart-Lung Institute / Laval Hospital, Quebec, Canada Supported by unrestricted grants from Eli-Lilly and BMS/Aventis
Introduction (1) Introduction (1) Trans-radial approach is associated with an extremely low rate of vascular complications and facilitates out- patient practice. The use of glycoproteins IIb-IIIa inhibitors and standard protocols prohibits same-day discharge. In EPIC study, the clinical benefit at 30 days of 12hr abciximab infusion following the initial bolus was entirely due to a significant reduction in urgent revascularization and no difference in death or MI was noted between bolus- only versus bolus + 12hr infusion.
Introduction (2) Introduction (2) In EPIC Study, there was a delayed benefit in terms of death or MI for the group with bolus + 12hr infusion compared to bolus-only. This benefit has been maintained up to 7 years post-PCI. At 30 days and 6 months in the EASY Study, we have reported clinical equivalence between abciximab as a bolus-only compared to bolus + 12hr infusion.
Objectives Objectives To report MACE (death, MI, target vessel revascularization) rates in EASY study up to 12 months post-PCI. To compare MACE rates in EASY study between abciximab bolus-only and abciximab bolus + 12hr infusion. To compare 12 months results in the randomized arms and in the registry.
Inclusion / Exclusion Criteria Inclusion / Exclusion Criteria Clinical Inclusion Criteria Clinical Inclusion Criteria Patients >18yrs Documented IHD and referred for CA ± PCI Radial / ulnar approach Written informed consent Clinical Exclusion Criteria Clinical Exclusion Criteria Contra-indication to same-day discharge Contra-indication to abciximab administration STEMI ≤ 72hrs LVEF ≤ 30%
Design Design Residual Dissection ≥ Residual Dissection ≥ grade B grade B Sub-occluded branch ≥ ≥ 1 mm 1 mm Sub-occluded branch Abciximab bolus TIMI < 3 post-stenting TIMI < 3 post-stenting No Thrombus post-stenting Thrombus post-stenting Uncomplicated trans-radial PCI Randomization Registry Bolus+Infusion group Bolus group Hospitalization Overnight hospitalization Same-day discharge + 12 hr infusion + 12 hr infusion No infusion 4-6 hrs, 24 hrs: Clinical FU, ECG, CK-MB 30 days, 6 mo, 1 yr: Clinical FU, ECG
Definitions of MACE Definitions of MACE Death: Death from any cause. All death considered cardiac unless obvious non-cardiac cause. Myocardial Infarction: PCI-related: CK-MB rise > 3 x ULN CABG-related: CK-MB rise > 10 x ULN Non procedure-related: Rise and fall of cardiac biomarkers or Q-wave. Target Vessel Revascularization: Any PCI or CABG involving initial target vessel.
Patient Characteristics Patient Characteristics Bolus Bolus + Infu. Registry N = 504 N = 501 N = 343 Age (yr) 60 ± 10 61 ± 10 62 ± 11 Male 395 (78%) 395 (79%) 261 (76%) Previous MI 219 (43%) 224 (45%) 152 (44%) Previous PCI 107 (21%) 93 (19%) 69 (20%) Unstable angina 334 (66%) 335 (67%) 234 (68%) TnT > 0.1ng/ml 93 (18%) 95 (19%) 63 (18%) Clopidogrel (>12hr) 463 (92%) 452 (90%) 299 (87%)
Procedure Characteristics Procedure Characteristics Bolus Bolus + Infu. Registry N = 504 N = 501 N = 343 2 Vx 142 (28%) 149 (29%) 132 (38%)* 3 Vx 31 (6%) 41 (8%) 23 (15%)* 2 lesions Rx 122 (24%) 138 (27%) 111 (32%)* 3 lesions Rx 27 (5%) 30 (6%) 77 (22%)* Lesions B2/C 321 (47%) 320 (46%) 414 (65%)* Stent size (mm) 3.0 ± 0.5 2.9 ± 0.5 2.9 ± 0.5 Length (mm) 18 ± 6 18 ± 5 19 ± 6 Duration (min) 42 ± 20 42 ± 19 68 ± 31* Infusion (hr) n/a 11 ± 2 11 ± 2 *p < 0.001
Results: Death Death Results: End Point: Bolus Bolus + Infu. Registry Death N = 504 N = 501 N = 343 Cardiac 0 (0%) 0 (0%) 1 (0.3%) 30 days Non-cardiac 0 (0%) 0 (0%) 1 (0.3%) Cardiac 1 (0.2%) 0 (0%) 1 (0.3%) 6 months Non-cardiac 0 (0%) 0 (0%) 0 (0%) Cardiac 1 (0.2%) 3 (0.6%) 1 (0.3%) 1 yea r Non-cardiac 1 (0.2%) 0 (0%) 1 (0.3%) Total 3 (0.6%) 3 (0.6%) 5 (1.5%) * *P = 0.13
Results: Myocardial Infarction Myocardial Infarction Results: End Point: Bolus Bolus + Infu. Registry Myocardial Infarction N = 504 N = 501 N = 343 Procedure-R 6 (1.2%) 8 (1.6%) 29 (8.5%) 30 days Not-relate d 1 (0.2%) 1 (0.2%) 1 (0.3%) Procedure-R 0 (0%) 1 (0.2%) 0 (0%) 6 months Not-relate d 1 (0.2%) 0 (0%) 1 (0.3%) Procedure-R 0 (0%) 0 (0%) 0 (0%) 1 yea r Not-relate d 5 (1.0%) 0 (0%) 1 (0.3%) Total 13 (2.6%) 10 (2.0%) 32 (9.3%)* * P < 0.001
Results: Revascularization Revascularization Results: End Point: Bolus Bolus + Infu. Registry Target Vessel N = 504 N = 501 N = 343 Revascularization P C I 1 (0.2%) 0 (0%) 1 (0.3%) 30 days CABG 0 (0%) 0 (0%) 7 (2.0%) P C I 17 (3.4%) 16 (3.2%) 13 (3.8%) 6 months CABG 3 (0.6%) 2 (0.4%) 12 (3.5%) P C I 10 (1.2%) 11 (2.2%) 17 (5.0%) 1 yea r CABG 2 (0.4%) 3 (0.6%) 6 (1.7%) Total 33 (6.5%) 32 (6.4%) 56 (16.3%) * * P < 0.001
Results: Composite Results: Composite End Point: Bolus Bolus + Infu. Registry Composite N = 504 N = 501 N = 343 30 days 7 (1.4%) 9 (1.8%) 35 (10.2%) * 6 months 28 (5.6%) 27 (5.4%) 61 (17.8%) * 1 yea r 46 (9.1%) 44 (8.8%) 85 (24.8%) * * P < 0.001
Results Results Log rank p < 0.001
Conclusion Conclusion In EASY Study, clinical equivalence between abciximab bolus-only and abciximab bolus + 12hr infusion was maintained at 6 months and 12 months. Patients in the registry displayed significantly worse outcomes at 30 days compared to the 2 randomized groups and this difference was maintained at 6 months and 12 months. Longer follow-up will be performed to determine whether these results are maintained at 3 years. Further analysis is required to determine whether worse prognosis in the registry is due to baseline characteristics of patients or is related to PCI results.
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