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Boston Scientific SYNERGY™ Stent Demonstrates Comparable Safety and Effectiveness Outcomes Versus PROMUS Element™ Platinum Chromium Stent
Date:11/11/2011

tion and revascularization and no reported cardiac deaths or stent thrombosis.  The SYNERGY Stent is designed to address potential limitations with durable polymer coatings used on currently available drug-eluting stents, which may be associated with chronic inflammation and impaired healing.  The impressive clinical and angiographic results from EVOLVE bode well for this innovative new coronary stent technology."

The primary angiographic endpoint of independently adjudicated mean late loss at six months was 0.10 mm for the SYNERGY Stent and 0.13 mm for the half-dose SYNERGY Stent, compared with 0.15 mm for the PROMUS Element Stent (p<0.001 for the non-inferiority comparison for both SYNERGY doses versus PROMUS Element).  Additional six-month angiographic outcomes for diameter stenosis and binary restenosis showed no statistical differences between the SYNERGY and PROMUS Element Stents.

The trial met the primary clinical endpoint of target lesion failure (TLF) at 30 days, defined as target-vessel-related cardiac death, target-vessel-related myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR).  At 30 days, TLF in both SYNERGY Stent arms was not statistically different from the PROMUS Element Stent (1.1 percent for the SYNERGY Stent versus 0.0 percent for the PROMUS Element Stent, p=0.49 for superiority comparison, and 3.1 percent for the half-dose SYNERGY Stent, p=0.12 for superiority comparison with the PROMUS Element Stent).  TLF continued to show no significant differences among the three stent groups out to six months with rates of 2.2 percent for the SYNERGY Stent versus 3.1 percent for the PROMUS Element Stent (p=1.00) and 4.1 percent for the half-dose SYNERGY Stent (p=0.72 versus the PROMUS Element Stent).  Clinical follow-up at six months demonstrated no events for cardiac death, Q-wave MI and stent thrombosis.  MI was 1.1 percent for the SYNERGY Stent, 0.0 percent for the PRO
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