
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System
The Endeavor® Sprint Zotarolimus-Eluting Coronary Stent System provides an enhanced delivery system and an excellent safety profile.
Healing First. Results That Last
5-Year ENDEAVOR trial pooled safety – Endeavor® stent maintains a unique safety profile.1
- 5-year ENDEAVOR pooled safety analysis: Endeavor DES showed a very low rate of ARC definite/probable ST (Endeavor = 0.8%, BMS = 1.7%, p = 0.051), despite having only 39% of patients on DAPT at 1 year
- Significant reduction in CD/MI vs. BMS (Endeavor 5.2% vs. BMS 8.4%, p = 0.003)
Additional Evidence Supporting Endeavor's Long-term Efficacy and Safety
- In ENDEAVOR IV, Endeavor DES showed significant difference in clinical performance vs. Taxus® DES with a 23% significant relative risk reduction in target vessel failure (p=0.049)
- In the ZEST study2, at 1 year, Endeavor DES was superior to Taxus DES and non-inferior to Cypher® DES in the composite primary endpoint of Death, MI and ischemia-driven TVR (Endeavor 10.1% and Taxus 14.2% p=0.003, Endeavor 10.1% and Cypher 8.3% p=0.25)
Durable Efficacy
- In ENDEAVOR IV 82% increase in TLR with Taxus DES vs. 44% increase with Endeavor DES from years 1–3 drove similar TLR rate at 3 years3 (p = 0.747)
- Only 0.3% increase in TLR between years 3 and 5 in ENDEAVOR II4
Reassuring Long-term Safety
- E-Five Registry5 2-year follow-up in over 2000 real-world patients5, 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)
- Significantly lower cardiac death/MI vs. BMS at 5 years (Endeavor 5.2% vs. BMS 8.4%, p = 0.003)1
- Numerically lower ST than BMS at 5 years (Endeavor = 0.8%, BMS = 1.7%, p = 0.051)1
- Statistically significant difference in ARC definite/probable VLST and CD/MI vs. Taxus DES in ENDEAVOR IV (p=0.004)3
- Rapid, complete and functional healing6,7
Excellent Deliverability and Short-term Safety
- Proven Driver® stent platform and low periprocedure/NQWMI3
Consistent Results Across Comprehensive and Robust Clinical Program
- TLR rates and safety outcomes among real-world patients consistent with ENDEAVOR pooled analysis
- Similar efficacy across multiple randomized clinical trials
- More than 10,000 Endeavor DES patients in trial program1
- Over 1200 Endeavor DES patients studied to 5 years1
References
- ENDEAVOR Pooled 5 year: EI (5 year); EII (5 year); EII CA (5 year); EIII (5 year); EIV (3 year); E pk (3 year)
- Park S, et al., ACC 2009.
- ENDEAVOR IV 3 year. p-Values for outcome differences are unadjusted for multiple comparisons.
- ENDEAVOR II 5 year Kandzari, PCR 2009
- E-Five Registry n=2116 prespecified subset, ACC 09
- 100% of Endeavor struts covered by 6 months in OCT. Guagliumi et al., ESC 2008.
- Haraguchi et al. TCT 2006
ENDEAVOR IV was not specifically designed or powered to individually compare VLST, CD/MI, or TLR
Enhanced Delivery System
Less force required to track in tortuosity.*
More Deliverable
- Shorter 3-mm tip length
- Low-profile system
- More flexible material
Greater Flexibility
- Softer Fulcrum balloon material
Enhanced Proximal Shaft With Increased Lubricity and Pushability
- Surface coating increases lubricity
- Stiffening wire improves transitioning of force
* Test conducted by measuring force required to track in a 3-dimensional tortuous model. Medtronic testing conducted with identical-sized Endeavor and Endeavor Sprint stent systems.
Last updated: 26 Feb 2013