Clinical Data

Comprehensive and Robust Clinical Program
  • More than 10,000 Endeavor patients in clinical trial program.
  • More than 2,000 Endeavor patients studied to 5 years.
  • Similar clinical performance across multiple randomised clinical trials and real-world registries.

Endeavor DES is the Only DES to Show Statistically Significant Reductions in Event Rates vs. Cypher AND Taxus DES

Primary endpoint: In-segment late lumen loss by QCA at 8 months, 0.36 for Endeavor vs. 0.13 for Cypher (p<0.001)

E III at 5 Years

p-values for outcome differences are unadjusted for multiple comparisons.
CD/MI and MI p-values were calculated by logrank test.
MACE p-value was calculated by Fisher Exact test.
ENDEAVOR III was not specifically designed or powered to individually compare MACE, MI or CD/MI.

 

Clinical Performance at 4 Years: ENDEAVOR IV Endpoints

p-Values for outcome differences are unadjusted for multiple comparisons.
p-Values were calculated by Fisher's exact test.
ENDEAVOR IV was not specifically designed or powered to individually compare TLR, MI, CD/MI or VLST.

 

ENDEAVOR IV

TVF at 4 Years

p-Values were calculated by logrank test. p-Values for outcome differences are unadjusted for multiple comparisons.
ENDEAVOR IV primary endpoint: noninferiority of Endeavor DES to Taxus DES at 9 months (target vessel failure).
RRR = relative risk reduction.

 

31% Observed Reduction in Cardiac Death/MI

p-Values were calculated by logrank test. p-Values for outcome differences are unadjusted for multiple comparisons.
ENDEAVOR IV was not specifically designed or powered to individually compare CD/MI.
RRR = relative risk reduction.

 

74% Significant Risk Reduction in Very Late Stent Thrombosis (VLST)

p-Values were calculated by logrank test. p-Values for outcome differences are unadjusted for multiple comparisons.
ENDEAVOR IV was not specifically designed or powered to individually compare VLST.
RRR = relative risk reduction.

 

Evidence of Late TLR Catch-up with Taxus DES Leads to Similar TLR Rates at 4 Years: 64% TLR increase with Endeavor vs 112% increase with Taxus DES

p-Value was calculated by logrank test. p-Values for outcome differences are unadjusted for multiple comparisons.
ENDEAVOR IV was not specifically designed or powered to individually compare TLR.

 

ENDEAVOR III

MACE 1-5 Years

ENDEAVOR III primary endpoint: In-segment late lumen loss by QCA at 8 mo was 0.36 for Endeavor vs. 0.13 for Cypher (p = <0.001).
p-Value was calculated by Fisher Exact test. p-Values for outcome differences are unadjusted for multiple comparisons.
ENDEAVOR III was not specifically designed or powered to individually compare MACE. MACE is composed of death, MI, emergent CABG and TLR. RRR = relative risk reduction.

 

Cumulative Incidence of CD/MI Out to 5 Years

p-Values are unadjusted for multiple comparisons. p-Values were calculated by logrank test.
ENDEAVOR III was not specifically designed or powered to individually compare CD/MI. RRR = relative risk reduction.

 

TLR to 5 Years

p-Values are unadjusted for multiple comparisons.
p-Values were calculated by logrank test.
ENDEAVOR III was not specifically designed or powered to individually compare TLR.
ENDEAVOR III primary endpoint: In-segment late lumen loss by QCA at 8 months. 0.36 for Endeavor vs 0.13 for Cypher (p<0.001).

DES Pivotal Trial

Pivotal Trials TLR: DES Arms



  ENDEAVOR II
n = 598
SIRIUS
n = 533
TAXUS IV
n = 622
RVD (mm) 2.73 2.78 2.75
Lesion length (mm) 14.0 14.4 13.4
Stent-to-lesion length ratio 1.84 1.40 1.58
B2/C lesions (%) 78.5 58.6 50.8
Diabetes mellitus (%) 18.2 25.0 24.4
LAD (%) 43 44 40
Recommended Plavix/Ticlid LOT (month) 3 3 6
Inclusion 2.25 vessels yes no no

Data come from different clinical trials and could differ in a head-to-head comparison.
R2 values are calculated by Medtronic, Inc.
SIRIUS 6-year TLR = 11.9% (presented at CRT, March 2009).
SIRIUS, Holmes et al., Circulation, 2004.
TAXUS IV, Stone et al., Circulation, 2004.
ENDEAVOR II: international enrollment; TAXUS IV and SIRIUS: US enrollment.

 

Pooled DES Data

Results come from separate clinical trials. Data may differ in a head-to-head comparison.
Xience V: No Pooled Data Available Beyond 2 Years
Stent thrombosis is a low-frequency event that current drug-eluting stent (DES) clinical trials are not adequately powered to fully characterize.
The true rate of VLST is unknown, however pooled data exist from the various DES programs that are shown here.
1Popma et al. PCR 2009.
25 year Outcomes in the Sirius Trial, Weisz et al. JACC Vol. 53, No. 17, 2009
3Mauri L et al. N Engl J Med. 2007;356:1020-1029.
4Lanksy, A. et al., Pooled Analysis of Three-Year Clinical Outcomes from the SPIRIT II and III Trials, CRT 2010.



DES Pooled Programs
Baseline Characteristics and Demographics

  Endeavor DES1
E I, E II, E II CA, E III, E IV
(n = 2132)
CYPHER DES2
RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS
(n = 878)
TAXUS DES2
TAXUS I, II, IV, V
(n = 1400)
Xience V™ DES /Promus™3 DES
SPIRIT II, SPIRIT III
(n = 892)
Age (years) 62 62 62 63
Male sex (%) 74 72 72 70
Diabetes (%) 23 22 25 27
Hypertension (%) 69 64 72 73
Hyperlipidemia (%) 81 71 70 71
LAD (%) 44 47 40 41
RVD (mm) 2.73 2.72 2.70 2.75
Lesion length (mm) 14.6 13.8 14.6 14.3
DAPT (months) 31 3 6 6

1Meredith et al., EuroPCR 2008. Note: DAPT therapy ≥6 mo in E IV.
2Mauri L et al., N Engl J Med, 356:1020-1029, 2007. Note: TAXUS V was a postmarket trial.
3Serruys PW et al., ACC.08.Stone GW et al., EuroPCR 2008. Note: SPIRIT II and SPIRIT III included single/dual de novo lesions.
Xience V/Promus data is a weighted average from SPIRIT II and SPIRIT III.
Data come from different trials and may differ in a head-to-head comparison.
Stent thrombosis is a low-frequency event that current drug-eluting stent (DES) clinical trials are not adequately powered to fully characterize.
The true rate of VLST is unknown, however pooled data exist from the various DES programs that are shown here.

 

ENDEAVOR Pooled vs. Driver BMS: ARC Definite/Probable ST at 5 Years

Pooled data used for analysis: E I 5-yr, E II 5-yr, E II CA 5-yr, E III 5-yr, E IV 5-yr, E pK 5-yr.
Driver data came from ENDEAVOR II.
Values were calculated by logrank test. p-Values for outcome differences are unadjusted for multiple comparisons.
0.3% ARC definite/probable VLST in more than 1000 patients to 5 years.

 

E-Five and ARRIVE Registries

ARC Definite/Probable ST

ARRIVE 1: Taxus IFU 2008.
Data come from different trials and could differ in a head-to-head comparison.
1E-Five Registry n=2116 prespecified subset ACC 09.



  E-Five
n =21161
ARRIVE I
n = 2487
Age (years) 62.1 ±11.0 63.7 ±11.5
Gender (males %) 77 68
History of diabetes mellitus (%) 30.1 30.4
Previous MI (%) 35.3 36.8
Previous PCI (%) 24.1 36.1
Lesion type (%)
  A 6.0 13.4
  B1 30.9 34.5
  B2 37.2 31.3
  C 25.9 20.8
LAD (%) 49.2 35.6

E-Five 12-month data: Rothman et al., EuroPCR 2008.
A head to head post market trial comparing Endeavor and Taxus in a "real world" population has not been performed, the true clinical differences between the two are unknown.
ARRIVE I: Taxus IFU 2008
1Prespecified subset.

TLR Across Subgroups at 12 and 24 Months

ARRIVE 1: Taxus IFU 2008.
Data come from different trials and could differ in a head-to-head comparison.
1E-Five Registry n=2116 prespecified subset ACC 09.

TLR Across Subgroups at 12 Months

E-Five was not specifically powered or designed to evaluate these subsets.
Pooled ARRIVE I and II: Taxus IFU, 2008.

Clinical Data Overview

RESOLUTE All Comers
24 Month Results Summary

 
 

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