Clinical Outcomes
The Endeavor® Sprint Zotarolimus-Eluting Coronary Stent System has proven performance in a comprehensive and robust clinical program:
- More than 10,000 Endeavor DES patients in clinical trial program
- Over 1200 Endeavor DES patients studied to 5 years
- Similar clinical performance across multiple randomized clinical trials and real-world registries
Randomized Trials
ENDEAVOR IV
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.
* ENDEAVOR IV was not specifically designed or powered to individually compare CD/MI.
ENDEAVOR IV primary endpoint: Noninferiority of Endeavor DES to Taxus DES at 9 months (target vessel failure).
p-Values were calculated by logrank test. p-Values for outcome differences are unadjusted for multiple comparisons.
RRR = relative risk reduction.
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.
p-Value was calculated by Fisher’s exact 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
Endeavor DES Displayed Low and Sustained TLR Rates to 5 Years
ENDEAVOR III primary endpoint: In-segment late lumen loss by QCA at 8 months. 0.36 for Endeavor DES vs. 0.13 for Cypher DES (p<0.001).
| Endeavor | 323 | 323 | 280 | 272 | 263 | 257 |
| CI (%) | 0.0 | 6.6 | 6.9 | 7.3 | 7.7 | 8.0 |
| Cypher | 113 | 113 | 107 | 101 | 97 | 91 |
| CI (%) | 0.0 | 3.5 | 4.5 | 4.5 | 6.5 | 6.5 |
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 Pooled Analysis
ENDEAVOR Pooled 5 year: EI (5 year); EII (5 year); EII CA (5 year); EIII (5 year); EIV (3 year); E pk (3 year).
p-values are unadjusted for multiple comparisons. Pooled Kaplan-Meier analysis.
| Days | 0 | 360 | 720 | 1080 | 1440 | 1800 |
|---|---|---|---|---|---|---|
| Endeavor Events n (%) | 2132 30 (1.4) | 2102 60 (2.8) | 2009 72 (3.4) | 1951 79 (3.8) | 1649 87 (4.4) | 1168 96 (5.2) |
| Driver Events n (%) | 596 15 (2.5) | 581 27 (4.5) | 555 34 (5.8) | 544 39 (6.6) | 529 41 (7.0) | 523 49 (8.4) |
ENDEAVOR Pooled 5 year: EI (5 year); EII (5 year); EII CA (5 year); EIII (5 year); EIV (3 year); E pk (3 year).
p-values are unadjusted for multiple comparisons.
p-value was calculated by log-rank test.