FDA Approves DES With Bioabsorbable Polymer (Synergy)

October 05, 2015

MARLBOROUGH, MA — American interventional cardiologists will soon have access to a very different type of drug-eluting stent (DES) now that the US Food and Drug Administration has approved an everolimus-eluting stent with a bioabsorbable-polymer (Synergy, Boston Scientific)[1].

Unlike traditional DES with a polymer that remains, Synergy's bioabsorbable polymer breaks down and is fully absorbed after the drug is released. Unlike other stents with bioabsorbable polymers, which in general are fully absorbed within 8 to 9 months, the Synergy polymer is fully absorbed after 3 months, leaving leaving behind a bare platinum-chromium stent.

Synergy is the first and only commercially available DES with a bioabsorbable polymer in the US. The stent received CE Mark approval in Europe in 2012.

The Synergy approval is based on data from the EVOLVE II study, a trial presented at the American Heart Association 2014 Scientific Sessions. As reported by heartwire from Medscape, the EVOLVE II investigators compared the Synergy stent against a durable-polymer everolimus-eluting stent (Promus Element Plus, Boston Scientific) in 1684 patients.

At 1 year, the rate of target lesion failure (TLF), a composite end point that included cardiac death, MI, or ischemia-driven revascularization, occurred in 6.5% of the Promus-treated patients and 6.7% of the Synergy patients, a nonsignificant difference (EVOLVE II was designed as a noninferiority trial).

Importantly, there was no difference in revascularization or stent-thrombosis rates at 12 months. With Promus, there were two definite/three probable cases of stent thrombosis, while there were two definite/one probable cases of stent thrombosis with Synergy. Long-term data from the EVOLVE study also showed very low rates of stent thrombosis and target lesion revascularization, according to Boston Scientific.

Speaking with the media at the AHA, Dr Dean Kereiakes (Christ Heart and Vascular Center, Cincinnati, OH) said the Synergy stent differs from other DES with bioabsorbable polymers in that the stent struts are thinner and that absorption of the polymer is much more rapid.

The rationale for the absorbable or bioresorbable polymer is that long-term exposure to the stent polymer can cause inflammation, which delays healing and has been linked with complications, including stent thrombosis. In eliminating the polymer, which modulates drug release, the hope is that stents with absorbable polymers will promote speedier healing and reduce the risk of vascular complications.

Boston Scientific said it is continuing to study the Synergy stent, including in the Synergy Dual Antiplatelet Therapy (DAPT) study, a prospective study testing the safety of 3-month DAPT in patients who receive the stent.

Kereiakes reports honoraria for consulting with Boston Scientific, Abbott Vascular, and Reva Medical, Harvard Clinical Research Institute, and Ablative Solutions.


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