Results of the SESAME trial, which evaluated the self-expanding super-elastic all-metal endoprosthesis stent (Sesame stent, Palmaz Scientific) in patients undergoing PCI of degenerated saphenous vein graft (SVG) lesions, proved to have 100 percent acute success, low 30-day major adverse cardiac events (MACE) rates and nine-month patency compared with balloon expandable stents without embolic protection, according to a study published in the November issue of Catheterization and Cardiovascular Intervention.
Alexander Abizaid, MD, PHD, of the Instituto Sao Paolo in Sao Paolo, Brazil, and colleagues enrolled 20 patients with 21 lesions at two sites between February 2005 and August 2005 who underwent elective PCI of the SVG lesions with a stenosis of 50 percent or greater with a Sesame stent.
During the trial, the researchers performed PCI without embolic protection, and used technical and procedural success as the trial’s primary endpoint. In addition, the researchers evaluated MACE rates at 30 days and nine months.
The results showed that acute success was 100 percent and no complications—either procedural or in-hospital—occurred.
No MACE occurred during the study and three patients underwent repeat PCI at nine months. One case of target lesions revascularization and two non-index lesion target vessel revascularizations occurred for a MACE rate of 14 percent at nine months post-procedure.
“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,” said the lead author Steven R. Bailey, MD, from the University of Texas Health Sciences Center in San Antonio. “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.”