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