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 randomized clinical trials and real-world registries.

Randomized Trials

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)

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

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

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).

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.

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