First-in-Man Sesame Stent Trial Results Published

November 16, 2010—The Society for Cardiovascular Angiography and Interventions (SCAI) announced the publication of results from the first-in-man trial of the Sesame self-expanding, super-elastic, all-metal endoprosthesis stent (Palmaz Scientific/Advanced BioProsthetic Surfaces, Ltd., San Antonio, TX) that was used in patients undergoing angioplasty of degenerated saphenous vein graft (SVG) lesions. Alexandre Abizaid, MD, et al published the findings in Catheterization and Cardiovascular Interventions (2010;76:781–786). The device demonstrated a 100% acute success rate, a low 30-day major adverse cardiac events (MACE) rate, and a 9-month patency rate that is comparable to balloon-expandable stents without embolic protection, concluded the investigators.

As detailed by the investigators, 20 patients with a total of 21 lesions were prospectively enrolled at two centers outside of the United States between February 2005 and August 2005. Patients underwent elective intervention of symptomatic SVG lesions with ≥ 50% stenosis. PCI was performed without embolic protection devices. All 21 SVG lesions were treated with Sesame stents.

The primary endpoint was technical and procedural success. Secondary endpoints included MACE at 30 days and 9 months.

The investigators reported that the acute success rate was 100%. No procedural or in-hospital complications occurred. One patient underwent a planned PCI at 28 days in a separate SVG. Follow-up was present in 20 patients at 30 days, with clinical (n = 19) and angiographic evaluation (18 patients/19 lesions) at 9 months. No MACE events occurred at 30 days.

At 9 months, three patients underwent repeat PCI. There was one target lesion revascularization and two nonindex lesion target vessel revascularizations for a MACE rate of 14% at 9 months.

According to SCAI, the nanosynthesized Sesame stent system limits plaque protrusion through the stent struts, as well as stent strut migration into the underlying plaque. The microporous mesh of the Sesame stent allows improved vascular healing and endothelialization compared to polymer-covered devices. Biocompatibility studies indicate that metals are advantageous over polymers, suggesting that a metal membrane would be a good choice for a covered stent.

“The SESAME trial is the first study to prospectively demonstrate that a self-expanding, microporous, membrane-covered stent can be safely used with a high success rate in treating complex SVG lesions, even in the absence of embolic protection devices,” commented study leader Steven R. Bailey, MD. “Even in severely degenerate SVG lesions, interventionists can safely achieve a high primary success rate with low MACE during the initial 30 days following the procedure.”