Compare Trial2 year follow-up
Peter SmitsMaasstad Ziekenhuis
RotterdamThe Netherlands
Disclosures
I have received a speaking fee from Abbott Vascular
Research Foundation of the Cardiology Department has
received unrestricted research grants from:
• Abbott Vascular
• Boston Scientific
Compare Trial
The COMPARE trial is
a physician initiated
single center
prospective randomized trial
comparing the
Taxus Liberté ™ versus Xience V™ stent
in an all-comer / real world situation
Compare TrialPurpose of the study
To study the outcome of 2e generation drug eluting
stents in a study design that reflects
everyday clinical practice
The study is patient oriented and uses only
symptom driven clinical end-points
Study Outline
Eligible Patients for PCI
Guide-wire passage± Predilatation
Operator blinded1:1 Randomisation
Taxus Liberte Xience V
Study Outline
Inclusion criteria• All patients eligible for PCI• Life expectancy of > 5 years
Exclusion criteria• No dual antiplatelet therapy for 12 months• Cardiogenic shock at presentation• Expected planned major surgery within 1 month• Participation in another trial• No informed consent
Endpoints
Primary endpoint• All death, non fatal MI and Target Vessel
Revascularization (TVR) at 12 months follow-up
Secondary endpoints *• Cardiac death, non fatal MI, ischemic driven TLR
rate annually during 5 years follow-up• All death, non fatal MI, TVR at 2 - 5 year follow-up• Incidence of definite, probable or possible stent
thrombosis annually during 5 years follow-up
* amended from 1,3 and 5 years to annual time points during 5 year follow up
RandomizedRandomized(N=1800)(N=1800)
XIENCE VXIENCE V(N=897)(N=897)
1-Year Follow-up1-Year Follow-up(N=1797; 99.8%)(N=1797; 99.8%)
Lost to f/u = 1 Lost to f/u = 2
2-Year Follow-up2-Year Follow-up(N=1795; 99.7%)(N=1795; 99.7%)
Patient Diagram and Follow-up
Taxus LibertéTaxus Liberté(N=902)(N=902)
Taxus LibertéTaxus Liberté(N=903)(N=903)
Taxus LibertéTaxus Liberté(N=900)(N=900)
XIENCE VXIENCE V(N=895)(N=895)
XIENCE VXIENCE V(N=895)(N=895)
Lost to f/u = 0Lost to f/u = 2
No study stent = 6 No study stent = 4
Clinical events were adjudicated by an independent CEC
Target vessel revascularizations were analysed by an independent QCA core lab.
AMI 25 %AMI 25 %
Calcification 34 %Calcification 34 %
Multistenting 62 %Multistenting 62 %
Ostial 19 %Ostial 19 %
Thrombus 24 %Thrombus 24 % CTO 4 %CTO 4 %
NSTEMI 23 %NSTEMI 23 %
Multivessel 27 %Multivessel 27 %
Saphenous graft 2 %Saphenous graft 2 %
Bifurcation 10 %Bifurcation 10 %
Diabetes 18 % Diabetes 18 %
Chronic renal failure 3 %Chronic renal failure 3 %
Left main 2 Left main 2
% %
Direct stenting 34 %Direct stenting 34 %
COMPARE TRIALCOMPARE TRIAL
““REAL REAL
WORLD”WORLD”
Dual anti platelet therapy
0102030405060708090
100
0 30 180 360 720
days follow-up
perc
en
tag
e
Taxus
Xience
15.2 %
11.4 %*
ns ns
ns
P = 0.02
Primary Endpoint Result @ 2 yr MACE (all death, non-fatal MI and TVR)
# Patients at Risk
Taxus 903 864 852 840 833 822 818 808 800 798 785 781 777
Xience 897 871 866 859 852 844 840 836 832 830 822 818 815
Taxus
Xience
P = 0.0016 (log-rank test)
RR = 0.66 (0.50-0.86)
13.7 %
9.0 %
Δ 4.7 %
Δ 2.9 %
9.1 %
6.2 %
Secondary Endpoint Result @ 2 yr MACE (cardiac death, non-fatal MI and TLR)
# Patients At Risk:
Taxus 903 865 854 844 837 826 822 812 806 804 795 792 788
Xience 897 873 870 863 856 848 845 841 837 835 827 823 820
P = 0.0038 (log-rank test)
RR = 0.65 (0.48-0.88)
11.4 %
7.4 %
Taxus
Xience
Δ 3.3 %
Δ 4.0 %8.2 %
4.9 %
First Stent Thrombosis @ 2 yr (Definite / Probable according to ARC)
3.9 %
0.9 %
Taxus
Xience
P < 0.0001 (log-rank test)
RR = 0.23 (0.11-0.49)
0.7 %
2.6 %
Δ 1.9 %
Δ 3.0 %
Early ST
92 % pts on DAPT
Early, Late and Very Late stent Thrombosis (Definite / Probable according to ARC)
0 15 30Days
p = 0.002
RR 0.13 (0.04-0.58)
0.2 %
1.7 %
p = 0.13
RR 0.38 (0.10-1.42)
Taxus
Xience
0.9 %
60 120 180 240 300 360
0.3 %
360 420 480 540 600 660 72030
1.5 %
0.3 %
p = 0.013
RR 0.23 (0.07-0.81)
Late ST
70 % pts on DAPT
Very Late ST
13 % pts on DAPT
Endpoint Analysis @ 2 yr First Non Fatal MI
Taxus
Xience
7.6 %
3.9 %
P = 0.0009 (log-rank test)
RR = 0.52 (0.35-0.77)
5.4 %
2.8 %
Δ 2.6 %
Δ 3.7 %
Endpoint Analysis @ 2 yr All Death & Cardiac Death
All
Death
Cardiac
Death
Taxus
Xience P = 0.67
P = 0.49
Endpoint Analysis @ 2yr Ischemic driven TVR & TLR
TVR
TLR
Taxus
Xience 7.7 %
3.1 %
P < 0.0001
RR = 0.40 (0.25–0.61)
5.9 %
2.6 %
P = 0.0005
RR = 0.44 (0.27-0.71)
Taxus
Xience
Subgroup analysis @ 2 yr
No Diabetes 60/744 (8%) 99/730 (14%) 0.001 0.59 (0.44-0.81)Diabetes 21/153 (14%) 25/172 (15%) 0.834 0.94 (0.55-1.62)
Woman 25/278 (9%) 42/249 (17%) 0.007 0.53 (0.34-0.85)Men 56/619 (9%) 82/654 (13%) 0.045 0.72 (0.52-1.00)
No ACS 32/356 (9%) 46/369 (12%) 0.131 0.72 (0.47-1.11)ACS 49/541 (9%) 78/534 (15%) 0.005 0.62 (0.44-0.87)
Single Vessel 55/653 (8%) 77/662 (12%) 0.053 0.72 (0.52-1.01)Multivessel 26/242 (11%) 47/239 (20%) 0.006 0.55 (0.35-0.85)
Restenosis 5/30 (17%) 10/28 (36%) 0.098 0.47 (0.18-1.20)De novo 76/867 (9%) 114/875 (13%) 0.004 0.67 (0.51-0.89)
No acute MI 62/657 (9%) 91/687 (13%) 0.028 0.71 (0.53-0.97)Acute MI 19/240 (8%) 33/212 (16%) 0.011 0.51 (0.30-0.87)
No proximal LAD 53/646 (8%) 85/671 (13%) 0.008 0.65 (0.47-0.90)Proximal LAD 24/233 (10%) 37/210 (18%) 0.026 0.58 (0.36-0.94)
Lesion length <20 mm 66/607 (11%) 102/640 (16%) 0.009 0.68 (0.51-0.91)Lesion length ≥ 20 mm 15/290 (5%) 22/263 (8%) 0.133 0.62 (0.33-1.17)
RVD ≥ 2.75 mm 52/438 (12%) 71/462 (15%) 0.127 0.77 (0.55-1.08)RVD <2.75 29/458 (6%) 53/441 (12%) 0.003 0.53 (0.34-0.81)
Overall 81/897 (9%) 124/903 (14%) 0.002 0.66 (0.50-0.86)
Paclitaxelbetter p value for interaction
0.17
0.32
0.60
0.35
0.52
0.31
0.75
0.79
0.19
0.1 1.0 10.0
No Diabetes 60/744 (8%) 99/730 (14%) 0.001 0.59 (0.44-0.81)Diabetes 21/153 (14%) 25/172 (15%) 0.834 0.94 (0.55-1.62)
Woman 25/278 (9%) 42/249 (17%) 0.007 0.53 (0.34-0.85)Men 56/619 (9%) 82/654 (13%) 0.045 0.72 (0.52-1.00)
No ACS 32/356 (9%) 46/369 (12%) 0.131 0.72 (0.47-1.11)ACS 49/541 (9%) 78/534 (15%) 0.005 0.62 (0.44-0.87)
Single Vessel 55/653 (8%) 77/662 (12%) 0.053 0.72 (0.52-1.01)Multivessel 26/242 (11%) 47/239 (20%) 0.006 0.55 (0.35-0.85)
Restenosis 5/30 (17%) 10/28 (36%) 0.098 0.47 (0.18-1.20)De novo 76/867 (9%) 114/875 (13%) 0.004 0.67 (0.51-0.89)
No acute MI 62/657 (9%) 91/687 (13%) 0.028 0.71 (0.53-0.97)Acute MI 19/240 (8%) 33/212 (16%) 0.011 0.51 (0.30-0.87)
No proximal LAD treated 53/646 (8%) 85/671 (13%) 0.008 0.65 (0.47-0.90)Proximal LAD treated 24/233 (10%) 37/210 (18%) 0.026 0.58 (0.36-0.94)
Lesion length <20 mm 66/607 (11%) 102/640 (16%) 0.009 0.68 (0.51-0.91)Lesion length ≥ 20 mm 15/290 (5%) 22/263 (8%) 0.133 0.62 (0.33-1.17)
RVD ≥ 2.75 mm 52/438 (12%) 71/462 (15%) 0.127 0.77 (0.55-1.08)RVD <2.75 29/458 (6%) 53/441 (12%) 0.003 0.53 (0.34-0.81)
Overall 81/897 (9%) 124/903 (14%) 0.002 0.66 (0.50-0.86)
RR ( 95% CI )Everolimus
better
Conclusions• In this all-comer trial, reflecting a real world patient
population, the major secondary endpoints at 2 years showed : – superiority of Xience V versus Taxus Liberté (p = 0.0016)
• MI, TVR, TLR and Stent thrombosis consistently resulted in significant better outcomes for Xience V compared to Taxus Liberté
– Between 1 and 2 years, when the vast majority of patients were no longer taking DAPT, a significant 77% reduction in very late definite or probable stent thrombosis in favour of Xience V was observed
• While there was a significant reduction in primary and secondary endpoints in the general patient population with Xience V, no such difference was observed in diabetic patients at 1 and 2 year FU
Investigators
Elvin Kedhi
Eugene McFadden
Carlos van Mieghem
Kaiyum Sheikjoesoef
Peter Smits (PI)
Jochem Wassing
CEC & Core Lab & Statistics
Cardialysis, Rotterdam
DSMBEric Boersma (chairman)Patrick SerruysBenno Rensing
CECMartijn AkkerhuisJean-Paul HerrmanPeter RadkeEvelyne RegarJeroen VosPascal Vranckx (chairman)
COMPARE TRIAL