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Endeavor Sprint Zotarolimus-Eluting Coronary Stent System
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News from EuroPCR 2009

5-Year ENDEAVOR II—Endeavor continues to demonstrate excellent long-term efficacy.⁴

• 7.5% TLR at 5 years.
• Only 0.3% increase in TLR between years 3 and 5.

5-Year ENDEAVOR pooled safety—Endeavor maintains a unique safety profile.⁵

• 5-year ENDEAVOR pooled safety analysis: Endeavor shows a very low rate of ARC definite/probable ST (Endeavor = 0.8%, BMS = 1.7%, p = 0.069), despite having only 39% of patients on DAPT at 1 year.
• Significant reduction in CD/MI vs. BMS (Endeavor 5.6% vs. BMS 8.4%, p = 0.012).

Additional evidence supporting Endeavor's long-term efficacy and safety

• In the ZEST study*, at 1 year, Endeavor DES is superior to Taxus and non-inferior to Cypher 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)
• E-Five Registry¹ 2-year follow-up in over 2000 real-world patients†, 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)

Durable efficacy

• Excellent 5.1% TLR to 2 years in real-world patients¹
• Similar TLR vs. Taxus® stent at 2 years (5.9% vs. 4.6%, p=0.295)²
• Only 0.3% increase in TLR between years 3 & 5 in ENDEAVOR II³

Reassuring long-term safety

• Significantly lower cardiac death/MI vs. BMS at 5 years (Endeavor 5.6% vs. BMS 8.4%, p = 0.012)4 ⁴
• Numerically lower ST than BMS at 5 years (Endeavor = 0.8%, BMS = 1.7%, p = 0.069)⁵
• Sixfold lower ARC definite/probable VLST from 1 to 2 years vs. Taxus (1 vs. 6 events, p=0.059)^{2, 9}
• Significant 50% reduction in all MI vs. Taxus at 2 years²
• ST rate 0.7% at 2 years; only 0.1% VLST from 1-2 years^{4, 5}
• Rapid, complete and functional healing.^{6, 7}

Excellent deliverability and short-term safety

• Low periprocedural NQWMI and proven Driver® stent platform.⁸

Consistent results across comprehensive and robust clinical program

• TLR rates and safety outcomes among real-world patients consistent with Endeavor pooled analysis¹⁰
• Similar efficacy across multiple randomized clinical trials
• More than 10.000 Endeavor patients in trial program^4,5
• 674 Endeavor patients studied to 5 years²

Endeavor offers more from a drug-eluting stent -

TLR reduction of a DES...
without compromising long-term safety

 

*Park S, et al., ACC 2009.
¹E-Five Registry n=2116 prespecified subset, ACC 09
²ENDEAVOR IV 2 year
³ENDEAVOR II 5 year
^{4, 5}ENDEAVOR Pooled 5 year: EI (5 year); EII (5 year); EII CA (4 year); EIII (4 year); EIV (2 year); E pk (2 year)
⁶100% of Endeavor struts covered by 6 months in OCT. Guagliumi et al., ESC 2008.
⁷Haraguchi et al. TCT 2006
⁸NQWMI (Non Q-Wave Myocardial Infarction): ENDEAVOR III—0.6%; ENDEAVOR IV—0.5%.
⁹The ENDEAVOR IV Trial was not specifically powered or designed to evaluate VLST.
¹⁰Rothman et al. TCT 2008
Taxus is a registered trademark of Boston Scientific Corporation.