Endeavor Provides Long-Term Reassurance
Healing First. Results that Last.
- In ENDEAVOR III at 5 years, Endeavor DES shows a significant 37% relative risk reduction vs. Cypher DES in MACE (Endeavor DES 14.0% vs. Cypher DES 22.2%, p = 0.0495)10
- Primary endpoint in ENDEAVOR III: In-segment late lumen loss by QCA at 8 months, 0.36 for Endeavor DES vs. 0.13 for Cypher DES (p<0.001)
- In the ZEST study2, at 2 years, Endeavor DES is superior to Taxus DES and non-inferior to Cypher DES in the composite primary endpoint of Death, MI and ischemia-driven TVR (Endeavor 11.3% and Taxus 15.2% p=0.014, Endeavor 11.3% and Cypher 9.9% p=0.43)
- 18% Observed Relative Risk Reduction in TVF at 5 years in ENDEAVOR IV
- Evidence of Late TLR Catch-Up in ENDEAVOR IV with Taxus DES Leads to Similar TLR Rates at 5 Years (Endeavor DES 7.7% vs Taxus DES 8.6%, p=0.70)
- In ENDEAVOR III, 86% increase in TLR with Cypher DES vs. 21% increase with Endeavor DES from years 1–5 drives similar TLR rate at 5 years (Endeavor DES 8.0% vs. Cypher DES 6.5%, p = 0.547)9
- Only 0.3% increase in TLR between years 3 & 5 in ENDEAVOR II3
Reassuring Long-Term Safety
- E-Five Registry4 2-year follow-up in over 2000 real-world patients4, many with complex attributes (11.4% AMI, 30.1% diabetic), showed very low 5.1% TLR and 0.7% ARC Def/Prob. ST to 2 years (0.1% ARC Def./Prob. VLST). These results are consistent with ENDEAVOR Pooled Analysis (Pre-Approval RCT trials)
- Significant Reduction in CD/MI vs. BMS at 5 Years in Pooled Analysis (Endeavor DES 5.7 % vs. BMS 8.4%, p = 0.016)1
- 78% Significant Relative Risk Reduction in Very Late Stent Thrombosis in ENDEAVOR IV at 5 years (Endeavor DES 0.4% vs Taxus DES 1.8%, p=0.012)
- In ENDEAVOR III at 5 years12, Endeavor DES shows 80% relative risk reduction in CD/MI (Endeavor DES 1.3% vs. Cypher DES 6.5%, p = 0.003)9
- Rapid, complete and functional healing.5,6
- Proven Driver stent platform and low periprocedure/NQWMI7
Consistent Results Across Comprehensive and Robust Clinical Program
- TLR rates and safety outcomes among real-world patients consistent with Endeavor pooled analysis8
- Similar efficacy across multiple randomised clinical trials
- More than 1,000 Endeavor patients in trial program1
- More than 2,000 patients studied to 5 years1
1 ENDEAVOR Pooled 5 year: EI (5 year); EII (5 year); EII CA (4 year); EIII (5 year); EIV (5 year); E pk (5 year)
2 Park S, et al., TCT AP 2010.
3 ENDEAVOR II 5 year Kandzari, PCR 2009
4 E-Five Registry n=2116 prespecified subset, ACC 09
5 100% of Endeavor struts covered by 6 months in OCT. Guagliumi et al., ESC 2008.
6 Haraguchi et al. TCT 2006
7 ENDEAVOR IV 5 year. p-Values for outcome differences are unadjusted for multiple comparisons.
8 Rothman et al. TCT 2008
9 p-Value was calculated by Fisher Exact test.
10 p-Value was calculated by logrank test. p-Values are unadjusted for multiple comparisons.
11 ENDEAVOR IV was not specifically designed or powered to individually compare VLST, CD/MI, or TLR
12 ENDEAVOR III was not specifically designed or powered to individually compare CD/MI, MACE, or TLR.
MACE is composed of Death, MI, Emergent CABG, TLR.
ENDEAVOR Pooled Analysis: E I 5-year, E II 5-year, E II CA 5-year, E III 5-year, E IV 3-year, E pK 3-year.
ARC definite/probable stent thrombosis definition used.
p-Values are unadjusted for multiple comparisons.
Clinical Data Overview
RESOLUTE All Comers
24 Month Results Summary