Introduction (1) Introduction (1) Trans-radial approach is - - PowerPoint PPT Presentation

A Randomized Trial

• f 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, OF Bertrand, R R Delarochellière Delarochellière, , J J Rodés-Cabau Rodés-Cabau, G , G Proulx Proulx, , O O Gleeton Gleeton, CM Nguyen, JP , CM Nguyen, JP Déry Déry, , G G Barbeau Barbeau, B No , B Noël, ël, E Larose, J E Larose, J Rouleau Rouleau, JR , JR Boudreault Boudreault, , P P Poirier Poirier, , L L Roy Roy

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-

• nly 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

• Patients >18yrs
• Documented IHD and referred for CA ± PCI
• Radial / ulnar approach
• Written informed consent
• Contra-indication to same-day discharge
• Contra-indication to abciximab administration
• STEMI ≤ 72hrs
• LVEF ≤ 30%

Clinical Inclusion Criteria Clinical Inclusion Criteria Clinical Exclusion Criteria Clinical Exclusion Criteria

Design Design

4-6 hrs, 24 hrs: Clinical FU, ECG, CK-MB 30 days, 6 mo, 1 yr: Clinical FU, ECG

No

Bolus group

Same-day discharge No infusion

Bolus+Infusion group

Overnight hospitalization + 12 hr infusion

Registry

Hospitalization + 12 hr infusion

Randomization Abciximab bolus Uncomplicated trans-radial PCI

Residual Dissection Residual Dissection ≥ ≥ grade B grade B Sub-occluded branch Sub-occluded branch ≥ ≥ 1 mm 1 mm TIMI < 3 post-stenting TIMI < 3 post-stenting Thrombus post-stenting Thrombus post-stenting

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 N = 504 Bolus + Infu. N = 501 Registry 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 N = 504 Bolus + Infu. N = 501 Registry 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: Results: Death Death

End Point: Death Bolus

N = 504

Bolus + Infu.

N = 501

Registry

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%)

Non-cardiac

1 (0.2%) 0 (0%) 1 (0.3%) 1 yea r Total 3 (0.6%) 3 (0.6%) 5 (1.5%) * *P = 0.13

Results: Results: Myocardial Infarction Myocardial Infarction

End Point: Myocardial Infarction Bolus

N = 504

Bolus + Infu.

N = 501

Registry

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 monthsNot-relate d 1 (0.2%) 0 (0%) 1 (0.3%)

Procedure-R

0 (0%) 0 (0%) 0 (0%)

Not-relate d

5 (1.0%) 0 (0%) 1 (0.3%) 1 yea r Total 13 (2.6%) 10 (2.0%) 32 (9.3%)* * P < 0.001

Results: Results: Revascularization Revascularization

End Point: Target Vessel Revascularization Bolus

N = 504

Bolus + Infu.

N = 501

Registry

N = 343 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%)

CABG

2 (0.4%) 3 (0.6%) 6 (1.7%) 1 yea r Total 33 (6.5%) 32 (6.4%) 56 (16.3%) * * P < 0.001

Results: Composite Results: Composite

End Point: Composite Bolus

N = 504

Bolus + Infu.

N = 501

Registry

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
• utcomes 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.