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One-Year EVOLVE Trial Clinical Results Confirm Comparable Safety And Effectiveness Data Of The Boston Scientific SYNERGY™ Stent Versus PROMUS Element™ Platinum Chromium Stent
Date:5/15/2012

s of revascularization and no cardiac-related deaths or stent thrombosis with SYNERGY at one year," said Dr. Verheye.  "The EVOLVE data demonstrate the effectiveness of drug elution from an ultra-thin, abluminal bioabsorbable polymer with this innovative coronary stent platform."

At one year, TLF in both study arms was not statistically different from the PROMUS Element Stent (4.4 percent, 4.2 percent and 5.1 percent for the full-dose SYNERGY Stent, half-dose SYNERGY Stent and PROMUS Element Stent, respectively; p=1.00 for superiority comparison of each SYNERGY Stent version with the PROMUS Element Stent).  TLF is defined as target-vessel-related cardiac death, target-vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR).  Clinical follow-up at one year demonstrated no cardiac related deaths, Q-wave MI, or stent thrombosis for any of the stent groups.  Periprocedural non-Q-wave MIs had previously been observed in one patient in the full-dose SYNERGY arm and three patients in the half-dose SYNERGY arm; an additional two non-Q-wave MIs occurred between 6 and 12 months in the full-dose SYNERGY arm; however, these were not considered related to the stent. Non-Q-wave MI rates were not significantly different between groups at any time point up to and including one year (3.3 percent for full-dose SYNERGY [p=0.11], 3.2 percent for half-dose SYNERGY [p=0.12], each compared to 0.0 percent for PROMUS Element).  TLR was 1.1 percent for both SYNERGY doses versus 5.1 percent for PROMUS Element (p=0.21).  Additionally, target vessel revascularization (TVR) was noted to be numerically lower with the SYNERGY Stent, but the difference was not statistically significant (3.3 percent for full-dose SYNERGY [p=0.09] and 4.2 percent for half-dose SYNERGY [p=0.17] each compared to 9.2 percent for PROMUS Element).  

"The SYNERGY Stent is a next-generation everolimus-eluting stent that combines the
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SOURCE Boston Scientific Corporation
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