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First Synergy Stents Implanted in EVOLVE II Trial
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The first procedures to implant the novel Synergy bioabsorbable polymer drug-eluting stent as part of the EVOLVE II trial were recently performed at The Christ Hospital in Cincinnati. The procedures were performed by Thomas Broderick, MD, and Joseph Choo, MD, interventional cardiologists at the hospital.
In the EVOLVE II trial, investigators aim to assess the safety and effectiveness of the Synergy stent system (Boston Scientific) and support FDA and Japanese regulatory approvals of the device for the treatment of atherosclerotic coronary lesions. The trial is expected to enroll approximately 2,000 patients at up to 160 sites worldwide, including the United States, Canada, Europe, Australia, New Zealand, Japan, India, Brazil and Singapore. Patients enrolled in the EVOLVE II trial may have up to three lesions in two different vessels and will be randomly assigned to receive either the Promus Element Plus everolimus-eluting platinum chromium coronary stent (Boston Scientific) or the Synergy stent and will then be followed for 5 years.
The Synergy stent uses the same concentration of everolimus drug as utilized in the Promus Element and Xience (Abbott Vascular)/Promus stents but features an ultra-thin bioabsorbable abluminal polymer coating that is absorbed shortly after drug elution ends at 3 months.
The EVOLVE II clinical trial builds upon the EVOLVE trial, which was a prospective, randomized, single blind, first human use study that compared the Synergy stent to the Promus Element stent. Clinical (30 days and 1 year) and angiographic (6 months) outcomes with the Synergy stent in EVOLVE were comparable to those observed with the Promus Element stent.
The Synergy stent system received CE mark approval in October and is an investigational device in non-CE mark countries.
Perspective
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Dean J. Kereiakes, MD
The iterative improvements with the Synergy stent compared with the Promus Element are that it has thinner struts with less metal, a two-connector design and even more flexibility/conformability to improve not only acute performance (ie, deliverability and trackability), but also late performance (ie, less stent fracture and geometric distortion of the vessel by the stent), which is expressed as ischemia-driven target lesion revascularization. For example, the degree of baseline (pre-stent) target vessel tortuosity and the magnitude of distortion that occurs following stent placement have both been associated with late drug-eluting stent restenosis. The optimal stent platform is the one that conforms with the normal anatomy and Synergy is a step forward in that direction.
In addition to enhanced flexibility, Synergy's 4-micron thick abluminal PLGA polymer provides the smallest polymer load of any bioabsorbable polymer DES and is absorbed within about 3 months, which facilitates vessel healing.
Ultimately, the Synergy stent will likely become the leading metal platform DES. The next major step beyond Synergy may be to eliminate the metal skeleton completely with an entirely bioabsorbable stent.
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