Results From The Minimizing Adverse Haemorrhagic Events By - - PowerPoint PPT Presentation
Results From The Minimizing Adverse Haemorrhagic Events By Transradial Access Site And Systemic Implementation of Angiox-MATRIX Access and Anti-thrombin Programs M. Valgimigli, MD, PhD Erasmus MC Rotterdam, The Netherlands on behalf of the
Erasmus MC Rotterdam, The Netherlands
NCT01433627
1:1 1:1
Aspirin+ P2Y12 blocker
Trans-Femoral Access
Unfractionated Heparin
with planned or bailout GPI
Bivalirudin
Bailout GPI
Trans-Radial Access
NCT01433627
39 93 132 200 276 380 490 685 857 1002 1190 1400 1684 1972 2248 2584 2926 3256 3560 3875 4144 4452 4726 5000 5322 5655 5896 6184 6458 6742 6982 7235 7444 7638 7844 8073 8404
Cumulative enrollment by month 8,404 8,404 8,404 patients with ACS undergoing coronary angiography ± PCI from 11th Oct 2011 to 7th Nov 2014
Operator Eligibility Criteria: I nterventional cardiologist expertise in TRI and TFI including at least 75 transradial coronary int
nt erve vent nt ions ns and at least 50% of interventions
performed via radial route in the year preceding site initiation
Complete follow-up to 30 days available in 4183 (99.7% ) of radial and 4191 (99·6% ) of femoral cohorts Am Heart J. 2014 Dec;168(6):838-45.e6.
29 71 108 167 235 324 421 591 733 856 1023 1200 1436 1670 1892 2176 2476 2738 3009 3276 3504 3762 4004 4228 4497 4787 4993 5233 5480 5735 5946 6176 6360 6521 6692 6896 7213
7,213 Cumulative enrollment by month First Recruited patient: 11th Oct 2011 Last Recruited patient: 7th Nov 2014 Complete follow-up information at 30 days available in all but 13 patients per group
94.1% of radial and 97.4% of femoral cohorts received respective treatment as allocated I n 5.8% of radial and 2.3% of TF cohort the allocated access was attempted but failed. I n 3 (0.1% ) in the radial and 13 (0.3% ) patients in the femoral groups the allocated access was not attempted
P=0.77 P<0.001 *
*: TIMI <3 and/or % final stenosis >30%
8.8% 10.3% 15% significant reduction at nominal 5% alpha which is however NOT significant at the pre-specificed alpha of 2.5%
Femoral Radial
Rate Ratio 0.83; 95% CI , 0.73 to 0.96; p= 0.0092
11.7% 9.8%
NNTB: 53 Femoral Radial
All-Cause, Cardiac, non-CV mortality, type of stent thrombosis
% RR:0.72 (0.53-0.99) P=0.045 RR: 0.75 (0.54-1.04) P=0.08 P=0.69 P=0.66 %
Mortality Stent Thrombosis
NNTB: 167
1.4% 2.5%
P=0.013 RR: 0.67
0.49-0.92
P=0.0004 RR: 0.37
0.21-0.66
BARC 3 or 5 P=0.0098 RR: 0.64
0.45-0.90
P=0.08 RR: 0.72
0.50-1.04
P=0.20 RR: 0.78
0.53-1.14
*
*: Major or minor ¶ ¶: moderate or severe
P=0.82 P=0.68
1.7% 2.3% UFH Bivalirudin % RR:0.70 (0.50-0.98) P=0.037 RR: 0.68 (0.48-0.97) P=0.032
1.4% 2.5%
P=0.07 RR: 0.59
0.33-1.04
P=0.005 RR: 0.53
0.34-0.83
BARC 3 or 5 P=0.008 RR: 0.61
0.42-0.88
P=0.0016 RR: 0.31 0.11-0.85 P=0.002 RR: 0.50
0.33-0.75
P=0.027 RR: 0.61
0.39-0.95
Major or minor Moderate or severe
UFH Better Bivalirudin Better 1 2 0.25 HAZARD RATIO (95% CI)
HAZARD RATIO (95% CI) P-VALUES
Superiority Interaction
0.98 Radial 0.94 (0.77-1.15) 0.95 (0.76-1.17) 0.62 0.56 MACE Femoral Radial NACE Femoral Radial Death Femoral 0.15 0.87 (0.72-1.05) 0.93 (0.75-1.14) 0.46 0.07 0.66 (0.42-1.03) 0.77 (0.47-1.28) 0.31 0.64 Radial Bleeding Femoral 0.0024 0.50 (0.32-0.79) 0.64 (0.37-1.10) 0.10 0.66 0.51
NACE, driven by a significant reduction of mortality and bleeding with no difference for myocardial infarction or stent thrombosis. This effect was independent from the anticoagulant used during PCI but expertise in TRI was a treatment modifier.